Regulatory Open Forum

Hello, everyone!

An interesting scenario has been posed to me by my development team and I'm unsure of how to analyze it. Here's the scenario...

We have a customer that works at a university and conducts research utilizing an investigational device that he's purchased from us. This particular device has wired sensors and the customer would like to work on making wireless sensors (note, our IP covers this). However, to complete his work he'd require some information from us (e.g. specifications). Initially, he's planning to complete this work with non-clinical sensors that my company would loan to him. Taking what he'd build using non-clinical sensors, he would apply the design to his investigational sensors and obtain IRB permission to utilize them in his clinic. He may publish his findings.

Our intention is to not utilize his design and put them through our design control process.

Information sharing would be via an NDA; we would not be a sponsor, but only providing information and loaning hardware.

Does this present any problems from my company's perspective? I'm unsure of how to approach this issue since we have no control over how a customer uses a device they've purchased.

Any assistance would be much appreciated.

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Tonia Bryant
Director, Quality & Regulatory Affairs
Cary NC
United States
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I don't know the answer to the biz risk or legal aspect, but an IDE requires design controls. Of course, design controls exist within a QMS. FDA expounds on this topic https://www.fda.gov/medical-devices/how-study-and-market-your-device/investigational-device-exemption-ide

There are some exceptions, which can be checked in 21 CFR 812.

Hope it helps.

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Adam Atherton
Farragut TN
United States
------------------------------

Original Message:
Sent: 17-Apr-2020 11:43
From: Tonia Bryant
Subject: Customer Asking to Design

Hello, everyone!

An interesting scenario has been posed to me by my development team and I'm unsure of how to analyze it. Here's the scenario...

We have a customer that works at a university and conducts research utilizing an investigational device that he's purchased from us. This particular device has wired sensors and the customer would like to work on making wireless sensors (note, our IP covers this). However, to complete his work he'd require some information from us (e.g. specifications). Initially, he's planning to complete this work with non-clinical sensors that my company would loan to him. Taking what he'd build using non-clinical sensors, he would apply the design to his investigational sensors and obtain IRB permission to utilize them in his clinic. He may publish his findings.

Our intention is to not utilize his design and put them through our design control process.

Information sharing would be via an NDA; we would not be a sponsor, but only providing information and loaning hardware.

Does this present any problems from my company's perspective? I'm unsure of how to approach this issue since we have no control over how a customer uses a device they've purchased.

Any assistance would be much appreciated.

------------------------------
Tonia Bryant
Director, Quality & Regulatory Affairs
Cary NC
United States
------------------------------

Hi Tonia,

There is probably a bit more information needed, but based on what you are saying it seems like having a clinical study protocol in place with IRB approval might be sufficient.  As Adam mentioned the relationship with proprietary information, NDAs, roles and responsibilities should all be defined and in place outside of the clinical requirements.  Whether you need an IDE or not if depending on if the device is considered significant risk or not.  Depending on these sensors or non-sensors changes/adjustments being made to the device, you will need to understand what and how the device would be used in a clinical setting with patients.  Then determine whether significant risk or non-significant risk.  This could be the difference between just having IRB approval or having IRB approval and FDA IDE.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 17-Apr-2020 20:23
From: Adam Atherton
Subject: Customer Asking to Design

I don't know the answer to the biz risk or legal aspect, but an IDE requires design controls. Of course, design controls exist within a QMS. FDA expounds on this topic https://www.fda.gov/medical-devices/how-study-and-market-your-device/investigational-device-exemption-ide

There are some exceptions, which can be checked in 21 CFR 812.

Hope it helps.

------------------------------
Adam Atherton
Farragut TN
United States

Original Message:
Sent: 17-Apr-2020 11:43
From: Tonia Bryant
Subject: Customer Asking to Design

Hello, everyone!

An interesting scenario has been posed to me by my development team and I'm unsure of how to analyze it. Here's the scenario...

We have a customer that works at a university and conducts research utilizing an investigational device that he's purchased from us. This particular device has wired sensors and the customer would like to work on making wireless sensors (note, our IP covers this). However, to complete his work he'd require some information from us (e.g. specifications). Initially, he's planning to complete this work with non-clinical sensors that my company would loan to him. Taking what he'd build using non-clinical sensors, he would apply the design to his investigational sensors and obtain IRB permission to utilize them in his clinic. He may publish his findings.

Our intention is to not utilize his design and put them through our design control process.

Information sharing would be via an NDA; we would not be a sponsor, but only providing information and loaning hardware.

Does this present any problems from my company's perspective? I'm unsure of how to approach this issue since we have no control over how a customer uses a device they've purchased.

Any assistance would be much appreciated.

------------------------------
Tonia Bryant
Director, Quality & Regulatory Affairs
Cary NC
United States
------------------------------