Leverage Over 40 Years of Experience

in designing and manufacturing Medical Devices and Equipment in all areas of Healthcare

From napkin sketch to market ready product MPE has built a vertical end-to-end model, to streamline the development process with a disciplined culture to help OEM’s convert their science to a scalable market ready product – better, faster.

Early engagement is critical. It ensures market launch success while avoiding landmines & unforeseen circumstances. We measure success in positive business outcomes, always starting with the end in mind.

On Time, On Budget

Averaging Over 10 Successful Medical Product Launches Per Year – Hitting The Market Requirements The First Time

Throughout the entire development process, our PMP Certified Project Management Team drives accountability by managing project scope, coordinating regulatory compliance and driving deliverables. Our discipline and process keep your project on task, on time, and on budget.

Accountability to successful market launches

Certified stage gate process managed by PMP certified project managers with the responsibility to hold all key stakeholders accountable to timelines and commitments with medical regulatory compliance in the forefront
Lower Cost, Lower Risk, Faster to Market utilizing:
- Design-to-Cost strategy starting early in the engagement
- Medical Device use case and workflow experience
- Alignment in engineering, quality/regulatory, manufacturing and supply chain avoiding costly delays common in hand-offs between concept to design to production
- Effective scope creep management
- Successful regulatory compliance strategies and management
- DFMEA & PFMEA to minimize risk throughout the process

Our Vertically Integrated Design and Contract Manufacturing Model

Manufacturing: MPE has invested in the manufacturing processes for the most expensive custom parts or critical quality components in the BOM
Supply Chain: MPE has built out a global supply chain for commodities to complete medical device assembly
Warehousing/3PL: MPE has created a warehousing and 3PL model to deliver complete medical systems globally on time at lower cost

How we add value

Medical Device Focus
Industrial Design with Human Factor Analysis and workflow utility
Product Design: systems, mechanical, electrical, testing and design validation, rapid prototyping, design for manufacturability & assembly
Quality Management and Regulatory Compliance
Vertical Manufacturing Capabilities: metal fabrication, powder coat, silk screen
Global Supply Chain
Finished Assembly and Test
Logistics and Inventory Management
Life Cycle Management

Industrial Design

Medical Device Experience and Focus

In-house industrial design reduces costly resets by generating solutions that satisfy user needs grounded in best design & manufacturing practices

Global focus on medical device use cases aligning
- Human Factors
- Workflow analysis
- Voice of Customer
- Behavior psychology
- Design Empathy
- Ergonomics
- Global requirements

Product Design

Converting Science to a Scalable Market Ready Product

MPE has expanded engineering capabilities including rapid prototyping to accelerate product development and time to market

Mechanical and electrical competence delivering complete medical system
- DfX: Design for Excellence - Manufacturability, Assembly, Test, Cost, and Servicability
- DFMEA & PFMEA exercises minimize risk throughout the process
- Proof-of-Concept & Prototype Development
- Industrial Process Engineering
- Systems Engineering
- 3D Modeling
- Packaging design, ISTA Testing

Regulatory Compliance

Mitigating Risk with QMS & Regulatory Strategies

FDA Registered Entity #3003500271

ISO 9001 & 13485 certified

Quality Management Control services include:
- Compliant Quality Management System: FDA, MDR
- Regulatory Compliance Management: UL, CE, IEC 60601, CSA
- Process Qualification Capabilities
- Full PPAP Submissions
- Advanced Metrology
- UDI Compliance
- 100% Material + Product Traceability Systems
- Supplier Quality Management System (SQM)
- Medical 510K Consulting Services
- Change control

Contact us today to learn more about our Solutions and how we can make this happen for you.

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