When your medical device design and development timeline is tight, meeting the challenge without cutting corners is essential. We keep you on the right path by continually soliciting insights from your customers. We’ll also save you time and money by employing our time-tested, proprietary Guideway™ design process. And we’ll help you finish sooner by creating FDA documentation as tasks proceed rather than at the project’s end.
Engage us for comprehensive medical product design and development services that begin with opportunity mining and conclude with manufacturing support of your product.
Continually harvesting user insights, employing a proprietary development process and accumulating FDA documentation as design proceeds allow us to meet accelerated design and development timetables.
MPE (Formerly MindFlow Design) has extremely high product development standards. Consistency and quality are assured through our structured, three-phase Guideway™ process.
Guideway™ Design Process Discipline Enables Us To:
- Anticipate and address all the factors that could impact the development process and plan.
- Keep development on the right track, saving you time and money.
- Identify hidden opportunities to improve your product’s initial concept or even discover new products that will meet a previously unknown market need.
- Ensure seamless integration of design and engineering through to production.
- Deliver final specifications for an exciting new product.
- Assist you in preparing for product manufacture.
In conformance with ISO 13485 requirements, we constantly review and improve elements of this process.
Engage us for comprehensive medical product design and development services that begin
with opportunity mining and conclude with manufacturing support of your product.
MPE (Formerly MindFlow Design) has extremely high product development standards. Consistency and quality are assured through a structured, three-phase proprietary process called Guideway™ which can be seen here. In conformance with ISO 13485 requirements, we constantly review and improve elements of this process.
Guideway™ Design Process Discipline Enables Us To:
- Anticipate and address all the factors that could impact the development process and plan.
- Keep development on the right track, saving you time and money.
- Identify hidden opportunities to improve your product’s initial concept or even discover new products that will meet a previously unknown market need.
- Ensure seamless integration of design and engineering through to production.
- Deliver final specifications for an exciting new product.
- Assist you in preparing for product manufacture.
AwarePoint – Isolated
Phase 1: Design Project Strategy
We aim to learn everything we can about your project circumstances through a rigorous process of discovery in six areas: Business goals, target users’ and customer’ needs, core technology and IP, market and competitive landscape, regulatory requirements, and manufacturing targets. The insights gained are essential in establishing project direction, informing the design process and formulating the metrics for validation and verification. This phase concludes with a strategy design review to make certain that no stone has been left unturned in defining the problem, creating the best project plan and determining the correct product requirements.
Phase 2: Product Development
We execute the project strategy. Work includes defining the best solution after analysis of various alternatives, developing it fully, and then verifying that it meets or exceeds the requirements. This phase concludes with delivery of a final prototype along with complete design specifications as well as results from verification testing.
Phase 3: Transfer to Manufacturing
We transfer a complete set of product specifications to your approved supplier and support them throughout the manufacturing process. The project concludes with article inspection reports and validation to assure quality through rigid adherence to product specifications.
