MPR Product Development 5 Things Entrepreneurs Need To Know Craig Mauch, Director Product Design November 6, 2013

Proprietary MPR Associates 320 King Street Alexandria VA mpr.com Outline 2 1.Business Model before Prototype 2.Characterize IP 3.Design for Market 4.Ready for Wireless 5.Stay Virtual

Proprietary MPR Associates 320 King Street Alexandria VA mpr.com About Us 3  Founded 1964; Revenue ~$50MM/year  220+ staff Scientists, engineers, designers  Headquartered in Alexandria, VA  Other office locations: Chelmsford, MA Somerville, NJ Houston, TX  ISO and ISO 9001 Certified

Proprietary MPR Associates 320 King Street Alexandria VA mpr.com Sample Client Base 4 Pharmaceuticals Commercial Products Lab Instruments Medical & Diagnostic Devices

Proprietary MPR Associates 320 King Street Alexandria VA mpr.com MPR Services 5 MPR’s Integrated Product Development Approach Core engineering analysis, design, systems, mechanical, electronics, software, risk management Comprehensive development services providing value, speed, and efficiency Strategic consulting strategic planning, go-to-market plan, regulatory, process improvement Product testing prototyping, pilot builds, verification & validation, test systems, Creative product design user needs, use case analysis, industrial design, human factors, ergonomics, usability

Proprietary MPR Associates 320 King Street Alexandria VA mpr.com What’s the Business Model ? 6 Lightning in a bottle OR Solid plan to commercialize idea

Proprietary MPR Associates 320 King Street Alexandria VA mpr.com What’s the Business Model ? 7 Lightning in a bottle OR Solid plan to commercialize idea Develop a solid plan before the prototype!

Proprietary MPR Associates 320 King Street Alexandria VA mpr.com Full Product Concept = Value Creation 8 Full Product Concept Addresses All Elements of Medical Device Value Creation Indications for Use and FDA Approval Key Activities and Resources Reimbursement Strategy Channels Unfair AdvantageCustomersValue Proposition Costs Revenue Customers willingness to pay Gross revenues Method of payment Gross-Net reductions Sales Costs Manufacturing Cost Development Cost Key Cost Drivers Indications for Use FDA Approval Path(s) Design Control FDA Compliant QS Address gaps, risks, opportunities in; Coverage, Coding, Payment Can’t be easily copied or bought. Patents Accreditation Credentialing How are we reaching them GPO’s Accrediting bodies Distributors Who are they: Patient segments Providers Payer segments Improvement over existing Standard of Care Why is this reasonable and necessary Clinical Benefit Performance Why is this different and what customer problem is solved? PRODUCTMARKET

Proprietary MPR Associates 320 King Street Alexandria VA mpr.com Characterize IP 9 Develop a bench top test bed for your device Characterize IP: How does it fundamentally work – 1st Principles ? What is the sensitivity to variations ? Is it repeatable ? Does it take a PhD researcher to make work or can a tech do it ? Are your conclusions drawn for test results supported by the data? Challenge, challenge, challenge it !

Proprietary MPR Associates 320 King Street Alexandria VA mpr.com 10 Gains provide a path to purposeful solutions Design for Market – Gather Inputs

Proprietary MPR Associates 320 King Street Alexandria VA mpr.com 11 Design for Market - Define the Problem

Proprietary MPR Associates 320 King Street Alexandria VA mpr.com Ready for Wireless 12 Wireless solutions:  Device connectivity  Cloud data storage  Cyber security  Mobile device solutions (Apple/Android)  Custom web apps Telehealth Ecosystem

Proprietary MPR Associates 320 King Street Alexandria VA mpr.com Ready for Wireless 13 Multiple Architectures for incorporating a smartphone/Tablet into your medical device The App is the Device Smartphone is the Data Conduit Remote Measurement & Control Smartphone is the medical device

Proprietary MPR Associates 320 King Street Alexandria VA mpr.com Stay Virtual – To staff or not to staff, that is the question ? 14 You should have a small core team Business Technical Marketing Building a complete staff distracts you from your business, creates an untenable fixed overhead, and requires management Some elements of outsourcing is usually required and recommended Most startups outsource the execution of the majority of the details of their company to experienced service providers