It’s tempting to believe that the heavy lifting is over once the first prototype is working. In my experience, that is very rarely true if the device is in any way programmable, if it has moving parts, cover panels with mating surfaces, or even a rudimentary user interface. In the tightly-regulated medical environment, the heavy lifting almost certainly comes on the back end of the development cycle, so it makes great sense to plan for it early, and plan for it well.
A major miscalculation is made when over-anxious entrepreneurs decide that a great product idea and a mostly-working prototype is ready to be fast-tracked into a production context.
“But the prototype works, and it looks great!” some clients say. “The customers are lining up and I need to generate revenue right away, so just order the parts and build it!”.
What they don’t realize fully is that elements of great design for a proof-of-concept prototype are very different than those of a mature, transfer-ready product. Further, they often don’t accept that the latter necessarily descend from the former; that a disciplined development process with input from Manufacturing and Regulatory departments leads to substantial reductions in overall product risk, cost, and project time through the Transfer process and into Production.
The Transfer and Sustaining Engineering stages require much finer and broader control on component or feature changes, documentation, traceability, inventory, and quality management. This is an inescapable artifact of volume-based manufacturing economics and a highly regulated field of endeavour.
Starfish is nearing transfer completion of a new and innovative medical device onto its Production floor. The process has been seamless and has cost considerably less than comparable transfers have in the past. Here’s what Starfish recommended the client do:
- Commit to Quality. The client embraced the value of implementing a quality policy early. They had already decided to install their own Quality Manager, and were working with a regulatory consultant. They purchased and integrated key pieces of Starfish’s proven “Anataomy of a Healthy Transfer” regulatory templates to supplement their internal Quality Management System, and thus saved many hours developing documentation and de-risked their regulatory path simultaneously.
- Leverage Experience. The client understood the importance of production controls, being the offspring of an established electronics design and manufacturing firm. Rather than question the need for production controls, they insisted on them.
- Leverage Expertise. The client contracted Starfish to participate in detailed Engineering reviews of the product prior to Transfer. Starfish personnel recommended a number of changes that resulted in design improvements and BOM cost reductions.
- Incorporate DFM early. The client recognized the value of Design-For-Manufacture principles and trained Starfish manufacturing personnel in their assembly processes before starting the formal transfer. Starfish manufacturing staff worked with the product directly and de-risked production processes prior to quoting, resulting in reduced labour quotes and a much better understanding of critical control points and unit test requirements.
- Design for Regulatory Compliance. This important input to process is often missed, and is very expensive to incorporate after the fact. Our client already understood the requirements and significance of IEC-60601 and verified their compliance as the design evolved. They contracted Starfish to review design documentation (including software source code) and develop verification plans in anticipation of the firm’s forthcoming IEC-60601 Edition 3 submission.
The above steps outline the anatomy of a healthy transfer.
A holistic view of the entire project and the willingness to partner with experts in medical device design and manufacturing environments maximize the likelihood that a product design will mature successfully through the transfer process and be well prepared for volume production.