We are currently going through the ISO 13485 and 9001 certification process which includes fairly intensive training sessions with our consultants. The final exercise was a simple four-question personality test for our executive team whose results proved eerily accurate across the board. The point of it all was to determine our personal strengths to see if we have a balanced team.
This exercise taught us that we should hire strategically to keep and increase balance. It further taught us that people are who they are from birth. Those that pursue careers aligned with their natural God-given strengths and qualities excel in what they do, and are happy. Those that don’t become square pegs trying to jam themselves into round holes their entire lives.
In my role developing medical products for organizations ranging from start-ups to Fortune 50 companies, occasionally I see people with the wrong skill sets creating strategy or working on specific tasks. At the executive level, miscast leaders can throw off the trajectory of an entire product initiative, leading to catastrophic outcomes. At the tactical, team-member level, this gap usually starts small but grows into something much more serious.
The task of balancing an entire company is best left to the Stanford Business School and Accenture types. I’m going to zoom in on a single issue that all R&D departments at medical product development companies wrestle with one way or another. That is — how to give constant consideration to the voice and needs of users as if they were sitting in on every development meeting.
Ever-Present User Advocates
A balanced product development team has user advocates in its inner circle. I consider the inner circle to be the people in the trenches, designing the product together day in and day out. Many would argue that should be the role of marketing, but I would respectfully disagree. Marketers don’t live in the trenches. The core development team should own the responsibility of sticking up for the user.
I’ve found that development teams usually consist of two types of people — insiders and outsiders. The “insiders” are highly technical and excel at solving seemingly impossible challenges related to technology. They are convergent thinkers constantly trying to hone in on a single solution that satisfies the product requirements. These type of people include mechanical, electrical, and software engineers.
The “outsiders” are highly creative and excel at connecting people physically and emotionally to technology through the five senses. They are divergent thinkers that constantly come up with new ways to solve a problem, even when a single path has been chosen. These include industrial designers, human factors engineers, or design researchers.
Technically Driven Teams
Most medical product manufacturers are technically driven, founded by and staffed with “insiders.” It seems to make sense because medical device development requires solving very difficult technical challenges. What is often overlooked is that the user experience and human factors challenges are often just as complex in their own way.
The good news is that it’s okay for the insiders to become consumed with the inner technical challenges over human factors. That’s who they are, it’s what they were born to do. However, improperly staffing the team is the fault of the organization.
As an example let’s look at two extremes. There are plenty of consulting medical device engineering firms with 30+ technical folks and not one user advocate on staff. They typically bring in an industrial designer to treat the aesthetics of an enclosure and a human factors consultant to do the final summative testing required by the FDA. Sometimes, this results in a technology looking for a problem to solve or simply a product that’s a pain in the butt to use. In either case it’s a risky proposition.
On the other hand, there are hundreds of consulting industrial design firms without a single engineer amongst a team of creative, divergent thinkers. At the end they might bring in engineering consultants to make what they’ve designed work or worse yet, hand it over to their customer’s engineering team. That silo-separated “throw it over the fence mentality” results in products that look great but don’t function properly or stand the test of time.
The key, remember, is balance.
Would you describe your most recent or current development team as balanced? Is yours a company that invests in technology, or creative solutions for people, or both? What do the conversations among your developers sound like? Do they reference the needs of people as much as they do capabilities of the technology?
You may further research the matter by determining where your actual dollars are invested.