Range of Services
A world-class Product Development Process (PDP) is a necessity for delivering superior products on-time, on-budget, and right-the-first-time. Optimum Technologies has its own PDP in place that consists of four (4) distinct phase-gate decision processes. The phase-gate approach instills a forward-looking philosophy so that throughout each of the tasks of a phase, our team is considering the impact on the project in the next phase. Our established and proven PDP provides you with the benefit of several decades of experience. We are able to successfully commercialize products.
OTI's PDP approach ensures there is an automatic system in place to significantly reduce risks inherent to medical and life science sector and has been specifically developed for products in medical and life science regulatory environment. Our risk management system has been modelled after ISO 14971 and our product development environment is ISO 13485 and FDA QSR compliant.
Our PDP ensures that from the very beginning of the design, and throughout subsequent phases, we focus on an exhaustive checklist of concerns. These are drawn from a myriad of business functions that are critical to success and are unique to your particular product. These include:
- Cost targets
- FDA regulatory planning
- I/P strategy and planning
- Documentation and design history file.
A good PDP ensures that your perspective, needs and requirements - and those of your end customer – are continuously factored into the design throughout the development process. The four process phases are:
- Phase 1: Product Definition, Project Planning and Concept Development.
- Phase 2: Detailed Design & Prototyping, Verification Testing and Manufacturing Process Design
- Phase 3: Pilot Build and Validation, Transfer to Manufacturing
- Phase 4: Manufacturing and Product Launch
Our goal is the successful commercialization of your device, so throughout our development process we consider how the final 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. 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). And because we work with these CMs frequently, we know exactly what documentation they’ll need from us during manufacturing transfer. At OTI, we don’t “throw products over the wall” to Manufacturing. We throw out the walls!