IDEAL Biomedical
How to Increase Market Success and Improve Health Outcomes
Implement a repeatable process of innovation — aka design controls
When I’m in a conference room teaching topics such as Need Statement Development and Needs Prioritization, I often take the time to ask the room, “What are some words that come to mind when you hear Design Controls? Don’t raise your hands, just start blurting out words.”
Slow. Stage-gate. Incremental. Documentation. Frustration. Administrative headache! Documentation. Constrains creativity. Investment of time. Documentation!
I once mentioned to a colleague that I was going to bring up design controls in an upcoming talk about stakeholder-centered design, he responded to me with, “I feel nauseated just thinking about those words.”
So why in the world would I include design controls in a talk about stakeholder-centered design?
My goal today is to dismiss the notion of design controls as a negative and re-introduce it as one with stakeholder-centered design. To me, they are the same thing. They are both ‘design’. I believe it is a matter of perspective whether to consider design controls as a hurdle to innovation or a catalyst that accelerates the process.
If you take anything away from this article, it is how critical the process of design is to ensure successful products reach patients and do the good they were intended for.
Design is a Process and it is Critical.
I can’t talk about design controls without first providing my definition of design. A bridge is my favorite example. I typically use the Golden Gate Bridge, but a search of personal photos reminded me of a beautiful photo of the Brooklyn Bridge that I took while adventuring through Manhattan with my wife on Boxing Day and featured at the beginning of this article.
When I learned Engineering Design there was a focus on identifying problems and solving problems. We can identify (hypothetical) problems associated with having ferries as the only method of crossing the East River.
We can come up with many solutions. Build a tunnel. Build a bridge. Have a ride-share program on either side of the river and stick with the ferries. However, identifying problems and brainstorming solutions will not produce the Brooklyn Bride (nor the Golden Gate Bridge) without design. It is not as simple as, “need a bridge — build a bridge.”
Design is the hard work between identifying problems and deploying solutions. If this were a process map: Problems are inputs, Solutions are outputs, and Design is the Black Box Process in the middle.
To me, design is independent of discipline. In engineering, we can build solutions, or we can design solutions. In science, we can conduct experiments, or we can design experiments. In business, we can write a business plan, or we can design a business model. Design is about intention. It’s about purpose. It is about understanding stakeholder needs so well that we can clearly articulate them. Design is meaningful work to make the experience of living better for all.
Design is the conscious and intuitive effort to impose meaningful order. — VICTOR PAPANEK
Getting back to design controls. Whether an experienced medical device professional or new to the topic; my goal is to shed new light on why we do it.
In the mid-1980s there was a study finding 44% of voluntary recalls from medical devices with quality problems in the market could have been prevented in design. The results of that study were published in a report, “Device Recalls: A Study of Quality Problems.” It was then announced in the Federal Register in May of 1990.
Here, the FDA is communicating that this study “should be useful” to companies. What I think the FDA was trying to say here is,
Hey, if you control your design process, you can increase product quality and minimize costly failures in the field.
About 7 years later the FDA published “Design Control Guidance for Medical Device Manufacturers.” Design is a process. Problems (or user needs) are the inputs and solutions are the outputs. The FDA’s guidance document was never intended to constrain design, but rather encourage companies to develop a controlled process. That is a repeatable process. After all, any quality process is one that is repeatable. In my opinion, this document was written with good intentions.
Some parts of a process are so critical to success, it is essential to control them. How about something like injection molding? Controlling the heat, pressure, flow, and cooling is critical. They are controlled.
If I’m eating at a Michelin Star restaurant, the food may be the most creative I’ve ever tried. But I would expect the preparation of that food to be the same quality each time, no matter the chef, no matter the night. Quality AND Creative food is prepared using a highly controlled process.
As a champion for stakeholder-centered design, guidance to control design is a statement that it is so critical to the success of health outcomes, that I should strive to make it a repeatable process.
That document is OLD and today we are living in a different era. This, in my opinion, makes the process of design even more critical.
In 1997 when the FDA published the guidance document, it was written for medical device manufacturers. These companies owned the process from user needs to commercial products. Today, however, the world looks very different. Clinical immersion experiences, medical innovation programs, and innovation accelerators are abundant at universities and hospitals all around the world. Significant design work is happening in research labs and clinics, yet there is no guidance document for medical innovators. I’ve spent my career working among students, faculty, and clinicians who are the champions of new medical innovations, yet the vast majority of them have never heard of design controls.
When design is happening at hospitals and universities and then transferred to medical device manufacturers for commercialization, there lies a significant disconnect.
Why are we controlling design?
To ensure our creative process of design is a repeatable one. To minimize downstream failures in the field. To increase the chances of product success in the market. To improve health outcomes for all.
Thank you for reading.
health. happiness. kindness. respect. to every-being and all-things
- ajds
