Houston Chronicle Sunday

TMC program boosting startups

Medical Center provides financial backing, so entreprene­urs can focus on innovation

- By Andrea Leinfelder STAFF WRITER

Alex Harb had worked nearly a year researchin­g and developing a text messaging service aimed at preventing one of the most debilitati­ng conditions of aging: loneliness. Now, he found himself at a domino game at the Trotter Family YMCA in west Houston, getting feedback from older adults on how his product displayed nearby events that might interest them. Peppered in with feedback on the product were unrelated tech-support questions.

“I can’t delete stuff from my phone,” said 65-year-old Johanna Balestra.

“My doctor says if I want to lose weight I can try this app,” said 76-year-old Andrea Hermann. “I’ve never put an app on here.”

The impromptu tech-support session proved just as valuable as the product feedback. Harb continued to learn which smartphone features older adults would embrace, one of the final tasks for Harb and his developmen­t team as they moved their product, called Lena, closer to commercial release.

Harb, a software developer, and his collaborat­ors, Dr. Joshua Reischer, an internist, and accountant Michael Evans, reached this point thanks to a program at the Texas Medical Center. The program takes a different approach to encouragin­g entreprene­urial activity by providing a financial backstop to help smart, creative people launch new ideas, products and companies to improve medical care without —

a least in the first year — maxing out their credit cards.

The program, the Texas Medical Center Biodesign fellowship, provides a salary of $70,000 plus health insurance to liberate would-be entreprene­urs from economic worries and their day jobs, allowing them to focus for an entire year on starting a company. While its fellows receive more guidance and support than your typical garage startup, TMC Biodesign still provides the drinking-from-a-firehose experience that is entreprene­urship — an experience that can start with too many ideas, feature a neverendin­g quest for money and undergo frequent adjustment­s to products and business plans.

Those who would work in life sciences must also contend with complex regulation­s.

“From concept to market is a huge gap,” said TMC Biodesign Program Director Toby Hamilton. “It’s years and years. It’s lots of money. It’s lots of stress and heart ache, and it’s tough.”

TMC Biodesign is modeled after a similar program at Stanford University that has helped launch 85 health technology companies since 2000. Of the 50 health technology companies started during the Stanford fellowship or its other courses, 70 percent are still active and 20 percent have been acquired. Of the 35 health technology companies started by alumni after completing the Stanford Biodesign fellowship, 86 percent are still active and 12 percent have been acquired.

Combined, these companies have created technologi­es that have assisted nearly 4 million patients, employed about 1,500 people and raised more than $1 billion from investors.

“We’ve created people who have a strong foundation in health care innovation and who have gone out to practice that,” said Dr. James Wall, director of program developmen­t for the Stanford Biodesign Innovation Fellowship and an associate professor of pediatric surgery.

For Harb, interviewi­ng domino players in June was just the beginning for his company. In December, Lena will become available to older adults at three Houston YMCA locations.

“We have just been accelerate­d incredibly quickly because we started at TMC,” Harb said.

Finding a problem

The program, launched in 2015, has historical­ly accepted six fellows each year and split them into two teams: one focused on creating a digital health solution using technologi­es such as smartphone­s, data analytics or wearable sensors, and a second team focused on developing a medical device.

Each team consists of a doctor (or medical student approachin­g graduation), technical person and business mind, providing different perspectiv­es and broad expertise to understand medical terminolog­y, use 3D printers to craft a prototype and put together a pitchbook for investors.

Harb and the five fellows in his class started July 30, 2018. The program began with a month of bookwork and classroom activities that outlined the program and taught courses on marketing, finance and the regulatory process. After that, the fellows began an all-day, everyday regimen of observing surgeons in operating rooms, interviewi­ng hospital administra­tors and talking to patients and their families.

“Seeing an open brain for the first time is crazy,” said Adrian Trömel, the business fellow on the medical device team.

Trömel, with an MBA and experience that includes working as an associate with the Houston Angel Network investor group, worked with teammates Dr. Vivek Sant and biomedical engineer Kristin Brune for three months observing procedures, furiously scribbling everything they saw, heard and smelled. They peppered physicians with questions. Surgeons sometimes would halt an operation to remove their gloves and draw what they were doing.

During 350 hours of observatio­n, the team identified more than 400 needs. They narrowed their focus based on a few criteria: Is the science advanced enough to tackle this? Do we care about the problem? And how many people does this affect?

They ultimately settled on preventing postoperat­ive ileus, a condition that occurs after abdominal surgery when intestines shut down for days or even months. A tube must be placed down the patient’s nose to pump out stomach contents that back up.

“They’re just sitting in the hospital waiting around for this issue to resolve itself,” Brune said.

Harb and his teammates went through the same process, identifyin­g some 450 needs before settling on loneliness and social isolation in older adults as the problem they wanted to solve.

Lena was inspired by Reischer’s personal experience. During his fellowship, he worked for an answering service that makes doctors available to answer patients’ questions on weekends. During one of those weekends, 12 of his 14 calls came from older adults who didn’t have a serious medical issue but, essentiall­y, just needed someone to talk to.

To validate this as a widespread problem, the team spoke with patients in geriatrici­an offices, interviewe­d internal medicine physicians, and read research papers on how loneliness can affect older adults’ health, such as accelerati­ng cognitive decline or worsening cardiovasc­ular disease.

“We realized that the root cause of the problem is real,” Harb said, “and there are very real challenges to addressing it today.”

Seeking an answer

In mid-January, both teams narrowed their focus to one “need.” They sought a solution — one that hadn’t already been invented.

For the medical device team, that started with a deep-dive into understand­ing postoperat­ive ileus, which eventually uncovered research out of Europe that indicated electric stimulatio­n could reverse postoperat­ive ileus.

Narrowing in on this idea, the team created a device that would target the vagus nerve, which runs from the brain to the abdomen. This nerve is also known as cranial nerve 10, so they named the company CNX Medical .

The team initially considered administer­ing this stimulatio­n to a patient’s neck or inside the abdomen during surgery. But the ear, they decided, would be less invasive. They designed a disposable ear piece that would provide a low-level electric stimulatio­n after the patient received anesthesia.

Their product developmen­t started with “lab bench” tests, in which team members tested the electric stimulatio­n on each other to measure heart rate and pain level. By March 28, they had a rough prototype to showcase at a Rice University business pitch competitio­n.

In late April, the team finalized a circuit that would create the desired voltage, pulse and frequency of the electric stimulatio­n. The electrical circuit was printed on a chip small enough to fit in the medical device. Soon after, the team began animal trials.

Lena started with an idea of hosting group phone calls in which older adults could discuss topics such as politics or history. The product was going to be called PatientKin.

But the Biodesign fellows couldn’t find a way to make money. So they decided to partner with organizati­ons, such as the YMCA, that receive insurance reimbursem­ents for offering programs to older adults. Each time an older adult attends a SilverSnea­kers exercise class at the YMCA, that Y receives a reimbursem­ent from the person’s insurance company. If Lena refers older adults to this program, it would receive a cut of the reimbursem­ent.

To introduce older adults to events, Lena sends a text message with a link that opens a chatbot — software that can simulate conversati­ons. The chatbot asks questions about where the person lives, which activities the person enjoys and what times and days the person likes to be active. Using artificial intelligen­ce, Lena then identifies and recommends nearby events.

Lena also connects its users with a member of the Lena staff who is a dedicated companion. This companion adds a human touch by texting older adults to check in and build a relationsh­ip . The company name is a nod to Elena Dinkin, associatio­n adviser for active older adults at the YMCA of Greater Houston. Dinkin worked closely with the Biodesign fellows and inspired them with her own work in the community.

Lena can also be used by those who provide services to older adults to reach and engage people. Dinkin particular­ly likes that Biodesign sends reminders to older adults about upcoming events.

“We all are tied to our phone,” she said. “The phone is our lifeline in so many ways.”

Graduation?

The Texas Medical Center doesn’t end the Biodesign program with a graduation ceremony. There’s a company launch party and small dinner, but “graduation” is not in the program’s vernacular, said Hamilton, the Biodesign program director.

“If we’re focused on a graduation or we start talking about that and it’s a big deal,” he said. “Our concern is that people are going to come here to get the education and the experience and not really be focused on commercial­izing.”

Harb is now CEO of Lena and will return to Houston after completing the Minneapoli­s Techstars accelerato­r program in December. Reischer remains a clinical adviser to Lena, but has returned his full-time focus to Health Note, a startup he founded prior to Biodesign that allows patients to fill out their visit intake forms from their phone. Michael Evans returned to his home in Ireland and is no longer with the company.

Kristin Brune and Dr. Vivek Sant are still running CNX as it continues with animal trials. Adrian Trömel left the company, but is still in Houston, working on another TMC-based startup.

Hamilton said it’s common for Biodesign fellows to leave the companies once the program is completed. Sometimes, their expertise isn’t as useful once the company is establishe­d. Or they don’t want to give up well-paying positions in medicine, technology or business for the uncertain startup lifestyle.

But ultimately, Hamilton hopes all fellows learn to identify needs, invent solutions and implement those solutions by bringing a product to market.

“I’ve armed them for the next time,” Hamilton said. “Most people who are into this, who like innovating and creating and inventing, they’re not going to stop when their year is up.”

 ?? Yi-Chin Lee / Staff photograph­er ?? Dr. Vivek Sant, left, and Kristin Brune used the program to create CNX, a device to prevent postoperat­ive ileus.
Yi-Chin Lee / Staff photograph­er Dr. Vivek Sant, left, and Kristin Brune used the program to create CNX, a device to prevent postoperat­ive ileus.
 ?? Photos by Yi-Chin Lee / Staff photograph­er ?? Dr. Vivek Sant, from left, Kristin Brune and Adrian Trömel field questions from judges after pitching their business plan in March at the H. Albert Napier Rice Launch Challenge Startup Competitio­n.
Photos by Yi-Chin Lee / Staff photograph­er Dr. Vivek Sant, from left, Kristin Brune and Adrian Trömel field questions from judges after pitching their business plan in March at the H. Albert Napier Rice Launch Challenge Startup Competitio­n.
 ??  ?? CNX Medical uses these protoype earbuds to prevent postoperat­ive ileus, which is a condition that happens after abdominal surgery when the intestines shut down for days or even months.
CNX Medical uses these protoype earbuds to prevent postoperat­ive ileus, which is a condition that happens after abdominal surgery when the intestines shut down for days or even months.
 ??  ?? Trömel and the CNX Medical team conducted all-day, everyday observatio­ns of surgeons in operating rooms.
Trömel and the CNX Medical team conducted all-day, everyday observatio­ns of surgeons in operating rooms.

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