There are lots of stories about FDA recalls where the FDA notes that if the vendor had followed the FDA’s approach, the recall could have been avoided. With that as our inspiration, our blogging team of medical device designers, developers, QA/RA, and manufacturing professionals recently brainstormed 11 medical device development mistakes that have surfaced multiple times in a variety of products.

 

Skip a thorough design review

By skipping a holistic design review you may miss critical changes. For example, if you change a part and overlook how it connects with the other parts, you may lose backwards compatibility with some of the original.  As a result, you will have to re-order parts, which could increase costs.  Instead of speeding up the project, you are often wasting time, money, or both.

Skip Alpha & Beta development phases

Skipping Alpha & Beta development phases and moving directly to manufacturing with an early prototype is usually a big and expensive mistake, or, at the least, a very painful exercise.  If time is truly of the essence, it may be worth it at the sacrifice of cost later.

For one project, the number of NCRs & ECRs created due to the rush to manufacturing almost broke our systems completely. It was costly to manufacture, but deadlines were met in record time and the gamble paid off.

Document poorly

Re-doing documentation costs time and money. You can lose a good regulatory submission because of poor documentation. This will cause a significant delay in bringing the device to the market.

Ignore potential issues

Potential issues are often ignored with the hope and assumption that all will be fine in the end. Instead, this usually results in a bunch of work needing to be redone once the issue becomes unavoidable and finally explored properly. It is faster and less costly to open that can of worms at the beginning.

Ignore impending regulation

Inadequate documentation is unlikely to improve over time. Although, to be fair, things were different 20 years ago. Only a small stack of papers was required for a 510(k) clearance. Now the size of the submission for 510(k) clearance is equivalent to what used to be Premarket Approval (PMA). The regulations have changed. Has your documentation procedure adjusted accordingly? The idea of ignoring an impending regulation until it comes into force gets expensive when you have to rush to meet the new standard.

Ignore secondary market regulation

Another costly mistake is when you design with the North American market as your focus and then want to quickly and suddenly expand into the European market. Much of the labelling requirements and electrical wiring colours will need to be changed. Not to mention meeting addition requirements like REACH.

Fail to quickly focus

”Hmm, maybe I like this feature from Option B with Option A. Can you make up a new version and we can talk about it?” Keeping too many options open often encourages decision paralysis or unlimited variations.  Many decision makers are indecisive when they have too many options. Instead they ask for updates of every single option, using up lots of time and effort. Narrow down the options sufficiently before seeking decisions.

Fail to fully understand your market

Knowing your market, where your device is going and how it’s going to be used are basics that need to be fully understood before you decide on its embodiment. For example, to change a device from a self-standing unit to a desk top unit required almost a year and half of development. The delay caused much unhappiness due to a lack of focus on what users actually wanted.

Define an intended use that is too broad or too narrow

Not effectively narrowing down your intended use soon enough is a common mistake. You need to nail that down and not try to meet the entire potential market’s requirements.

The other end of that spectrum is narrowing down your options too soon. It’s easy to assume without testing that your solution is the path. The result is often getting way down the road and then realizing “it’s too late we can’t change that!”  This is when your design reviewer or rubber duck debugging helps. Rubber duck debugging is the act of explaining your solution out loud to a third party (inanimate or otherwise) and discovering issues as you try to explain it.

Add team members without adequate debriefing

Sometimes a project starts with no technical / ID person assigned. This is not the problem. The mistake comes when a person is identified and assigned a task without a thorough walk-through of the complete project.  It is no surprise later on when the new team member misses one of the important use cases of the device.

Make sure new team members have the opportunity to understand Use Cases completely instead of just being assigned to deliver a task. This shortcut often turns out to be a costly mistake. Instead, make sure all team members consider the whole problem, not just deliver on a specific task.

Misclassify a device

Team members still recall a mistake from a long time ago, when a device was assumed to be Class II.  In the end, Health Canada confirmed it to be Class III. The new submission required a huge amount of additional evidence and documentation. That was a costly mistake.

It also happens on a smaller scale.  There are standards for particular classes of devices.  If your design doesn’t account for a standard early on, it will cost you dearly.  Which leads to another costly mistake – not talking to the FDA early on in a project.

And so we end our blog with the organization that inspired it.  When in doubt, talk to the FDA or other regulatory authority.  After all, if you follow their approach, recalls/warnings/costs will likely be avoided.

Astero StarFish is the attributed author of StarFish Medical team blogs.  We value teamwork and collaborate on all of our medical device development projects.

 


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