“Shepherding a new medical technology from the back of the napkin to the bench to the bedside is an exciting enterprise for innovators and their partners. While not nearly as much fun as 3D printing and prototyping, establishing accuracy in market size and understanding what manufacturing at scale really means must be considered as early as possible in the design process if a new device or technology is going to successfully enter the market and prove its value.”
GCMI and our colleagues at the Georgia Manufacturing Extension Partnership (GaMEP) at Georgia Tech offer three key considerations and solutions related to the challenges of manufacturing at scale, but the Golden Rule here is design for manufacturability from day one.
- Designing for Manufacturability Must Be Part of the Early Design Challenge
Design decisions with manufacturing at the right scale need to be made upfront, even if large-scale production seems far off. A device might serve its purpose perfectly as a 3D printed prototype, but producing it at scale for clinical use based on designs only appropriate for small batch production can become an expensive nightmare. Note: proof of concept is NOT a concern to scale for new medical devices, the same way your IP or scientific publications are NOT a concern to regulatory bodies.
- The Pitfalls of Scaling Up Your Supply Chain
Moving from small batch production to large-scale manufacturing of medical devices can throw your supply chain into disarray. You will almost always need a different supply chain at increasing production volumes in your device’s pathway to commercialization. All against an unforgiving, expensive running clock.
- The Contract Manufacturer Conundrum
A critical decision is whether to manufacture your device in-house or partner with a contract manufacturer. This decision is dependent on the device’s complexity, volume, timing and available resources.
A RELATED KEY RESOURCE: GCMI can be your medtech manufacturer of record
Contract manufacturers are not in the business purely for altruism. They require sufficient scale and a compelling economic case to take on a job even if they are able to meet regulatory requirements pursuant to ISO-13485 certification, good manufacturing practices (GMP) and compliance with 21 CFR 820.
In small batches or for highly custom devices GCMI has the capacity to serve as the “manufacturer of record” including ISO 13485 compliance for innovators ready to move into production for test articles, ‘show and tell’ or educational examples, clinical trials or highly custom technologies specific to a patient’s unique anatomy.
Do not underestimate the value this resource can provide to your new medical technology and the unmet clinical or patient need it addresses.
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