Sponsors and 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.

I. The M2D2 $200K Challenge is interested in receiving a broad range of applications and is seeking biotech, diagnostic and medical device technologies.

Sponsors and Areas of Interest

Amgen

  • Large molecule drug delivery technologies that simplify and optimize the patient experience (ex. tissue-specific delivery, long acting doses, self-administration)
  • Digital and/or device-based technologies to support medication adherence or delivery
  • Next generation miniaturized, highly parallel and/or rapid analytical systems for:
    • Measuring large molecule solution attributes (ex. viscosity, aggregates, impurities)
    • Aseptically measuring attributes of single cells (ex. cell surface antigens, adherence propensity)
    • High-throughput sample preparation for large molecule multi-attribute measurements (ex. digestion, labelling)
    • Advanced cell-based (or surrogate) assays for critical quality attribute assessment
    • Modular systems for synthetic molecule continuous manufacturing (ex. light catalyzed or enzymatic micro-reactors)
    • Automation hardware and software to support high-throughput experimentation

Asahi Intecc

  •    Novel vascular diagnostic and therapeutic medical devices
  • ·  Novel endoscopic-related diagnostic and therapeutic medical devices

BARDA DRIVe

  • Technologies and methods that can signal infection or injury before the onset of noticeable symptoms
  • Technologies that provide early health status information to medical care providers
  • Host-based diagnostics, monitoring devices and predictive analytics tool
  • Host-targeted therapeutics and clinical management approaches
  • Technologies that utilize alternative routes of administration for administering therapeutics (oral, intranasal, transdermal patches, sublingual, and buccal mechanisms of administration)
  • Technologies that enable easier deployment/uptake of therapeutics and can be administered without a trained health-care professional
  • Advanced Manufacturing Technologies – The purpose of the innovations and enhancement to advanced manufacturing technologies may include but is not limited to improving pharmaceutical quality, rapidly scale manufacturing capabilities, shorten supply chains, increase manufacturing resilience to disruption, accelerate availability of emerging therapies/vaccines, and reduce the risk of pharmaceutical shortages. Advanced manufacturing technologies may include but is not limited to continuous manufacturing and additive manufacturing (including 3D printing)

Boston Scientific

  • Applications for robotics in medical development and delivery
  • AI (Artificial Intelligence) tools and applications to optimize and automate development, manufacturing and/or supply chain in order to increase efficiencies and provide lower overall cost of healthcare for patients
  •  Novel materials, coatings, or processes to enhance manufacturing, performance and distribution/shelf life of    medical devices.
  • Point of care technologies for:
    • Heart
    • Blood
    • Lung
    • Sleep disorders

Hologic

  • Devices intended to simplify and improve therapeutic procedures in the women’s health space, filling treatment gaps and advancing patient care.
  • Conditions of interest include:
    • Fertility
    • Laparoscopic GYN surgery
    • Pelvic organ prolapse
    • Fecal incontinence
    • Pelvic/bladder pain
    • Contraception (non-hormonal)

Johnson & Johnson

  • Cardiovascular/AFib
  • Obesity
    • More durable interventions
    • Prevent/reduce morbidities
  • Osteoporosis
    • Minimize fracture reate
    • Improve healing
  • Sports Medicine
    • Rotator cuff healing and repair
    • Cartilage repair
  • Surgery
    • Improved treatment options
    • Minimally invasive procedures
  • Osteoarthritis
    • Early interventions
    • Better surgical outcomes
  • Neurovascular
  • Surgical oncology
  • Fracture healing
  • Anti-infectives/
  • Disc degenerative disease/
  • 3D printing
  • Digital surgery
  • Wound healing
  • Vision
    • Contact lens (myopia, astigmatism & hyperopia, beauty & performance)
    • Dry eye
    • Surgical (cataract & refractive)
    • Glaucoma
  • Health technology
  • Smart device for therapy delivery
  • Disease interception; prevention
  • Digital & mobile wellness
  • Patient; consumer engagement
  • Lung cancer
  • Holistic solutions
  • Consumer products, diagnostic, medical devices & pharmaceuticals

Kohler

  • Novel/innovative point-of-care and in-home health technologies/services to provide better patient outcomes and to support healthcare more broadly

Sarepta Therapeutics 

  • AAV Gene Therapy
  • CRISPR/Cas9 Genome and Epigenome Editing
  • PMO Antisense Oligonucleotides for splice modulation or translational inhibition
Ventures involving technologies licensed from universities or research labs are encouraged to apply. Intellectual property is required but a business does not already need to be organized.

Challenge Rules

II. Eligibility:
  1. An Applicant can be a duly-organized and existing legal business entity, 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. The applicant can also be an individual or team with a venture involving technologies licensed from universities or research labs.
  2. If the applicant is a Company, it can be organized as a for-profit or non-profit entity.
  3. If the applicant is a Company, it must be in good standing in the state in which it is organized.
  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.
  6. The $200K Challenge welcomes international applicants.
III. Application Process:
A. Phase I Judging 
Applicant submits basic non-confidential information regarding company and business concept. In rare circumstances additional information may be requested, such as business plans, financial statements and projections, published patent applications and related documents. M2D2 will review initial applications and select up to fifteen applicants to proceed to the Phase II Reception and Presentations. 
B. Phase II Reception & Presentations 
Applicant attends virtual pitch event on March 24, 2021, 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. Panel of reviewers score applicant. Applicant must attend and give presentation in person to be considered for an award. $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 virtual Awards Announcement with Mintz, to be held on April 7, 2021. Following the presentation of awards, winners will be invited to deliver a 4-minute presentation. 
D. Incubation of Award Winners at M2D2 
Upon selection of the applicants receiving awards, each applicant will negotiate with M2D2 and the appropriate Program Sponsors to define the terms of incubation including the specific in-kind services to be provided and the requirements for such. 
IV. Selection and Judging Criteria: 
Applicant will be evaluated based on its chance for market success. The following categories will be used in evaluating the applicant. 
  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 
V. Legal Documentation Required: 
The below documents should be 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. 
VI. 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, legal services, design services, regulatory services, and reimbursement 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. 
VII. 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. 
VIII. Limitation of Liability: 
Applicant releases the Commonwealth of Massachusetts, the University of Massachusetts, Johnson & Johnson Innovation, Massachusetts Life Sciences Center, Amgen, Asahi Intecc, Hologic, Kohler, MPR Product Development, Mintz, RQMIS Inc., Sarepta Therapeutics, Deshpande Foundation and Argenta Advisors, 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. 
Applicant agrees to indemnify the Commonwealth of Massachusetts, the University of Massachusetts, Johnson & Johnson Innovation, Massachusetts Life Sciences Center, Amgen, Asahi Intecc, Hologic, Kohler, MPR Product Development, Mintz, RQMIS Inc., Sarepta Therapeutics, Deshpande Foundation and Argenta Advisors, 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. 
Applicant 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. Applicant 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. 
IX. Governing Law: 
The parties agree that this Competition shall be governed, construed, interpreted, and enforced according to the laws of the Commonwealth of Massachusetts.