Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

I'm looking for information on the number of regulatory resources within a company based on company size and global footprint to benchmark our team's current resources against.  Thanks in advance for any information.

There are some reports out there you can buy on this. However, having tried to do this a number of times, I can say it is insanely difficult. Business leaders like to think it is like a sales force "each territory should have $XX in sales" but regulatory is far more complex than that. When I worked for larger companies we even paid outside consulting firms to assess this, and still we didn't get what we needed.

Some things to consider:

- number of products company has
- number of changes those products undergo
- number of products in the pipeline
- number of geographies
- specific geographies (China takes more resources than Argentina)
- product classifications - EU Class III take more resources than Class !. In the US, PMAs take more resources to maintain than 510(k)s
- product complexity (difficult science or product complexity - like capital equipment and software) take more time to put together and maintain than something like a simple splint or even a well established implant
- skill levels of employees - more junior (cheaper) staffing often is less efficient than more experienced staff
- language - do you work in local languages or in one language and use translators?

The list goes on. If you can find a pretty close match for all that, then you can benchmark. Otherwise you'll end up with confusion. I once had a situation where we "benchmarked" and found a firm who had 1 RA person for $100 million in implant sales. This was used as evidence for why we "did not need 4 people." However, they forgot to note that while their implants were 510(k) ours were PMA, and that they didn't count said companies OUS RA staff, and that there were no drug/device combos in their mix. All of which made our needs quite different, benchmark or no benchmark.

If you really need this data, try giving much more detail on the categories you need to match.

g-

------------------------------
Ginger Glaser RAC
Vice-President, Engineering
MN
------------------------------

Original Message:
Sent: 09-Oct-2017 12:21
From: Anonymous Member
Subject: Regulatory Resource benchmarking

This message was posted by a user wishing to remain anonymous

I'm looking for information on the number of regulatory resources within a company based on company size and global footprint to benchmark our team's current resources against.  Thanks in advance for any information.

This message was posted by a user wishing to remain anonymous

Thanks for the response.  I'm looking to benchmark regulatory team support for a mid-size company:  1000-2000 employees, sells products to global markets (EU, Canada, US, Japan, China, etc.) around 100 countries in total, annual sales $300-$500M, class 1 and class 2 products.  Team supports both sustaining products and new product development.  New product development pipeline averages 5 projects at a time, and sustaining product changes are frequent and on-going. Team also supports staying abreast of all applicable regulations (med device, pesticide, environmental, etc.) for products.
Original Message:
Sent: 10-Oct-2017 11:28
From: Ginger Glaser
Subject: Regulatory Resource benchmarking

There are some reports out there you can buy on this. However, having tried to do this a number of times, I can say it is insanely difficult. Business leaders like to think it is like a sales force "each territory should have $XX in sales" but regulatory is far more complex than that. When I worked for larger companies we even paid outside consulting firms to assess this, and still we didn't get what we needed.

Some things to consider:

- number of products company has
- number of changes those products undergo
- number of products in the pipeline
- number of geographies
- specific geographies (China takes more resources than Argentina)
- product classifications - EU Class III take more resources than Class !. In the US, PMAs take more resources to maintain than 510(k)s
- product complexity (difficult science or product complexity - like capital equipment and software) take more time to put together and maintain than something like a simple splint or even a well established implant
- skill levels of employees - more junior (cheaper) staffing often is less efficient than more experienced staff
- language - do you work in local languages or in one language and use translators?

The list goes on. If you can find a pretty close match for all that, then you can benchmark. Otherwise you'll end up with confusion. I once had a situation where we "benchmarked" and found a firm who had 1 RA person for $100 million in implant sales. This was used as evidence for why we "did not need 4 people." However, they forgot to note that while their implants were 510(k) ours were PMA, and that they didn't count said companies OUS RA staff, and that there were no drug/device combos in their mix. All of which made our needs quite different, benchmark or no benchmark.

If you really need this data, try giving much more detail on the categories you need to match.

g-

------------------------------
Ginger Glaser RAC
Vice-President, Engineering
MN

Original Message:
Sent: 09-Oct-2017 12:21
From: Anonymous Member
Subject: Regulatory Resource benchmarking

This message was posted by a user wishing to remain anonymous

I'm looking for information on the number of regulatory resources within a company based on company size and global footprint to benchmark our team's current resources against.  Thanks in advance for any information.

OK, what you describe is close enough to a job I used to have that I can give you one data point. For a little more info, at that job we had about 1200+ employees and sold our products in 50ish countries. We had two divisions, one of which had largely PMA products and the other of which was almost exclusively 510(k) products. We also had drug/device combination products.

At our biggest, when we launched about 4-6 new products a year, we had 25 regulatory employees. If I remember, that included a VP, 4 directors, 2 managers and 18 specialists at various levels. Two regulatory employees were based in Europe and two others exclusively supported our distributor markets.

g-

------------------------------
Ginger Glaser RAC
Vice-President, Engineering
MN
------------------------------

Original Message:
Sent: 12-Oct-2017 12:43
From: Anonymous Member
Subject: Regulatory Resource benchmarking

This message was posted by a user wishing to remain anonymous

Thanks for the response.  I'm looking to benchmark regulatory team support for a mid-size company:  1000-2000 employees, sells products to global markets (EU, Canada, US, Japan, China, etc.) around 100 countries in total, annual sales $300-$500M, class 1 and class 2 products.  Team supports both sustaining products and new product development.  New product development pipeline averages 5 projects at a time, and sustaining product changes are frequent and on-going. Team also supports staying abreast of all applicable regulations (med device, pesticide, environmental, etc.) for products.
Original Message:
Sent: 10-Oct-2017 11:28
From: Ginger Glaser
Subject: Regulatory Resource benchmarking

There are some reports out there you can buy on this. However, having tried to do this a number of times, I can say it is insanely difficult. Business leaders like to think it is like a sales force "each territory should have $XX in sales" but regulatory is far more complex than that. When I worked for larger companies we even paid outside consulting firms to assess this, and still we didn't get what we needed.

Some things to consider:

- number of products company has
- number of changes those products undergo
- number of products in the pipeline
- number of geographies
- specific geographies (China takes more resources than Argentina)
- product classifications - EU Class III take more resources than Class !. In the US, PMAs take more resources to maintain than 510(k)s
- product complexity (difficult science or product complexity - like capital equipment and software) take more time to put together and maintain than something like a simple splint or even a well established implant
- skill levels of employees - more junior (cheaper) staffing often is less efficient than more experienced staff
- language - do you work in local languages or in one language and use translators?

The list goes on. If you can find a pretty close match for all that, then you can benchmark. Otherwise you'll end up with confusion. I once had a situation where we "benchmarked" and found a firm who had 1 RA person for $100 million in implant sales. This was used as evidence for why we "did not need 4 people." However, they forgot to note that while their implants were 510(k) ours were PMA, and that they didn't count said companies OUS RA staff, and that there were no drug/device combos in their mix. All of which made our needs quite different, benchmark or no benchmark.

If you really need this data, try giving much more detail on the categories you need to match.

g-

------------------------------
Ginger Glaser RAC
Vice-President, Engineering
MN

Original Message:
Sent: 09-Oct-2017 12:21
From: Anonymous Member
Subject: Regulatory Resource benchmarking

This message was posted by a user wishing to remain anonymous

I'm looking for information on the number of regulatory resources within a company based on company size and global footprint to benchmark our team's current resources against.  Thanks in advance for any information.