There are few areas of prototype development that are as closely regulated as medical device design. This regulation doesn’t end just at the design stage; it carries through to development, validation and testing and through to production.
The regulations and controls in the industry are necessary to ensure all devices including implants, wearables and stationary devices for patient care are safe and manufactured under approved, controlled conditions. Understanding the regulations around the design, development, validation and testing of medical devices will be critical in getting final approval for use.
A Focus on Design
There are some San Diego companies offering medical device design that focus on all aspects of the process from assisting with the concept development through to assisting with production manufacturing.
However, within these full-service types of companies, some will have a focus or specialization in design. This will be essential as the design stage of the process has to be completed correctly to prevent complications and the need for revisions later on in the process.
Look for a company with experience in medical device design when choosing an engineering consultant and development company. Without extensive experience, the design and development company will have less real-world experience in working with requirements and regulations.
Shorter Development Times
Using the latest in technology and software programs, engineers in these specialized companies can shorten the design and development time considerably. With the option to use technology to test designs virtually prior to any prototype development, issues can be addressed, reworks completed and modifications made to ensure the safety and quality of the device without the cost and time required to produce the physical prototype.
After going through extensive virtual tests, the prototype manufacturing results in a final product that is effective, efficient and free from defects or failure. This benefits the company as it allows for shorter times from the idea to prototype production and through the validation and approval process.
Most of the top San Diego companies offering design and development of medical devices will also be able to complete all required validation and testing processes as well as move into production manufacturing. This may be through an in-house production service or, for specialized or unique parts and components, through a pre-approved group of third-party production companies.
By using the design firm to manage the production services, the same high quality of service and product will be guaranteed. This assurance and adherence to quality of components are essential for medical devices, and it will save your business time, logistics and vetting of these subcontracted production companies.