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Bioengineering, Cardiovascular Medicine, Global Health, Stanford News, Technology

Stanford-India Biodesign co-founder: “You can become a millionaire, but also make a difference”

Stanford-India Biodesign co-founder: "You can become a millionaire, but also make a difference"

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.

4499846308_9f084d26f0_zThe three Indian biodesign fellows who were at Stanford for the past six months have returned to New Delhi, where they’ll finish up their fellowship. They’re the last class of fellows from the Stanford-India Biodesign program, and in India they’ll be joining two teams already in progress as part of the new School of International Biodesign (SIB).

Balram Bhargava, MD, executive director of Stanford-India Biodesign (India), was at Stanford for the fellow’s final presentation of their prototype. He helped establish the relationship between Stanford and India and is now revamping the new self-sufficient program.

How did Stanford-India Biodesign originate?

I was at a retirement party in September 2006 for Ulrich Sigwart, MD, who developed the first stent. He called in some friends from all over the world, including Paul Yock, MD (director of the Stanford Biodesign Program). Paul and I shared a taxi ride to Ulrich’s vacation home and got talking. That’s when the program started. By January 2008 the first batch of fellows was here.

The basic intent was to start this innovative program in India and ultimately make it self-sufficient. We selected students from India and sent them to Stanford, then they finished out their fellowship in India.

How has the program changed over the years?

Our early fellows returned from Stanford with high-end ideas such as robots. I had to pull them all down back to the ground. My role was to give this program a soul, and I think I have been successful at that. After a few years Stanford also accepted that frugal design was the right thing for the world and I’m happy about that.

Many of our students had the intention of setting up a company and becoming millionaires. We’ve given them the idea that you can become a millionaire, but at the same time you can make a difference. That’s the delicate balance we want to teach. The students have been very bright and many of them have really delivered on this dream.

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Cardiovascular Medicine, Stanford News, Technology

Stanford-India Biodesign fellows develop prototype device to improve success of pacemaker implants

Stanford-India Biodesign fellows develop prototype device to improve success of pacemaker implants

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.

IMG_6136 560When the Indian biodesign fellows observed a pacemaker implantation earlier this year, the surgeon spent four hours trying to firmly insert wires from the pacemaker into the heart muscle. Even after a painstaking surgery, the wires fall out in about five percent of cases. That’s an expensive and risky problem.

The team’s solution, which was officially revealed at the biodesign symposium last week, is a device made of popsicle sticks and a spring that attaches to the long wire that screws into the heart. The spring records the amount of force a surgeon uses when screwing in the wire. If it records a higher force, that likely means the screw went firmly into the heart muscle. A lower force means it might not have inserted well and the surgeon should try again.

The team presented their prototype to an audience of faculty, the program’s alumni and local business leaders. Harsh Sheth, MD, said their inexpensive solution to a widespread problem met with good reviews. “We were strongly encouraged to continue developing this,” he said. The team needs to finish their fellowship, but they say they might return to the idea when they are done.

Sheth and his fellow teammates Shashi Ranjan, PhD, and Debayan Saha, all had prior experience in either surgery or engineering but had never been through a deliberative process that would result in a device that combines medical needs, engineering expertise and business sense.

They’ll take their newfound skills back to India, where they’ll start the process over in the second phase of their fellowship. Their departure marks the end of Indian biodesign fellows spending immersive time at Stanford. Ranjan told me that he’s glad he applied to the program when he did rather than waiting a year, when he would have done the entire program in India.

“Being at Stanford was an amazing experience,” he said. “We had access to Silicon Valley, business, technology. We don’t have anything like that [at home].” In the future, fellows might visit the U.S. or other partner countries for shorter stays, and Stanford fellows will have opportunities to learn about biodesign in India.

Previously: Success breeds success: Early innovators in India created a sense of possibilityA jugaad for keeping pacemakers in placThe next challenge for biodesign: constraining health-care costs and Stanford-India Biodesign co-founder: Our hope is to “inspire others and create a ripple effect” in India
Photo by Amy Adams

Cardiovascular Medicine, Medical Apps, Precision health, Research, Stanford News, Technology

MyHeart Counts shows that smartphones are catching on as new research tool

MyHeart Counts shows that smartphones are catching on as new research tool

using iPhone - 560

In the three months since Stanford researcher and cardiologist Michael McConnell, MD, told ABC’s Nightline that the new MyHeart Counts iPhone app would give scientists “a whole new way to do research,” the number of users has continued to steadily climb.

“Traditionally reaching many people to participate in research studies is quite challenging,” McConnell told business correspondent Rebecca Jarvis in March. “The ability to reach people through their phone is one major advance.”

The number of iPhone owners who have downloaded the app and consented to participate in a large-scale study of the human heart has now reached 40,000. In an effort to keep updated on how the app is progressing as a new research method, I reached out to McConnell, the lead investigator of the study, with a few questions. The MyHeart Counts study continues to break ground as a new method for reaching large numbers of research participants in a short amount of time, McConnell told me. Comparing it to traditional research trials, he said:

There have been larger research studies, particularly national efforts to study their populations, but we believe enrolling this many participants in such a short time frame is unprecedented.

The app, which was launched in early March, collects data about users’ physical activity using the smartphone’s built-in motion sensors. Participants also answer surveys concerning their cardiac-risk factors. In return, they get coaching tips and feedback on their chances of developing heart disease.

McConnell says that the next phase of the project, which will use behavior-modification methods to encourage healthy behaviors, is about to be launched. App users will be given more personalized feedback about their individual behaviors and risk, based on the American Heart Association’s Life’s Simple 7 guidance. Future tips will include messages on everything from how to manage blood pressure, eat better, lose weight and control blood sugar. Part of the study is to determine whether these type of “pings” used through apps are actually successful at changing human behavior, McConnell told me:

Healthy behaviors are critical to preventing heart disease and stroke, so the MyHeart Counts app will study which motivational tools are most helpful. This will follow the second activity and fitness assessment… The initial approach will be empowering participants with more personalized feedback about their individual behaviors and risk.

To sign up for the MyHeart Counts study, visit the iTunes store.

Previously: Lights, camera, action — Stanford cardiologist discusses MyHeart counts on ABC’s Nightline, Build it (an easy way to join research studies) and the volunteers will comeMyHeart Counts app debuts with a splash and Stanford launches iPhone app to study heart health
Photo by Japanexperterna (CC BY-SA)

Big data, Cardiovascular Medicine, Patient Care, Public Health, Research, Stanford News

Widely prescribed heartburn drugs may heighten heart-attack risk

Widely prescribed heartburn drugs may heighten heart-attack risk

PrilosecHeartburn – that burning sensation in the chest that occurs when stomach acid rises up into your esophagus – has absolutely nothing whatsoever to do with the heart. People with heartburn (that’s a lot of us) are at no increased risk of developing heart disease. At least, not unless they’re taking the most commonly used class of drugs for treating heartburn.

That drug class would be proton-pump inhibitors, or PPIs, and it includes omeprazole (Prilosec), lansoprazole (Prevacid), esomeprazole (Nexium) and a few more. All three are available over the counter. Although the labels direct users not to take these drugs for longer than a couple of weeks without consulting their physicians, people often pop them on a daily basis for months or years on end.

But a new PLOS ONE study, led by Stanford biomedical-informatics expert Nigam Shah, PhD, MBBS, and cardiovascular surgeon Nick Leeper, MD, shows a clear association between prior use of PPIs for heartburn and elevated risk of serious cardiovascular events including heart attacks. In a news release covering that “big data” study, which combed through nearly 3 million electronic health records to ferret out the PPI/cardiovascular-risk connection, I wrote:

… PPIs are among the world’s most widely prescribed drugs, with $14 billion in annual sales… In any given year, more than 20 million Americans – about one in every 14 – use PPIs… More than 100 million prescriptions are filled every year in the United States for PPIs, a class of drugs long considered benign except for people concurrently taking the blood thinner clopidogrel (Plavix). However, the new study upends this view: It indicates that PPI use was associated with a roughly 20 percent increase in the rate of subsequent heart-attack risk among all adult PPI users, even when excluding those also taking clopidogrel.

That increased risk was seen among younger adults (under age 45), too.

The study, in other words, found that everybody’s cardiovascular risk goes up if they use PPIs. Now, a 20 percent increase in risk may not amount to much if your baseline risk is very low to begin with (say, that of a 20-year-old woman in top physical condition with no genetic predisposition to high blood pressure or elevated cholesterol). But for many of us, especially if we’re middle-aged, a little pudgy, or struggling with hypertension or hypercholesterolemia, that 20 percent looms larger.

Importantly, people who take the second-most-widely prescribed class of drugs prescribed for heartburn, so-called H2 blockers, appear to suffer no ill effects from them in the cardiovascular-risk department, according to the study’s findings. H2 blockers, which have been around longer than PPIs, are reasonably effective.

So, why do PPIs, but not H2 blockers, cause trouble? As I noted in my release:

The study’s findings lend support to an explanation for an untoward effect of PPIs on heart-disease risk proposed by Stanford scientists a few years ago. Research done then showed that PPIs impede the production of an important substance, nitric oxide, in the endothelial cells that line all of the nearly 100,000 miles of blood vessels in an averag adult’s body.

Nitric oxide relaxes blood vessels. So it figures that chronic use of a drug that shuts down that chemical’s generation could cause chronic blood-vessel constriction and follow-on cardiovascular problems.

Read those labels, people.

Previously: How efforts to mine electronic health records are beginnning to influence critical care, New research scrutinizes off-label drug use and Damage to dead-cell disposal system may increase heart disease
Photo by John

 

Bioengineering, Cardiovascular Medicine, Stanford News, Surgery, Technology

A jugaad for keeping pacemakers in place

A jugaad for keeping pacemakers in place

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.

IMG_6308After months of observing clinics and winnowing down the most pressing (and commercially viable) medical needs, the Stanford-India Biodesign team has developed what looks like nothing so much as a very elaborate clothespin. It is intended to help doctors ensure that coiled pacemaker leads that screw into heart tissue stay put. Currently, about five percent of those leads fall out, requiring costly additional surgery. Worldwide, the number of people whose leads fall out is estimated at 80,000 to 100,000.

Debayan Saha says their prototype is a perfect example of Indian Jugaad. It’s made of what looks like the contents of a scrap pile, and he says could both work and be cheap to produce in it’s current low-tech form. But just because it’s inexpensive doesn’t mean it’s not cleverly designed. That’s what the Indian team brings to Biodesign, he said – smart technology at low cost.

“Getting the prototype exactly right made use of all the resources we have here at Stanford,” Saha said. “But the final product is something we could produce at very low cost.” Creating technology in a developing country requires creative solutions to keep that technology affordable.

IMG_6326The group has a provisional patent on their device and they will present their it to the entire biodesign team June 8. Until that presentation they are keeping it’s exact function under wraps. They did recently test the prototype in a lamb heart, with good results. They were consistently able to screw the pacemaker lead more securely into the heart tissue.

Harsh Sheth, MD, said the team (which also includes Shashi Ranjan, PhD) will be heading back to India at the end of June and will repeat the same process there – visiting clinics, assessing needs, and prototyping a solution. He said they might later return to their Stanford prototype or keep working on whatever they design in India.

Previously: From popsicle sticks to improved medical careThe next challenge for biodesign: constraining health-care costs and Stanford-India Biodesign co-founder: Our hope is to “inspire others and create a ripple effect” in India
Photos, of Debayan Saha screwing a pacemaker lead into a lamb heart using their prototype, and of the coiled screw going into the heart, courtesy of Amy Adams

Cardiovascular Medicine, Events, Patient Care, Stanford News

Honoring doctors, nurses of the early days of Stanford’s coronary care unit

Honoring doctors, nurses of the early days of Stanford’s coronary care unit

image.img.320.highWhen I was in the hospital recently to give birth to my daughter, I saw my doctors briefly during their rounds, but it was the nurses and nurse midwives who primarily cared for me. So when I read in a recent Inside Stanford Medicine feature story that 50 years ago, nurses weren’t even allowed to perform tasks like start IVs, I was shocked.

In the 1960s, Stanford was home to one of the earliest coronary care units, led by Alfred Spivack, MD. Spivack taught the nurses working on the unit to take on tasks that were, at the time, mainly done by physicians. Joan Fair, PhD, RN, who was one of the unit’s original nurses and is now a cardiovascular researcher, recalls:

“Some doctors were totally against nurses doing these kinds of things… It also took time for some doctors to accept our opinions about how their patients were doing, or if we saw a problem and called them and asked them to take a different line of treatment.”

Joan Mersch, MSN, the unit’s former nurse coordinator, described in the piece how beneficial this extra training was to patients. “When you know how to read electrocardiograms, recognize lethal cardiac rhythms, perform resuscitation and defibrillation — it saves patient lives,” she said. “You understand what needs to be done, and you can take action.”

A big proponent of using technology to improve care, Spivack depended on the nurses to learn how to use the devices and incorporate them in the daily care of patients. And he also encouraged the nurses to pursue their research interests; many, like Fair, went on to obtain graduate degrees.

Last month, almost two dozen former nurses from the unit came together for a dinner celebrating a major gift from Spivack, which will pay for the nurses’ station in the new heart acute care unit when the new adult hospital opens in 2018.

Photo by Steve Fisch

Bioengineering, Cardiovascular Medicine, Stanford News

From popsicle sticks to improved medical care

From popsicle sticks to improved medical care

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

IMG_6141 300Shashi Ranjan, PhD, and Harsh Sheth, MD, fiddled with popsicle sticks and tiny wires in the final throes of prototyping possible biodesign solutions for two medical needs: fixing pacemaker leads or improving catheter urine drainage.

The popsicle stick device hardly looked like something that would inspire confidence in a person undergoing surgery, but if it worked and could be miniaturized and made out of more durable materials it could provide a solution for the pacemaker leads that are prone to coming unfixed after they are inserted.

The team had narrowed their search down from the 315 medical needs they had originally identified using a weighted matrix of requirements. Sheth told me that what stood out about addressing the final two needs was the large number of people who could benefit, lack of other solutions and lack of competing products.

All of those add up to a product that could inspire venture funding and eventual development, which is the goal of the biodesign process.

Sheth said the prototypes they were building now would help determine which of the two needs the group eventually chose to address, and how. They had four ideas to try out for the pacemaker leads and five ideas for improving urine drainage. “We’ll know which of these ideas have value after this step,” Sheth told me.

The group (which includes Debayan Saha, who was elsewhere during this prototyping session) returns to India after the Stanford phase of the fellowship ends in June. At that point they’ll repeat the process of identifying medical needs and prototyping solutions in India. Sheth and Ranjan said they hope to have patents in place for their Stanford prototype, with the idea of potentially returning to it after the fellowship.

Previously: The next challenge for biodesign: constraining health-care costsFollowing the heart and the mind in biodesign and Stanford-India Biodesign co-founder: Our hope is to “inspire others and create a ripple effect” in India

Cardiovascular Medicine, Pediatrics, Stanford News, Transplants

Ventricular assist device helps teen graduate from high school

Ventricular assist device helps teen graduate from high school

TJ Balliao verticalWhen 17-year-old TJ Balliao was diagnosed with heart failure earlier this year, his doctors at Lucile Packard Children’s Hospital Stanford told him that he needed to receive a ventricular assist device right away. TJ was experiencing bouts of unstable heart rhythm so serious that medication alone wasn’t enough to keep him alive. The VAD, a pump implanted in his heart to help it move blood through his body, could help him survive long enough to receive a heart transplant.

But something unexpected happened after the surgery to implant TJ’s ventricular assist device. He made a strong recovery – so strong that his cardiologist, David Rosenthal, MD, offered him the opportunity to go home with his VAD, graduate from high school with his class this June, and delay a heart transplant indefinitely.

In a recent story I wrote about TJ’s case, Rosenthal explained how this could benefit TJ not just now, but also in the long run:

“It’s possible that using a VAD to intentionally delay a heart transplant could add to the patient’s total lifespan,” said Rosenthal, who directs the hospital’s pediatric heart failure and transplantation program and is professor of pediatrics at the Stanford University School of Medicine. “Survival after transplant is not as long as the natural lifespan, especially for children.”

The benefits of a VAD are many. It helps patients maintain strength while waiting for a new heart; otherwise, heart failure weakens the body, making recovery from eventual transplant more difficult. When a child is stabilized by use of a VAD, the medical team can be more selective about choosing a donor heart that is an excellent match for the recipient, too. “Plus,” said Rosenthal, “there is some likelihood that a small proportion of patients’ hearts will be able to recover and those children will avoid transplant completely.”

TJ and his medical team aren’t sure if or when he will ultimately move toward getting a heart transplant. But he’s been accepted to San Jose State University to study civil engineering, so he may be in class in the fall with his VAD battery pack at his side.

Previously: Packard Children’s heart transplant family featured tonight on Dateline, Liberated from LVAD support: One patient’s story and Pediatric social worker discusses the emotional side of heart transplants
Photo courtesy of Lucile Packard Children’s Hospital Stanford

Cardiovascular Medicine, Medical Education, Research, Stanford News

Stanford med student/HHMI fellow testing new way to deliver treatment to heart

Stanford med student/HHMI fellow testing new way to deliver treatment to heart

Jensen and Woo 560

The human heart has fascinated second-year medical student Christopher Jensen ever since he first flipped through anatomy books as a child. Now, the Howard Hughes Medical Institute (HHMI) has given Jensen a special opportunity to pursue his passion.

Jensen is one of 68 medical students from across the U.S. chosen to take part in the HHMI Medical Research Fellows Program. This program gives medical students a chance to try their hand at research by offering them funding, mentorship and a full year to explore the medical research project of their choice.

Recently, I spoke with Jensen about his interest in the heart and his HHMI project. “I was homeschooled,” Jensen told me. “My parents bought me books on biology and I thought that anatomy – the heart in particular – was fascinating.”

Later, when Jensen studied biology at school, his interest grew: “The more I learned about the heart, the more I wanted to understand it better. I was in awe and wonder of how this one organ could supply blood for the whole body.”

Jensen’s curiosity about the heart led him to Stanford where he met his HHMI mentor, Y. Joseph Woo, MD, chair of Stanford’s Department of Cardiothoracic Surgery. “When I saw Woo’s work I was enthralled,” Jensen said.

Jensen’s one-year research project with Woo will focus on a growth factor, called Neuregulin-1ß, that plays an essential role in the development of heart, skin and brain cells. “We’ve already demonstrated neuregulin’s ability to rescue and regenerate heart muscle immediately after a heart attack,” Jensen told me.

In these studies, Neuregulin-1ß is given during surgery as an injection to the heart. This delivery method prevents neuregulin from acting on the entire body (which could have negative side effects) but it limits this treatment to surgical procedures. Jensen’s goal is to develop a non-surgical way to target heart cells with the neuregulin treatment so it can quickly be given to a patient after they have a heart attack.

Over the next year, Jensen and Woo will test a special hydrogel that could provide a way to transport neuregulin through the veins to targeted tissues in the heart. The hydrogel, Jensen explained, forms a gummy, slow-dissolving solid when it reaches the heart. This therapy could help cardiac surgeons target heart cells with Neuregulin-1ß for long periods of time whenever the treatment is needed. “This would be a phenomenal advancement and could pave the way for minimally invasive therapies in the hospital,” Jensen said.

“I’m excited about this research,” Jensen told me. “It could lead to other work in the field or a career in cardiac surgery and research.” It also possible that, one day, it could lead to a therapy to treat patients suffering from heart failure.

Previously: A new era for stem cells in cardiac medicine? A simple, effective way to generate patient-specific heart muscle cells
Photo courtesy of Christopher Jensen

Cardiovascular Medicine, Chronic Disease, Patient Care, Stanford News

Monitoring heart failure from home

Monitoring heart failure from home

blood pressure readingSometimes, the best way to prevent a visit to the hospital is to become your own care provider. That’s the theory behind a new Stanford-led project that monitors heart-failure patients at home.

From an Inside Stanford Medicine story on the pilot program:

“There is abundant evidence in the literature that suggests home monitoring can improve patient outcomes,” said Rita Ghatak, PhD, director of Stanford’s Aging Adult Services, one of the sponsors of the program. “It can improve survival, days out of the hospital, quality of life and it provides an extra measure of psychosocial support.”

Project leaders teach heart-failure patients, such as 74-old-year Earl Shook, who is featured in the story, how to measure their blood pressure and oxygen saturation at home. Patients also receive visits from specially trained nurses. A nurse caught when Shook’s blood pressure was climbing too high and helped get him in to the cardiologist the next day.

Shook said it was hard to leave the hospital, but he was reassured by the home-monitoring program. “It let me know there was somebody still caring for me.”

Previously: Exercise may boost heart failure patients’ mental and physical health, Failing at prescribing the best heart-failure treatments and Home health-care treatments for lymphedema patients cut costs and improve care 
Photo by sriram bala

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