A brief summary on how to mine, discover and clearly recognize innovation potential. In this post we’ll describe our process, tools and lessons learned since we launched in Fall 2018.

Ultimately our mission is to address high-impact needs and solve them through clever engineering and business strategies. To be successful, our innovation process is designed to be as nimble and efficient as possible for identifying, understanding and prioritizing clinical unmet needs. Our goal is to build something not found outside of technology transfer offices - a pipeline.

Central to everything we do is building productive provider relationships. It requires time, attention and patience - if we achieve success, it will be because of their passion for improving healthcare. Still it does present challenges - their time is scarce and unpredictable. Patient care is always #1 (as it should be). With these things in mind and others, we launched FastTraCS in Fall 2018 and got to work.

Starting Line

Those familiar with device innovation probably have heard of Stanford Biodesign, a methodology developed by Paul Yock, MD and colleagues since 2000. Their [book ](https://www.amazon.com/ Biodesign-Process-Innovating-Medical-Technologies/dp/0521517427)published in 2009 has been mandatory reading for our team, also commonly used for biomedical engineering curricula at UNC and elsewhere. This was our jumping off point.

Biodesign: The Process of Innovating Medical Technologies

Some fundamental concepts that we adopted and pressure tested:

Clustering Unmet Needs

Strategic Focus: A structured deceision framework to help filter needs and opportunities Need Statements: Not unique to Biodesign; Standarization accross complicated medical knowledge Need Rescoping: Optimization activity to determine the limits and most tractable path to concept generation Need Profiling: Master record of a given unmnet need, including disease fundamentals, patient/procedure target, competitive landscape, IP, etc. Clinical Outcomes: Measurable and feasibly tested clinical outcomes are paramount. We later pivoted and built upon this.

Problem Discovery Clustering While Biodesign is a respected, validated and disciplined approach, it was designed with education in mind (i. e. free student labor, yay!) and was fostered in a different organizational culture with a heavy dose of Silicon Valley spirit (and VC money). Much of what we do still is, at it’s core, based on these and other Biodesign principles.

Adaptation

In our startup phase we engaged with different departments/MDs , and we learned a few lessons:

  1. There is no shortage of problems to be found in healthcare.
  2. Most providers have knowledge gaps about commercialization and value. Value outside their practice isn’t clear and requires a “Trust, but Verify” approach.
  3. Electronic Healthcare Records suck, no one likes them.
  4. Providers, like the rest of us, get really frustrated when they can’t care for patients effectively.
  5. Problems exist that technology cannot fix.

In the span of several months, our team collected data for several hundred problems, leading to lots of discussion around where the opportunities may be. Several promising needs were advanced for additional research, interviews, clinical shadowing and follow-ups. As we exited this startup phase, we learned to prioritize our time and be better at working with MDs.

In the future, we’ll post specific cases about these unmet needs.

Google Ventures: Sprint

Several team members suggested a new approach, inspired by a book called Sprint, written by [Jake Knapp](http:/ /jakeknapp.com/) and colleagues. It was recognized this might be a solution to our problem of limited MD time and engagement. As outlined in the book, the process is a total non-starter. It’s a major time commitment, full-time effort for **one week, **start to finish. However, the tactics and tools used are translatable.

We decided to see if a ‘Sprint-lite’ approach might work.

So we invited groups of MDs (~4-8) in a few departments to participate for a one hour session - free food is key. Here are the main components:

Main components of Need Discovery session

Educate Providers: Brief them about Design-Thinking and the Why (build all the things!) Mind Dump: Unfettered Post-It generation in silence Self-Selection: Okay so you have 20 notes, great. Pick the best two. Group Review: Brief summary of their best, displayed on a whiteboard Voting: Three votes for the ‘best’ in the room

The resulting sessions killed two birds with one stone, discovery and validation (albeit incomplete) in under 60 minutes. Consensus from other providers in the room gave us more confidence that any given problem was worth our time to  evaluate.

Next step? Background research.

What’s an esophagogastroduodenoscopy? How do you pronounce it!?

So begins Pubmed literature reviews, clinical case studies, finding clinical guidelines/standards (e.g. Up-to-Date - subscription required), team discussion and solution landscaping (e.g. GlobalData - subscription required). This synthesis period takes significant time but we’ve gotten faster and smarter about it.

At this point our benchmark is clear:

How unmet is this unmet need?

If the need is compelling, what follows marks entry into subsequent phases like need validation, patent landscaping, patient journey mapping and conceptualization. For now, we’ll leave these topics for the future.

New Normal: Online Collaboration Tools

As the COVID-19 pandemic arose, we experienced a drastic change to our work routine - telework arrived. So a 100-year pandemic brought on an avalanche of challenges and unmet needs. FastTraCS' focus has rapidly shifted to help providers deliver more effective, and safer, patient care until we return to normalcy.

As we prepare to operate more virtually, our approach is adapting further. Our workflow already included tools such as Slack, Trello, Zoom and Google Docs, we adopted new ones like Mural.co  - a digital work space / whiteboard solution.

Mural.co Template