Recently I polled some of our senior development staff about the most common mistakes in Medical Device Product development they have seen.  After a bunch of collating and organizing I got the list down to 12 common mistakes.

These I grouped into 3 headings:

• Get the Product Wrong
• Cut Corners in Implementation
• Rush to Market

As you can see from the title of this post, I’ll focus on category #1 today.

Given that entrepreneurial companies are always resource and time constrained some stern advice to do everything perfectly is not helpful and that is not the spirit of this post.  Every action by an early stage company is a decision not to do other important or critical things. My real intention is to outline the costs of not focusing sufficiently in a few key areas.

So without further delay, here are the top 5 ways to get the medical device product wrong. Tune in next for the other two categories.

Don’t Get Enough Clinical Input

This is by far the most common issue we see.  Companies charge into product development without spending enough time watching the procedure they are purporting to improve.  They don’t understand the clinical workflow, or the reaction of the clinicians, or the ergonomics of the surgery well enough to make the decisions they are making.

Big companies with formal ‘voice of the customer’ processes aren’t immune either.  One of my favorite examples is a Big Company intravascular ultrasound system.  In their second generation model a touchscreen was used to replace tried and true tactile operator interface.  We have observed more than one case of operators reverting to the old model despite its disadvantages because they hated the touchscreen.  How much impartial operator feedback did they really get?

Don’t Worry About the Financial Model

Sometimes when a company is technology led there isn’t enough attention paid to the financial model and margins for the product.  The same goes for consumables of course.  Distribution is expensive in the field, especially for novel devices in medical specialty areas.  Manufacturing and supply chain management add significantly to the raw cost of goods.

Sometimes the reimbursement model is not sufficiently considered, or the cost and time required to get a new CPT code is not understood.

Miss Some Critical Requirements

In many cases companies miss critical requirements by not documenting them or by not being aware of changes at the FDA.  Typical examples would be required standards such as IEC60601 for safety, HE75 for industrial design, and ISO62304 for medical software, or ISO13485 for the quality system.

According to ISO13485 and FDA QSR, specifications are supposed to be driven in part by a risk analysis.  Often companies skip that and end up having to layer risk analysis in afterwards which defeats the purpose and exposes them to expensive re-spins.

Not understanding competing IP well enough is another great example.

Don’t think about Regulatory Early Enough

Regulatory clearance is one of the highest risk areas in most development programs.  It should get a lot of attention.  Sometimes projects get quite far advanced before the risk class is figured out.  My friend Bill Saltzstein has convincingly argued that ‘design for regulatory’ is its own discipline. 

The risk class often determines how much clinical data will be required which can be more expensive than the whole product development effort.  We have often seen that the product can be reimagined to drop it down in risk by, for example, making motorized actions manual.  Sometimes the magnitude of the impacts of these design decisions are not understood by those making them.

Don’t Make Enough Prototypes

Companies are understandably concerned about their ideas getting out into the wild.  Often they expose themselves to additional risk by not getting outsiders to look at and try their prototypes. Everybody inside already believes and that prevents them from seeing the obvious usability and functional issues in the prototypes.

Many times we’ve been in situations where expensive redesigns had to be undertaken to resolve fundamental functional issues which could have been bench tested before expensive detailed product design was undertaken.

And that’s it for today’s list.  Each of these is more than a worthy blog topic on its own but that will have to wait for another day.