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The next challenge for biodesign: constraining health-care costs

This post is part of the Biodesign’s Jugaad series following a group of Stanford Biodesign fellows from India. (Jugaad is a Hindi word that means an inexpensive, innovative solution.) The fellows will spend months immersed in the interdisciplinary environment of Stanford Bio-X, learning the Biodesign process of researching clinical needs and prototyping a medical device. The Biodesign program is now in its 14th year, and past fellows have successfully launched 36 companies focused on developing devices for unmet medical needs.

5445002411_0f22229afd_z 300Founder and director of the Stanford Biodesign Program Paul Yock, MD, describes himself as a “gismologist." His inventions include a balloon angioplasty system that is in widespread use and many other devices primarily related to ultrasound imaging of the vascular system. I recently spoke with him about the program he helped found, the iterative biodesign process, and the ongoing relationship with the Stanford-India Biodesign Program.

What’s next for the Stanford Biodesign Program?

We’ve been really pleased with the results of the Biodesign Program so far in terms of being able to take newcomers into the process, then repeatedly and reliably seeing good ideas coming out and seeing patients getting treated from those good ideas.

The challenge is that the world has changed profoundly since we founded this program. There's no question that new technologies – despite being good for patients – contribute to escalation of health-care costs. We are in a phase of reinventing our process to take into account the fact that the sickest patient in the system is the system itself. We have to invent technologies that help constrain costs. We will need to modify the process of needs-finding not only to look for important clinical needs but important value needs as well. Inventors in general don't like thinking about economics and so we have to not only figure out how to update the process but also figure out how to make it attractive for our fellows to learn and practice.

Could the India fellows help you incorporate affordability into the process?

One of the big reasons we decided to do the India program in the first place was to shock our system into thinking about really affordable technology innovation. It is remarkable how good our fellows from India are at thinking this way and how immersed they have been from an early age with value-based design and invention.

Affordability is very much a part of the Indian culture and technology innovation is clearly something that we are very good at here. I think we have only started to capitalize on the fusion of their culture and ours. I think there is a hybridization here that really is going to be cool. Our grand strategy is to have a number of different platforms – it could be companies, incubators, or other experiences – where our fellows can get a deep exposure in India. We aren't fans of parachuting people in for two weeks to invent something good to give to India. What we really want to do is have trainees get a deep experience in what it's like to invent and develop technologies in that setting to influence the way we invent here.

How did you arrive at the drawn out, iterative process the fellows use to identify medical needs they want to address?

There's a long tradition of what is called user centered design that says if you want to design a product you need to talk to the user and understand what their needs are. That’s essentially where our process starts. What's fundamentally different with health care is that there isn't just one user. There's this really complex network of stakeholders who influence whether a technology will actually make it into patient care. You can't just design for the patient because there are also the doctors, nurses, hospitals, insurance companies, regulatory agencies and financers to name a few. To make it all still more complex, this whole system is in tremendous flux because of health-care reform.

So what we've done is blow out the needs characterization stage to take all these stakeholders into account in a rigorous way, up front, before any inventing happens.  There's also a bit of psychology at play here. In health care it is really easy to fall in love with the first need that comes your way. Looked at in isolation, pretty much any clinical need looks compelling. You need to put in a disciplined process, a semi-quantitative way of weighing one need against the other in order to make a good decision about which need to pursue. It is easier to get rid of the one you thought you loved if it really doesn't meet the criteria you set out.

What has it been like translating that process to biodesign in India?

Entering into this we were not at all sure that the process was going to work in India, and for a few years it didn't look like it was. But with enough critical mass and enough experience it turned a corner and the outcome has been really remarkable.

What is vastly trickier in India is the implementation phase. Once you have an invention that addresses a clinical need, how you get that through a business mechanism to deliver it to patients is really challenging. There needs to be a community of people who understand the process and can help each other. With the first couple generations of fellows we had enormously talented young innovators but there wasn't a community around them in India to help. The clinicians didn't understand what the process was all about. The business apparatus wasn't there. There were essentially zero incubators or venture funding for these projects. The first generations of fellows really helped make that happen and they accomplished a huge amount just in doing that. It was then a few years later where all of a sudden a new idea could take root in a way that hadn't been possible earlier.

You're located in the Clark Center, which is home to Stanford Bio-X. Has being part of that interdisciplinary environment played a role in your success?

It has been critically important that we have a university-wide identity. We draw on the good graces of not just the engineering school and medical school but also the business school, Humanities and Sciences and others, and Bio-X has provided a Switzerland-like framework for us to operate in. We're neutral for anybody from any department to interact with.

The location of the Clark Center has also been ideal. In three minutes one direction our fellows are able to be in the hospital and in the other direction to be in an engineering lab.

And then just the legitimization of being part of Bio-X was tremendous for our start up. It gave us credibility both within the university and in going out and interfacing with industry.

Previously: Following the heart and the mind in biodesign, Stanford-India Biodesign co-founder: Our hope is to “inspire others and create a ripple effect” in India and Writing a “very specific sentence” is critical for good biodesign
Photo by OpenSource.com

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