Partnership Goals For Scale-Up Success

By Jason Larocco, SMC Ltd.

Partnering with a Contract Manufacturing Organization (CMO) for scale-ups requires a host of considerations about both the CMO and your own organization. The challenge is amplified for small, medium, or startup medical technology organizations, who often operate at the cutting edge of ingenuity, combining common problems (e.g., lack of resources) with challenges unique to their design.

Identifying your core competencies is vital to determine which functions and processes will stay in-house and which will require third-party solutions to complete scale-up. Potential CMO partners should be able to help a medtech understand the implications of its outsourcing needs, relevant to the company’s inputs and methods.

SMC creates a validation master plan (VMP) for each client. It describes what we expect from each build and contains associated documentation. The plan is approved by both organizations and serves as a living document throughout the project. Changes may occur, but the rationale for adjustments and their implications for subsequent builds are always understood and agreed upon by both partners, as well as properly documented.