We’ve gathered five contract medical device development tips from our KMC Systems experts to help with your medical instrumentation development project.
Enjoy!1. To speed time to market, implement rapid product development techniques in the medical device development process. Use a robust library of software code to facilitate the reuse of said code, which controls common hardware used in medical devices and instrumentation. Flexible medical software development/integration tools, such as our proprietary “ecDiag” software, expedite the software development testing and integration efforts and provide a foundation for manufacturing product testing.
- Bob Evans, KMC Systems Program Manager
2. Take the time to listen to the voice of the customer, engage with users and perform IVD instrument concept testing during the concept phase of a medical device development project. This will expose instrument behavior that can enhance or hinder architectural medical development. Using simulation modeling for feasibility analysis and developing a precise definition of an IVD instrument's features and functions before entering into the medical design phase provides many advantages.
- Walter Gilde, KMC Systems Business Development Manager
3. Go slow to go fast in medical device development! There is a temptation to rush the transition from prototype to manufacturing. Moving too quickly can create unnecessary iterations and engineering changes – not to mention lost time awaiting new parts. For efficiency and accuracy, make sure the design, BOM and CAD model are complete before transitioning from medical design to manufacturing.
- Dan Frisbie, Senior Principal Manufacturing Engineer and Manager of the Manufacturing Engineering Group
4. Multidiscipline collaboration throughout the medical product lifecycle is essential to successfully transition a new medical device design into a controlled manufacturing environment. Design and manufacturing engineers must operate as a unified team. It is also important to include the customer as an integral part of that team. Frequent and open communication can help identify potential program risks. Early risk identification allows the team to address and mitigate those risks and avoid technical pitfalls and schedule delays during medical device development.
- Jerry Sevigny, Senior Principal System Engineer
5. Make sure the medical device regulatory strategy is well thought out and clearly communicated up front in development. For instance, changes in device classification based on “level of concern” can be costly later on.
- Gregg Wilder, Program Manager