Contract manufacturing is a term that has been around for decades in the medical device industry. However, medtech companies are increasingly calling these service providers to assume more responsibilities, including design and development. Whether because of pricing pressures, government regulations, or rapidly evolving manufacturing techniques, manufacturers are offering a wider menu and forming business partnerships with medical device companies.
However, every type of outsourcing has its difficulties. There are some tricks to get the most out of it, though.
1. Clearly define roles, responsibilities, and expectations: “For example, what kind of support is the contract manufacturer willing to provide in the early stages? Who will assemble the prototype within each phase? Who will do the testing?”
2. Constant vigilance will minimize surprises: “A lack of communication will inevitably lead to nasty surprises, but “over communicating”—too many e-mails or too many meetings—can negatively affect productivity.”
3. Truly understand the level of each partner’s expertise: “Hope for the best, but plan for the worst.”
4. Fool me once…: “Learn from past mistakes, which often are due to putting off “trivial” issues early on in the process that then turn into much larger problems later on.”
If you are having issues with your medical device contract manufacturer; you are interested in arranging a business partnership or curious to learn more about medical device contract manufacturing, drop us a line! Biokyra is a Biomedical Engineering Company that develops minimally invasive medical devices, from the idea/need to the pre-series production. Our goal is to make your idea become an innovative and successful product. Therefore, we provide feasibility analysis, materials research, validation tests, and many other services.