M2D2 $200K CHALLENGE 2021
Call for Applications - Important Information
The University of Massachusetts’ Medical Device Development Center (M2D2) is pleased to launch the 10th Annual M2D2 $200K Challenge, an opportunity designed to showcase the innovative ideas and entrepreneurial spirit of seed and early-stage medical device and biotech companies. The M2D2 $200K Challenge Program is sponsored in partnership with
Johnson & Johnson Innovation, Massachusetts Life Sciences Center, Amgen, Asahi Intecc, Hologic, Kohler, MassMEDIC, MPR Product Development, Mintz, RQMIS Inc., Sarepta Therapeutics, Deshpande Foundation, BARDA DRIVe and Argenta Advisors.
The M2D2 $200K Challenge will award valuable in-kind mentoring and development services provided by the program sponsors to selected finalist companies. Applicants from across the nation and beyond are invited to participate, but should clearly indicate their intent to leverage the resources provided as awards in the competition.
Key 2021 dates and deadlines:
- January 14th: Application open
- February 19th: Application deadline
- March 5th: Finalists announcement
- March 8th: Deliverables due (140-character technology description, company/instituion logo, headshot)
- March 8th - 23rd: Coaching sessions for finalists
- March 17th: Final application and posters due
- March 23rd: Presentations due
- March 24th: Pitch-off showcase
- April 7th: Awards ceremony
I. The M2D2 $200K Challenge is interested in receiving a broad range of applications and is seeking biotech, diagnostic, theapeutic, and medical device technologies.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 150 start-up companies and entrepreneurs since the program kicked off in the spring of 2007.
Areas of Interest
Novel solutions to address unmet needs for women’s health
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
Novel vascular diagnostic and therapeutic medical devices
Novel endoscopic-related diagnostic and therapeutic medical devices
ENACT (Early Notification to Act, Control and Treat) - technologies and methods to a) identify and characterize biological, behavioral, and physiological signatures that can signal infection or injury before the onset of noticeable symptoms and b) technologies that provide early health status information to medical care providers.
Infection Severity & Solving Sepsis – Host-based diagnostics, monitoring devices and predictive analytics tool; Host-targeted therapeutics and clinical management approaches
Beyond the Needle – technologies that (1) utilize alternative routes of administration for administering therapeutics, such as but not limited to: oral, intranasal, transdermal patches, sublingual, and buccal mechanisms of administration, (2) involve simplified logistics that enable easier deployment and uptake, and (3) able to 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)
Applications for robotics in medical device 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:
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:
-Laparoscopic GYN surgery
-Pelvic organ prolapse
JOHNSON & JOHNSON
Atrial fibrillation: detection, treatment, monitoring, ablation
Novel/innovative point-of-care and in-home health technologies/services to provide better patient outcomes and to support healthcare more broadly
· 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
Ventures involving technologies licensed from universities or research labs are welcomed and encouraged to apply.
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:
Company will be evaluated based on its chance for market success. The following categories will be used in evaluating the Company.
-Area(s) of focus
-Regulatory pathway and status
-Funding Requirements and Financial Forecast
-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.
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.