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
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
In-house industrial design reduces costly resets by generating solutions that satisfy user needs grounded in best design & manufacturing practices
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
PRODUCT DESIGN
CONVERTING SCIENCE TO A SCALABLE MARKET READY PRODUCT
In-house industrial design reduces costly resets by generating solutions that satisfy user needs grounded in best design & manufacturing practices
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
GLOBAL FOCUS ON MEDICAL DEVICE USE CASES ALIGNING
- 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
MITIGATING RISK WITH QMS & REGULATORY STRATEGIES
FDA Registered Entity #3003500271
ISO 9001 & 13485 certified
GLOBAL FOCUS ON MEDICAL DEVICE USE CASES ALIGNING
- 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.
