The medical market for cosmetic devices is booming. However, quickly launching new products to meet demand is becoming more challenging because device manufactures face increased regulatory scrutiny. To help meet regulatory requirements, aesthetic and other medical-device OEMs are partnering with electronics manufacturing services (EMS) companies that also offer expertise with the FDA filings necessary to get new products to market in a timely manner.
This was the case for a developer of skin rejuvenation and aesthetic products. The company has developed a product for laser-based treatments but did not have the resources to develop all of the documentation necessary to support regulatory and FDA approval. To get the product to market, the company realized it needed to engage with a global EMS partner that had facilities certified for medical-device manufacturing and the regulatory expertise to support a successful product launch. After an investigation of several firms, the developer chose a contract manufacturer that specializes in electronics manufacturing, Sanmina.
Why this EMS
Sanmina already manufactured a range of medical products and has experience producing aesthetic rejuvenation products, including experience with laser and high-intensity light technology. Equally important, its Medical Division includes a team of regulatory-compliance personnel that provides medical regulatory services to customers.
Sanmina assigned a team of engineers with a regulatory-compliance officer and placed them onsite to work with the client’s designers and help prepare the required documents, including the Device Master Record (DMR), the collection of all models, drawings, instructions and other documents used to produce a product. By having a team onsite early in the design and production cycle, the EMS specialists were able to provide feedback, optimizing the design for manufacturing and ensuring the product was released on time.
Early engagement in design and product engineering was supported by the contract manufacturer’s Part 11 compliant documentation control system. The system provides revision control and a secure repository for all product documentation, manufacturing instructions and processes. These systems are deployed in all Sanmina medical facilities. The EMS has 21 ISO 13485-2003 Certified facilities including nine FDA registered facilities. The contract manufacturer’s production systems and software are also FDA Part-11 compliant.
After working side-by-side with the client company’s engineering team, the aesthetic rejuvenation product was successfully launched. Sanmina continues to make these products, and has introduced another new product for this customer. What’s more, it is in early stages of product design and development for the client’s next generation device.