M2D2 Services : Massachusetts Medical Device Development Center : UMass Lowell

The Massachusetts Medical Device Development Center is prepared to assist the medical device entrepreneur through every obstacle until the desired goal is reached, whether that is a start up company or licensed technology.

If you believe your medical device would benefit from the services provided by M2D2, start a conversation with M2D2 by filling out an M2D2 Participation Application Form. There is no obligation to purchase fee based programs, and no risk with a Confidential Disclosure Agreement offered.

The M2D2 Team will confirm receipt of your application and then review your application within 30 days of receipt. If appropriate, we may also invite you and your team to discuss your application with the M2D2 management team.

M2D2’s free and fee-based services will guide the inventor from start to finish.

Once the concept is formed, the M2D2 business department offers the following:

Marketing plans.
Business plans.
Business analysis.
Assistance with STTR/SBIR applications.

UMass Lowell has world renown engineering and plastics labs offering:

Prototype development.
Prototype assistance considering costs, schedule and quality.
Design feedback.

Early input from medical school faculty can be invaluable. The UMass Medical School is well equipped in:

Medical assessments.
Facilities partnership with clinical investigators.
Medical expertise.
Dedicated central service for support through life cycle of clinical study (feasibility to close-out).
Access to patient population for clinical trials.

Once a compelling prototype is produced, connections within the medical device community save time. M2D2 provides:

A network of private sector design, fabrication, and testing firms.
Interface with MassMEDIC IGNITE program.

Funding can be a major roadblock. Introductions to investors is a desirable asset. M2D2 supplies:

Connections to Massachusetts Venture Capitalist and Angel Network.
Fastlane loans (up to $75,000) with inventor raising matching funds.

M2D2 also offers:

Incubator space with wet labs.
Regulatory support for FDA submissions.

Fastlane Loan Program:

M2D2 offers limited funding through its Fastlane Loan Program. Twice a year, technologies are selected to compete in a two step approval process for a loan up to $75,000. In order to qualify, the entrepreneur must raise matching funds. All funds must be used at M2D2 facilities either on the Lowell or Worcester campuses.

If the awardee is able to successfully commercialize the supported technology, the inventor reimburses M2D2 for the Fastlane loan amount. In addition, within 60 days of achieving $500,000 in sales of the supported technology, the awardee pays a success fee to M2D2 in an amount equal to the Fastlane loan.

If the awardee is not able to commercialize the product, then nothing is owed to M2D2.

An example:

An entrepreneur would like a prototype made of his invention. He currently has $55,000 from a grant from his institution, and is selected to apply for Fastlane funding for an additional $55,000. In his Fastlane application, he proposes that $30,000 is spent at UMass Lowell for design and manufacturing of his prototype, and the remaining $80,000 is spent at the UMass Worcester campus for testing. The technology is accepted for Fastlane funding. A year later, the inventor is able to commercialize the product and submits $55,000 to M2D2 for reimbursement of the loan. Three years later, $500,000 is reached in sales, and the inventor pays a $55,000 success fee to M2D2.

M2D2 Forms for Entrepreneurs

The Massachusetts Medical Device Development Center attempts to provide all forms in an electronic format, with most in PDF format. Adobe Acrobat is required to view PDF files and can be downloaded free at: Adobe Acrobat.

Note: some forms are external links to federal or state websites.

M2D2 Funding Forms

If you believe your medical device would benefit from the services provided by M2D2, please complete and submit the M2D2 Participation Application file linked below. The M2D2 Team will confirm receipt of your application and then review your application within 30 days of receipt. If appropriate, we may also invite you and your team to discuss your application with the M2D2 management team.

STTR/SBIR Funding and Forms (STTR Due dates are April 5, August 5 and December 5, 2009)

NIH STTR/SBIR Topics