Hiring specialists to complete different aspects of the production of a medical device is the norm within the industry. It is simply too costly to have specialists in computer software, electronics, machining and all other specializations in-house, even for very large manufacturing companies.
In addition, by hiring specialists that have the certifications and experience to provide top medical device contract manufacturing services, the company can pick and choose the best of the best rather than having to stick with an in-house team that may not have the most current training and may not be interacting daily with best practices and the most current regulations and requirements.
Early Involvement
Ideally, when in the design stages of the medical components, start to work with your partners in the different specialized services. This is instrumental in bringing in the right design components.
In some cases, the contractors may be able to suggest changes in the design that provide benefits to the medical components. This could result in lower costs of production, more durable medical devices or devices that can be smaller or better suited to a specific need.
Expertise in Medical Devices
Designing and developing prototypes and production of medical components is very different than with other types of parts, even those for very demanding sectors such as military, defense or aerospace.
Always review the contractor’s past experience in working specifically in the development of medical devices or equipment. By taking the time to check and verify this background, you will find a contractor with a knowledge of the process of the validation steps as well as the medical device regulations. Not only will this be valuable to your design and development team, but it can save costly delays and problems throughout the entire process from concept to approval and market.
