Our goal is the successful commercialization of your medical device, so throughout our development process we consider how the final medical optics device will be manufactured and serviced. The manufacturer is often the client, but when the client’s strategy is to outsource, we support that process.
Optimum Technologies services include:
- Customer and user research
- Product roadmapping
- Regulatory planning
- IP strategy and planning
- Concept development
- Risk Management
- Industrial design and ergonomics
- Human factors studies
- Detailed design and engineering
- Manufacturing process development
- Design verification and pilot build
- Supply chain creation and manufacturing transfer
- Sustaining engineering
Our risk management system has been modified after ISO 14971 and our product development environment is ISO 13485 and FDA QSR compliant.
We can provide pre-production runs ourselves, and we also partner with select New England contract manufacturers with specific expertise in medical disposables, laboratory consumables, and “box build”. With the client’s permission, these CMs have a seat at the table during product development to ensure Design For Manufacture and Assembly (DFMA).
Because we work with these CMs frequently, we know exactly what documentation they’ll need from us during manufacturing transfer. At Optimum Technologies, we don’t “throw products over the wall” to manufacturing. We throw out the walls!