Hand-off Dangers in Medical Product Design

If you’ve spent any time in the medical product design and development industry, you’re familiar with the phrase “throw it over the fence.”  It’s often used in a playful manner to describe a moment in time when one discipline has completed most of its work on a medical product design project and then “throws” it over the proverbial fence to the next group.

I contend that medical product development should never be viewed as a relay race with hand-offs.  A better metaphor is that of a soccer game where all the players are present on the field for the entire game.  Although responsibility shifts from one player to another, everyone is actively contributing toward pushing the ball forward.

A couple years ago, an industrial design firm owner I know received a call from a distraught client CEO demanding to know why the product design he had approved months prior had changed.  The design firm owner had the unenviable task of explaining to the executive that his very own engineering department had changed the original design.  The CEO then had to rehire the design firm to fix the design, resulting in hundreds of thousands of dollars in scrapped tooling and a delayed product launch.

In this example, the design firm handed off the design to the client’s engineering department and then exited the project.  A lack of engagement continuity is unfortunately a very common problem with outsourcing industrial design work, but it’s just as common among internal teams.  It’s so prevalent, in fact, that I dedicated an entire article, Beware of Faltering Design Commitment, to the idea.

While a lack of continuity can happen just about any time on the development continuum, there are three moments in time where development projects are most likely to run into trouble. Chronologically, these situations present the greatest danger:

1  The research gets thrown over the fence to the designers – At this point, design researchers have wrapped up their diagnosis of the problem and have submitted strategic recommendations. Industrial designers take over and begin creating solutions based upon the findings.  The mindset shifts from asking questions to proposing designing solutions.

2  The design gets thrown over the fence to the engineers – After industrial designers have exhausted all possible solutions, they finalize a single design direction. Engineers take the reins and begin the detailed development work required to make the concept a reality.  Divergent creative thinking gives way to a more convergent analytical mindset.

3  The engineering gets thrown over the fence to manufacturingEngineers have created, tested, and verified that the final design meets all product requirements. The manufacturing team begins the difficult task of building a supply chain and ensuring that vendors produce the product according to the specifications.

How, then, may hand-off disasters be prevented?

Maintain Strategic Continuity

Picture the entire product development continuum from your CEO’s first mention of the initiative down to the first product as it rolls off the production line.  At some point the development process shifts from being strategic to more tactical in nature.  A point where the direction is set and the long hard journey begins.

You can think of the three moments in time mentioned above as descending steps where different people enter the team.  People added to the project are less privy to the foundational decisions. They are simply expected to do.  The problem is that newcomers may feel the urge to make their mark. This often results in late stage changes that don’t align with the project vision.

When the engineering team took over in the example above I’m sure they had great intentions.  In the name of cost reduction or manufacturing efficiency they reshaped a little of this and shaved off a little of that.  The hand-off had left them without the strategic guidance of the visionaries.  If the design and engineering teams had continued to collaborate throughout the entire project, misdirection, wasted money, and wasted time could have all been avoided.

So those responsible for developing the strategy either need to be involved in changing it down the line or the implementers shouldn’t be permitted to make changes that affect the vision.

Plan for Constant Change

Medical device development is complicated, has a lot of moving parts and operates in anything but a static environment.   New outside factors always present themselves, making it impossible to completely foresee how and when the project will end.  Some of the most common factors are budget changes, evolving requirements, newcomers being added to the team and shifting management priorities.

Had the designers in the above example been retained to monitor project development through to the point of manufacture, the risk of the project going off track would have been reduced. Think of keeping designers in the loop as an insurance policy.

The takeaway is this: have later contributors included early and early contributors included later.  When change happens later in the process, the original contributors should be present to participate.

How to Proceed in a Nutshell

Design researchers should drive the research phase, with designers and engineers providing helpful input.  Designers will then lead concept development while collaborating with the other two groups.  Once the strategic vision has been set, engineers should take the most prominent role. Make sure your engineers remain involved enough to detect and solve manufacturing issues as they arise. Be sure to keep designers and marketing folks in the loop throughout the entire development process to validate users’ needs have been met.

And if a need for changes should arise, all hands should be on deck because everyone has a role to play in setting a new course.

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