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Empower Medical Devices

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The Physician’s Product Development Partner

Empower Medical Devices is in the business of commercializing medical device development ideas and sharing profits with healthcare professionals. Our processes protect the intellectual properties and ideas of inventors and use a formal product development system to keep inventors informed during each stage. We target product development opportunities often ignored by larger companies.

As a catalyst for change, Empower Medical Devices brings medical device ideas to life by legitimizing innovation with a solid and proven process for design, development, manufacturing and marketing. We help physicians achieve FDA approval for Class I, II or III products. Our services include market evaluation, engineering, manufacturing, distribution, compliance, finance, sales and after-sales support.

Empower Medical Devices differs from most medical device engineering firms and contract manufacturers, because we provide more transparency than anyone, and we do it all – from concept to carton. Other firms may only specialize in one or two steps in the process. Empower Medical Devices is with you every step of the way – our regular progress review meetings include YOU in every session. You don’t have to take our word for it, just check our testimonials.

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Full Service in Scope

We take your rough idea or completed product design through a comprehensive A to Z process to bring your product to market.

The Harvard Business School finds 80% of new product launches fail; other sources can be as high as 95%*. To dramatically reduce risk, Empower Medical Devices utilizes the Stage-Gate® Process to conduct a complete analysis and provide a holistic and systematic process to ensure your product idea is successful.

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Market Assessment

Empower Medical Devices will validate your product idea or design by conducting an extremely thorough Market Assessment to optimize success and profitability. Our Stage-Gate® process determines if there is adequate market demand in the market for your product concept.

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Capital Infusion

Many medical device manufacturers do not provide access to capital. Empower Medical Devices has the financial resources to provide the capital required to bring your product idea to life.

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We are open about all aspects of our operation and share all information with our physician partners. We consider our relationship a partnership for life. We involve you every step of the way, including at every Stage-Gate review.

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The Engineering & Manufacturing Difference

At Empower Medical Devices, we have our own world class engineering and manufacturing teams and facilities to support the development of medical devices. Our expertise allows us to properly manage the design and production of any medical device, anywhere, including at other partner facilities. With over 20 years in operation, you can feel confident that your product will be manufactured expertly and efficiently.

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Medical Expertise

The Empower Medical Devices Advisory Board is comprised of medical professionals and experienced engineering and manufacturing experts, all with decades of experience in developing or using medical products.

Bring Empower Medical Devices Your Idea

Let’s start the conversation today!

*MarketSmart Newsletter; May 3, 2017; “What Percentage of New Products Fail and Why?” Lonny Kocina; published by Media Relations Agency
*Stage-Gate® is a trademark owned by Stage-Gate International..

The Medical Product Development Process

Ideation & Concept

Concept Development
General Design & Function
Preliminary Evaluation

Business Model Options

Royalty Based
Equity Based

Market Assessment

Detailed Market Analysis
Volume Forecast
VOC – Market Overview
VOC – Customer Needs
VOC – Value & Price
VOC – Buyer Behavior
Competitive Analysis
Viability Assessment

Capital Infusion

Access to Capital Resources
Fast Decision Making
Successful Track Record

Proven Processes & Tools

Quality Product Launch
Advanced Quality Product Planning (APQP)
Failure Modes & Effects Analysis (FMEA)
Stage-Gate® Idea-to-Launch Process

Design & Development
Design Engineering & Prototype

Design Concept Detailed
CAD Drawing
Rapid Prototype

Testing & Validation

Internal Testing of Device for QA
Conducted by Expert Engineers
Studies and Trials
Meet FDA Class 1, 2 or 3 Requirements

Patent & Regulatory Approval

Patent Application
FDA Approval
CE (Europe)
Other Approvals and Requirements

Sourcing & Equipment

Fast Decisions for Investments
Source Materials & Equipment
Global Manufacturing Centers & Manufacturing Partners

Product Launch

Dedicated Production Lines
Utilize Quality & Other Process Tools
Ship Anywhere Worldwide

Product Launch

Target Marketing
Go to Market Plan
Sale of Company Option

8964 Little Mountain, Road Mentor, OH 44060

Phone: 317-690-0764