What to Look for When Choosing a New CMO
Choosing the right CMO, with the qualified capabilities and experience your device needs prevents problems such as high failure rates, cost over-runs, misalignment on critical quality requirements, which could lead to missed deadlines and the loss of speed-to-market. Flexan has a proven history of becoming a trusted CMO for our clients. Here are some key factors and steps involved in choosing a new CMO.
Current Challenges in Medical Device Manufacturing
There are several challenges medical device innovators face when creating a medical device, which can be mitigated or resolved with the right CMO. They include:
- Cost of design and production. Supply issues and supply chain disruptions over the past year have added additional costs to the development and manufacturing of the medical device. The right CMO can spot these issues and reduce costs, save money in the long run and still help bring a product to market. We work with polymers, so we know which polymers will produce the right device functionality for your design needs. We help address the options to discuss costs and any potential issues we foresee with it.
- Government regulations. Each year, government regulatory bodies (FDA, accredited ISO 13485 Certification Bodies, etc.), introduce new regulations and programs (ie. EU MDR, MDSAP), which can add to the cost or delay the speed-to-market for a new medical device. Negotiating your way through this minefield should be a serious part of your CMO decision, because the right one will have years of experience navigating in the regulatory arena.
- Risk prevention & mitigation. Taking action to reduce an organization’s exposure to potential risks and reduce the likelihood that those risks will happen. Given the realities, both FDA & ISO Quality System requirements mandate risk analysis and risk mitigation throughout the development process. A robust contract review performed by the CMO is most effective way of meeting customer standards and requirements.