Manufacturing

Making Time for Medical Device Manufacturing

Christopher Rannefors / March 1, 2016

Medical device machining accounts for an astounding 50% of annual R&D spend in the United States and has an estimated market size of $170 billion in 2017 (IBISWorld & SelectUSA). Given MakeTime’s excellence in R&D manufacturing, it was clear to us that we needed to take a deeper dive into the world of medical devices. Our first order of business was exhibiting at the “Superbowl of Medical Device Manufacturing”, MD&M West in Anaheim, CA this past month. During our time at the conference we were well received by industry veterans such as Viacyte and York Industries who were curious to learn more about our model. Our positive reception and joint marketing efforts with our new partner Autodesk only helped further validate our involvement in the space.

Medical device machining is a complicated market and it’s easy to get caught in the weeds, so knowing exactly where MakeTime fits is incredibly important. The FDA classifies medical devices in three different groups:

  • Class I devices are low risk and subject to minimal regulations
  • Class II devices are higher risk and require greater regulation to ensure safety
  • Class III devices are subject to rigorous regulations and often require FDA approval

Each of these classes have incredibly complex supply chains and often lack transparency. The number of FDA warning letters sent out have almost doubled in the past few years due to excessive field failures, poor quality parts, or lapses in communication regarding design changes (medicaldesign.com). On top of all that, constantly evolving FDA regulations as well as technological enhancements mean new products often fail to comply or maintain relevancy by the time they hit market.

Like a moth to a flame, these pain points drew us in. MakeTime’s networked supply chain cuts lead times and guarantees on-time parts delivery. Our strategic sourcing model illuminates the low visibility in the market and allows purchasers to cover their contingency planning in case of any unexpected changes. If one supplier ever falls down, we have hundreds more in the MakeTime network to take their place. This also presents opportunities for timely re-work or extensions of in-house CNC capabilities. Linda Braddon, President of Secure BioMed Evaluations, said last year that, “Perfection in device manufacturing — or in any manufacturing — comes from shaping a system and a supply chain that is reliable, validated and reproducible (Medical Product Outsourcing),” and we couldn’t agree more.

With these advantages, MakeTime is well suited as the go-to resource for R&D across all classes of medical devices. When it comes to production level runs, MakeTime’s supplier base is perfectly tuned to work with almost all Class I medical device makers, but will have to grow into Class II and Class III devices as we add more medical specific suppliers to the network over the coming years. During that time, the medical device industry is poised to grow rapidly and desperately needs new services to adapt to an ever-changing technological and regulatory landscape. We don’t pretend to be an end-all solution for medical device machining, but rather we want to act as a high speed vendor to help fill the gaps in existing supply chains. See you all at MD&M West 2017!