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2019 M2D2 $200K Challenge - Rules

Rules

M2D2, the Massachusetts Medical Device Development Center, is a joint initiative of the Lowell and Worcester campuses of the UMass system. Its aim is to help new biotech and medical device entrepreneurs develop products every step of the way, from proof-of-concept to commercialization. Its affiliated faculty and staff have assisted more than 100 start-up companies and entrepreneurs since the program kicked off in the spring of 2007.
The M2D2 $200K Challenge is interested in receiving a broad range of applications and is seeking biotech, diagnostic and medical device technologies.
SponsorsAreas of Interest
Amgen

Large molecule drug delivery technologies that simplify and optimize the patient experience as well as minimize the impact of therapy delivery on patients’ daily lives. Example areas of interest include technologies for targeted delivery (e.g., cell, tissue, organ, system, tumor), long acting doses, and selfadministration outside of a health-care setting 

Digital and/or biomarker-based diagnostics that support the identification and medication adherence of patients with serious diseases Digital and/or device-based technologies that support the proper use of drug delivery devices 

Technologies that dramatically lower the cost and complexity of incorporating electronic functionality in disposable drug delivery devices. Example areas of interest include technologies for energy harvesting and battery-less pump systems

Asahi InteccNovel vascular treatments Diagnostic Devices Cardiovascular Neurovascular Peripheral vascular Interventional oncology ENT Orthopedic
BARDA DRIVeSepsis solutions and technologies Health security transformative technologies
Boston ScientificMinimally invasive treatment or diagnostic device for solid tumors Minimally invasive circulatory assist devices Minimally invasive devices for diagnosis and treatment in the areas of: Gastrointestinal disease Urology Pelvic health Interventional cardiac and peripheral artery disease Electrophysiology
CAPCaTPoint of care technologies for: Heart Blood Lung Sleep disorders
Deshpande FoundationThe Deshpande Foundation is looking to sponsor 2-3 finalist teams from India with airfare and lodging so they can attend both the finalist pitch-off on March 27th as well as the awards ceremony on April 10th. Teams must be accepted as finalists in order to be eligible for the sponsorship. 
HologicDevices intended to simplify and improve diagnosis and therapeutic procedures in the female pelvic health space, filling treatment gaps and improving patient care. Conditions of Interest include: Stress urinary incontinence Overactive bladder Pelvic organ prolapse Fecal incontinence Abnormal uterine bleeding Uterine cancer Fertility
Johnson & Johnson3D Printing Cardiovascular Digital Surgery Neurovascular Oncology Obesity Osteoarthritis Osteoporosis Surgery Vision Care
Ventures involving technologies licensed from universities or research labs are encouraged to apply.
Eligibility
  1. An Applicant must be a duly-organized and existing legal business entity (hereafter referred to as “Company”), including a partnership, corporation, limited liability company, or joint venture, or similar business organization or association under the law of the jurisdiction in which the Company is organized.
  2. The Company must be organized as a for-profit entity.
  3. The Company must be in good standing in the Commonwealth of Massachusetts, and if legally organized in another state or jurisdiction, must be existing and in good standing in that state or jurisdiction.
  4. All technology involved in the venture must be advanced enough that it is capable of demonstration.
  5. Company will be encouraged but not required to locate at M2D2 for at least 6 months following the conclusion of the competition (May to November 2019).
  6. The $200K Challenge welcomes international applicants.
Application Process
A. Phase I Judging
  • Company submits basic non-confidential information regarding Company and business concept. Documents may include business plans, financial statements, and projections published patent applications and any applicable documents as requested. M2D2 will review initial applications and select up to fifteen companies proceeding to the Phase II Reception and Presentations.
B. Phase II Reception & Presentations
  • Company attends reception and presentation event on March 27, 2019, on the campus of UMass Lowell, Lowell MA 01854, providing a four-minute presentation to a Panel of Reviewers followed by one minute Q & A. This event will be open to the public. Reviewers for this round will be arranged by M2D2 and will include the event sponsors, Johnson & Johnson Innovation, Amgen, Boston Scientific, Mintz, R&Q, and MPR. A panel of reviewers scores Company. $200K Challenge finalists will be invited to the Phase III Final Awards Announcement and Presentation. 
C. Phase III Final Awards Announcement and Presentation
  • $200K Challenge finalists will be invited to the Awards Announcement and Reception at the Boston office of Mintz, to be held on April 10, 2019. Following the presentation of awards, winners will be invited to deliver a 5-minute presentation. 
D. Incubation of Award Winners at M2D2
  • Upon selection of the Companies receiving awards, each Company will negotiate with M2D2 and the appropriate Program Sponsors to define the term and terms of incubation including the specific in-kind services to be provided and the requirements for such.
Selection and Judging Criteria
Company will be evaluated based on its chance for market success. The following categories will be used in evaluating the Company.
  1. Unmet need
  2. Area(s) of focus
  3. A. proposed solution B. clinical status C. market status D. regulatory pathway and status
  4. Competitive Advantage
  5. Scope
  6. Management team
  7. Funding Requirements and Financial Forecast
  8. Business Plan
  9. Level of interest expressed in interacting with M2D2 and program sponsors
Legal Documentation Required
The below documents must be made available upon request:
  • Articles or Certificate of Incorporation (corporation) or Articles of Organization (limited liability company) or Articles of Limited Partnership, or similar publicly filed organic documents.
  • By-laws (corporation), Partnership Agreement, or Operating Agreement (limited liability company).
  • Certificate(s) of good standing from the Commonwealth of Massachusetts and, if applicable, from state or country of organization.
  • Redacted License Agreements, where applicable, noting Company’s IP rights.
Prizes
The $200K Challenge will award up to $200,000 of in-kind medical device, diagnostic and biotech development services from the Program Sponsors. This may include and be in the form of: general services from Johnson & Johnson Innovation, Amgen, Asahi Intecc, Boston Scientific, Hologic, legal services from Mintz, design services from MPR, regulatory services from R&Q, medical device / biotech development services from M2D2. All services offered will be mutually agreed upon between the winning company or companies and the Program Sponsors providing those services. Typically, 4 to 8 awards are made per year
Final Scoring, selections, and award(s) are made at the sole discretion of the Panel of Reviewers.
Disclosure of Information
No promise of confidentiality, non-competition or non-disclosure is made by the University of Massachusetts, Reviewers, and Sponsors. Any company submitting information for consideration in this competition acknowledges that its information may be made public, and that any presentations may be open to any interested parties, including the general public.
Limitation of Liability
Company releases the Commonwealth of Massachusetts, the University of Massachusetts, Johnson & Johnson Innovation, Amgen, Asahi Intecc, Boston Scientific, Hologic, Mintz, MPR, and R&Q, and their respective directors, officers, employees, agents, reviewers, sponsors, and all award suppliers from any and all liability for any injuries, losses, or damages of any kind resulting from acceptance, possession, or use of any award or participation in this competition, to the fullest extent permitted by applicable law.
Company agrees to indemnify the Commonwealth of Massachusetts, the University of Massachusetts, Johnson & Johnson Innovation, Amgen, Asahi Intecc, Boston Scientific, Hologic, Mintz, MPR, and R&Q, and their respective sponsors, reviewers, agents or employees against any claim that Company’s involvement violated any rules or regulations of the U.S. or any other country as a result of Company's participation.
Company or individual is solely responsible for compliance with any laws, rules and regulations that may be applicable to participation in the competition or to any awards received.
Company or individual is solely responsible for all (both U.S. and non-U.S.) taxes, withholdings or other governmental assessments that might be applicable as a result of participating in this competition.
Governing Law
The parties agree that this Competition shall be governed, construed, interpreted, and enforced according to the laws of the Commonwealth of Massachusetts.