Innovative medtech requires an understanding of feasibility and usability. In other words, you need to figure out “fusability.”

Jeff Champagne, MPR Associates

Creating a new disruptive medtech product is never easy. Whether as part of a large multinational or a two-person startup, from the beginning, the odds are stacked against your success. How can you improve your probability of a positive outcome?

The key is to find ways to reduce your risk of failure. Try looking at the development as process as opposed to a result, a voyage as opposed to a destination. A risk-based approach to the process looks at all the things that could possibly go wrong, ranks those risks and then develops a plan of action to ensure that those things never happen. An objective of this plan is to prove “fusability.” This convergence of feasibility and usability helps to reduce risk while compartmentalizing the challenges.

Breaking it down into the key components, fusibility includes a number of dimensions:

• Market feasibility – What is the unmet need and is there a viable market for the product? The solution to the unmet need must provide compelling value for the relevant stakeholders. Are there incumbent players or technologies that stand to be disrupted and might put up barriers?

• Clinical feasibility – Has the product been proven to improve outcomes and lower costs? Does its use fit within the framework for current healthcare delivery? Does it fit within (or better yet, improve) the workflow/workload for clinicians?

• Technical feasibility – Have the necessary technology solutions been proven? If not, what are the risks associated with development of those solutions?

• Commercial feasibility – Has the business model been defined with a clear path to revenue? Is there a clear path for reimbursement? Who is the customer and how is the device purchased?

• Organizational feasibility – Does the team have the skills and experience to win? Investors don’t care where your MBA is from or how many PhDs or MDs you have on your team. Having a team member who has been all the way through the gauntlet, successfully launched and had an exit is sacrosanct. The entrepreneur is “the jockey” and the technology is “the horse.” You can’t win if either is faulty

Answering these key questions requires identifying all stakeholders and what they value, de-risking technical “big rocks” and understanding the requirements for the ideal product construct. This is an iterative process, and finding the best solution to an unmet need is as much about poking holes in all of the assumptions baked into your plan as it is about the technical engineering of a solution. It’s important to start with the end in mind but recognize that there are many ways to solve the problem, and as new information is learned, the concept will need to adapt. There is a reason the NSF iCorps program makes would-be entrepreneurs interview hundreds of people. Many seemingly disparate points of view must be considered before a winning product can be ideated never mind realized.

Here are some useful tips to keep in mind about developing a medtech product:

Don’t fall in love too fast

No matter what you do, make sure you resist the urge to fall in love with your product too soon. The blindness this infatuation creates can be impenetrable to objective critique. You’ll have plenty of time to admire your creation when it’s on the market. First make sure that you have created the right product.

Develop a ‘vertical slice’

When it comes to engineering emerging technologies, most of what we see as new is simply a convergence of existing technologies with some new enabling piece of the puzzle. But just because something works well in some scenarios does not mean that it will converge as planned.

Try thinking of a proof of concept demonstration as developing a “vertical slice.” According to Craig Mauch, our director of product design, a vertical slice is the integration of all the functioning components of a system acting as a system to accomplish a task. It may not look like the final product but it is critical to proving that each component of the solution can work together. The vertical slice provides early feedback and avoids “surprises” later on that often occur when this advice is not heeded.

Most people consider the technical specs on off the shelf components as tried and true. But when operating as part of a larger system they may not be up to the task. One example of this could be power consumption for a component. Under normal circumstances specs may represent actual performance but when daisy chained together with constraints and less than optimal conditions, performance could be skewed.

Ignore human factors and usability at your own peril

The human factors aspects of a product should never be an afterthought. For a medical device, applying usability engineering principles to reduce the risk of use error is a required part of the process, but it is not sufficient to create a great product. Developers need to have empathy for the user which means having an appreciation for their capabilities and limitations based on their education, backgrounds, working environments, stress level, medical condition, etc.

The sooner you can get physical prototypes into prospective users’ hands the better, as you often discover unexpected results in the ways people interact with things. This should an iterative process that is done early and often so that user feedback can be incorporated as the design evolves. When done effectively, the usability process also answers some of the feasibility questions and yields products that fit seamlessly into the life of key stakeholders, are easily adopted by all stakeholders and provide value to each, solving pains and providing gains, all while outperforming the status quo.

Keep these concepts top of mind in each approach and you’ll surely increase your chances of success.

Jeff Champagne is director of business development at MPR Associates.

The opinions expressed in this blog post are the authors’ only and do not necessarily reflect those of Medical Design and Outsourcing or its employees.