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Entrepreneurship
Business Planning
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Venture Capital
Regulatory
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Return to top
Entrepreneurship
Business Planning
General Financing
Venture Capital
Regulatory
Reimbursement
Clinical Affairs
Intellectual Property
Below is a compendium of tools and information to assist you with all aspects of building your business. If you have suggestions of additional resources you would like to see posted here, please send that information to info@medtechignite.com.
General Entrepreneurship Information
MassMEDIC's Boot Camp for MedTech Entrepreneurs
Dealing with the Angels-The Pre-Venture Financing RoundRichard Lucash, Eckert Seamans
Co-Founders, Launchpad Venture Group Due Diligence for Venture Financing-What You Can Expect
Lawrence S. Wittenberg, Goodwin Procter Protecting Your IP Assets
John Gagel and Tu Nguyen, Fish and Richardson Do's and Don'ts of Team Building
Mary F. Moriarty, Korn-Ferry International Compensation Strategies-What are your Options at this Early Stage?
Martin Somelofske, Deloitte Consulting LLP Product Development Fundamentals for the MedTech Entrepreneur
Andy Ditson, Cambridge Consultants Regulatory and Reimbursement Check-List for Emerging Medical Device Companies
Phil Lavin, Averion Assessing Market Opportunities and Developing an Appropriate Entry Strategy
Christopher Dimmock, Seidler Bernstein Decision-Making and Problem Solving Techniques for the Start-up Company
Lucinda Doran and Steven LaPierre, Center for Quality of Management
Customer Needs Assessment: Is There a Market for Your Technology?
Models of Customer Needs AssessmentMaria Shepherd, Principal
Data Decision Group Building a Company Around Unmet Market Needs: A Case Study
Doug Adams, CEO and Founder
SOLX, Inc.
SBIR & STTR Workshop for Small Businesses and Entrepreneurs
in the Medical Device Industry
Mass MEDIC Introductory Remarks
(Powerpoint, 432kb)Laura Allen, Director of MedTech IGNITE and Special Projects
Massachusetts Medical Device Industry Council M2D2 Introduction (Powerpoint, 13.6mb)
Stephen McCarthy, Co-Director
Massachusetts Medical Device Development Center, UMassLowell State Funding Opportunities Overview (Powerpoint, 200kb)
Bob Kispert, Director of Federal and University Programs
John Adams Innovation Institute, Massachusetts Technology Collaborative "Lab to Life:" Funding Opportu"NIH"ties Through the NIH SBIR/STTR Programs (Powerpoint, 17mb)
JoAnne Goodnight, Program Director
National Institutes of Health "Lessons Learned:" What to Avoid and What Defines a Successful Application (Powerpoint, 735kb)
Mike Dempsey, MedTech IGNITE Mentor, NIH Scientific Group Reviewer Case Study: Biodegradable Stent (Powerpoint, 13.6mb)
Tim Wu, VasoTech Case Study: Smart Insulin (Powerpoint, 938kb)
Todd Zion, Ph.D., President, CEO and Co-Founder
SmartCells, Inc.
Business Planning
Bplans.com
A comprehensive source of sample business plans, as well as tools to manage early stage businesses. SBA Business Plan Basics
Instructions on developing a business plan and resources to aid you through your company's entire lifecycle.
A comprehensive source of sample business plans, as well as tools to manage early stage businesses. SBA Business Plan Basics
Instructions on developing a business plan and resources to aid you through your company's entire lifecycle.
General Financing Information
MassMEDIC's Boot Camp - Building Successful MedTech Companies: Financing Strategies for Entrepreneurs
Due Diligence - What You Need to Know Before Approaching Angel InvestorsJohn J. Schwartz, Member
Boston Harbor Angels Creating Deal Velocity - Deal Terms That Really Matter
John Hession, Partner
McDermott Will & Emery Corporate Investment in Start-Ups - Two Companies' Perspectives
Medtronic's Perspective
Rachael Scherer, Vice President, Emerging Technologies Marketing
Medtronic, Inc.
Afferent's Perspective
Jason Harry, Founder
Afferent Corporation
Rachael Scherer, Vice President, Emerging Technologies Marketing
Medtronic, Inc.
Afferent's Perspective
Jason Harry, Founder
Afferent Corporation
Start-Up Company Business Case Presentation
Ralph Grabowski, President
Hemetrics Development Corporation
Presentation by John Hession, a partner at McDermott, Will & Emery on critical considerations for start-up companies in the areas of: equity compensation techniques; intellectual property management; financing terms; and securities regulations. Creating Deal Velocity: Deal Terms that Really Matter (Powerpoint, 733kb)
Presentation by John Hession on current venture capital trends, including the results of a recent VentureOne survey on deal structures and terms. Also provides in-depth detail on term sheets and strategies for improving company valuation. Venture Capital Annotated Model Term Sheet (Word, 235kb)
Mock term sheet, with definitions of terms and explanations of issues to consider provided. Sale of Series A Preferred Stock: Summary of Terms and Conditions (PDF, 780kb)
An overview of guidelines frequently deployed in term sheets and their definitions. Ten Thoughts About Equity Compensation for Investors and Entrepreneurs (PDF, 42kb)
Details on top issues entrepreneurs should be aware of when considering equity compensation. Private Company Financings Report: Up Downs vs Down Rounds - An Indicator of the Overall Investment Climate (PDF, 250kb)
A guide from Cooley Godward Kronish on how entrepreneurs can assess the investment climate for venture-backed companies.
Venture Capital
VCexperts.com
Industry news and weekly commentaries on private equity and venture capital trends.
Industry news and weekly commentaries on private equity and venture capital trends.
Regulatory and Reimbursement Information
MassMEDIC's Boot Camp - Bringing a Product to Market and Avoiding Regulatory Pitfalls
Understanding the Regulatory LandscapeJames Wason, Ph.D., Principal
The Maelor Group, Inc. The 510(k) Process: Smooth Sailing or a Choppy Ride
Rosina Robinson, RN, MEd, RAC, Principal Consultant
Medical Device Consultants, Inc. Introducing New Technologies: The Challenge of a PMA
Robert Yocher, Vice President of Regulatory Affairs
Genzyme Corporation Reimbursement Fundamentals: Stakeholders, Coding Requirements, Payment Systems
Charles Matthews, Director
Boston Healthcare Associates Pathway to Coverage: Overcoming Reimbursement Hurdles
Susan Garfield, MSc SM, Director, Global Reimbursement, Policy and Economic Strategy
QIAGEN, Inc. Key Steps to Shaping a Reimbursement Strategy
Charles Matthews
A Practical Guide to FDA Regulatory Processes
James Wason, Executive Vice President, Medical Device Consultants, Inc.
Clinical Affairs Information
Clinical Affairs Boot Camp - Successful Design and Execution of Preclinical and Clinical Studies
Safety and Efficacy in Preclinical Studies: An Intro to Biocompatibility, andRegulatory Compliance in Preclinical Research (PDF, 981kb)
Laurence Lister, Director of Biocompatibility
Toxikon Corporation The Central Role of Experimental Models in Interventional Device Development and Regulation (PDF, 13mb)
Peter Markham, President & CEO
Concord Biomedical Sciences and Emerging Technologies, Inc. Understanding Biostatistics (Powerpoint, 174kb)
Joseph Massaro, Associate Professor of Biostatistics
Boston University School of Public Health
Michael Imhoff, MD, PhD, Managing Director
Boston MedTech Advisors Europe
Intellectual Property
FreePatentsOnline.com
This site allows free patent searching, free PDF downloading of patents, competitive intelligence alerts, and organizing and sharing documents. 6 "Great" Mistakes Entrepreneurs Make - A Practical Guide to IP Issues for Entrepreneurs (Powerpoint, 124kb)
A primer from Steven Frank at Goodwin Procter that cautions entrepreneurs against 6 common financing and strategy mistakes and offers detailed advice on patent protection issues.
This site allows free patent searching, free PDF downloading of patents, competitive intelligence alerts, and organizing and sharing documents. 6 "Great" Mistakes Entrepreneurs Make - A Practical Guide to IP Issues for Entrepreneurs (Powerpoint, 124kb)
A primer from Steven Frank at Goodwin Procter that cautions entrepreneurs against 6 common financing and strategy mistakes and offers detailed advice on patent protection issues.