In developing a new medical device, some start-ups proceed with a high degree of confidence that their core technology engineering prototype should become faithfully transformed into the actual product that will come to market.
What they actually have at this point in time is a technical solution – nothing more and nothing less.
With apologies to Winston Churchill’s rallying cry to Brits in World War II, the prototype is not the end. It is not even the beginning of the end. But it is, perhaps, the end of the beginning.
A company that confuses a prototype with a market-ready product direction may be headed for trouble. To illustrate, recently I met with leaders of a medical device startup that is developing a breakthrough in vitro diagnostic technology. In vitro diagnostic instruments are used to analyze a person’s blood or other biological sample to detect diseases, conditions or infections.
Taking one glance at the engineering prototype and the short project schedule, I knew rough times lay ahead. In its quest to develop new technology, the tech team made broad and unsubstantiated assumptions about the product’s ultimate functionality, consumer interface and appearance. The schedule didn’t allow time to verify that this was the best solution by subjecting these assumptions to challenge. And moving forward, the company intended to use the same tech-heavy development team to move the product to market as it did inventing the technology, another red flag.
The Three Stages of Diagnostic Device Development
Looking at the big picture, the development process for a medical device like this one can be divided into three stages: science development, technology invention and product design.
In the first stage, scientists seek to diagnose a certain disease or condition in a biological sample. They typically work in a laboratory environment while employing the scientific method to prove or disprove their hypothesis. If the test results are favorable, the development process moves from the science lab to the engineering lab.
In this second stage, technologists and engineers are brought in to invent a core technology that can automate the scientific test. Their focus is on creating and inventing the single core technology prototype that proves automation is feasible. In so doing, they wrestle with physics and math to solve problems. They do this every day so they are experts. What they don’t do frequently, or potentially ever, is design products for mass manufacturing or for use with people.
In the third stage, the art of product design translates a technical solution into a marketable product that meets the needs of the company, intended markets and the people that will use it. Good product design teams practice developing products for commercialization and human use daily. Over the course of a year, they might develop many different types of medical products, and hundreds over decades.
Moving From The Engineering Bench To The Real World
As the development process shifts from the bench to the real world, less technically oriented people should drive medical device design.
We repeatedly see companies attempt to address this transition in the wrong way. They say “okay, it’s time for industrial design” with the expectation they hire a single industrial designer in an attempt to connect their technology with people. The truth is that the task requires access to multidisciplinary skills including industrial design, the sub-specialties of human factors engineering and bio-mechanical engineering, social scientists, plus marketing. At this point, the engineers who sweated and strained to develop the core technology should shift to a supporting role. I’m not suggesting that they go away but rather stay focused on refining the design of the core technology throughout development.
The in vitro diagnostic start-up’s management believed that the core technology prototype, with only cosmetic improvements, could represent the actual product that would enter the market. That bedrock assumption driving the design activities resulted in an unrealistic schedule, so we declined to pursue the project further.
While completion of a core technology prototype is a huge milestone in the life of a young start-up, it truly signals just the end of the beginning.
At this moment, a company should pause, reflect on the best way to move forward and re-calibrate its approach if necessary.