Regulatory Open Forum

I'm trying to figure out what to make of Jeff Shuren's statement at last week's FDLI meeting, that CDRH should be allowed to fail.  This was in the context of its efforts to "modernize."

I'm having a hard time seeing how CDRH could fail at much of anything without harm to patients.  And probably to the industry, as well.

I'm also puzzled as to who it is that could give CDRH permission to fail, and what that permission would look like.

Anyone have any insights here?  Maybe I'm missing something.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Hi Julie - I was not at FDLI, though the slides are available online:
https://www.fdli.org/wp-content/uploads/2018/05/Center-for-Devices-and-Radiological-Health.pdf 

As someone who did not attend, it's certainly an interesting comment after reading the NYT opinion piece on medical devices:
Opinion | 80,000 Deaths. 2 Million Injuries. It's Time for a Reckoning on Medical Devices

I would welcome to hear more context from you on when the comment was made, possibly in relation to his presentation?
Many thanks,
Nicole

------------------------------
Nicole Damour
Senior Manager Global Regulatory Affairs CMC
Philadelphia PA
------------------------------

Original Message:
Sent: 06-May-2019 13:05
From: Julie Omohundro
Subject: Should CDRH be allowed to fail?

I'm trying to figure out what to make of Jeff Shuren's statement at last week's FDLI meeting, that CDRH should be allowed to fail.  This was in the context of its efforts to "modernize."

I'm having a hard time seeing how CDRH could fail at much of anything without harm to patients.  And probably to the industry, as well.

I'm also puzzled as to who it is that could give CDRH permission to fail, and what that permission would look like.

Anyone have any insights here?  Maybe I'm missing something.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

As for context, I apologize for the quick post and lack of more detail, but just back from a trip and wanted to get it out there before I got caught up.  Yes, it was part of his presentation and in much the context Andrea describes below. 

I think context is important if you are trying to figure out what Shuren meant.  I think the question is addressable as a standalone.  I'm inclined to want to address it first as a standalone, not biased or narrowed by "what Shuren meant."  Then, once I have all possible interpretations, I might try to figure out which one fits best as intention by Shuren.  So I was putting to the blog as more of a standalone question, and with reference to Shuren's presentation as the original inspiration for the question.  Maybe I should have just left that part out.

PS  I have a very low opinion of, and a deep animosity towards, news outlets and am rarely pleased to see links to their "stories."  In this case, yes, the timing of the two might be "interesting," just like the timing of the KHN article, Gottlieb's resignation, and CDRH's sweeping new program on surgical staplers was "interesting."


------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 07-May-2019 08:16
From: Nicole Damour
Subject: Should CDRH be allowed to fail?

Hi Julie - I was not at FDLI, though the slides are available online:
https://www.fdli.org/wp-content/uploads/2018/05/Center-for-Devices-and-Radiological-Health.pdf

As someone who did not attend, it's certainly an interesting comment after reading the NYT opinion piece on medical devices:
Opinion | 80,000 Deaths. 2 Million Injuries. It's Time for a Reckoning on Medical Devices

I would welcome to hear more context from you on when the comment was made, possibly in relation to his presentation?
Many thanks,
Nicole

------------------------------
Nicole Damour
Senior Manager Global Regulatory Affairs CMC
Philadelphia PA

Original Message:
Sent: 06-May-2019 13:05
From: Julie Omohundro
Subject: Should CDRH be allowed to fail?

I'm trying to figure out what to make of Jeff Shuren's statement at last week's FDLI meeting, that CDRH should be allowed to fail.  This was in the context of its efforts to "modernize."

I'm having a hard time seeing how CDRH could fail at much of anything without harm to patients.  And probably to the industry, as well.

I'm also puzzled as to who it is that could give CDRH permission to fail, and what that permission would look like.

Anyone have any insights here?  Maybe I'm missing something.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Nicole, where did you get these slides?  I couldn't find them on FDLI's conference website and I don't recognize them.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 07-May-2019 08:16
From: Nicole Damour
Subject: Should CDRH be allowed to fail?

Hi Julie - I was not at FDLI, though the slides are available online:
https://www.fdli.org/wp-content/uploads/2018/05/Center-for-Devices-and-Radiological-Health.pdf

As someone who did not attend, it's certainly an interesting comment after reading the NYT opinion piece on medical devices:
Opinion | 80,000 Deaths. 2 Million Injuries. It's Time for a Reckoning on Medical Devices

I would welcome to hear more context from you on when the comment was made, possibly in relation to his presentation?
Many thanks,
Nicole

------------------------------
Nicole Damour
Senior Manager Global Regulatory Affairs CMC
Philadelphia PA

Original Message:
Sent: 06-May-2019 13:05
From: Julie Omohundro
Subject: Should CDRH be allowed to fail?

I'm trying to figure out what to make of Jeff Shuren's statement at last week's FDLI meeting, that CDRH should be allowed to fail.  This was in the context of its efforts to "modernize."

I'm having a hard time seeing how CDRH could fail at much of anything without harm to patients.  And probably to the industry, as well.

I'm also puzzled as to who it is that could give CDRH permission to fail, and what that permission would look like.

Anyone have any insights here?  Maybe I'm missing something.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Oh...I think they are from the 2018 conference?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 09-May-2019 03:03
From: Julie Omohundro
Subject: Should CDRH be allowed to fail?

Nicole, where did you get these slides?  I couldn't find them on FDLI's conference website and I don't recognize them.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 07-May-2019 08:16
From: Nicole Damour
Subject: Should CDRH be allowed to fail?

Hi Julie - I was not at FDLI, though the slides are available online:
https://www.fdli.org/wp-content/uploads/2018/05/Center-for-Devices-and-Radiological-Health.pdf

As someone who did not attend, it's certainly an interesting comment after reading the NYT opinion piece on medical devices:
Opinion | 80,000 Deaths. 2 Million Injuries. It's Time for a Reckoning on Medical Devices

I would welcome to hear more context from you on when the comment was made, possibly in relation to his presentation?
Many thanks,
Nicole

------------------------------
Nicole Damour
Senior Manager Global Regulatory Affairs CMC
Philadelphia PA

Original Message:
Sent: 06-May-2019 13:05
From: Julie Omohundro
Subject: Should CDRH be allowed to fail?

I'm trying to figure out what to make of Jeff Shuren's statement at last week's FDLI meeting, that CDRH should be allowed to fail.  This was in the context of its efforts to "modernize."

I'm having a hard time seeing how CDRH could fail at much of anything without harm to patients.  And probably to the industry, as well.

I'm also puzzled as to who it is that could give CDRH permission to fail, and what that permission would look like.

Anyone have any insights here?  Maybe I'm missing something.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Hi Julie:
I wasn't at the conference so I'm only responding based on the information that is available in your post; however, yes CDRH should be allowed to fail and that doesn't mean increased patient risk - or as you mentioned industry risk.

CDRH and FDA work diligently to put new programs in place that benefit the public health and access to new technologies, but just like everyone else, CDRH is made up of people - people just like you and me. If we "industry" or "the American People" expect them to be unfailing, then we can also expect change in regulation, policies, guidances, etc to come to a screeching halt. Who will try to be innovative when there is no room to fail?

When CDRH puts a new program into place it doesn't mean that they are being reckless regarding the level of scientific information required to determine safety and efficacy. Modernization is going to mean stepping into the unknown from a regulatory structure and review standpoint, but it doesn't mean stripping out the intelligence and experience of the reviewers on the files. They are the front line in knowing what questions need to be asked no matter what the program. 

It is in telling the Agency that they cannot fail that we fail the American Public, stifle innovation, and get left behind globally.

------------------------------
Andrea Artman
Frederick MD
United States
------------------------------

Original Message:
Sent: 06-May-2019 13:05
From: Julie Omohundro
Subject: Should CDRH be allowed to fail?

I'm trying to figure out what to make of Jeff Shuren's statement at last week's FDLI meeting, that CDRH should be allowed to fail.  This was in the context of its efforts to "modernize."

I'm having a hard time seeing how CDRH could fail at much of anything without harm to patients.  And probably to the industry, as well.

I'm also puzzled as to who it is that could give CDRH permission to fail, and what that permission would look like.

Anyone have any insights here?  Maybe I'm missing something.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Andrea, thanks for your comments.  You have done a nice job of articulating my worst interpretation of "what Shuren meant."  (And I mean that, nice job, not as a backhanded compliment.  I don't have to like it to appreciate it.)

When anyone talks about stifling innovation in this industry, I always react with this quote by Irish author Flannery O'Connor:

Everywhere I go, I'm asked if I think universities stifle too many aspiring young writers.  My answer is, I think they don't stifle enough of them.

When it comes to FDA and the medical device industry, I'm strongly pro-stifling and even more strongly anti- what passes for "innovation" in this industry.  I'm fine with being left behind globally.  More than that, I'm sick of our obsession with being first, and also very tired of being first, which is a different matter.

As a point of clarification, the quote was not about whether the agency can fail, or whether it can be expected to fail, but whether it should be "allowed" to fail, which is a very different question.  The former question is not worth asking, IMO, since obviously anyone and anything can fail, so answered before it is asked.  Whether or not one expects failure is a question that can only be answered meaningfully on an individual basis, I think.


------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 07-May-2019 08:25
From: Andrea Artman
Subject: Should CDRH be allowed to fail?

Hi Julie:
I wasn't at the conference so I'm only responding based on the information that is available in your post; however, yes CDRH should be allowed to fail and that doesn't mean increased patient risk - or as you mentioned industry risk.

CDRH and FDA work diligently to put new programs in place that benefit the public health and access to new technologies, but just like everyone else, CDRH is made up of people - people just like you and me. If we "industry" or "the American People" expect them to be unfailing, then we can also expect change in regulation, policies, guidances, etc to come to a screeching halt. Who will try to be innovative when there is no room to fail?

When CDRH puts a new program into place it doesn't mean that they are being reckless regarding the level of scientific information required to determine safety and efficacy. Modernization is going to mean stepping into the unknown from a regulatory structure and review standpoint, but it doesn't mean stripping out the intelligence and experience of the reviewers on the files. They are the front line in knowing what questions need to be asked no matter what the program.

It is in telling the Agency that they cannot fail that we fail the American Public, stifle innovation, and get left behind globally.

------------------------------
Andrea Artman
Frederick MD
United States

Original Message:
Sent: 06-May-2019 13:05
From: Julie Omohundro
Subject: Should CDRH be allowed to fail?

I'm trying to figure out what to make of Jeff Shuren's statement at last week's FDLI meeting, that CDRH should be allowed to fail.  This was in the context of its efforts to "modernize."

I'm having a hard time seeing how CDRH could fail at much of anything without harm to patients.  And probably to the industry, as well.

I'm also puzzled as to who it is that could give CDRH permission to fail, and what that permission would look like.

Anyone have any insights here?  Maybe I'm missing something.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Julie -

Thank you - However, based on your follow-up, I think you are misinterpreting my definition of innovation.  Your question was around the modernization of the FDA review process, not innovative medical devices to market.  In this discussion, I am referring to the innovation of new processes and streamlined procedures that allow the FDA and more specifically CDRH to review scientifically sound data in a different way.

In developing innovative and streamlined PROCESSES, FDA can better protect the public health and allow access of medical devices to the US public upon demonstrating safety and efficacy.  I am not a firm believer in speed to market.  I am a firm believer in solid science that makes sense and provides the appropriate level of data. 

It is in trying new programs that CDRH should be allowed to fail - not in protecting the health and welfare of its citizens.  America doesn't need to be first - we need to be smart about how we get there.

------------------------------
Andrea Pilon Artman
President & Principal Consultant
SpectRA Compliance, LLC
Frederick, MD
USA
------------------------------

Original Message:
Sent: 07-May-2019 09:04
From: Julie Omohundro
Subject: Should CDRH be allowed to fail?

Andrea, thanks for your comments.  You have done a nice job of articulating my worst interpretation of "what Shuren meant."  (And I mean that, nice job, not as a backhanded compliment.  I don't have to like it to appreciate it.)

When anyone talks about stifling innovation in this industry, I always react with this quote by Irish author Flannery O'Connor:

Everywhere I go, I'm asked if I think universities stifle too many aspiring young writers.  My answer is, I think they don't stifle enough of them.

When it comes to FDA and the medical device industry, I'm strongly pro-stifling and even more strongly anti- what passes for "innovation" in this industry.  I'm fine with being left behind globally.  More than that, I'm sick of our obsession with being first, and also very tired of being first, which is a different matter.

As a point of clarification, the quote was not about whether the agency can fail, or whether it can be expected to fail, but whether it should be "allowed" to fail, which is a very different question.  The former question is not worth asking, IMO, since obviously anyone and anything can fail, so answered before it is asked.  Whether or not one expects failure is a question that can only be answered meaningfully on an individual basis, I think.


------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 07-May-2019 08:25
From: Andrea Artman
Subject: Should CDRH be allowed to fail?

Hi Julie:
I wasn't at the conference so I'm only responding based on the information that is available in your post; however, yes CDRH should be allowed to fail and that doesn't mean increased patient risk - or as you mentioned industry risk.

CDRH and FDA work diligently to put new programs in place that benefit the public health and access to new technologies, but just like everyone else, CDRH is made up of people - people just like you and me. If we "industry" or "the American People" expect them to be unfailing, then we can also expect change in regulation, policies, guidances, etc to come to a screeching halt. Who will try to be innovative when there is no room to fail?

When CDRH puts a new program into place it doesn't mean that they are being reckless regarding the level of scientific information required to determine safety and efficacy. Modernization is going to mean stepping into the unknown from a regulatory structure and review standpoint, but it doesn't mean stripping out the intelligence and experience of the reviewers on the files. They are the front line in knowing what questions need to be asked no matter what the program.

It is in telling the Agency that they cannot fail that we fail the American Public, stifle innovation, and get left behind globally.

------------------------------
Andrea Artman
Frederick MD
United States

Original Message:
Sent: 06-May-2019 13:05
From: Julie Omohundro
Subject: Should CDRH be allowed to fail?

I'm trying to figure out what to make of Jeff Shuren's statement at last week's FDLI meeting, that CDRH should be allowed to fail.  This was in the context of its efforts to "modernize."

I'm having a hard time seeing how CDRH could fail at much of anything without harm to patients.  And probably to the industry, as well.

I'm also puzzled as to who it is that could give CDRH permission to fail, and what that permission would look like.

Anyone have any insights here?  Maybe I'm missing something.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Andrea, your distinction is a valid one and worth noting.  However, everything I have heard from CDRH on "modernizing" and "innovating" says that, as CDRH is approaching this, they are essentially flip sides of the same coin.  The reason CDRH always gives for its burning need to "modernize" its processes is in order to "foster innovation" in medical devices.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 07-May-2019 10:00
From: Andrea Artman
Subject: Should CDRH be allowed to fail?

Julie -

Thank you - However, based on your follow-up, I think you are misinterpreting my definition of innovation.  Your question was around the modernization of the FDA review process, not innovative medical devices to market.  In this discussion, I am referring to the innovation of new processes and streamlined procedures that allow the FDA and more specifically CDRH to review scientifically sound data in a different way.

In developing innovative and streamlined PROCESSES, FDA can better protect the public health and allow access of medical devices to the US public upon demonstrating safety and efficacy.  I am not a firm believer in speed to market.  I am a firm believer in solid science that makes sense and provides the appropriate level of data.

It is in trying new programs that CDRH should be allowed to fail - not in protecting the health and welfare of its citizens.  America doesn't need to be first - we need to be smart about how we get there.

------------------------------
Andrea Pilon Artman
President & Principal Consultant
SpectRA Compliance, LLC
Frederick, MD
USA

Original Message:
Sent: 07-May-2019 09:04
From: Julie Omohundro
Subject: Should CDRH be allowed to fail?

Andrea, thanks for your comments.  You have done a nice job of articulating my worst interpretation of "what Shuren meant."  (And I mean that, nice job, not as a backhanded compliment.  I don't have to like it to appreciate it.)

When anyone talks about stifling innovation in this industry, I always react with this quote by Irish author Flannery O'Connor:

Everywhere I go, I'm asked if I think universities stifle too many aspiring young writers.  My answer is, I think they don't stifle enough of them.

When it comes to FDA and the medical device industry, I'm strongly pro-stifling and even more strongly anti- what passes for "innovation" in this industry.  I'm fine with being left behind globally.  More than that, I'm sick of our obsession with being first, and also very tired of being first, which is a different matter.

As a point of clarification, the quote was not about whether the agency can fail, or whether it can be expected to fail, but whether it should be "allowed" to fail, which is a very different question.  The former question is not worth asking, IMO, since obviously anyone and anything can fail, so answered before it is asked.  Whether or not one expects failure is a question that can only be answered meaningfully on an individual basis, I think.


------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 07-May-2019 08:25
From: Andrea Artman
Subject: Should CDRH be allowed to fail?

Hi Julie:
I wasn't at the conference so I'm only responding based on the information that is available in your post; however, yes CDRH should be allowed to fail and that doesn't mean increased patient risk - or as you mentioned industry risk.

CDRH and FDA work diligently to put new programs in place that benefit the public health and access to new technologies, but just like everyone else, CDRH is made up of people - people just like you and me. If we "industry" or "the American People" expect them to be unfailing, then we can also expect change in regulation, policies, guidances, etc to come to a screeching halt. Who will try to be innovative when there is no room to fail?

When CDRH puts a new program into place it doesn't mean that they are being reckless regarding the level of scientific information required to determine safety and efficacy. Modernization is going to mean stepping into the unknown from a regulatory structure and review standpoint, but it doesn't mean stripping out the intelligence and experience of the reviewers on the files. They are the front line in knowing what questions need to be asked no matter what the program.

It is in telling the Agency that they cannot fail that we fail the American Public, stifle innovation, and get left behind globally.

------------------------------
Andrea Artman
Frederick MD
United States

Original Message:
Sent: 06-May-2019 13:05
From: Julie Omohundro
Subject: Should CDRH be allowed to fail?

I'm trying to figure out what to make of Jeff Shuren's statement at last week's FDLI meeting, that CDRH should be allowed to fail.  This was in the context of its efforts to "modernize."

I'm having a hard time seeing how CDRH could fail at much of anything without harm to patients.  And probably to the industry, as well.

I'm also puzzled as to who it is that could give CDRH permission to fail, and what that permission would look like.

Anyone have any insights here?  Maybe I'm missing something.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Julie,

The two are closely related.  FDA can only foster device innovation by reforming their systems to allow adequate review of emerging technologies as they are not developing the technologies themselves.  CDRH has to be agile enough to determine how best to regulate new technologies AND ensure that appropriate data and oversight is given.  It is not one or the other.  There is always a risk - benefit profile and determining what risk is acceptable given the benefits of a device is a difficult issue to address.  This ration also varies widely based on multiple factors including the patient.

The way FDA has chosen to classify medical devices based on each type of device instead of through categories / rules such as "implantable", "non-implantable", "sterile", "non-sterile", "animal origin", etc. creates a greater platform to tailor the scientific requirements to be specific to each device and intended use.  CDRH and industry should be using this platform to think about specific requirements for specific devices.   What works for one type of device made of material A may not be appropriate for a different device of the same type made of material B.  It is in this way of coming together to develop reasonable, sound, scientific data, which provides ample scientific evidence, that FDA and Industry can together help bring new technologies to the American public.

I firmly believe there are ways that FDA can foster innovation, have the ability to fail, and keep the public safe.

------------------------------
Andrea Pilon Artman
President & Principal Consultant
SpectRA Compliance, LLC
Frederick, MD
USA
------------------------------

Original Message:
Sent: 07-May-2019 13:30
From: Julie Omohundro
Subject: Should CDRH be allowed to fail?

Andrea, your distinction is a valid one and worth noting.  However, everything I have heard from CDRH on "modernizing" and "innovating" says that, as CDRH is approaching this, they are essentially flip sides of the same coin.  The reason CDRH always gives for its burning need to "modernize" its processes is in order to "foster innovation" in medical devices.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 07-May-2019 10:00
From: Andrea Artman
Subject: Should CDRH be allowed to fail?

Julie -

Thank you - However, based on your follow-up, I think you are misinterpreting my definition of innovation.  Your question was around the modernization of the FDA review process, not innovative medical devices to market.  In this discussion, I am referring to the innovation of new processes and streamlined procedures that allow the FDA and more specifically CDRH to review scientifically sound data in a different way.

In developing innovative and streamlined PROCESSES, FDA can better protect the public health and allow access of medical devices to the US public upon demonstrating safety and efficacy.  I am not a firm believer in speed to market.  I am a firm believer in solid science that makes sense and provides the appropriate level of data.

It is in trying new programs that CDRH should be allowed to fail - not in protecting the health and welfare of its citizens.  America doesn't need to be first - we need to be smart about how we get there.

------------------------------
Andrea Pilon Artman
President & Principal Consultant
SpectRA Compliance, LLC
Frederick, MD
USA

Original Message:
Sent: 07-May-2019 09:04
From: Julie Omohundro
Subject: Should CDRH be allowed to fail?

Andrea, thanks for your comments.  You have done a nice job of articulating my worst interpretation of "what Shuren meant."  (And I mean that, nice job, not as a backhanded compliment.  I don't have to like it to appreciate it.)

When anyone talks about stifling innovation in this industry, I always react with this quote by Irish author Flannery O'Connor:

Everywhere I go, I'm asked if I think universities stifle too many aspiring young writers.  My answer is, I think they don't stifle enough of them.

When it comes to FDA and the medical device industry, I'm strongly pro-stifling and even more strongly anti- what passes for "innovation" in this industry.  I'm fine with being left behind globally.  More than that, I'm sick of our obsession with being first, and also very tired of being first, which is a different matter.

As a point of clarification, the quote was not about whether the agency can fail, or whether it can be expected to fail, but whether it should be "allowed" to fail, which is a very different question.  The former question is not worth asking, IMO, since obviously anyone and anything can fail, so answered before it is asked.  Whether or not one expects failure is a question that can only be answered meaningfully on an individual basis, I think.


------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 07-May-2019 08:25
From: Andrea Artman
Subject: Should CDRH be allowed to fail?

Hi Julie:
I wasn't at the conference so I'm only responding based on the information that is available in your post; however, yes CDRH should be allowed to fail and that doesn't mean increased patient risk - or as you mentioned industry risk.

CDRH and FDA work diligently to put new programs in place that benefit the public health and access to new technologies, but just like everyone else, CDRH is made up of people - people just like you and me. If we "industry" or "the American People" expect them to be unfailing, then we can also expect change in regulation, policies, guidances, etc to come to a screeching halt. Who will try to be innovative when there is no room to fail?

When CDRH puts a new program into place it doesn't mean that they are being reckless regarding the level of scientific information required to determine safety and efficacy. Modernization is going to mean stepping into the unknown from a regulatory structure and review standpoint, but it doesn't mean stripping out the intelligence and experience of the reviewers on the files. They are the front line in knowing what questions need to be asked no matter what the program.

It is in telling the Agency that they cannot fail that we fail the American Public, stifle innovation, and get left behind globally.

------------------------------
Andrea Artman
Frederick MD
United States

Original Message:
Sent: 06-May-2019 13:05
From: Julie Omohundro
Subject: Should CDRH be allowed to fail?

I'm trying to figure out what to make of Jeff Shuren's statement at last week's FDLI meeting, that CDRH should be allowed to fail.  This was in the context of its efforts to "modernize."

I'm having a hard time seeing how CDRH could fail at much of anything without harm to patients.  And probably to the industry, as well.

I'm also puzzled as to who it is that could give CDRH permission to fail, and what that permission would look like.

Anyone have any insights here?  Maybe I'm missing something.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Ah, well, I'm not a believer.  I adore uncertainty.

So one last question, I can't resist.  If CDRH were to persuade Congress to let it dump the standard of "valid scientific evidence" and...I don't know, just wing it, I guess...how might that sit with you?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 07-May-2019 15:19
From: Andrea Artman
Subject: Should CDRH be allowed to fail?

Julie,

The two are closely related.  FDA can only foster device innovation by reforming their systems to allow adequate review of emerging technologies as they are not developing the technologies themselves.  CDRH has to be agile enough to determine how best to regulate new technologies AND ensure that appropriate data and oversight is given.  It is not one or the other.  There is always a risk - benefit profile and determining what risk is acceptable given the benefits of a device is a difficult issue to address.  This ration also varies widely based on multiple factors including the patient.

The way FDA has chosen to classify medical devices based on each type of device instead of through categories / rules such as "implantable", "non-implantable", "sterile", "non-sterile", "animal origin", etc. creates a greater platform to tailor the scientific requirements to be specific to each device and intended use.  CDRH and industry should be using this platform to think about specific requirements for specific devices.   What works for one type of device made of material A may not be appropriate for a different device of the same type made of material B.  It is in this way of coming together to develop reasonable, sound, scientific data, which provides ample scientific evidence, that FDA and Industry can together help bring new technologies to the American public.

I firmly believe there are ways that FDA can foster innovation, have the ability to fail, and keep the public safe.

------------------------------
Andrea Pilon Artman
President & Principal Consultant
SpectRA Compliance, LLC
Frederick, MD
USA

Original Message:
Sent: 07-May-2019 13:30
From: Julie Omohundro
Subject: Should CDRH be allowed to fail?

Andrea, your distinction is a valid one and worth noting.  However, everything I have heard from CDRH on "modernizing" and "innovating" says that, as CDRH is approaching this, they are essentially flip sides of the same coin.  The reason CDRH always gives for its burning need to "modernize" its processes is in order to "foster innovation" in medical devices.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 07-May-2019 10:00
From: Andrea Artman
Subject: Should CDRH be allowed to fail?

Julie -

Thank you - However, based on your follow-up, I think you are misinterpreting my definition of innovation.  Your question was around the modernization of the FDA review process, not innovative medical devices to market.  In this discussion, I am referring to the innovation of new processes and streamlined procedures that allow the FDA and more specifically CDRH to review scientifically sound data in a different way.

In developing innovative and streamlined PROCESSES, FDA can better protect the public health and allow access of medical devices to the US public upon demonstrating safety and efficacy.  I am not a firm believer in speed to market.  I am a firm believer in solid science that makes sense and provides the appropriate level of data.

It is in trying new programs that CDRH should be allowed to fail - not in protecting the health and welfare of its citizens.  America doesn't need to be first - we need to be smart about how we get there.

------------------------------
Andrea Pilon Artman
President & Principal Consultant
SpectRA Compliance, LLC
Frederick, MD
USA

Original Message:
Sent: 07-May-2019 09:04
From: Julie Omohundro
Subject: Should CDRH be allowed to fail?

Andrea, thanks for your comments.  You have done a nice job of articulating my worst interpretation of "what Shuren meant."  (And I mean that, nice job, not as a backhanded compliment.  I don't have to like it to appreciate it.)

When anyone talks about stifling innovation in this industry, I always react with this quote by Irish author Flannery O'Connor:

Everywhere I go, I'm asked if I think universities stifle too many aspiring young writers.  My answer is, I think they don't stifle enough of them.

When it comes to FDA and the medical device industry, I'm strongly pro-stifling and even more strongly anti- what passes for "innovation" in this industry.  I'm fine with being left behind globally.  More than that, I'm sick of our obsession with being first, and also very tired of being first, which is a different matter.

As a point of clarification, the quote was not about whether the agency can fail, or whether it can be expected to fail, but whether it should be "allowed" to fail, which is a very different question.  The former question is not worth asking, IMO, since obviously anyone and anything can fail, so answered before it is asked.  Whether or not one expects failure is a question that can only be answered meaningfully on an individual basis, I think.


------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 07-May-2019 08:25
From: Andrea Artman
Subject: Should CDRH be allowed to fail?

Hi Julie:
I wasn't at the conference so I'm only responding based on the information that is available in your post; however, yes CDRH should be allowed to fail and that doesn't mean increased patient risk - or as you mentioned industry risk.

CDRH and FDA work diligently to put new programs in place that benefit the public health and access to new technologies, but just like everyone else, CDRH is made up of people - people just like you and me. If we "industry" or "the American People" expect them to be unfailing, then we can also expect change in regulation, policies, guidances, etc to come to a screeching halt. Who will try to be innovative when there is no room to fail?

When CDRH puts a new program into place it doesn't mean that they are being reckless regarding the level of scientific information required to determine safety and efficacy. Modernization is going to mean stepping into the unknown from a regulatory structure and review standpoint, but it doesn't mean stripping out the intelligence and experience of the reviewers on the files. They are the front line in knowing what questions need to be asked no matter what the program.

It is in telling the Agency that they cannot fail that we fail the American Public, stifle innovation, and get left behind globally.

------------------------------
Andrea Artman
Frederick MD
United States

Original Message:
Sent: 06-May-2019 13:05
From: Julie Omohundro
Subject: Should CDRH be allowed to fail?

I'm trying to figure out what to make of Jeff Shuren's statement at last week's FDLI meeting, that CDRH should be allowed to fail.  This was in the context of its efforts to "modernize."

I'm having a hard time seeing how CDRH could fail at much of anything without harm to patients.  And probably to the industry, as well.

I'm also puzzled as to who it is that could give CDRH permission to fail, and what that permission would look like.

Anyone have any insights here?  Maybe I'm missing something.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Everything that I've posted today hinges on valid scientific data.  Therefore, the removal of this requirement is absurd in my view.  Defining what "valid scientific data" means for each device, now that is something I can get behind.

------------------------------
Andrea Pilon Artman, MS, CQE
President & Principal Consultant
SpectRA Compliance, LLC
Frederick, MD
USA
andrea.artman@spectracompliancellc.com
------------------------------

Original Message:
Sent: 07-May-2019 15:25
From: Julie Omohundro
Subject: Should CDRH be allowed to fail?

Ah, well, I'm not a believer.  I adore uncertainty.

So one last question, I can't resist.  If CDRH were to persuade Congress to let it dump the standard of "valid scientific evidence" and...I don't know, just wing it, I guess...how might that sit with you?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 07-May-2019 15:19
From: Andrea Artman
Subject: Should CDRH be allowed to fail?

Julie,

The two are closely related.  FDA can only foster device innovation by reforming their systems to allow adequate review of emerging technologies as they are not developing the technologies themselves.  CDRH has to be agile enough to determine how best to regulate new technologies AND ensure that appropriate data and oversight is given.  It is not one or the other.  There is always a risk - benefit profile and determining what risk is acceptable given the benefits of a device is a difficult issue to address.  This ration also varies widely based on multiple factors including the patient.

The way FDA has chosen to classify medical devices based on each type of device instead of through categories / rules such as "implantable", "non-implantable", "sterile", "non-sterile", "animal origin", etc. creates a greater platform to tailor the scientific requirements to be specific to each device and intended use.  CDRH and industry should be using this platform to think about specific requirements for specific devices.   What works for one type of device made of material A may not be appropriate for a different device of the same type made of material B.  It is in this way of coming together to develop reasonable, sound, scientific data, which provides ample scientific evidence, that FDA and Industry can together help bring new technologies to the American public.

I firmly believe there are ways that FDA can foster innovation, have the ability to fail, and keep the public safe.

------------------------------
Andrea Pilon Artman
President & Principal Consultant
SpectRA Compliance, LLC
Frederick, MD
USA

Original Message:
Sent: 07-May-2019 13:30
From: Julie Omohundro
Subject: Should CDRH be allowed to fail?

Andrea, your distinction is a valid one and worth noting.  However, everything I have heard from CDRH on "modernizing" and "innovating" says that, as CDRH is approaching this, they are essentially flip sides of the same coin.  The reason CDRH always gives for its burning need to "modernize" its processes is in order to "foster innovation" in medical devices.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 07-May-2019 10:00
From: Andrea Artman
Subject: Should CDRH be allowed to fail?

Julie -

Thank you - However, based on your follow-up, I think you are misinterpreting my definition of innovation.  Your question was around the modernization of the FDA review process, not innovative medical devices to market.  In this discussion, I am referring to the innovation of new processes and streamlined procedures that allow the FDA and more specifically CDRH to review scientifically sound data in a different way.

In developing innovative and streamlined PROCESSES, FDA can better protect the public health and allow access of medical devices to the US public upon demonstrating safety and efficacy.  I am not a firm believer in speed to market.  I am a firm believer in solid science that makes sense and provides the appropriate level of data.

It is in trying new programs that CDRH should be allowed to fail - not in protecting the health and welfare of its citizens.  America doesn't need to be first - we need to be smart about how we get there.

------------------------------
Andrea Pilon Artman
President & Principal Consultant
SpectRA Compliance, LLC
Frederick, MD
USA

Original Message:
Sent: 07-May-2019 09:04
From: Julie Omohundro
Subject: Should CDRH be allowed to fail?

Andrea, thanks for your comments.  You have done a nice job of articulating my worst interpretation of "what Shuren meant."  (And I mean that, nice job, not as a backhanded compliment.  I don't have to like it to appreciate it.)

When anyone talks about stifling innovation in this industry, I always react with this quote by Irish author Flannery O'Connor:

Everywhere I go, I'm asked if I think universities stifle too many aspiring young writers.  My answer is, I think they don't stifle enough of them.

When it comes to FDA and the medical device industry, I'm strongly pro-stifling and even more strongly anti- what passes for "innovation" in this industry.  I'm fine with being left behind globally.  More than that, I'm sick of our obsession with being first, and also very tired of being first, which is a different matter.

As a point of clarification, the quote was not about whether the agency can fail, or whether it can be expected to fail, but whether it should be "allowed" to fail, which is a very different question.  The former question is not worth asking, IMO, since obviously anyone and anything can fail, so answered before it is asked.  Whether or not one expects failure is a question that can only be answered meaningfully on an individual basis, I think.


------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 07-May-2019 08:25
From: Andrea Artman
Subject: Should CDRH be allowed to fail?

Hi Julie:
I wasn't at the conference so I'm only responding based on the information that is available in your post; however, yes CDRH should be allowed to fail and that doesn't mean increased patient risk - or as you mentioned industry risk.

CDRH and FDA work diligently to put new programs in place that benefit the public health and access to new technologies, but just like everyone else, CDRH is made up of people - people just like you and me. If we "industry" or "the American People" expect them to be unfailing, then we can also expect change in regulation, policies, guidances, etc to come to a screeching halt. Who will try to be innovative when there is no room to fail?

When CDRH puts a new program into place it doesn't mean that they are being reckless regarding the level of scientific information required to determine safety and efficacy. Modernization is going to mean stepping into the unknown from a regulatory structure and review standpoint, but it doesn't mean stripping out the intelligence and experience of the reviewers on the files. They are the front line in knowing what questions need to be asked no matter what the program.

It is in telling the Agency that they cannot fail that we fail the American Public, stifle innovation, and get left behind globally.

------------------------------
Andrea Artman
Frederick MD
United States

Original Message:
Sent: 06-May-2019 13:05
From: Julie Omohundro
Subject: Should CDRH be allowed to fail?

I'm trying to figure out what to make of Jeff Shuren's statement at last week's FDLI meeting, that CDRH should be allowed to fail.  This was in the context of its efforts to "modernize."

I'm having a hard time seeing how CDRH could fail at much of anything without harm to patients.  And probably to the industry, as well.

I'm also puzzled as to who it is that could give CDRH permission to fail, and what that permission would look like.

Anyone have any insights here?  Maybe I'm missing something.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

We are definitely in agreement here!

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 07-May-2019 15:35
From: Andrea Artman
Subject: Should CDRH be allowed to fail?

Everything that I've posted today hinges on valid scientific data.  Therefore, the removal of this requirement is absurd in my view.  Defining what "valid scientific data" means for each device, now that is something I can get behind.

------------------------------
Andrea Pilon Artman, MS, CQE
President & Principal Consultant
SpectRA Compliance, LLC
Frederick, MD
USA
andrea.artman@spectracompliancellc.com

Original Message:
Sent: 07-May-2019 15:25
From: Julie Omohundro
Subject: Should CDRH be allowed to fail?

Ah, well, I'm not a believer.  I adore uncertainty.

So one last question, I can't resist.  If CDRH were to persuade Congress to let it dump the standard of "valid scientific evidence" and...I don't know, just wing it, I guess...how might that sit with you?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 07-May-2019 15:19
From: Andrea Artman
Subject: Should CDRH be allowed to fail?

Julie,

The two are closely related.  FDA can only foster device innovation by reforming their systems to allow adequate review of emerging technologies as they are not developing the technologies themselves.  CDRH has to be agile enough to determine how best to regulate new technologies AND ensure that appropriate data and oversight is given.  It is not one or the other.  There is always a risk - benefit profile and determining what risk is acceptable given the benefits of a device is a difficult issue to address.  This ration also varies widely based on multiple factors including the patient.

The way FDA has chosen to classify medical devices based on each type of device instead of through categories / rules such as "implantable", "non-implantable", "sterile", "non-sterile", "animal origin", etc. creates a greater platform to tailor the scientific requirements to be specific to each device and intended use.  CDRH and industry should be using this platform to think about specific requirements for specific devices.   What works for one type of device made of material A may not be appropriate for a different device of the same type made of material B.  It is in this way of coming together to develop reasonable, sound, scientific data, which provides ample scientific evidence, that FDA and Industry can together help bring new technologies to the American public.

I firmly believe there are ways that FDA can foster innovation, have the ability to fail, and keep the public safe.

------------------------------
Andrea Pilon Artman
President & Principal Consultant
SpectRA Compliance, LLC
Frederick, MD
USA

Original Message:
Sent: 07-May-2019 13:30
From: Julie Omohundro
Subject: Should CDRH be allowed to fail?

Andrea, your distinction is a valid one and worth noting.  However, everything I have heard from CDRH on "modernizing" and "innovating" says that, as CDRH is approaching this, they are essentially flip sides of the same coin.  The reason CDRH always gives for its burning need to "modernize" its processes is in order to "foster innovation" in medical devices.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 07-May-2019 10:00
From: Andrea Artman
Subject: Should CDRH be allowed to fail?

Julie -

Thank you - However, based on your follow-up, I think you are misinterpreting my definition of innovation.  Your question was around the modernization of the FDA review process, not innovative medical devices to market.  In this discussion, I am referring to the innovation of new processes and streamlined procedures that allow the FDA and more specifically CDRH to review scientifically sound data in a different way.

In developing innovative and streamlined PROCESSES, FDA can better protect the public health and allow access of medical devices to the US public upon demonstrating safety and efficacy.  I am not a firm believer in speed to market.  I am a firm believer in solid science that makes sense and provides the appropriate level of data.

It is in trying new programs that CDRH should be allowed to fail - not in protecting the health and welfare of its citizens.  America doesn't need to be first - we need to be smart about how we get there.

------------------------------
Andrea Pilon Artman
President & Principal Consultant
SpectRA Compliance, LLC
Frederick, MD
USA

Original Message:
Sent: 07-May-2019 09:04
From: Julie Omohundro
Subject: Should CDRH be allowed to fail?

Andrea, thanks for your comments.  You have done a nice job of articulating my worst interpretation of "what Shuren meant."  (And I mean that, nice job, not as a backhanded compliment.  I don't have to like it to appreciate it.)

When anyone talks about stifling innovation in this industry, I always react with this quote by Irish author Flannery O'Connor:

Everywhere I go, I'm asked if I think universities stifle too many aspiring young writers.  My answer is, I think they don't stifle enough of them.

When it comes to FDA and the medical device industry, I'm strongly pro-stifling and even more strongly anti- what passes for "innovation" in this industry.  I'm fine with being left behind globally.  More than that, I'm sick of our obsession with being first, and also very tired of being first, which is a different matter.

As a point of clarification, the quote was not about whether the agency can fail, or whether it can be expected to fail, but whether it should be "allowed" to fail, which is a very different question.  The former question is not worth asking, IMO, since obviously anyone and anything can fail, so answered before it is asked.  Whether or not one expects failure is a question that can only be answered meaningfully on an individual basis, I think.


------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 07-May-2019 08:25
From: Andrea Artman
Subject: Should CDRH be allowed to fail?

Hi Julie:
I wasn't at the conference so I'm only responding based on the information that is available in your post; however, yes CDRH should be allowed to fail and that doesn't mean increased patient risk - or as you mentioned industry risk.

CDRH and FDA work diligently to put new programs in place that benefit the public health and access to new technologies, but just like everyone else, CDRH is made up of people - people just like you and me. If we "industry" or "the American People" expect them to be unfailing, then we can also expect change in regulation, policies, guidances, etc to come to a screeching halt. Who will try to be innovative when there is no room to fail?

When CDRH puts a new program into place it doesn't mean that they are being reckless regarding the level of scientific information required to determine safety and efficacy. Modernization is going to mean stepping into the unknown from a regulatory structure and review standpoint, but it doesn't mean stripping out the intelligence and experience of the reviewers on the files. They are the front line in knowing what questions need to be asked no matter what the program.

It is in telling the Agency that they cannot fail that we fail the American Public, stifle innovation, and get left behind globally.

------------------------------
Andrea Artman
Frederick MD
United States

Original Message:
Sent: 06-May-2019 13:05
From: Julie Omohundro
Subject: Should CDRH be allowed to fail?

I'm trying to figure out what to make of Jeff Shuren's statement at last week's FDLI meeting, that CDRH should be allowed to fail.  This was in the context of its efforts to "modernize."

I'm having a hard time seeing how CDRH could fail at much of anything without harm to patients.  And probably to the industry, as well.

I'm also puzzled as to who it is that could give CDRH permission to fail, and what that permission would look like.

Anyone have any insights here?  Maybe I'm missing something.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Dear Julie and Andrea,

Thank you two for a delightful and thought provoking discussion.  No real discourse here as I believe we are all on the same page with respect to the CDRH initiatives and goals.   I was not at the meeting and no reference to failing in the slide deck so it must have been verbalized.  Context is key.  The FDA cant just sit still as technology passes them by.  The congressional criticism of the 510k process dating back several years has resulted in over 50 cross cutting guidance documents related to modernizing the process to keep pace.  Few branches of government have engaged to adapt to the rapidly changing world around us.  One look at what is going on with the MDR in the EU validates the work that FDA is doing to move the regulatory process forward not backwards. 


------------------------------
Mac McKeen RAC, MBA
University of Minnesota
Minneapolis, MN
United States
------------------------------

Original Message:
Sent: 07-May-2019 16:23
From: Julie Omohundro
Subject: Should CDRH be allowed to fail?

We are definitely in agreement here!

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 07-May-2019 15:35
From: Andrea Artman
Subject: Should CDRH be allowed to fail?

Everything that I've posted today hinges on valid scientific data.  Therefore, the removal of this requirement is absurd in my view.  Defining what "valid scientific data" means for each device, now that is something I can get behind.

------------------------------
Andrea Pilon Artman, MS, CQE
President & Principal Consultant
SpectRA Compliance, LLC
Frederick, MD
USA
andrea.artman@spectracompliancellc.com

Original Message:
Sent: 07-May-2019 15:25
From: Julie Omohundro
Subject: Should CDRH be allowed to fail?

Ah, well, I'm not a believer.  I adore uncertainty.

So one last question, I can't resist.  If CDRH were to persuade Congress to let it dump the standard of "valid scientific evidence" and...I don't know, just wing it, I guess...how might that sit with you?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 07-May-2019 15:19
From: Andrea Artman
Subject: Should CDRH be allowed to fail?

Julie,

The two are closely related.  FDA can only foster device innovation by reforming their systems to allow adequate review of emerging technologies as they are not developing the technologies themselves.  CDRH has to be agile enough to determine how best to regulate new technologies AND ensure that appropriate data and oversight is given.  It is not one or the other.  There is always a risk - benefit profile and determining what risk is acceptable given the benefits of a device is a difficult issue to address.  This ration also varies widely based on multiple factors including the patient.

The way FDA has chosen to classify medical devices based on each type of device instead of through categories / rules such as "implantable", "non-implantable", "sterile", "non-sterile", "animal origin", etc. creates a greater platform to tailor the scientific requirements to be specific to each device and intended use.  CDRH and industry should be using this platform to think about specific requirements for specific devices.   What works for one type of device made of material A may not be appropriate for a different device of the same type made of material B.  It is in this way of coming together to develop reasonable, sound, scientific data, which provides ample scientific evidence, that FDA and Industry can together help bring new technologies to the American public.

I firmly believe there are ways that FDA can foster innovation, have the ability to fail, and keep the public safe.

------------------------------
Andrea Pilon Artman
President & Principal Consultant
SpectRA Compliance, LLC
Frederick, MD
USA

Original Message:
Sent: 07-May-2019 13:30
From: Julie Omohundro
Subject: Should CDRH be allowed to fail?

Andrea, your distinction is a valid one and worth noting.  However, everything I have heard from CDRH on "modernizing" and "innovating" says that, as CDRH is approaching this, they are essentially flip sides of the same coin.  The reason CDRH always gives for its burning need to "modernize" its processes is in order to "foster innovation" in medical devices.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 07-May-2019 10:00
From: Andrea Artman
Subject: Should CDRH be allowed to fail?

Julie -

Thank you - However, based on your follow-up, I think you are misinterpreting my definition of innovation.  Your question was around the modernization of the FDA review process, not innovative medical devices to market.  In this discussion, I am referring to the innovation of new processes and streamlined procedures that allow the FDA and more specifically CDRH to review scientifically sound data in a different way.

In developing innovative and streamlined PROCESSES, FDA can better protect the public health and allow access of medical devices to the US public upon demonstrating safety and efficacy.  I am not a firm believer in speed to market.  I am a firm believer in solid science that makes sense and provides the appropriate level of data.

It is in trying new programs that CDRH should be allowed to fail - not in protecting the health and welfare of its citizens.  America doesn't need to be first - we need to be smart about how we get there.

------------------------------
Andrea Pilon Artman
President & Principal Consultant
SpectRA Compliance, LLC
Frederick, MD
USA

Original Message:
Sent: 07-May-2019 09:04
From: Julie Omohundro
Subject: Should CDRH be allowed to fail?

Andrea, thanks for your comments.  You have done a nice job of articulating my worst interpretation of "what Shuren meant."  (And I mean that, nice job, not as a backhanded compliment.  I don't have to like it to appreciate it.)

When anyone talks about stifling innovation in this industry, I always react with this quote by Irish author Flannery O'Connor:

Everywhere I go, I'm asked if I think universities stifle too many aspiring young writers.  My answer is, I think they don't stifle enough of them.

When it comes to FDA and the medical device industry, I'm strongly pro-stifling and even more strongly anti- what passes for "innovation" in this industry.  I'm fine with being left behind globally.  More than that, I'm sick of our obsession with being first, and also very tired of being first, which is a different matter.

As a point of clarification, the quote was not about whether the agency can fail, or whether it can be expected to fail, but whether it should be "allowed" to fail, which is a very different question.  The former question is not worth asking, IMO, since obviously anyone and anything can fail, so answered before it is asked.  Whether or not one expects failure is a question that can only be answered meaningfully on an individual basis, I think.


------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 07-May-2019 08:25
From: Andrea Artman
Subject: Should CDRH be allowed to fail?

Hi Julie:
I wasn't at the conference so I'm only responding based on the information that is available in your post; however, yes CDRH should be allowed to fail and that doesn't mean increased patient risk - or as you mentioned industry risk.

CDRH and FDA work diligently to put new programs in place that benefit the public health and access to new technologies, but just like everyone else, CDRH is made up of people - people just like you and me. If we "industry" or "the American People" expect them to be unfailing, then we can also expect change in regulation, policies, guidances, etc to come to a screeching halt. Who will try to be innovative when there is no room to fail?

When CDRH puts a new program into place it doesn't mean that they are being reckless regarding the level of scientific information required to determine safety and efficacy. Modernization is going to mean stepping into the unknown from a regulatory structure and review standpoint, but it doesn't mean stripping out the intelligence and experience of the reviewers on the files. They are the front line in knowing what questions need to be asked no matter what the program.

It is in telling the Agency that they cannot fail that we fail the American Public, stifle innovation, and get left behind globally.

------------------------------
Andrea Artman
Frederick MD
United States

Original Message:
Sent: 06-May-2019 13:05
From: Julie Omohundro
Subject: Should CDRH be allowed to fail?

I'm trying to figure out what to make of Jeff Shuren's statement at last week's FDLI meeting, that CDRH should be allowed to fail.  This was in the context of its efforts to "modernize."

I'm having a hard time seeing how CDRH could fail at much of anything without harm to patients.  And probably to the industry, as well.

I'm also puzzled as to who it is that could give CDRH permission to fail, and what that permission would look like.

Anyone have any insights here?  Maybe I'm missing something.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

So, I gather you haven't read any of my Regulatory Watchcat rants.  Nor my comments about tidepools and bubbles in this forum.  If there is anything we are not all on in this industry, it is the same page.

Interestingly, I was googling for information about the Congressional criticism of the 510(k) that fueled the last CDRH purge at the top and found a reference to a similar round of criticisms, meetings, etc in the 1980s.  I went through the post-Temple report purge in the mid-90s.  I wouldn't be surprised if I missed one in the 2000s, when I was often otherwise occupied.

The more things don't change, the more they stay the same...

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 08-May-2019 09:21
From: Mac McKeen
Subject: Should CDRH be allowed to fail?

Dear Julie and Andrea,

Thank you two for a delightful and thought provoking discussion.  No real discourse here as I believe we are all on the same page with respect to the CDRH initiatives and goals.   I was not at the meeting and no reference to failing in the slide deck so it must have been verbalized.  Context is key.  The FDA cant just sit still as technology passes them by.  The congressional criticism of the 510k process dating back several years has resulted in over 50 cross cutting guidance documents related to modernizing the process to keep pace.  Few branches of government have engaged to adapt to the rapidly changing world around us.  One look at what is going on with the MDR in the EU validates the work that FDA is doing to move the regulatory process forward not backwards.


------------------------------
Mac McKeen RAC, MBA
University of Minnesota
Minneapolis, MN
United States

Original Message:
Sent: 07-May-2019 16:23
From: Julie Omohundro
Subject: Should CDRH be allowed to fail?

We are definitely in agreement here!

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 07-May-2019 15:35
From: Andrea Artman
Subject: Should CDRH be allowed to fail?

Everything that I've posted today hinges on valid scientific data.  Therefore, the removal of this requirement is absurd in my view.  Defining what "valid scientific data" means for each device, now that is something I can get behind.

------------------------------
Andrea Pilon Artman, MS, CQE
President & Principal Consultant
SpectRA Compliance, LLC
Frederick, MD
USA
andrea.artman@spectracompliancellc.com

Original Message:
Sent: 07-May-2019 15:25
From: Julie Omohundro
Subject: Should CDRH be allowed to fail?

Ah, well, I'm not a believer.  I adore uncertainty.

So one last question, I can't resist.  If CDRH were to persuade Congress to let it dump the standard of "valid scientific evidence" and...I don't know, just wing it, I guess...how might that sit with you?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 07-May-2019 15:19
From: Andrea Artman
Subject: Should CDRH be allowed to fail?

Julie,

The two are closely related.  FDA can only foster device innovation by reforming their systems to allow adequate review of emerging technologies as they are not developing the technologies themselves.  CDRH has to be agile enough to determine how best to regulate new technologies AND ensure that appropriate data and oversight is given.  It is not one or the other.  There is always a risk - benefit profile and determining what risk is acceptable given the benefits of a device is a difficult issue to address.  This ration also varies widely based on multiple factors including the patient.

The way FDA has chosen to classify medical devices based on each type of device instead of through categories / rules such as "implantable", "non-implantable", "sterile", "non-sterile", "animal origin", etc. creates a greater platform to tailor the scientific requirements to be specific to each device and intended use.  CDRH and industry should be using this platform to think about specific requirements for specific devices.   What works for one type of device made of material A may not be appropriate for a different device of the same type made of material B.  It is in this way of coming together to develop reasonable, sound, scientific data, which provides ample scientific evidence, that FDA and Industry can together help bring new technologies to the American public.

I firmly believe there are ways that FDA can foster innovation, have the ability to fail, and keep the public safe.

------------------------------
Andrea Pilon Artman
President & Principal Consultant
SpectRA Compliance, LLC
Frederick, MD
USA

Original Message:
Sent: 07-May-2019 13:30
From: Julie Omohundro
Subject: Should CDRH be allowed to fail?

Andrea, your distinction is a valid one and worth noting.  However, everything I have heard from CDRH on "modernizing" and "innovating" says that, as CDRH is approaching this, they are essentially flip sides of the same coin.  The reason CDRH always gives for its burning need to "modernize" its processes is in order to "foster innovation" in medical devices.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 07-May-2019 10:00
From: Andrea Artman
Subject: Should CDRH be allowed to fail?

Julie -

Thank you - However, based on your follow-up, I think you are misinterpreting my definition of innovation.  Your question was around the modernization of the FDA review process, not innovative medical devices to market.  In this discussion, I am referring to the innovation of new processes and streamlined procedures that allow the FDA and more specifically CDRH to review scientifically sound data in a different way.

In developing innovative and streamlined PROCESSES, FDA can better protect the public health and allow access of medical devices to the US public upon demonstrating safety and efficacy.  I am not a firm believer in speed to market.  I am a firm believer in solid science that makes sense and provides the appropriate level of data.

It is in trying new programs that CDRH should be allowed to fail - not in protecting the health and welfare of its citizens.  America doesn't need to be first - we need to be smart about how we get there.

------------------------------
Andrea Pilon Artman
President & Principal Consultant
SpectRA Compliance, LLC
Frederick, MD
USA

Original Message:
Sent: 07-May-2019 09:04
From: Julie Omohundro
Subject: Should CDRH be allowed to fail?

Andrea, thanks for your comments.  You have done a nice job of articulating my worst interpretation of "what Shuren meant."  (And I mean that, nice job, not as a backhanded compliment.  I don't have to like it to appreciate it.)

When anyone talks about stifling innovation in this industry, I always react with this quote by Irish author Flannery O'Connor:

Everywhere I go, I'm asked if I think universities stifle too many aspiring young writers.  My answer is, I think they don't stifle enough of them.

When it comes to FDA and the medical device industry, I'm strongly pro-stifling and even more strongly anti- what passes for "innovation" in this industry.  I'm fine with being left behind globally.  More than that, I'm sick of our obsession with being first, and also very tired of being first, which is a different matter.

As a point of clarification, the quote was not about whether the agency can fail, or whether it can be expected to fail, but whether it should be "allowed" to fail, which is a very different question.  The former question is not worth asking, IMO, since obviously anyone and anything can fail, so answered before it is asked.  Whether or not one expects failure is a question that can only be answered meaningfully on an individual basis, I think.


------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 07-May-2019 08:25
From: Andrea Artman
Subject: Should CDRH be allowed to fail?

Hi Julie:
I wasn't at the conference so I'm only responding based on the information that is available in your post; however, yes CDRH should be allowed to fail and that doesn't mean increased patient risk - or as you mentioned industry risk.

CDRH and FDA work diligently to put new programs in place that benefit the public health and access to new technologies, but just like everyone else, CDRH is made up of people - people just like you and me. If we "industry" or "the American People" expect them to be unfailing, then we can also expect change in regulation, policies, guidances, etc to come to a screeching halt. Who will try to be innovative when there is no room to fail?

When CDRH puts a new program into place it doesn't mean that they are being reckless regarding the level of scientific information required to determine safety and efficacy. Modernization is going to mean stepping into the unknown from a regulatory structure and review standpoint, but it doesn't mean stripping out the intelligence and experience of the reviewers on the files. They are the front line in knowing what questions need to be asked no matter what the program.

It is in telling the Agency that they cannot fail that we fail the American Public, stifle innovation, and get left behind globally.

------------------------------
Andrea Artman
Frederick MD
United States

Original Message:
Sent: 06-May-2019 13:05
From: Julie Omohundro
Subject: Should CDRH be allowed to fail?

I'm trying to figure out what to make of Jeff Shuren's statement at last week's FDLI meeting, that CDRH should be allowed to fail.  This was in the context of its efforts to "modernize."

I'm having a hard time seeing how CDRH could fail at much of anything without harm to patients.  And probably to the industry, as well.

I'm also puzzled as to who it is that could give CDRH permission to fail, and what that permission would look like.

Anyone have any insights here?  Maybe I'm missing something.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

I have been reminded that the fuss in the 80s led to the SMDA of 1991, the year I started in RA.

I'm not sure about those slides.  I don't recognize them and, if you look at the URL, it appears they were from the 2018 conference.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 08-May-2019 10:19
From: Julie Omohundro
Subject: Should CDRH be allowed to fail?

So, I gather you haven't read any of my Regulatory Watchcat rants.  And my comments about tidepools and bubbles in this forum.  If there is anything we are not all on in this industry, it is the same page.

Interestingly, I was googling for information about the Congressional criticism of the 510(k) that fueled the last CDRH purge at the top and found a reference to a similar round of criticisms, meetings, etc in the 1980s.  I went through the post-Temple report purge in the mid-90s.  I wouldn't be surprised if I missed one in the 2000s, when I was often otherwise occupied.

The more things don't change, the more they stay the same...

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 08-May-2019 09:21
From: Mac McKeen
Subject: Should CDRH be allowed to fail?

Dear Julie and Andrea,

Thank you two for a delightful and thought provoking discussion.  No real discourse here as I believe we are all on the same page with respect to the CDRH initiatives and goals.   I was not at the meeting and no reference to failing in the slide deck so it must have been verbalized.  Context is key.  The FDA cant just sit still as technology passes them by.  The congressional criticism of the 510k process dating back several years has resulted in over 50 cross cutting guidance documents related to modernizing the process to keep pace.  Few branches of government have engaged to adapt to the rapidly changing world around us.  One look at what is going on with the MDR in the EU validates the work that FDA is doing to move the regulatory process forward not backwards.


------------------------------
Mac McKeen RAC, MBA
University of Minnesota
Minneapolis, MN
United States

Original Message:
Sent: 07-May-2019 16:23
From: Julie Omohundro
Subject: Should CDRH be allowed to fail?

We are definitely in agreement here!

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 07-May-2019 15:35
From: Andrea Artman
Subject: Should CDRH be allowed to fail?

Everything that I've posted today hinges on valid scientific data.  Therefore, the removal of this requirement is absurd in my view.  Defining what "valid scientific data" means for each device, now that is something I can get behind.

------------------------------
Andrea Pilon Artman, MS, CQE
President & Principal Consultant
SpectRA Compliance, LLC
Frederick, MD
USA
andrea.artman@spectracompliancellc.com

Original Message:
Sent: 07-May-2019 15:25
From: Julie Omohundro
Subject: Should CDRH be allowed to fail?

Ah, well, I'm not a believer.  I adore uncertainty.

So one last question, I can't resist.  If CDRH were to persuade Congress to let it dump the standard of "valid scientific evidence" and...I don't know, just wing it, I guess...how might that sit with you?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 07-May-2019 15:19
From: Andrea Artman
Subject: Should CDRH be allowed to fail?

Julie,

The two are closely related.  FDA can only foster device innovation by reforming their systems to allow adequate review of emerging technologies as they are not developing the technologies themselves.  CDRH has to be agile enough to determine how best to regulate new technologies AND ensure that appropriate data and oversight is given.  It is not one or the other.  There is always a risk - benefit profile and determining what risk is acceptable given the benefits of a device is a difficult issue to address.  This ration also varies widely based on multiple factors including the patient.

The way FDA has chosen to classify medical devices based on each type of device instead of through categories / rules such as "implantable", "non-implantable", "sterile", "non-sterile", "animal origin", etc. creates a greater platform to tailor the scientific requirements to be specific to each device and intended use.  CDRH and industry should be using this platform to think about specific requirements for specific devices.   What works for one type of device made of material A may not be appropriate for a different device of the same type made of material B.  It is in this way of coming together to develop reasonable, sound, scientific data, which provides ample scientific evidence, that FDA and Industry can together help bring new technologies to the American public.

I firmly believe there are ways that FDA can foster innovation, have the ability to fail, and keep the public safe.

------------------------------
Andrea Pilon Artman
President & Principal Consultant
SpectRA Compliance, LLC
Frederick, MD
USA

Original Message:
Sent: 07-May-2019 13:30
From: Julie Omohundro
Subject: Should CDRH be allowed to fail?

Andrea, your distinction is a valid one and worth noting.  However, everything I have heard from CDRH on "modernizing" and "innovating" says that, as CDRH is approaching this, they are essentially flip sides of the same coin.  The reason CDRH always gives for its burning need to "modernize" its processes is in order to "foster innovation" in medical devices.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 07-May-2019 10:00
From: Andrea Artman
Subject: Should CDRH be allowed to fail?

Julie -

Thank you - However, based on your follow-up, I think you are misinterpreting my definition of innovation.  Your question was around the modernization of the FDA review process, not innovative medical devices to market.  In this discussion, I am referring to the innovation of new processes and streamlined procedures that allow the FDA and more specifically CDRH to review scientifically sound data in a different way.

In developing innovative and streamlined PROCESSES, FDA can better protect the public health and allow access of medical devices to the US public upon demonstrating safety and efficacy.  I am not a firm believer in speed to market.  I am a firm believer in solid science that makes sense and provides the appropriate level of data.

It is in trying new programs that CDRH should be allowed to fail - not in protecting the health and welfare of its citizens.  America doesn't need to be first - we need to be smart about how we get there.

------------------------------
Andrea Pilon Artman
President & Principal Consultant
SpectRA Compliance, LLC
Frederick, MD
USA

Original Message:
Sent: 07-May-2019 09:04
From: Julie Omohundro
Subject: Should CDRH be allowed to fail?

Andrea, thanks for your comments.  You have done a nice job of articulating my worst interpretation of "what Shuren meant."  (And I mean that, nice job, not as a backhanded compliment.  I don't have to like it to appreciate it.)

When anyone talks about stifling innovation in this industry, I always react with this quote by Irish author Flannery O'Connor:

Everywhere I go, I'm asked if I think universities stifle too many aspiring young writers.  My answer is, I think they don't stifle enough of them.

When it comes to FDA and the medical device industry, I'm strongly pro-stifling and even more strongly anti- what passes for "innovation" in this industry.  I'm fine with being left behind globally.  More than that, I'm sick of our obsession with being first, and also very tired of being first, which is a different matter.

As a point of clarification, the quote was not about whether the agency can fail, or whether it can be expected to fail, but whether it should be "allowed" to fail, which is a very different question.  The former question is not worth asking, IMO, since obviously anyone and anything can fail, so answered before it is asked.  Whether or not one expects failure is a question that can only be answered meaningfully on an individual basis, I think.


------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 07-May-2019 08:25
From: Andrea Artman
Subject: Should CDRH be allowed to fail?

Hi Julie:
I wasn't at the conference so I'm only responding based on the information that is available in your post; however, yes CDRH should be allowed to fail and that doesn't mean increased patient risk - or as you mentioned industry risk.

CDRH and FDA work diligently to put new programs in place that benefit the public health and access to new technologies, but just like everyone else, CDRH is made up of people - people just like you and me. If we "industry" or "the American People" expect them to be unfailing, then we can also expect change in regulation, policies, guidances, etc to come to a screeching halt. Who will try to be innovative when there is no room to fail?

When CDRH puts a new program into place it doesn't mean that they are being reckless regarding the level of scientific information required to determine safety and efficacy. Modernization is going to mean stepping into the unknown from a regulatory structure and review standpoint, but it doesn't mean stripping out the intelligence and experience of the reviewers on the files. They are the front line in knowing what questions need to be asked no matter what the program.

It is in telling the Agency that they cannot fail that we fail the American Public, stifle innovation, and get left behind globally.

------------------------------
Andrea Artman
Frederick MD
United States

Original Message:
Sent: 06-May-2019 13:05
From: Julie Omohundro
Subject: Should CDRH be allowed to fail?

I'm trying to figure out what to make of Jeff Shuren's statement at last week's FDLI meeting, that CDRH should be allowed to fail.  This was in the context of its efforts to "modernize."

I'm having a hard time seeing how CDRH could fail at much of anything without harm to patients.  And probably to the industry, as well.

I'm also puzzled as to who it is that could give CDRH permission to fail, and what that permission would look like.

Anyone have any insights here?  Maybe I'm missing something.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

So I've pondered this topic some more and have decided that, if CDRH wants permission to fail at "modernizing" its processes for, say, purchasing office supplies and making travel arrangements, fine with me.  If it wants permission to fail at modernizing its processes for achieving its missions, that's another matter entirely:

• protecting the public health by ensuring the safety, efficacy, and security of medical devices;
• helping to speed innovations that make medical products more effective, safer, and more affordable;
• helping the public get the accurate, science-based information they need to use medical devices;
• fostering development of medical devices to respond to deliberate and naturally emerging public health threats.

That strikes me as the same thing as a medical device manufacturer saying it wants permission to fail at "modernizing" the processes by which it produces its products.  If failing means it tries but its "modernized" processes never produce products that can be shown to be substantially equivalent or safe and effective (or even "classified" or "granted"), and therefore it never sells any products produced with its "modernized" processes, fine.  If failing means it tries and ends up selling products that...oops...turn out to not to be, then not at all fine.

I wonder if CDRH has change control procedures in place for its processes.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 06-May-2019 13:05
From: Julie Omohundro
Subject: Should CDRH be allowed to fail?

I'm trying to figure out what to make of Jeff Shuren's statement at last week's FDLI meeting, that CDRH should be allowed to fail.  This was in the context of its efforts to "modernize."

I'm having a hard time seeing how CDRH could fail at much of anything without harm to patients.  And probably to the industry, as well.

I'm also puzzled as to who it is that could give CDRH permission to fail, and what that permission would look like.

Anyone have any insights here?  Maybe I'm missing something.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

I'm also still hung up on the question of who it is that could give CDRH permission to fail, or, perhaps more to the point, who it is that CDRH feels the need to get permission from, as well as the question of what that permission would look like.  Or maybe the better question would be, what a lack of that permission would look like.

Because I heard this at the FDLI meeting, the first possibility that comes to mind is device lawyers.  Not sure what that would mean in terms of why their permission is needed, or of what permission or lack thereof would look like.  I am interested to see if this was a one-time comment, or if this is something that has been incorporated into Shuren's "stump speech."  That would suggest permission is needed from a broad range of constituents.  Why, I don't know.

If anyone hears this statement at other meetings, would be very interested to know which one(s).

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 06-May-2019 13:05
From: Julie Omohundro
Subject: Should CDRH be allowed to fail?

I'm trying to figure out what to make of Jeff Shuren's statement at last week's FDLI meeting, that CDRH should be allowed to fail.  This was in the context of its efforts to "modernize."

I'm having a hard time seeing how CDRH could fail at much of anything without harm to patients.  And probably to the industry, as well.

I'm also puzzled as to who it is that could give CDRH permission to fail, and what that permission would look like.

Anyone have any insights here?  Maybe I'm missing something.

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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
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At the recent MDIC meeting, Shuren was again talking about failing, although this time not asking for anyone's permission and with the caveat, not in a way that would adversely affect patient safety. (Good luck with that.)  This time it was that it "needs to be able to fail." 

Despite all the inspirational slogans about success that you read all over the internet, failing is one of the very few things that you can reliably do, just because you want to, without anyone's permission, and without reliance on luck, skill, talent, knowledge, or much of anything else.   Seems to me that CDRH shouldn't need to be able to fail, but should already be quite able to fail if it wants to. In that case, what's the point of saying this?  Why not just do it?  Is this more talking instead of walking?

I think it's a good bet that he hasn't said this just twice, and I just happened to be present both times.  It's more likely that he keeps saying it.  I fear it's become part of his stump speech.  Stump speeches are normally meant to be inspiring.  Do you find it inspiring for the head of CDRH to keep harping on failure? I know I don't.

At this point, I just want to throw up my hands and walk away, but that's not in my nature, so we'll see how that works out for me.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 06-May-2019 13:05
From: Julie Omohundro
Subject: Should CDRH be allowed to fail?

I'm trying to figure out what to make of Jeff Shuren's statement at last week's FDLI meeting, that CDRH should be allowed to fail.  This was in the context of its efforts to "modernize."

I'm having a hard time seeing how CDRH could fail at much of anything without harm to patients.  And probably to the industry, as well.

I'm also puzzled as to who it is that could give CDRH permission to fail, and what that permission would look like.

Anyone have any insights here?  Maybe I'm missing something.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------