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.


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.

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


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.

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
Medtronic's Perspective
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

VCexperts.com
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, 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


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


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.



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