Making Time for A Medical Device Testing System

Posted by Steve Beyer on Feb 17, 2016 10:39:10 AM

Medical Device Testing


It’s what everyone wants and needs more of, and it’s all metered out the same.

When we think about time in the context of our work, it often falls into conversations like, “we are out of it” or “there’s not enough of it” or “I wish we had more of it.”

The fact of the matter is, you’re not getting any more!

 Your best strategy: don’t give it away up front on your project.

A recent project with a global manufacturer of medical devices had us collaborating with our client’s regulatory, R&D, manufacturing and legal teams months before the anticipated kickoff of the body of the project. As the lead systems integrator, our respective project managers began to “straw-man” out the project with sponsors inside the client and our company. This preliminary engineering phase had us looking at many dimensions of the program for this device. 

The client’s business development team couldn’t join at the time; they would catch up later.  We went ahead without them for the time being, and developed the user requirements, schedule, validation plans, and so on. For about six months, we diligently drove the project plan forward, gaining clarity, setting expectations. The ISO:13485 plans were modeled, tested, and refined early. We touched base several times with BusDev with our plans, informing them of our trajectory and left them with questions to be answered when the time was available. 


When the time came and the BusDev team joined in on the effort, we learned the entire business case had evolved nearly 180 degrees.  The pivot was caused by a new device in the same space from a start-up that was previously not expected to have had much impact owing to expected lags they were likely to encounter in their qualifications and FDA/CMMS submissions and trials.  But the new device was getting fast-tracked and was speeding ahead.  As a result, new requirements, features, and tests were needed.  BusDev was accelerating the product announcement for an upcoming trade show instead of waiting for the company’s annual meeting.  Prototypes were needed NOW and we weren’t going to have time to iterate the way we had hoped.  “Lean” would be an understatement.  We were in for a ride.

Time was of the essence, and we were running out of it.

In the end, the prototypes got to the show in San Diego, and they worked, and the device is helping people afflicted with this disorder.  Mission accomplished.

I failed to mention that there were voices early on suggesting that, without the BusDev team’s participation, it would not be worth starting the preliminary engineering process.  Without all stakeholders we wouldn’t have the whole picture, and we all know things change, so why waste time?  We didn’t waste time—we invested it.  Our payback was the planning and pre-thinking that went into the contingencies, alternatives, plans, and considerations that were well-enough understood by the time BusDev tossed in the wrench that we could adapt what we had instead of beginning from a cold start. 

It was stressful to be sure, and we burned a lot of cycles but the time invested in that was not for naught.  Our paperwork had to change, certainly.  The test equipment “IQ-OQ-PQ” protocols planning still had tremendous value, the test fixtures we envisioned had to adapt but were valuable.  The patent searches and claims were revised, not started from scratch.  In short, the time was well spent even given the curve ball thrown at us.  The FDA paperwork was underway and needed modifications to be sure, but the parallel approach in the early months clearly saved significant time in the ultimate project lifecycle.

While we can’t share exact figures, it is understood that a delayed entry would have lost irreplaceable revenue, market share, and credibility for our client.  We all know that revenue earned up front is the richest, best, and most difficult to later match.  Early adopters, competitive advantage, time value of money, etc.  But that is for another post.  Suffice to say that spending time wisely with as many team members as practical, including your system integrator, is the smart way to get out in front of the challenges and surprises that accompany nearly every project. 

Start now, and see how Optimation can help.  For case studies and capability overviews in medical devices testing development, manufacturing, and medical device testing visit our specialty pages on our website, or contact us.  We will make the time.

Topics: Purchasing, Project Management, Test Systems

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