In developing a medical device, agreement on a design approach brings with it no guarantee that the product will ultimately appear and function as expected. sometimes subtle viewpoint differences cause the development trajectory to veer slightly from the intended path, putting schedules, budgets and product performance at risk.

What’s wrong here?

Your team has just completed a world-class design for your next medical device.  At this early stage, years may pass before it’s fully developed, passes clinical trials, and hits the market. You’ve completed numerous mock-ups, including a final appearance model and gained top-level approval.   The results of early formative usability testing tell you that you’ve nailed it and the user experience will be phenomenal.  The design is unique, innovative and will send your competition scrambling. The marketing vice -president is especially pleased because the design captures the essence of your brand and offers a seamless extension of the product line’s family design language. The pride and excitement of the entire team is like a snowball gaining size and momentum as it rolls down a giant hill.

Then the engineering manager walks into the room, thanks the industrial design team for a job well done and says, “The engineering team will take it from here.  We understand the design intent delivered by the industrial design team and will do our best to keep it intact.”   This is too often the first step in a lengthy process where the original design intent is compromised in the name of “function” or “requirements” until it’s no longer recognizable.  The promises made to the leadership team, the product family consistency, and the hope for a superior user-experience all vanish.

Undermining the design intent, however unintentional, can have catastrophic financial consequences. It happens because engineers and industrial designers are very different breeds of cat.

Engineers operate in a world where physics and mathematics enable them to prove right from wrong.  Their convergent mindsets are great for efficient decision-making and accomplishing goals.  Driving a project schedule forward come hell or high water is just one of their gifts.  They were born with a deeply rooted desire to mitigate risk and exploit efficiencies.  All of these traits and beliefs are essential to developing core medical technologies.  Technology development is so challenging in fact, that it requires armies of engineers.  It’s natural that over time, many climb the corporate ladder.  So frequently in medical device development, an engineer’s way of thinking becomes management’s way of thinking.

By contrast, industrial designers leverage empathy, creativity and feelings fueled by a divergent mindset to open doors rather than close them.  Their quest for perfection and attention to details is both a gift and a curse.  It’s in their nature to seek out seemingly unrelated pieces of information, make connections, and shift the mindset of an entire team.  On medical device projects, I’ve seen ratios of more than fifty engineers to one industrial designer.  Numerically outnumbered, designers are relative scarce on the top rungs of the corporate ladder.

Management Is To Blame

Straying from the original design intent is not the designer or engineer’s fault, but rather a management and process issue.  Granted, an industrial designer makes the greatest contributions on the front end and engineering plays a much larger role during detailed development and transfer to manufacturing. But if the designer is not present, often as a minority of one, to assure the original design intent by fighting for the design and controlling the changes, this is evidence of a serious process flaw.   It is management’s responsibility to empower and support the designer throughout the entire development process.

To better understand the problem, it’s helpful to look outside the medical device industry.  Consumer product companies are generally really good at controlling design intent and driving it through to completion because they are marketing and sales-driven organizations.  Their desire to create an emotional connection between their products and their customers trumps all.  They realize that industrial design is the tool for making that connection so they empower their designers. Some companies now have a chief design officer (CDO) on their leadership teams. Dyson and Airbnb are rare examples of companies with industrial designer CEO’s .

The medical device industry requires a new way of thinking that includes adopting a more consumer-minded approach. Industrial designers should be empowered (read required) to provide design oversight through product launch.

Recently, a medical device industry leader formally gave us that power and responsibility in a situation involving a class two medical device that we were designing. User and marketplace research were telling us the maximum acceptable product size. For various reasons, the engineering team wished to exceed this. The vice president for engineering weighed in, agreeing with us that a larger size would hinder the design intent and some key usability features. Recognizing that his company’s technical orientation might suffocate the industrial design effort, he mandated that all decisions affecting the industrial design or user interaction be approved by the design lead through to the point of product commercialization.

To reiterate, a negligible or undefined role for industrial design in the later product development stages can throw an entire process out of kilter and result in a costly re-do.

Five Ways to Maintain Your Design Focus

1. Leadership – Consider including a champion of design in your leadership circle or at least in management. Include design thinking in the development of your business strategy and product development plans.  Think of design as a leadership role not simply a tactical task.
2. Design Strategy – Have your design leader create a clear and concise design strategy. If you’ve hired the right person, design oversight will be included without even asking for it.
3. Budget – Include a budget for design oversight. The amount will depend on the complexity of the product and the length of the program.  It could range from consistent review and advice to major design changes that require additional rounds of revisions, prototyping and verification.  The key is that money is allotted throughout the entire program.
4. Quality Management System – Update your QMS process so design oversight plays a key role in your product development process.
5. Empowerment – Require signature approval by the industrial design lead in design reviews and at critical milestones. Remember an engineer is not an industrial designer and beyond the lack of formal training, they just don’t have the right mindset.