Breakaway Simple


Taking the pratical approach to medical device product development

Take credit for what you do

Between the raw design process, creating design history file deliverables, technical file content, risk management file content, human factors / usability engineering file content, it seems like at times like we spend more time on paperwork versus actually designing, creating and testing the device!

Welcome to the evermore highly regulated world of medical devices.

The device makers are not only mandated to create safe and effective devices that meet the clinical need but also they must prove they’ve followed the regulated design and development (D&D) process as they do so.

It is not enough to just hire a design group, or couple of design engineers, you need development engineers, quality engineers, regulatory specialists, and clinical specialists. If you’ve got software in the device you’ll need a slew of software people as well. Having all the right resources working in parallel will speed the process.

If a small company or start-up is tackling the process of creating new devices, the D&D team members will have to wear many hats. Engineers will have to be equally versed in design but also in writing while following the regulations. This feels to most engineers like it is slowing them down. I cannot argue with that. But realize that it is the price of admission to this industry.

What may be a better mind-set for all folks involved to realize is that we have to spend as much time creating as we do taking credit for what we do. This is done by writing it down.

If you don’t have the proper documentation and the end of the D&D process you’ll end up spending as much time putting it together (and re-doing testing, and possibly re-designing) at the end for the regulatory submission and subsequent release to market as you would have spent doing it along with the process in the first place.

By the way, the rules for design and development of medical devices set up by FDA (21 CFR part 820.30) and the European Commission (92/43/EEC Medical Device Directive per ISO 13485) are meant to ensure the team designs devices to be both safe and effective. They are basically good engineering and product development practices.

So next time you’re feeling bogged down by the paperwork as you move through making a new device, consider it taking credit for what you do. Besides, you can take comfort in knowing that the device used to save you some day was designed and developed in the best system in the world.


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Debbie Barber

Canopy Medical

Kristin Mortenson