Innovations in medical devices, implants, and equipment are driving both doctor and patient demand for life-saving and life-altering parts, components and systems. As technology brings options to incorporate new technology into medical equipment, the need for diverse teams to work on medical product designs becomes a critical factor.
Often, innovative ideas are formulated to new companies and not existing medical equipment brands. These startup companies are facing a very daunting task, both in understanding and incorporating very rigid regulations and verification processes, but also in finding contract manufacturers with the ability to provide medical product design support.
Taking the time to find a company with the experience and expertise to provide medical product design services to integrate with your in-house team will be critical. In some cases, the medical device company may want to outsource all of the design work. This lends itself to using the design team of the contract manufacturing service to provide a seamless move from design to development, prototyping, and then on to production once the product is approved.
Relying on In-House Designers
A common mistake by startup medical device companies is the use of only in-house design teams. These teams may be very experienced and even have a solid understanding of regulations, but they will not necessarily understand the manufacturing process and the options to consider.
By working with the manufacturer of medical product design, the costly reworking of the design can be avoided. This will help to keep the project on schedule and avoid delays which increase the time to approval and marketing.
Laws and Regulations
With all types of medical devices, it is critical to have more than a working knowledge of the regulations governing materials, manufacturing processes and compliance with safety requirements.
When the design team is part of the services offered by a contract medical manufacturer, these regulatory issues will be built into the process, allowing for quality control and full compliance with documentation and verification.