$200K Challenge 2021
Submission Deadline02/21/2021
Description

The $200K Challenge is an international competition for early-stage medical device and biotech technologies. University spin-outs are welcomed and encouraged to apply. The $200K Challenge is being sponsored by Johnson & Johnson Innovation, the Massachusetts Life Sciences Center, Asahi Intecc, AmgenBoston Scientific, Hologic, Kohler, MassMEDIC, Mintz LevinMPR, Sarepta Therapeutics, Argenta Advisors, RQMIS Inc., BARDA DRIVe and The Deshpande Foundation.

Any questions may be directed to maryann_picard@uml.edu or brennan_fournier@uml.edu


FAQs

Is there an application fee?

  • No, there is no application fee.

Who can enter?

  • Inventors, entrepreneurs, start-ups, and university researchers are all welcome to enter the challenge!

Do I need to have a registered company to apply?

  • No, university researchers and research teams are encouraged to apply. In the field where it asks for company name, type "none."

Can I enter as part of a team?

  • Yes! You can enter as an individual or team working in academic, research, or commercial start-up setting and have an innovative product or solution. 

Does an applicant have to give up any equity?

  • No, no equity is taken.

When do I need to submit my application?

  • You or your team leader needs to complete and submit all the application materials before the midnight deadline on Monday, February 19th, 2021 EST.

What are the eligibility criteria for the M2D2 $200K Challenge program?

  • M2D2 seeks early to mid-stage start-ups in the medical device and biotech spaces. Specific areas of focus can be found here. We encourage those who are developing a product and/or service in the healthcare areas outlined to apply.

How do you select finalists for the M2D2 $200K Challenge?

  • M2D2, along with its Challenge sponsors, evaluates all applications based on value, strength, and execution plan. The company strength for each category is evaluated using multiple metrics.
  • Value – product, customer validation, business model & healthcare economics, competition, IP, market opportunity, and patient benefit
  • Strength – team strength, development plan, responsiveness/coachable, freedom to operate, regulatory & clinical burden, funding to date, resources needed
  • Execution plan – stage of development, evidence, time to market, traction, partnerships & relationships, time to key milestones, upcoming funding
  • Interaction with M2D2 and program sponsors is also used as an evaluation metric.

We just raised a Series E, can we still apply?

  • Yes! M2D2 encourages applications from companies at all stages of fundraising, from friends and family to seed and beyond to apply to the $200K Challenge. Preference is given to companies with transformative potential and those who will benefit the most from working with M2D2 and the Challenge sponsors.

We are developing a transformative healthcare technology at a university research lab. Can we apply?

  • Yes! Ventures involving technologies licensed from universities or research labs are encouraged to apply.

I noticed there is coaching available for finalists. What is this like?

  • All finalists are offered coaching appointments to meet with subject matter and pitch experts to refine their presentations and be ready for the pitch-off showcase event on March 24th. Coaching is organized by Mintz and is held online via Webex.

We are based outside the U.S. Can we apply to the $200K Challenge?

  • Yes, international applicants are welcomed and are encouraged to apply.

I applied previously but didn’t receive an award. Should I reapply?

  • Yes, you should apply again as long as the proposal isn’t identical. The needs of the industry and sponsor interests are constantly evolving and can change from year to year. Any updates that took place over the past year should be highlighted in your application.

What are the key dates I should be aware of?

  • January 14th: Application Period Opens
  • February 19th: Application Deadline
  • March 5th: Finalists Announcement
  • March 8th: Deliverables Due (140-character description of technology, company/institution logo, and headshot)
  • March 8th - March 23rd: Coaching Sessions for Finalists
  • March 17th: Final Application and Posters Due
  • March 23rd: Presentations Due
  • March 24th Finalists Pitch Event
  • April 7th: Winners Announcement and Award Presentation

Will finalists be notified ahead of time if they should attend the awards event on April 7th?

  • No! All finalists are expected to attend the awards event virtually and be prepared to present their slide deck to the audience. It is a great opportunity for networking with Challenge sponsors, investors, fellow entrepreneurs, and others. 

If I’m not selected as a finalist, will I receive a written explanation?

  • Unfortunately, due to the high number of applications, we cannot provide a written explanation to every applicant who isn’t selected as a finalist. Most times, it is due to not being properly aligned with the call for applications.
Rules

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

General

Novel solutions to address unmet needs for women’s health

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

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)

BOSTON SCIENTIFIC

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.

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.  

Conditions of interest include:
-Fertility
-Laparoscopic GYN surgery
-Pelvic organ prolapse
-Fecal incontinence
-Pelvic/bladder pain
-Contraception (non-hormonal)

 

JOHNSON & JOHNSON

3D Printing
Atrial fibrillation: detection, treatment, monitoring, ablation
Cardiovascular
Digital Surgery
Neurovascular
Oncology
Obesity
Osteoarthritis
Osteoporosis
Sensor technologies
Surgery
Vision Care

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

Platform Technologies

·       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)

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 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.

-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.

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