Medical devices are increasingly expensive to design and to move through the approval process. Through the use of specialized medical device design services, it is possible for an OEM to reduce the cost of the development of the device while still meeting all standards and requirements.
Outsourcing Benefits
A very big challenge with medical device design is having the most experienced and knowledgeable in-house team. For most OEMs, this means having engineers and medical device designers on-staff and in-house.
A better alternative and one that is much more cost-effective is to work with a medical design firm throughout the development phase. This allows the company to tap into the expertise and experience while paying a set rate.
There are both medical device design companies and those companies that can move from design to prototyping and then on to manufacturing. Ideally, the second option provides the best and fastest path from concept through to market.
Cutting Costs, Not Quality
By choosing experienced companies with a proven track record in delivering quality medical devices to meet or exceed all standards required by the FDA, there is no concern for cost reductions equating to quality reductions.
Look for contract manufacturing companies specializing in the medical device production sector that are ISO 9001 certified, which ensures continuous quality improvement programs are in place. It will also be essential in the medical device field to ensure the company has ISO 13485 certification, which is specifically for the production of medical devices and components.
Additionally, make sure the design company is FDA registered and that the quality systems in use are 21 CFR Part 820 compliant. The top companies will also have a full listing of specific certifications and compliances they offer, which will be applicable to different industries.
