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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But this is the way we’ve always done it…

We hear these words several times a week. In our consulting practices, business, and service groups, the need to cling to old ways of doing things is ever present. No one likes change. Even if the current practice is the source of the problem, why change?  It is always a challenge when we go into a new client company and because we see the situation with fresh eyes, we recognize the issues, redundancies or inefficiencies that the folks there for years may not recognize. Sometimes, what happens is the people do know the issues as well…but are not able to make the changes. Sometimes they have chosen to not speak up. However, sometimes they are so close to the problem, they can’t see the forest for the trees. This puts the outside consultant into a unique role. While not everyone is glad to see you, you have been brought in for a reason.

So how do you go about change and keep the company you are working with in compliance, and also happy for the help?

1. Start with a gap analysis to identify issues.

2. Do a systems analysis to identify the issues that make things much more difficult that they need to be.

3. Create a plan to fix the issues and introduce best practices where possible

While the people in the trenches need to see the gaps, the executives need to see the gap and systems analysis and endorse the plan. Miss any one of these key elements and you are not serving your client well. Involving the “doers” in the company in the creation of the plan is a key to success, and without executive support, the plan will fail.

Does this mean that you do an overly cumbersome analysis for every project? Not at all. Whether it is an overall evaluation of quality systems or product development / design control, or a regulatory project, these three steps apply. If you haven’t done this, you won’t be able to effectively articulate why change in a plan, strategy, or system will help and defend against the statement….”but this is the way we’ve always done it”.

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Why Breakaway Simple?

Breakaway….to move away or escape suddenly.  Simple….not involved or complicated.

So why did we decide to name our new blog Breakaway Simple…because we want you or your company to move away from the rest of pack and to learn to do it in an uncomplicated way. We work in the regulated field of medical devices, biologics and pharmaceuticals. Areas that are not likely related with either the words quick or simple, but we believe and have learned through many years of working with startups in this area that it can be done and with very successful results. We hope through this blog to help you through the areas that are often are roadblocks to success and compliance in the regulated medical industry.

You will likely see snippets from our life interwoven as well. We both apply Breakaway Simple to our lives as well. In addition to being busy medical development consultants, we are moms and have many hobbies/interests that help to keep us overly busy. When you are this busy…simple is the only way. I also like to think that we are also breakaway people by nature. We both started our businesses young and have excelled in that area. You will see that we have unique opinions on things (which don’t always agree). We hope that our lives and business experiences are both interesting and helpful to you.

This blog will likely evolve over time. We haven’t done this before. Feel free to let us know what you think and please let us know topics areas that you are interested in. We are looking forward to this new adventure.

So…breakaway from the pack and set yourself apart!

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Debbie Barber

Canopy Medical

Kristin Mortenson