Wednesday, December 30, 2015

MIN-Corps 2015 Year End Review

The mission of MIN-Corps is to accelerate technology commercialization across the University of Minnesota.  We have three objectives:
  • Increase the entrepreneurial mindset & skill set among U of MN STEM students, research staff and faculty.
  • Build the capabilities of science and engineering students, research staff and faculty to identify the commercial potential of their discoveries and inventions, and test those ideas in the marketplace.
  • Partner with relevant campus and local programs to promote a culture of innovation and entrepreneurship at the University of Minnesota.
2015 was our first full year as an NSF-funded National Innovations Corps site.  So how did we do?

We started the year with two types of programs:  a full-semester 2-credit course and single-session noncredit seminars. In mid-year, we “pivoted” as a result of an opportunity to develop a new faculty-oriented program in conjunction with our colleagues at MN-REACH (UMN is one of three NIH-funded Research Evaluation and Commercialization Hubs). After fine-tuning our “minimum viable products” with our program participants this fall, we are going into 2016 with a refreshed “theory of change” and a comprehensive slate of programs for all our constituents (faculty, research staff, graduate students and undergrads).  Thank you to all our collaborators and program participants!

STARTUP Course – A fourteen-week, 2-credit course that trains participants to apply the Lean Startup methodology to a specific business concept, and provides them with hands-on faculty and business mentor support, as well as mini-grants for prototyping and customer discovery/customer development.  
  • Spring 2015 – 13 STEM business concepts
  • Fall 2015 – 7 STEM business concepts (enrollment is typically higher in spring)
Students’ rating of readiness to assess market feasibility of a business concept increased:
  • Average pre-course readiness: 2.8 on a scale of 1 (“very low”) to 5 (“very high”)
  • Average post-course readiness: 3.9 with 0 students < 3, and 61% at 4 or 5
Examples of a few participant business concepts:
  • High-speed bearingless motor
  • Sickle cell anemia crisis treatment
  • Device to correct dog incontinence
  • Recycled plastic filament for 3D printers
Spring 2015 MIN-Corps Seminar Series – Noncredit seminars on innovation and entrepreneurship offered to the broad University community
  • 10 Types of Innovation – 145 registered participants
  • Securing Intellectual Property – 55
  • Funding Research and Innovation-Driven Ventures:  SBIR and STTR – 70
  • Lean Startup 101 – 120
  • 3D Printing and Bionics  - 127
  • Tapping the Potential of Plant Genomics – 55
Medical Technology Commercialization Bootcamps – One-day immersion into Lean Innovation principles and commercialization processes specific to diagnostics, pharmaceuticals, medical devices and health care IT.  This program was designed and delivered in conjunction with MN-REACH.
  • Summer 2015 – 43 participants who had submitted pre-proposals for research commercialization grants from MN-REACH
  • Fall 2015 – 46 participants, including researchers intending to apply for MN-REACH grants as well as Fellows from the Medical Devices Center and Fellows from the MnDRIVE Brain Conditions Initiative fellows
Participant testimonials:
  • “The biggest issue I hadn’t thought of was working towards a target consumer so early…. I can see how this would help tailor the experiments to bring the technology to the market in a more streamlined fashion.”
  • “I was surprised by the requirement for fine tuning the first application of the technology.  This was a real reality check…”
Medical Technology Commercialization Value Proposition Design Workshops – Four half-day, hands-on workshops applying the Value Proposition Canvas and Customer Discovery methods to specific medical technology projects.  Targeted to researchers invited to submit proposals (essentially business cases) for MN-REACH commercialization funding.  Sessions included presentations and project-specific advice from industry experts.
  • Summer 2015 – 8 project teams
  • Fall 2015 – 8 project teams
Testimonials:
  • "The Value Proposition Development series (all four parts) was also well attended and informative.  It was wonderful to watch the innovators start to grasp the key concepts of the Lean LaunchPad approach and also the manner by which understanding the customer and his or her needs can influence development of the technology….It was also great to see a strong positive response to all the external speakers that you brought in.  It was clear that the innovators benefitted from the perspective and experience of the external mentors." – Allison Hubel, Deputy Director for Skills Development, MN-REACH
  • "I learned a lot about the commercialization process that will be useful throughout my career. The class content and discussions with experts from industry have given me insight into how to design my next round of experiments to maximize the likelihood of translation to the clinic." (program participant)
As a result of our collaboration with MN-REACH (our own application of Customer Discovery), we’ve developed a more comprehensive “theory of change” that acknowledges the full journey to commercialization of academic research:

 
We now have a more comprehensive program design:

 
In 2016, we’re looking forward to continuing our STARTUP course and our collaboration with MN-REACH to provide education to researchers interested in medical technology commercialization.  We’ll also be adding: 
  • An Environment and BioTechnology Commercialization Bootcamp and Value Proposition Design Workshops series in collaboration with the MnDRIVE Environment Initiative and the UMN BioTechnology Institute
  • Strategy Clinics for researchers that have gone through Lean LaunchPad training and are now going through the tough slog of commercialization. 
  • Emerging Opportunities Forums on innovation and entrepreneurship opportunities in Agriculture and Consumer-Driven Health Care
  • Ecosystem Events to encourage greater interactions between UMN researchers seeking to commercialize their research with the Twin Cities business community
It promises to be an exciting year!

Tuesday, December 22, 2015

A Trade Secrets Strategy May Protect IP, But Can Harm Business

Source:  Theranos

The MIN-Corps blog has had several postings (here, here and here) using Theranos as a case study in how not to build a science-based business. Theranos is an 11-year old “startup” with a possibly revolutionary technology to do comprehensive testing using tiny amounts of blood.  Earlier this year, Theranos was a “unicorn,” a young(ish) Silicon Valley company with a multi-billion dollar valuation.  But then a series of Wall Street Journal articles (here, here,  here, and here) questioning the effectiveness of the technology and the validity of its blood tests.  What then followed were FDA investigations, and withdrawal by marketing partners Walgreens and Safeway.  Since there hasn’t been a funding round since these articles and events, the current valuation of Theranos is anyone’s guess, but you can be sure it’s less today than it was six months ago.

Now the Wall Street Journal has another article about investigations by both the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) into the blood testing equipment and protocols.  What’s striking is that it still isn’t clear what’s going on with the technology itself, probably because Theranos has chosen not reveal it via patents, but to protect their IP via a trade secrets strategy.

Let’s assume that the technology is the real deal.  Then wouldn’t it be in Theranos’ interest to prove it?  But, that means sharing details about the technology to impartial third parties – the most common means being via peer-reviewed journal articles.  A trade secrets strategy makes that tough, and Theranos has been tying itself into knots trying to defend itself without revealing anything proprietary.  To quote from the most recent WSJ article:
  • “Theranos has said that all its lab work is accurate and reliable. In recent weeks, Elizabeth Holmes, the company’s founder and chief executive, has defended Theranos in public appearances and pledged to publish peer-reviewed data on its tests. Ms. Buchanan, the spokeswoman, said the data aren’t ready and declined to specify when the information will be published. After working on a technology for 11 years and submitting info to the FDA for regulatory approval, wouldn’t you think that they’d be able to produce the data more quickly?
  • “In response to questions from the Journal, Theranos last week made available three senior company scientists, who discussed their work and certain documents and regulatory submissions by Theranos. However, the company said the documents couldn’t be disclosed by the Journal or reflected in this article because they contained confidential information and trade secrets.  Huh?
  • “Theranos’s spokeswoman, Ms. Buchanan, said Theranos believes that the former employee who filed the FDA complaint is ‘uninformed’ and ‘disgruntled.’ The FDA’s approval was ‘hard earned and the product of significant efforts by dozens of exemplary scientists and engineers—honest, hardworking, highly qualified individuals.’” Wouldn’t it be better just to produce your proof rather than start hurling insults? Wouldn’t it be better to make those “exemplary” scientists available on the record?
For all its issues, the disclosure inherent in patenting allows for vetting, as well as for others to build on your innovation while you hold exclusive rights for 20 years after filing.  Assuming that their technology works, Theranos’ business would probably be in better shape if they had chosen a less secretive IP strategy.

If you are a university-based inventor, go talk with your tech transfer office about an IP strategy that allows for peer-reviewed validation of your science.

Wednesday, December 16, 2015

Bridging The Chasm Between Invention and Commercialization Part 2: Skills

Translational Research: Getting the message across, http://www.nature.com/news/2008/080611/full/453839a.html#close

This is the second in a series of postings about bridging the Valley of Death – the chasm between university-generated innovations and real-world products and services.  The first post examined the role of misaligned institutional incentives, and how they are beginning to change.  Future entries will look at tech transfer practices, as well as access to ecosystem resources.  This post focuses on skills gaps.  

Eric Kaler, the president of the University of Minnesota, was a coauthor on a Proceedings of the National Academy of Sciences article titled, Changing the academic culture: Valuing patents and commercialization toward tenure and career advancement.” The piece argues the following benefits for a university that generates a lot of basic research to also promote commercialization:
  • Increased Opportunities for Research Funding (not just from federal agencies, but also from industry, foundations and alumni)
  • Access to Unrestricted Funds for Further Institutional Investment (i.e. licensing royalties)
  • Sustains High Scholarship Level (perhaps counterintuitively, the more a faculty researcher partners with industry, the more he or she publishes in high-impact journals, and the more those papers are cited)
  • Student Success (real-life research opportunities at all levels; increased career options for doctoral students and post-docs)
  • Increased Prestige (commercialization = knowledge dissemination = public recognition)
  • Public Benefit (make those innovations available to society)
  • Economic Development (jobs, jobs, jobs – especially important for public universities)
Let’s say that academics buy into this argument.  Then what?  Where does someone who has spent decades developing deep expertise as a researcher even start?  This is where academic commercialization education programs, like the NSF-funded National Innovation Corps, come in.

The I-Corps got started when Errol Arkilic, a program director at the NSF realized the power of Lean LaunchPad methodology to move innovations out of the lab and into marketplace, and contacted Steve Blank, one the major evangelizers of the Lean LaunchPad (aka Lean Startup or Lean Innovation) approach.  Steve has a nice podcast about those early conversations.  The first National Innovation Corps cohort was run through the Lean LaunchPad paces in Fall 2011.  Since that early success five years ago, the National Innovation Corps (NIN) has expanded to over 40 major universities around the US, offering various flavors of Lean Startup curricula and support.

The whole point of Lean LaunchPad is to go out and talk to customers, but this is easier said than done.  There is a methodology to customer discovery, value proposition design and business model design.  The NIN is not a passive curriculum (just reading The Lean Startup on an airplane is not going to cut it), but an immersion experience, where teams apply concepts to their specific projects in order to move them forward.

  • At the national and regional levels, seven universities act as “nodes,” providing10-week experiential training to entrepreneurial teams composed of an entrepreneurial lead (typically a grad student or post-doc), a principal investigator (faculty), and a mentor (an experienced entrepreneur).  This intense immersion program not only provides information about such topics as customer discovery and the business model canvas, but – more importantly – forces teams to go out and speak to LOTS of customers (100 is the goal) in order to (in)validate their value proposition hypotheses. 
  • At the local level, 36 universities currently act as “sites,” with a wide variety of Lean LaunchPad-inspired offerings.  The sites develop skills at the local level and also feed teams to the node programs. But, more importantly, they adapt to local conditions and spread the Lean LaunchPad mindset and skill set across their institutions, as well as their broader educational and business communities. 
Here is a directory of current National I-Corps nodes and sites.

Here at the University of Minnesota, our MIN-Corps program accelerates commercialization through four touch-points:

-- Awareness building

Bootcamps - What does commercialization even entail?  A one-day bootcamp to expose faculty, research staff, grad students and industry partners to key concepts, processes and considerations.  This spring, we’ll be doing bootcamps on Medical Technology Commercialization, and Environmental Tech & Biotechnology Commercialization

- Emerging Opportunities Forum – What are the commercialization implications of breakthrough research?  An opportunity for academics and business people to explore new themes

-- Skills development

               -  Our STARTUP course is the classic LeanStartup curriculum, but with an extra layer of external advisors and mentors.  This rigorous and intense semester-long program is focused on students on the undergrad and graduate level, with the occasional participation of post-docs and faculty

               -  Value Proposition Design Workshops are our version of “Lean LaunchPad Lite.”  Primarily focused at faculty, as well as the post-docs and grad students working on commercialization research within their labs.  This spring, we’ll be doing workshop series on Medical Technology Commercialization and Environmental Tech & Biotechnology Commercialization

-- Connections

               -  In all our programs, we bring in external advisors and mentors.  These experts challenge our participants’ assumptions and help them make customer connections to vet their value propositions.  They also may help with the initial steps to launch their ventures. The experts are sourced from multiple sources, including the mentors and judges who support the Minnesota Cup venture competition, as well as the business advisory group of the Venture Center at the UMN Office for Technology Commercialization.

-- Ongoing support

               - We’re now formalizing something that we’ve done informally for a long time – providing advice and connections to past program participants.  The business concepts that come out of the U of M are often very ambitious, and may take months or years to get off the ground.  Ongoing Strategy Clinics are monthly meetings for past program participants who are actively working on commercialization to continue to build knowledge and connections, gain new insights, and do mutual problem-solving.

See the MIN-Corps site for more info on our programs.