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An alternative to fast failure in medical device innovation

on April 25, 2012 Source: Healing Innovation

We have all read entrepreneurial experts push the idea of allowing yourself to fail.  They even want you to do it fast.  Basically, the longer it takes, the more “wasted money”.  But, for a medical device inventor or company, the more precise advice may be to challenge your weaknesses early because they might fail in time for you to adapt or correct.

As inventors and startup medtech companies, we are often afraid to show our warts, which means avoiding testing our potential Achilles heels, often until way too late in the process, when our decisions are more strained and our options are limited.

While most of us want to be honest and ethical, at the same time we don’t want to unearth remote red flags that will scare investors, regulatory agencies or acquirers.  Potential weaknesses in our product design, business model or infrastructure are too often overlooked by downplaying their impact (discounting the risk or probability of occurrence) or extrapolating from insufficient data.

There is a fine line between pushing through roadblocks to reach our goals, and being in denial.  Wishful thinking can be a medical device project’s downfall.  One extreme scenario is when a bench top simulated model shows the device failing and we justify the lack of a problem by concluding that the in vivo environment would not be as rigorous or the defect would not cause any clinical events.  By the time we find out we underestimated, the hole is pretty deep.

From an engineering perspective, we have tools that help temper our predilection to downplay weakness, such as a Failure Modes & Effects Analysis (FMEA).  When done objectively with a cross-functional team, an FMEA helps a product development team identify design weaknesses and their clinical effects.  This forces the team to mitigate the high-risk items through design changes, more stringent testing, etc.

The problem is that FMEAs are too often conducted after the design is fully baked and changing course is painful.  And, failure modes are just as possible for the business model or project resourcing, yet these facets of the product’s ultimate success are rarely objectively and proactively challenged.

The solution is not to paralyze every decision with over analysis or extreme conservatism.  It’s to attack your weaknesses as early as possible in the evolution of your product and business.  The soft spots are not hard to find, if our eyes are open and we don’t wear blinders.

It is one thing to plan for success, but hoping for the best without challenging weaknesses early is a recipe for unfulfilled potential.

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