10 Tips to Help Prevent a Medical Device Development Failure

We asked industry experts, including our collaborative product development partners Farm and Sunrise Labs Inc. to share their experience and tips on how to prevent failure during the development phase of a medical instrumenation project.  End_Effector_Circle

10 tips from those in the-know on how to fend off medical development failure:

KMC's Jerry Sevigny"Collaborate as a team and bring up issues early. Communication is key to preventing medical product development failure. If the team doesn’t communicate and you act as islands, you can end up with a big disaster." 
Jerry SevignyKMC Systems Senior Principal System Engineer


Farm's Jon Taylor"Apply for a Provisional patent and let it lapse (i.e. do not convert it into a true patent application in the one-year grace period). This can cause major problems in a crowded IP space." 
Jon TaylorFarm Principal Engineer


Sunrise Lab's Eric Soederberg"Discovering late in the product development cycle that the present product design can’t meet a critical requirement is a nightmare. The key to avoiding this is to identify critical performance challenges early; then build and test proof of concept prototypes in areas that present technical risk." 
Eric SoederbergVice President and General Manager, Sunrise Labs Inc.


KMC's Mike Kallelis"Choosing a medical device manufacturer because they’ve told you they’re the quickest and cheapest is risky in medical product design. Do your research, take experience into account and listen to why a project might take longer or cost more before making your decision." 
Mike KallelisKMC Systems Business Development Director


Farm President Jack Harkins"Poor program management and ongoing communication of requirements. Create a solid development plan and staff PM with experienced people who have both deep technical and good communication skills." 
Jack HarkinsFarm President


KMC Systems Director of Quality Assurance and Regulatory Compliance"Inadequate verification and/or validation of design changes. Using a risk-based approach, ensure that an appropriate level of testing, analysis, demonstration, or inspection is performed and documented to ensure the right solution has been proposed and there will be no unexpected side effects from the change." 
Gail WiegandKMC Systems Director of Quality Assurance and Regulatory Compliance


Beth Loring of Farm"Failing to do any usability engineering, submitting to the FDA for 510(k) or PMA approval, and having the FDA reject the application and require usability validation testing!" 
Beth LoringFarm Vice President, Research and Usability


KMC's Dan Frisbie"Moving from prototype, to transition for manufacturing too soon can actually slow you down. If the design, BOM and CAD models are incomplete, there will typically be many engineering changes. Those changes at this stage create a lot of extra rework and scarp as we wait for new parts. Go slow to go fast!" 
Dan FrisbieKMC Systems Senior Principal Manufacturing Engineer and Manager of the Manufacturing Engineering Group


Sarah R 56 x 56"Rushed design, due to unrealistic time or budget expectations. How to prevent it? Set design requirements as early as possible and estimate budget and timeline appropriately to fit with sufficient buffer to deal with unexpected issues. Be flexible with both budget and timeline to account for changes in design requirements." 
Sarah ReedFarm Associate Program Manager


KMC's Bob Evans"Don’t minimize or overlook the importance of the design effort for shipment packaging or it will sneak up and bite you. Be sure to understand the shock and vibration fragility levels of the subsystems and components in your instrument. This data is critical for the design of appropriate isolation and packaging methods to prevent damaging transmittance of external-shipment-induced forces to the instrument. Of course, packaging designs must accommodate the non-operational temperature extremes as well and transport by ship or plane can add additional challenges. The last thing you want on any program is to damage an instrument while going through your verification testing, resulting in schedule delay and added cost. Or, even worse, would be shipping a product that arrives at a customer site DOA!" 
Bob EvansKMC Business Development and Marketing Manager

It's important to employ good medical device design and manufacturing practices in every stage of a project. To learn more about KMC Systems' medical instrumentation development capabilities, download the fact sheet. 

Download the KMC Development Sheet

Do you have a medical device development project horror story of your own? Please share it - and how to prevent it – in the comments below!

Topics: medical equipment manufacturing, medical device manufacturer, medical device development