Why Your Medical Device QMS Should Match the Size of Your Company

Medical device startups tend to share many common issues. They are usually striving for better resources (such as people and capital) as well as the knowledge and expertise required to deal with the U.S. Food and Drug Administration (FDA) and successfully bring a product to market.

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For many startups, a quality management system (QMS) might not appear to be a priority, but I’m here to tell you it needs to be.

I had a chat with David Amor not so long ago about this very topic and why startups need to implement a “right-sized” QMS. Amor is the managing partner at Qara Partners, as well as a board member at both AdrenaCard and RemindTrak. Amor’s a man of many hats and has considerable experience in the world of medical device quality, regulatory, and R&D. He also serves as an adjunct professor at St. Cloud State University in Minnesota, where he teaches courses on quality, risk management, and design controls.

We recently had a talk about startups and the important aspects they should consider with a QMS.

What do we mean by ‘right sized?’

Amor has usually seen medical device startups falling into one of two traps when it comes to a QMS. Many startups:
• Have no idea about a QMS and what it entails. They might have a napkin sketch of a product they would like to develop, but they freak out when they learn about all the regulatory requirements involved. They think the battle is done when they get to market and don’t think about commercializing and compliance issues.
• They might overestimate what is involved for a QMS. The startup might overburden itself by assuming it needs to have a heap of documentation; however, regulatory authorities don’t expect premarket startups to have a lot of documents already.

This brought up a story from work I had been involved with a handful of years ago. I was working with a startup in a consulting capacity. They founders had some funding but were working on a shoestring budget while waiting for a large cash injection. They wanted my help with work on a quality system because they were struggling with it a bit.

When I got in there, I noted that the current QMS was actually a very impressive system, which had been put together for them by another expert. It had everything, which really was the root of the problem for this company. It was overburdened with compliance, which meant it just never kept up with it.

A lot of people in startups are ex-employees of bigger organizations. They think they should bring in the same processes they were used to, but find it’s too much. Companies can blow a lot of money on a robust QMS, but this only ends up slowing them down. If you think about the end result of this, patients will be affected because the device will be slower to market.

What exactly do you need to know to ensure you have a QMS that makes sense?

For Amor, there’s a common question that is asked: What is enough? What are the key parts of a QMS that are an absolute must?

His simple answer: Let’s just see what the FDA says. They tell us in their own documentation and, surprisingly, it’s not a particularly big task to read through it.

Here are the key basics:
• Management controls. Your company should have good managerial oversight, access to resources, and experienced knowledge.
• Design controls. Complying with FDA 21 CFR 820.30 is key to developing a quality product.
• Corrective and preventive actions (CAPA). This is the FDA’s “window” into your company. Inspectors have said that they’ll look at the CAPA process as an indication of how well other processes are managed.
• Production and process control. How you are controlling the process to ensure that you’re producing a well-designed, safe, effective device?

As a very basic strategy, simply follow the guidelines the FDA has already provided.

I recommend that if you’re still in product development and haven’t submitted your 510(k), you can’t do much with CAPA. When in pre-market, you need to be lean and flexible. There are no nonconformances if the product isn’t out the door yet.

There’s a period to stay lean during the early post-market stage, as well. The level of compliance should be commensurate with the risk of the product. For example, a toothbrush doesn’t have the same product risk as a pacemaker.

From a startup perspective, though, it can be overwhelming getting to a point where the necessary steps are understood. The key will always be to start with the regulations and focus on those key points. It is also helpful to hire an experienced consultant for practical advice.

It’s not just about having the QMS at the end of the day; it’s about having the records and documentation, and putting them to use. How can you use them to make improvements?

The importance of your design history file

A good example of what happens when you don’t have a robust system is what happened with the decline of Theranos. The company lacked a real design control process, which can be seen in its documentation. Amor warns that, while Theranos might have been able to get away with it as a smaller company, it most certainly can’t now that it has scaled. Every startup should be aware of this: You will attract FDA interest as a scaled company.

Every startup wants to be huge, but be aware that the FDA’s expectations for a QMS will also be higher. Build the foundation as a small company so that you’re able to scale it as you grow. Get that “right-sized” QMS for where you are right now.

If you’re ever questioning the size of the QMS you need, take a look at what the regulations say. They actually do provide guidelines that tell you they don’t expect the same level from smaller, less complex companies. This applies to both the FDA and ISO environments.

On a recent consulting job, David heard from a European regulatory body that said “we care more that you are following your procedures, not that your procedures are the best in the world.” This totally makes sense. They want to see a working QMS and that you demonstrate meeting requirements in some way, which is better than a complex system that ultimately doesn’t get followed.

In another recent example, a startup called having their 510(k) clearance in place already and they had suddenly realized they needed a whole lot of aspects to a QMS that they hadn’t even started, including design controls and risk management. How on earth did they put together an acceptable 510(k) without design controls?

David agrees - it makes sense that you should develop a product under design controls. The FDA wants to see that you’ve demonstrated equivalence, or that you are at least as, or more safe than a similar company. Using that documentation would be an easy and practical way to demonstrate that equivalence.

Keeping up with your design history file will probably make your 510(k) submission easier. Shouldn’t you have objective evidence to prove that you’ve designed your device properly and tested it?

Most failures prior to the introduction of design history file requirements were found to be related to design. As engineers and developers, we should have control of our design and show our planning through to validation. Was it the right product, and has it been built well?

Final thoughts

Navigating medical device compliance can be a daunting task at all levels, but most especially if you’re a fairly green startup. To sum up, keep these few tips in mind:

• Quality management systems should be a priority; however, work on having one that is “right sized” for your company.
• There is no such thing as a non-conformance if you are pre-market. This eliminates CAPA, but that is a clear system you will need in place once you’ve gone to market.
• Keep a good design history file from the beginning. This will not only assist with your 510(k) submission, but will also help you as you scale up.

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