Farm Design has advice on how to get the most out of outsourcing medtech development.
It is a trend Qmed/MPMN has noted before: medtech companies increasingly calling on contract manufacturers to take on more responsibilities, including actual design and development.
The situation has helped spark a wave of mergers and business partnerships allowing manufacturers to offer a wider menu of services. Farm Design (Hollis, NH) lists a few reasons for this trend, including pricing pressures, government regulations, and rapidly-evolving manufacturing techniques.
Asking a contract manufacturer to do more with development, however, has its own pitfalls. Farm has a blog post full of advice on how to prevent such problems, and get the most out of a medical device development outsourcing arrangement.
Here are the key points:
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? Says Farm Design: "Recognizing, defining, and communicating these roles during the development cycle is important for grounding expectations within the team."
2. Constant vigilance will minimize surprises.
The trick is to find the right balance in the communications strategy, says Farm Design. "A lack of communication will inevitably lead to nasty surprises, but "overcommunicating"--too many e-mails or too many meetings--can negatively affect productivity."
3. Truly understand the level of each partner's expertise.
A Farm Design puts it: hope for the best, but plan for the worst. One example of many in their blog post is about how design for manufacture and assembly (DFMA) to reduce cost is also a team effort. Perhaps the OEM doesn't care whether printed circuit board assemblies are one- or two-sided or surface-mount-only, but the contract manufacturer might only be equipped for high-speed, surface-mount-only manufacturing. "The development partner is responsible for the design of the product, but the CM can play an effective support role during development," Farm Design says.
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. For example, don't delay selection of a contract manufacturer until after a design is complete. Use standards and templates from the start.
|Refresh your medical device industry knowledge at MEDevice San Diego, September 1-2, 2015.|
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