At StarFish Medical, we work with clients who have ground-breaking ideas and technologies that improve patient outcomes including saving lives.  This makes for very exciting and fulfilling work, but new development also means there is no boilerplate plan that can be pulled off the shelf and executed.

Our project management approach builds on PMI (Project Management Institute) and INCOSE (International Council of System Engineering) fundamentals. To adapt project management of innovation for medtech product development, we emphasize Attitude, Building (and testing), Communication and Definition.

Attitude.  The mindset and expectations of the team matter considerably.  Imagine that you are going on vacation to the beaches of French Riviera.  Just as you take off, the pilot announces that you are being re-routed to Alaska.  Had you known, you would have packed boots instead of sandals and snowshoes instead of snorkels. Instead of being prepared and set for the adventure, your trip is ruined.

The same applies to an innovative project.  If the team is expecting a fully mapped out plan with no surprises, they are going to respond to the challenges with the wrong mentality.  Recognize that innovative projects are going to bring surprises and this requires an openness and willingness to confront problems head on.

The following quote from Pixar’s CEO Ed Catmull captures this mentality perfectly: “What makes [us] special is that we acknowledge we will always have problems, many of them hidden from our view; that we work hard to uncover these problems, even if doing so means making ourselves uncomfortable; and that, when we come across a problem, we marshal all of our energies to solve it.”

Build (and Test).  Mark Zuckerberg’s “Move fast and break things” is one flavor of the ubiquitous fail early, fail often mantra which is really aimed at investing the minimal amount of time and capital to prove or disprove a concept.  Nothing is as definitive as a test to identify whether or not your product has legs.  This takes some consideration to determine how to conduct the test quickly and inexpensively (cardboard mock-ups and 3D printing are often good methods).

Success or failure, the testing sheds valuable light on the product or concept viability and helps ensure that resources (cash and people) are not committed to fruitless work.  In the most extreme case the concept is not viable and unfortunately the project may end, but this is still a better outcome than throwing good money after bad.

Communication  There is a tremendous amount of learning and discovery happening; every day brings surprises and the morning’s plan could be obsolete before lunch.  Scrum-style communication works well as do detailed burndown charts which sometimes cover periods as short as a week.  With multi-location (and possibly multi-national) teams, the other critical element is having a collaboration tool that supports rapid dissemination of information.   Finally, depending on the number of teams involved (i.e. client, StarFish, consulting firms), a division of responsibility (DOR) is often required to ensure explicit definition of work being done by the various parties and their team members.

Definition (Requirements). The single biggest contributor to inefficiency is when teams are working on the wrong thing.  This waste generally stems from improperly defining what the product needs to be (requirements) or from communication breakdowns (see above). There is no silver bullet for addressing this issue. Both discipline and time are required to define what the product should be at the very beginning of the project. Then challenge the definition constantly.  It should be everything you need to meet your user and market requirements and nothing more.

You are successful if you are left with a lean set of requirements that also identifies when you need these features in your development timeline.  Many projects have important funding milestones where additional cash will be released following the demonstration of key functionality.  To make the best use of limited cash and time, it is important to only develop the MVP (minimum viable product) for each stage of the work.

With the right attitude, making an allowance for building and testing, establishing strong communications and investing sufficient time to define the requirements, the team (and the project manager) are going to be on the fast track to success on an innovative project.