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RESOURCES
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.
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General Entrepreneurship
Business Planning
General Financing
Venture Capital
Regulatory and Reimbursement Clinical Affairs Intellectual Property
Regulatory and Reimbursement Clinical Affairs Intellectual Property
General Entrepreneurship Information
Entrepreneur.com
A cross-industry view of starting a company, including: raising money, hiring staff, and building sales channels.
Springboard Templates for Entrepreneurs
Springboard, one of the premiere entrepreneurship programs in the country, offers valuable templates on writing a business plan and an executive summary, as well as guidelines on how to approach company valuations.
A cross-industry view of starting a company, including: raising money, hiring staff, and building sales channels.
Springboard Templates for Entrepreneurs
Springboard, one of the premiere entrepreneurship programs in the country, offers valuable templates on writing a business plan and an executive summary, as well as guidelines on how to approach company valuations.
MassMEDIC's Boot Camp for MedTech Entrepreneurs, October 18, 2005
Dealing with the Angels-The Pre-Venture Financing Round
Richard Lucash, Eckert Seamans
Co-Founder, 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
Dealing with the Angels-The Pre-Venture Financing Round
Richard Lucash, Eckert Seamans
Co-Founder, 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? April 17, 2008
Models of Customer Needs Assessment
Maria Shepherd, Principal
Data Decision Group
Building a Company Around Unmet Market Needs: A Case Study
Doug Adams, CEO and Founder
SOLX, Inc.
Models of Customer Needs Assessment
Maria 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.
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, June 22, 2007
Due Diligence - What You Need to Know Before Approaching Angel Investors
John 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
Start-Up Company Business Case Presentation
Ralph Grabowski, President
Hemetrics Development Corporation
Due Diligence - What You Need to Know Before Approaching Angel Investors
John 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
Financing High-Tech Companies (Powerpoint, 546kb)
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
Regulatory and Reimbursement Information
MassMEDIC's Boot Camp - Bringing a Product to Market and Avoiding Regulatory Pitfalls, December 13, 2007
Understanding the Regulatory Landscape
James 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
Understanding the Regulatory Landscape
James 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
Medical Device Regulatory Approvals and Reimbursement Processes
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, March 21, 2008
Safety and Efficacy in Preclinical Studies: An Intro to Biocompatibility, and
Regulatory 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
Safety and Efficacy in Preclinical Studies: An Intro to Biocompatibility, and
Regulatory 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
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.