Startup companies have a steep learning curve in the medical device industry. To offset this issue, partnering with a top medical device design company that can move from design through to manufacturing provides definite advantages, including decreasing the time from concept to approval and market.
It is essential to partner with a medical device design company that has a reputation for confidentiality and protection of intellectual property. In the highly competitive field of medical devices, including implantables and wearables, having a partner that maintains confidentiality in all aspects of the design and prototyping is a critical consideration.
In addition, the company providing medical device design should also offer the following services and features.
Experience in the Process
Look for companies that have a proven record in the medical device industry. This is a specialized type of manufacturing, and the contract manufacturer should have a significant client base of established, emerging, and cutting-edge medical device companies.
Understanding of FDA Regulations and Requirements
While in-house engineers and design teams may have specialized knowledge in FDA requirements and regulations, the dedicated teams at medical device contract manufacturing companies work exclusively in this area. This ongoing immersion in the required regulations by the FDA or international governing bodies is an advantage to a startup or an existing medical device company.
Ability to Move from Design to Prototyping and Manufacturing
There are specialized medical design companies that offer more than just the design process. Instead, they offer full prototyping through to manufacturing, which offers obvious benefits. These benefits include an understanding of the verification processes for materials, the quality control required for medical device manufacturing, as well as full compliance with ISO 13845 and 21 CFR Part 820 compliance with all quality control systems.
Take the time to consider options in partnering with a medical device contract manufacturer offering design services. Look for experience, reputation, and the ability to provide the services required now and in the future.
