Lessons learned at BMES Coulter College

From August 3rd to August 6th, rising undergraduate seniors from twelve international Biomedical Engineering college programs convened in Atlanta Georgia for an educational contest of who could develop the best medical device design and prepare the best investor pitch on the supporting business.  The Coulter College event was hosted by the Biomedical Engineering Society with support from the Wallace H. Coulter Foundation.

Four students and a faculty educator from each university were given one of three medical opportunity areas to research before the event as their homework.  In an exciting twist this year, the students and faculty were split up upon arrival and were notified of their new team assignments by their table seating at Thursday night's dinner.

Thursday evening kicked off by Andrew DiMeo with his talk on how to craft an excellent Need Statement.  The students were introduced to the need statement as the What that Matters.  What (not How) problem are you solving and why does it matter?  The criteria for a need statement needs to solution-free, bias-free, concise, assumption-free, includes a metric for desired change, and is poetic.  For a group of engineers, adding poetry to the need statement was perhaps the most daunting challenge.

At 8am Friday morning, the students each gave a 2 minute presentation of their project mission and need statement, having stayed up late the night before working on their poetry.  Following the presentations, Ty Hagler got the design day kicked off with a talk on brainstorming and creative performance. We learned that the experts of creativity are 5-year old children, who are also experts at being silly.

Ty introduced the students to the discipline of Industrial Design and walked the group through several tips and techniques to be more creative and have better ideation sessions.  He used the metaphor of gunpowder to explain the interrelated importance of a good need statement and creative performance.  If gunpowder were left on a table by itself and ignited, all it would to is explode and make a big mess.  But, when encased in constraints and applied to strategic intent, the combination can change the course of human history.  Following the talk, the students then worked on refining their need statements and quickly brainstorming solutions that they could present for a series of consultation meetings with business advisors, regulatory consultants, and industrial designers from Trig.

After a round of consultations, the students learned the importance of a Quick-Kill Experiment in any new product program designed to shut it down as soon as evidence shows the technology or market for the new product is not feasible.

In following rounds of consultations, the student teams worked toward refining their ideas into a presentation to be delivered Saturday morning.  The three industrial designers from Trig, Ty Hagler, Patrick Murphy, and Kelly Harrigan, settled in for a late night to refine the designs provided by the students into polished concept illustrations.  In an example of correlation without causation, the student team that won the Overall Best Design also brought the design team a beer from the bar to keep motivation high.  Thank you Team 10!  You guys rock.

In between working groups, students were given presentations on specific topics that they would immediately apply to their projects, learning and doing in rapid succession. In a presentation on intellectual property, we learned through a razor blade case study that while owning a patent gives the right to exclude others from selling the invention, it does not necessarily give the owner of a patent the right to practice the invention.

We also learned about the latest strategies for getting FDA regulatory approvals spanning pharmaceuticals, medical devices, and tricky combinations of drug delivery devices.  Of particular interest was the evolving FDA oversight on mobile medical apps that either connect to a medical device for control or could be used for active patient monitoring or analyzing device data.  If a medical app does anything more than help patients access information, its likely the app will need to pass FDA oversight.

Rounding out the educational presentations, we learned about developing business models using the C3i Business Model framework that ties together each of the elements of the previous speakers and introduced the topics of How to Make Money and How to Finance the venture.  The speaker walked us through a case study in developing the financial value proposition of a new colonoscopy technology, systematically building a set of forecasted cost and benefit assumptions.  He stressed that the value proposition for a medical device needs to address all stakeholders: patients, clinicians, payers, insurers, funding sources, and eventual strategic acquirers of the venture.

On the last day of the event, exhausted but happy student teams pitched their completed company presentations with complete plans for the business model, regulatory strategy, unmet need, and innovative design solution.   The Trig industrial design team was thrilled to be a part of another successful Coulter College and get the privilege to interact with so many talented and creative students from such diverse backgrounds.  We certainly appreciate the tireless efforts of the organizers and advisors to put on another great educational event.