Startup and small medical device companies have utilized the contract manufacturing model for a number of years. These outsourcing organizations have proven to be a stable, logical and cost effective way to manage the construction of the product and find resolution to manufacturing challenges. In addition, the value proposition is the elimination of having to construct an in-house clean room and incur direct labor overhead to support the program.

Quality System:

ISO certified and FDA registered contract manufacturing organizations must have a top shelf Quality System in place, to assist the manufacturer in grinding through a myriad of regulatory and quality questions. Medical Device contract manufacturers are frequently audited, not only by their customers, but multinational companies courting the start up that has demonstrated early successful clinical results.

In-house Engineering Staff:

Top tier contract medical device manufacturing firms contribute to the evaluation and enhancement of process development as the product roles out of R&D and into the manufacturing phase. Full service CM’s employ an engineering staff that understand and engage in “lean process” manufacturing practices, has the ability to clearly delineate improvement steps and decrease “down time”.  In addition, a CM that has the ability to develop tools and fixtures in-house can reduce “Outside Processing” charges and delays. Because all devices are unique in design and function, there will always be the need to customize or retool fixtures on a timely basis.

Full-service Provider:

The better Medical Device Contract Manufacturers will also incorporate additional services so that the majority of the steps from product concept to commercialization can be accomplished under one roof. A well bred contract manufacturer has experience in more sophisticated processes, such as micro soldering and different bonding methodologies.

To round out the skill set of the well versed contract manufacturer, they should also be able to provide Packaging Design and Development, Packaging Validation in accordance with ASTM 11609 standards, and Distribution Testing. This group could provide more “boutique” services such as in-house Sterilization and Validation, as well as, Cleaning and Decontamination Services.


The medical device industry is a complex one. It is imperative to choose a full service, turnkey contract manufacturer, which can move the company from process development through commercialization with Fulfillment & Distribution Services.  Keeping on targeted timelines and reducing downtime through miscues, the startup company will generally have a greater chance of success with the investors and venture capital groups when affiliated with an experienced CM that has been down the “acquisition road” with previous clients.