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.
Sponsors and Areas of Interest
- 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 self-administration 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.
- Asahi Intecc
- Any area of vascular treatment and diagnostic devices including, but not limited to, cardiovascular, neurovascular, peripheral vascular and interventional oncology.
- Minimally invasive treatment devices for gastrointestinal disease, electrophysiology, ENT and orthopedics.
- Clinical management strategies supported by enhanced education and awareness
- Rapid diagnostics and prognostics
- Continuous multi-dimensional patient monitoring
- Machine learning-based disease management feedback algorithms
- Optimized therapeutic interventions
- Health security transformative technologies
- Minimally 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, and electrophysiology
- Point of care technologies for heart, blood, lung, and sleep disorders
- Complementary and integrative health solutions
The 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 25 as well as the awards ceremony on April 7th. Teams must be accepted as finalist in order to be eligible for the sponsorship.
Areas of interest include 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, and contraception (non-hormonal).
Johnson & Johnson
Areas of interest include 3D printing, atrial fibrillation (detection, treatment, monitoring, and ablation), cardiovascular, digital surgery, neurovascular, oncology, obesity, osteoarthritis, osteoporosis, sensor technologies, surgery, and vision care. Ventures involving technologies licensed from universities or research labs are encouraged to apply.
- AAV Gene Therapy: Capsids, genome constructs/payloads, manufacturing assets/capabilities, gene therapy immunology or immunomodulators, non-viral delivery vehicles, re-dosing strategies
- CRISPR/Cas9 Genome and Epigenome Editing: Gene editing immunogenicity or immunomodulators, novel Cas enzymes, gRNA design/screening, unique expression constructs, viral/non-viral delivery vehicles, epigenome editing (dCas9)
- Antisense Oligonucleotides for Splice Modulation or Translational Inhibition (Ideally Using PMO Chemistry): Novel drug conjugates (i.e. cell-penetrating peptides, antibodies, targeting ligands, etc) or delivery vehicles (i.e. nanoparticles, exosomes, etc)
- Muscle: Diseases resulting from defects in skeletal muscle, cardiac muscle or the neuromuscular junction
- Central/Peripheral Nervous System: Diseases resulting from defects in neuronal differentiation, maturation, innervation or injury
- Disease-Area Expansion: Beyond our core Therapeutic Areas, we are also open to assessing disease indications that are amenable to our platform technologies
- 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.
- 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.
- All technology involved in the venture must be advanced enough that it is capable of demonstration.
- 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).
- The $200K Challenge welcomes international applicants.
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.
- Unmet need
- Area(s) of focus
- A. proposed solution B. clinical status C. market status D. regulatory pathway and status
- Competitive Advantage
- Management team
- Funding Requirements and Financial Forecast
- Business Plan
- 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.
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.
The parties agree that this Competition shall be governed, construed, interpreted, and enforced according to the laws of the Commonwealth of Massachusetts.