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