We’ve gathered five medical device design expert tips from our Expert Tips pages to provide a glimpse into the KMC Systems knowledge pool.
1. Adequately validate and verify design changes. Using a risk-based approach, ensure that an appropriate level of testing, analysis, demonstration, or inspection is performed and documented to ensure the right solution has been proposed and there will be no unexpected side effects from the change.
2. Avoid costly re-designs and lost time when developing a complex disposable cartridge and accompanying instrument by demonstrating feasibility before beginning the hardware and software development of the instrument. Because cartridge and instrument design are so interrelated, it is also critical to involve the contract design and manufacturing partner early.
- Gail Wiegand, KMC Systems Director of Quality Assurance and Regulatory Compliance
3. Determining the state of the product design is a critical element in understanding what services a CM should offer to provide a smooth transition to manufacturing. A thorough review of the drawing/documentation package is a minimum requirement.
- Ron Jellison, KMC Systems Vice President and General Manager
4. Design flexible and scalable parts for use across multiple platforms for rapid product development. For example, KMC’s Internal Research and Development (IR&D) team has developed an XYZ axis robot arm. The design could be used in many different types of instruments with only minor customization. This would reduce overall design time and provide a proven, cost effectice and reliable option.
- Dan Frisbie, KMC Systems Senior Principal Manufacturing Engineer
5. The formation of lasting relationships, whether personal or in business, is based on the fundamental elements of trust, commitment, and communication. Before a medical device company entrusts an outsourced partner with their brand for a medical device design program there must be comfort that honest behavior is intrinsic.
- Bob Evans, KMC Systems Program Manager
What medical device design tips do you have? Please share them in the comments below!