Early stage Medical Device Companies that are preparing to manufacture their long awaited R&D project need to make crucial upfront decisions, such as, whether they develop the infrastructure to internally manufacture or outsource all or a portion of the process? These decisions are not taken lightly and are based on a number of factors.
Does the OEM have in house quality and regulatory functionaries to properly guide the company through the regulatory hurdles? Does the technical staff have the experience to make qualified process decisions once they are in the thick of it? Do obtaining these capabilities and the costs associated with setting up a clean room, hiring and training production personnel outweigh the option of utilizing a seasoned Medical Device Contract Manufacturer?
A successful clinical build can make or break the early stage company for a variety of reasons. When a product moves from the R&D phase to feasibility build, many times these units are utilized for initial clinical evaluation. The manufacturing process may be fine tuned and often amended during the qualifying builds, but the end result has to be a safe and efficacious product that delivers clinical results. Clinical builds must be delivered in a medical setting that has little margin for error, hence the significance of choosing the correct partner. Who is best positioned to accomplish that task?
The better Medical Device Contract Manufacturers have a top notch Quality System that incorporates all the in process check points to reduce the risk of producing an inferior product. This group understands that compliance with federal FDA regulations; accurate documentation and traceability are first order. For OEM’s wishing to maintain complete control over the product and the build process, many outsourcing partners encourage greater flexibility and access through services such as cleanroom rentals, engineering support, in-house testing and on-site staffing.
For instance at LSO, our clients can rent workspace and bring in their manufacturing staff to execute clinical builds under the guidance of LSO’s engineering department and quality system. Furthermore they are given access to our support services such as Sterilization Validation, Package Testing & Validation and other manufacturing resources.
Clinical trials can bring complications and headaches of their own, and third-party assistance specializing in handling these situations can save the time and resources of a medical device OEM. During final analysis, the OEM generally comes to the conclusion that a viable Medical Device Contract Manufacturer is many times the most cost effective, clinically sound and process oriented choice. With that being said, the last factor that needs to be evaluated is the “aggravation factor”. Why would a start up want to make a significant investment when so much is riding on their decision to attempt a go themselves or trust the judgment, experience and equity of a well seasoned Medical Device Contract Manufacturer?