M2D2 $200K CHALLENGE 2022
Call for Applications - Important Information
The University of Massachusetts’ Medical Device Development Center (M2D2) is pleased to launch the 11th 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, MassMEDIC, MPR Product Development, Mintz, RQMIS Inc., Sarepta Therapeutics, Draper, 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 2022 dates and deadlines:
- January 14th: Application open
- February 20th: Application deadline
- March 4th: Finalists announcement
- March 9th: Deliverables due (140-character technology description, company/instituion logo, headshot)
- March 10th - 21st: Coaching sessions for finalists
- March 15th: Final application and posters due
- March 21st: Presentations due
- March 22nd: Pitch-off showcase
- April 6th: Awards ceremony (To Be Confirmed)
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
General
- Novel solutions to address unmet needs for women’s health
- Develop a new product for the treatment of Trigeminal Neuralgia
- Implantable and capable of holding a fixed position.
- Able to be fixated to the trigeminal nerve and vessel without the occurrence of dislocation.
- Sufficient decompression.
- Incapable of causing granulomas.
- Visible with all medical imaging methods.
- The Challenge should help to:
- Remove the risk of recurrent trigeminal neuralgia after MVD surgery.
- Relieve patients of pain caused by trigeminal neuralgia indefinitely.
- Give surgeons visibility of implantable post operation.
AMGEN
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Drug delivery and manufacturing technologies that enable multiple new therapeutics and optimizes the patient experience (ex. advanced assembly of multi-specifics)
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Innovative digital and/or automated technologies to support life science operations:
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Automation, miniaturization, & high-throughput
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Data collection, utilization, & management
ASAHI-INTECC
- Novel vascular diagnostic and therapeutic medical devices
- Novel endoscopic-related diagnostic and therapeutic medical devices
BARDA DRIVe
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Infection Severity and Solving Sepsis - The Solving Sepsis program aims to reduce the incidence, morbidity, mortality, and economic burden of sepsis.
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ReDirect - BARDA is requesting abstract submissions for projects that repurpose existing therapeutics as MCMs against chemical threats (cyanide, opioids, nerve agents, chlorine, sulfur mustard, etc.).
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Bringing Laboratory Testing to the Home - DRIVe is seeking platform technologies for on-demand, at-home detection of biochemical health markers, with a preference for multiplexed biochemical assays.
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Digital Health Tools for Pandemic Preparedness - DRIVe is interested in supporting the development of novel digital health tools that can be the first line of defense and augment existing medical countermeasures in the event of a future infectious disease epidemic or pandemic.
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Home-based, Over-the-Counter Diagnostics for the Detection of SARS-CoV-2 - DRIVe is seeking abstract submissions for the development of Emergency Use Authorized (EUA), home-based in-vitro diagnostic assays that can detect SARS-CoV-2 in samples collected in a home setting.
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Enabling Technologies to Support Home-Based Diagnostics for SARS-CoV-2 Acute Infection - DRIVe is seeking abstract submissions for (1) technologies that can enable more wide-spread adoption of at-home testing, and (2) improvements on current technological limitations of diagnostic sensitivity/specificity and performance.
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Mitigating Long-term Effects (MILE) of Respiratory Distress - DRIVe is interested in host-targeted therapeutic product candidates as threat agnostic approaches to aid in mitigating long-term outcomes. DRIVe is interested in further study of host therapeutic product candidates that may be implemented early in the progression of acute lung injury to specifically reduce the long-term morbidity and mortality resulting from the initial injury or infectious insult.
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Endotyping for Host-Directed Therapeutics - DRIVe is interested in further de-risking the development of host-directed therapeutics by validating targeted enrollment strategies based on individual patient characteristics, including immune profiling, biomarker analysis, or other methods of patient stratification (i.e, Endotyping for Host-Directed Therapeutics). Ultimately the goal is to increase the likelihood of meeting therapeutic efficacy endpoints by evaluating the drug specifically in the sub-population for which that therapeutic will most benefit.
BOSTON SCIENTIFIC
Minimally invasive devices or digital health solutions in:
- Peripheral Vascular Interventions
- Cardiology
- Urology and Pelvic Health
- Endoscopy
- Structural Heart spaces
Cyber physical systems are of particular interest
CAPCAT
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. Areas of interest include:
- GYN transvaginal procedures, such as:
- Tubal obstruction (HSG, selective HSG)
- Biopsy collection
- Vaginal Surgery
- GYN Laparoscopic surgery
- Pelvic organ prolapse
- Pelvic/bladder health
- Contraception (non-hormonal)
- Fertility
JOHNSON & JOHNSON
- 3D Printing
- Atrial fibrillation: detection, treatment, monitoring, ablation
- Cardiovascular
- Digital Surgery
- Neurovascular
- Oncology
- Obesity
- Osteoarthritis
- Osteoporosis
- Sensor technologies
- Surgery
- Vision Care
SAREPTA THERAPEUTICS
- AAV and non-viral Gene Therapy
- AAV and non-viral Gene Editing (e.g., CRISPR, epigenetics, other transposase)
- Novel CRISPR-Cas enzymes
- PMO Antisense Oligonucleotides for splice modulation or translational inhibition
- Targeting of Oligonucleotides to muscle tissue
- AAV Engineering and targeting for neurological applications
- Immune modulation for gene therapy/editing
- Promoter engineering for gene therapy/editing
- Non-viral gene therapy/editing delivery to muscle and/or neurological applications
Draper
- Biodefense
- Biodetection
- Biomedical threat detection capabilities
- Exposure monitoring
- Biosurveillance
- Pathogen analysis and identification
- Rapid pathogen sequencing tools
- Medical Countermeasures/Preventative Therapies
- Military Medicine/Combat Care
- Prolonged Field-Care in Austere Environments
- Organ Support
- Hemorrhage Control
- En Route Intensive Care
- Deployable Medical Care
- Rapid Diagnostics (Clinical and Austere Environments)
- Human Performance and Preventative Health
- Microbiome/Probiotics
- Environmental Health and Protection
- Immune System Stimulants
- Novel wearables, Decision Aids, Algorithms to improve performance and effectiveness
- General
- Organ-on-Chip Technology
- Immune System Models
- Multi Organ Models
- Precision Medicine
- Biomanufacturing
- Novel Therapies
- Medical Devices
- Implantable therapeutic devices
- Other
- Biological Computing
- Data Storage
- High Strength Polymers
- Cryptographic Materials
Therapeutic Areas
· 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.
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 the in-person event on March 22, 2022, 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 6, 2022. 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.
-Unmet need
-Area(s) of focus
-Proposed solution
-Clinical status
-Market status
-Regulatory pathway and status
-Competitive Advantage
-Scope
-Management team
-Funding Requirements and Financial Forecast
-Business Plan
-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.