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Autoimmune Disease, Bioengineering, Immunology, Research, Stanford News

Adult humans harbor lots of risky autoreactive immune cells, study finds

Adult humans harbor lots of risky autoreactive immune cells, study finds

dangerIf a new study published in Immunity is on the mark, the question immunologists may start asking themselves will be not “Why do some people get autoimmune disease?” but “Why doesn’t everybody get it?”

The study, by pioneering Stanford immunologist Mark Davis, PhD, and colleagues, found that vast numbers of self-reactive immune cells remain in circulation well into adulthood, upending a long-established consensus among immunologist that these self-reactive immune cells are weeded out early in life in an organ called the thymus.

A particular type of immune cell, called “killer T cells,” is particularly adept at attacking cells showing signs of harboring viruses or of becoming cancerous. As I wrote in my news release about Davis’s study:

[The human immune system generates] a formidable repertoire of such cells, collectively capable of recognizing and distinguishing between a vast array of different antigens – the biochemical bits that mark pathogens or cancerous cells (as well as healthy cells) for immune detection. For this reason, pathogenic invaders and cancerous cells seldom get away with their nefarious plans.

Trouble is, I wrote:

[This repertoire includes] not only immune cells that can become appropriately aroused by any of the billions of different antigens characteristic of pathogens or tumors, but also immune cells whose activation could be triggered by myriad antigens in the body’s healthy tissues. This does happen on occasion, giving rise to autoimmune disease. But it happens among few enough people and, mostly, late enough in life that it seems obvious that something is keeping it from happening to the rest of us from day one.

It’s been previously thought that the human body solves this problem by eliminating all the self-reactive T cells during our early years via a mysterious select-and-delete operation performed in a mysterious gland called the thymus that’s nestled between your heart and your breastbone. Sometime in or near your early teens, the thymus mysteriously begins to shrink, eventually withering and largely turning to useless fat. (Is that mysterious enough for you? It sure creeps me out.)

But Davis and his team used some sophisticated technology – some of it originally invented by Davis, some of it by Stanford bioengineering professor and fellow study co-author Stephen Quake, PhD – to show that, contrary to prevailing dogma, tons of self-reactive killer T-cells remain in circulation well into adulthood. Then the scientists proceeded to explore possible reasons why the immune system keeps these risky cells around (it boils down to: just in case a pathogen from Mars comes along and we need to throw the kitchen sink at it) and why (at least most of the time) they leave our healthy tissues alone: A still-to-be-fully-elucidated set of molecular mechanisms keeps these self-reactive cells locked in the biochemical equivalent of parking gear, shifting out of which requires unambiguous signs of an actual pathogen’s presence: bits of debris from a bacterial cell wall, or stretches of characteristically viral DNA.

That’s our immune system, folks. Complicated, mysterious, and yet somehow incredibly efficient. You really don’t want to leave home – or even the womb – without it.

Previously: In human defenses against disease, environment beats heredity, study of twins shows, Knight in lab: In days of yore, postdoc armed with quaint research tools found immunology’s Holy Grail, In men, a high testosterone count can mean a low immune response and Deja vu: Adults’ immune systems “remember” microscopic monsters they’ve never seen before
Photo by Frederic Bisson

Bioengineering, Imaging, Neuroscience, Research, Stanford News, Stem Cells

New way to watch what stem cells transplanted into the brain do once they get there

New way to watch what stem cells transplanted into the brain do once they get there

binocularsStem cell replacement therapy is a promising but problem-plagued medical intervention.

In a recent news release detailing a possible way forward, I wrote:

Many brain disorders, such as Parkinson’s disease, are characterized by defective nerve cells in specific brain regions. This makes disorders such as Parkinson’s excellent candidates for stem cell therapies, in which the defective nerve cells are replaced. But the experiments in which such procedures have been attempted have met with mixed results, and those conducting the experiments are hard put to explain them.

That’s because there’s been no good way to evaluate what those transplanted stems cells are doing once you’ve put them inside a living individual. I mean, you’re not gonna break into someone’s brain every couple of days to take a peek, right? Instead, you have to look for behavioral changes. Is the patient or experimental animal walking better (if you’re trying to treat Parkinson’s), or (if it’s Alzheimer’s) remembering better ? Then, even when you see those changes, you still don’t know whether new nerve cells derived from the newly transplanted cells integrated into the proper brain circuits and are now functioning correctly there, or whether the originally transplanted cells are just sitting around secreting some kind of feel-good factor to pep up ailing cells in the vicinity, juicing their  performance. Or maybe it was a placebo effect.

It’s hard to improve on a procedure when you don’t really know what went wrong – or even what went right – on the last attempt. Optimizing the regimen becomes a matter of guesswork and luck.

But in a new study in NeuroImage, neuroscientist/bioengineer Jin Hyung Lee, PhD, and her colleagues came up with a way to peer deep into the living brain and view the results of a stem-cell transplant procedure. They combined an established brain-imaging technique with a newer but increasingly widespread one, called optogenetics, that lets researchers stimulate specific cells.

The first step in optogenetics is to genetically modify the cells you want to stimulate, so that their surfaces become coated by a photosensitive protein that generates electric current in response to laser light. Lee’s team performed this operation on the stem cells before transplanting them into rats’ brains. This way, they could selectively stimulate nerve cells derived from those stem cells and,  using the brain-imaging technique, see if doing so triggered nerve-cell activity at the site of the transplant as well as other places in the brain with which the new cells had established connections.

In these experiments, the stem-cell-derived nerve cells survived, matured into nerve cells, integrated into targeted brain circuits and, most important, fired on cue and ignited activity in downstream nerve circuits. But had all that not happened, at least the researchers would have been able to pinpoint the weak link in the chain.

In principle, the new approach should be possible to use for all kinds of stem-cell therapies, and in humans as well as animals. As Lee told me when I interviewed her for my release on her new study, “If we can watch the new cells’ behaviors for weeks and months after we’ve transplanted them, we can learn – much more quickly and in a guided way rather than a trial-and-error fashion – what kind of cells to put in, exactly where to put them, and how.”

If this light-driven stem-cell-monitoring technique or some others I’ve reported on hold up, brave explorers may no longer have to poke around in the dark.

Previously: Alchemy: From liposuction fluid to new liver cells, Iron-supplement-slurping stem cells can be transplanted, then tracked to make sure they’re making new knees, You’ve got a lot of nerve! Industrial-scale procedure for generating plenty of personalized nerve cells and Nano-hitchhikers ride stem cells into heart, let researchers watch in real time and weeks later
Photo by Nicki Dugan Pogue

Applied Biotechnology, Bioengineering, Ophthalmology, Research, Science, Technology

New retinal implant could restore sight

New retinal implant could restore sight

2618400441_c19946dff4_zIf your car battery runs out of juice, the car won’t run, but that doesn’t mean it’s time to scrap the car. Similarly (at least slightly), if your photoreceptors are worn out due to a disease such as retinitis pigmentosa or macular degeneration, then you might not be able to see, but your eyes still have a lot of functioning parts.

That’s the principle behind a new retinal implant developed by team of Stanford-led researchers. Unlike previous devices, which require wires and unwieldy surgeries, the new implant is wireless and needs only a minimally invasive surgery to inject a small, photovoltaic chip inside the eye. The team published their results in Nature Medicine.

That chip capitalizes on the remaining capabilities of existing retinal cells known as bipolar and ganglion cells and produces more refined images than existing devices. The chip responds to signals from special glasses worn by the recipient.

“The performance we’re observing at the moment is very encouraging,” Georges Goetz, a lead author of the paper and graduate student in electrical engineering at Stanford, said in our press release. “Based on our current results, we hope that human recipients of this implant will be able to recognize objects and move about.”

The implant has only been used in animal studies, but a clinical trial is planned next year in France.

“Eventually, we hope this technology will restore vision of 20/120,” co-senior author Daniel Palanker, PhD, told me. “And if it works that well, it will become relevant to patients with age-related macular degeneration.”

Previously: Stanford researchers develop solar powered wireless retinal implant, Factors driving prescription decisions for macular degeneration complex — and costly and Tiny size, big impact: Ultrasound powers miniature medical implant 
Photo by Ali T

Ask Stanford Med, Bioengineering, Cardiovascular Medicine, Stanford News, Technology

The next challenge for biodesign: constraining health-care costs

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.

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Bioengineering, Cardiovascular Medicine, Stanford News, Technology

Defining a new way of thinking: Slower decisions could result in better medical devices

Defining a new way of thinking: Slower decisions could result in better medical devices

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.

2331754875_e6a2a81429_zIt’s now early April – half way through the six-month fellowship – and the Stanford-India Biodesign fellows are still figuring out what medical need they’re going to address during their time at Stanford. On June 8 they’ll be revealing prototypes. For many past students in this program, those prototypes have gone on to launch successful companies.

That’s not to say that the fellows are slow, it’s just to say that the Biodesign process the fellows are learning takes time – more time than I, for one, had expected.

I asked the fellows if they thought they would be able to take this painstaking approach into the real world, where people make much faster and often less careful decisions when developing medical devices.

“We hope this will define a new way of thinking,” Debayan Saha, one of the fellows, told me. As a group they also said they were learning a lot about the value of slow decisions.

As an example, they pointed to one of the 35 medical needs still on the “maybe” list, down from more than 300 they had identified during clinical visits. This one had to do with measuring levels of molecules in the blood. At each step, they’d scored the medical needs on their list against a criterion, like the number of people it applied to or the cost of letting that need go untreated. That allowed them to strategically eliminate needs that seemed worth addressing at first blush, but that wouldn’t make business sense.

At each round, this one medical need scored near the top. It had been looking like a real contender for the one they might eventually chose to address.

Then came today, when the fellows were scoring whether other devices already address the need and the cost spent each year if the need wasn’t addressed. That gave them a sense of whether there was a market for any device they might develop. That need, which had seemed so strong, scored low, much to the team’s surprise.

“This had been a favorite but this is the first time we are seeing that it is maybe not a great need,” Shashi Ranjan, PhD, told me. Harsh Sheth, MD, emphasized that in other settings where people make much faster decisions they might have ended up wasting time prototyping a device that would never find a place in the market.

To my eye, this careful approach makes the final selection almost seem inevitable (though not obvious at the outset). The team knows the criteria they have to meet (good market size, few competing devices, no patents standing in the way of eventually marketing their device) and they have a list of options.

From there, it’s a matter of slowly assessing which option best fits the criteria, which seems like a lesson that goes well beyond designing medical devices: Choosing health insurance. Buying cars. They are learning a lesson in good decision-making along with how to develop and market devices.

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

Bioengineering, Cardiovascular Medicine, Stanford News, Technology

Following the heart and the mind in biodesign

Following the heart and the mind in biodesign

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.

15125593898_7ee05d0a60_zWhen I showed up to meet with the Biodesign fellows, Debayan Saha greeted me by saying, “We are arguing – please join us.”

The source of the argument turned out to be a thorny one. The team had previously attended cardiovascular disease clinics and from those visits identified more than 300 possible needs that, if addressed, might improve patient care.

Now, their job was to narrow down those 300+ needs to the one they would eventually develop a prototype device to address.

Part of the process Stanford Biodesign fellows learn is a rigorous method for identifying medical needs that also make business sense to address. The first step: eliminate the duds.

In this round, the each team member had individually rated the needs according to their individual levels of interest on a scale of 1 to 4. That interest could reflect the fact that they think the technology is interesting, or the fact that the need is one they would be excited about addressing.

Now they were trying to rate the needs on the same 1 to 4 scale according to the number of people who would benefit if it were addressed. The combination of these two ratings—one subjective and the other objective—would produce a shorter list of needs that were both of interest to the fellows and would benefit enough people that any future company could be successful

That objective rating was the source of the polite disagreement I had walked into. As one example, if a particular need applied to people who had a stroke, should they assume that all people who have had a stroke would benefit from a solution (giving the need a higher rating of 4), or would only a small subset benefit (giving the need a lower rating of 1 or 2)?

By and large Harsh Sheth, MD, leaned toward 4s while Shashi Ranjan, PhD, leaned toward 2s. Saha mostly just leaned back. Much discussion ensued.

In the end the team managed to assign a single score indicating the number of people represented by each need. When combined with their subjective scores, the group was able to eliminate the lowest scoring needs and reduce the list to a mere 133.

One interesting thing I learned is that this careful rubric is harder to apply in India, where good numbers about how many people have particular conditions are harder to come by. Ranjan told me that even in India they would likely use U.S. numbers for some conditions and just scale up to the Indian population. I mentally added this lack of good data to the list of reasons Stanford-India Biodesign Program executive director (U.S.) Rajiv Doshi, MD, told me that biodesign is more challenging in India.

Previously: Writing a “very specific sentence” is critical for good biodesign and Good medical technology starts with patients’ needs
Photo by Yasmeen

Bioengineering, Cardiovascular Medicine, Stanford News, Technology

Writing a “very specific sentence” is critical for good biodesign

Writing a "very specific sentence" is critical for good biodesign

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.

1 After several weeks spent following doctors through cardiovascular disease clinics, Debayan Saha, Shashi Ranjan, PhD, and Harsh Sheth, MD, together identified 315 apparent medical needs ranging from better ways of monitoring patients to improvements of existing devices. During the course of their six-month fellowship, they’ll develop a prototype device to solve just one.

The first step toward picking that one is to better define the 315.

This is more complicated than it seems. For example, one of the needs they’d originally written down involved real-time monitoring of certain molecules in the patient’s blood. They revised that phrasing because it defined the solution – real time – rather than the problem, which is the need for doctors to have more accurate information about the patient’s blood so they can make better treatment decisions. “One solution to the problem might be real-time, but there might be another way,” Sheth said.

Similarly, another need they identified had to do with a device that was inconvenient for doctors to use during a medical procedure. Did they need to improve the device to make a procedure more efficient, or was the need specifically for a smaller device? With another device, they debated whether the real need was to reduce the patient’s pain or to reduce the blood loss.

Some of these decisions might sound like splitting hairs – whether the problem is pain or blood loss, there is a clear need for a better device. But the distinction makes a difference down the road. If they chose to focus on the pain rather than the blood loss, that would effect what insurance will pay for its use and intellectual property – factors that make a difference in whether or not a device can get funding and eventually reach patients.

“We need a very specific sentence to make very clear the need we are trying to solve,” Saha said.

Eventually the team will sort through this list of needs to identify the single focus of the remainder of their time.

One thing I found interesting: In fourteen years of the program, each year with several teams working on the same medical field, no two teams have ever developed devices to satisfy the same need.

Previously: Good medical technology starts with patients’ needs and Biodesign program welcomes last class from India
Photo of Shashi Ranjan and Harsh Sheth on a clinical visit by Kurt Hickman

Bioengineering, Stanford News

Miniature chemistry kit brings science out of the lab and into the classroom or field

Miniature chemistry kit brings science out of the lab and into the classroom or field

KorirA few months ago, Stanford bioengineer Manu Prakash, PhD, and graduate student George Korir were recognized for an ingenious (to me) contraption built from a music box that creates a simple way of doing very small scale chemistry experiments.

That award, from the Gordon and Betty Moore Foundation and the Society for Science & the Public, recognized the device for its possible use as a chemistry set for kids, but Prakash and Korir also see it as useful for scientists in a lab or out in the field.

They’ve now published the device in PLoS ONE , describing its functionality for scientists as well as kids.

The general idea is that this 100 gram device uses a hand crank to wind a long punch card through metal prongs. In its original state, those metal prongs then each played a note on queue. In their reconfiguration, each metal prong releases a droplet of a chemical or controls pumps and valves.

At only two inches in length, Prakash and Korir say the device is easy to carry and could be programmed to carry out chemistry experiments outside the lab – testing water quality or soil samples, for example.

“The platform is simple to use and its plug and play nature makes it accessible to both untrained health workers in the field and young children in classrooms,” Prakash wrote.

This device is part of Prakash’s ongoing focus on frugal science – devices that are inexpensive and functional enough to bring science out of the lab and into the world. He previously developed a 50 cent microscope called the Foldscope that is being used by groups worldwide to investigate their environment. Some of the images taken through the Foldscope can be viewed here.

Previously: Music box inspires a chemistry set for kids and scientists in developing countries and Foldscope beta testers share the wonders of the microcosmos
Photo by Kurt Hickman

Bioengineering, Cardiovascular Medicine, Medical Education, Research, Technology

Good medical technology starts with patients’ needs

Good medical technology starts with patients' needs

biodesign fellows

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.

The first step in solving a medical challenge is identifying a problem in need of a solution. This seems intuitive, but often people start from the other direction – they’ve developed a technology and go looking for some way to apply it.

Learning that workflow is one thing that brought Shashi Ranjan to the Stanford Biodesign program from Singapore. “I was making devices but didn’t see them going into people,” he told me. “I wanted my technology to go into the real world.”

As the fellows encounter patients and doctors, they are compiling a list of existing medical needs.

Ranjan, along with Harsh Sheth, recently visited the Stanford South Asian Translational Heart Initiative run by Rajesh Dash, MD, PhD, to witness first-hand cardiovascular needs encountered by South Asians in the Bay Area. (The third member of their team, Debayan Saha, was at a different clinic that day.) After observing some patients, what became clear to the two is that lifestyle changes are a major barrier to improving cardiovascular disease risk in South Asians, just like in any other population.

Some of the problems they encountered appear obvious: How do you help people get more exercise and maintain a healthy weight? Develop a device to solve that and the team would help many more people than just patients with cardiovascular disease.

The two had also observed that many people who are overweight have sleep apnea, or short pauses in breathing during sleep, which can contribute to heart disease risk. The devices that exist to help sleep apnea look like cumbersome gas masks and aren’t conducive to a restful slumber. Several patients they observed don’t use the device regularly despite knowing that it could lower their risk of having a heart attack.

After observing patients, the pair added to their growing list of 300 plus medical needs a better air mask for sleep apnea, along with simplified screening for people who are at risk of heart disease. Patients at Dash’s clinic are asked to make routine visits for specialized bloodwork and other screenings. “Can we make the tests simpler but still effective, and available at the point of care?” Sheth asked.

I asked Dash why he wanted to work with Biodesign fellows like Ranjan and Sheth – their presence in the office visit certainly made the room tight and patients perhaps a tad uncomfortable. He told me that training people to make better medical devices is critical to providing good care.

The fellows from India are particularly valuable he said. “They learn how we are approaching the problem here then help find solutions that are effective in India.”

Over the next few weeks, the team will stop visiting clinics and will begin the arduous task of narrowing down their list of more than 300 observed medical needs to the one that will become the focus of their fellowship. (Four other teams are going through a similar process, and they’ll all present their prototypes at a symposium in June.)

Previously: One person’s normal = another person’s heart attack? and Biodesign program welcomes last class from India
Photo, of Shashi Ranjan and Harsh Sheth observing as Rajesh Dash, MD, meets with a patient, by Kurt Hickman

Bioengineering, Stanford News

Biodesign program welcomes last class from India

Biodesign program welcomes last class from India

Clark CenterIn January, three fellows from India arrived to Stanford to join the Biodesign program, which immerses clinicians, scientists, engineers and business people in the biodesign process for innovating successful medical devices.

What makes these three unique is that they’re the last class from the Stanford-India Biodesign program to visit home base, housed within the Clark Center and the interdisciplinary environment of Stanford Bio-X. The Indian program has been so successful that after this year they will become independent.

I’ll be following this final group of Indian fellows on their whirlwind tour of clinics, prototyping demos, brainstorming sessions, and courses on intellectual property and regulatory steps as they develop and prototype a medical device – and blogging about them along the way.

The three fellows I’ll be following – Debayan Saha, Shashi Ranjan, PhD, and Harsh Sheth, MD – all say they were drawn to the program in part because of its unique approach. Commonly, people develop medical devices and then look for a problem to apply it to. Or, they come up with a prototype that meets a real need, but don’t research the intellectual property or costs in advance and fail because of that oversight.

In the end, real needs are unmet.

In the Biodesign program, fellows first observe clinicians to learn what the needs are. Then they research the intellectual property, medical costs of the disease, and regulatory hurdles they would have to overcome before they ever start prototyping.

The end result has been 36 start-up companies and international programs in India, Singapore and Ireland all trying to replicate the process and meet their country’s own unique medical needs.

By June, Saha, Ranjan and Sheth will have developed a device prototype that solves a medical need in cardiovascular medicine, and that could potentially get to market. Sheth brings clinical expertise – he is a surgeon – while Ranjan and Saha both have engineering backgrounds.

So far, the group says their clinical visits have resulted in a list of more than 300 needs, which they say will grow before it shrinks down to the final one they decide to address. I’ll be documenting the process of whittling 300+ needs down to a single prototype, and interviewing leaders in Biodesign along the way.

For my next installment: The fellows visit a south Asian cardiovascular disease clinic run by Rajesh Dash, MD, PhD, and wonder if a device can change patient attitudes.

Previously: Biodesign fellows take on night terrors in children, Stanford Biodesign Program releases video series on the FDA system and A medical invention that brings tears to your eyes
Photo of the Clark Center by L.A. Cicero

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