Health care has always been ripe for innovation. Whether it’s increasing safety in operating rooms, developing systems to reduce patient wait times, or improving drug delivery, there are endless opportunities to improve the efficacy and efficiency of health care. The Covid-19 pandemic made the need for these solutions all the more pressing.
“There were a number of startups from MIT that addressed problems related to the pandemic,” says George Whitfield, entrepreneur in residence at the Martin Trust Center for MIT Entrepreneurship. “One company, Biobot Analytics, developed a technology to monitor disease spread by looking at wastewater in sewers. In a case of unbelievable serendipity, they developed this right as Covid was starting to spread.”
Another startup inspired by the Covid-19 pandemic, Teal Bio, developed a comfortable, reusable, and transparent respirator that can be worn by health care professionals on long shifts. The company has identified a number of benefits to their design, including lower costs, decreased waste, and an improved ability to identify emotions. Teal Bio was co-founded by Department of Mechanical Engineering (MechE) Leaders for Global Operations alumnus Jason Troutner MBA ’19, SM ’19 and Giovanni Traverso, assistant professor of mechanical engineering at MIT.
Traverso is no stranger to startups. He has co-founded seven of them. An MD-PhD, Traverso is both an assistant professor at MIT and a physician at Brigham and Women’s Hospital. His companies range in size from one employee to 140 employees. With the exception of Teal Bio, the thread that connects his companies is gastroenterology.
“These companies are launching systems that make it easier for patients to receive medication one way or another, particularly through the GI tract,” says Traverso.
One of the companies that Traverso co-founded, Lyndra Therapeutics, hopes to revolutionize how patients take medications. They have developed an oral drug-delivery platform called LYNX, which consistently delivers one, two, or four weeks of medication in one capsule that releases the medication over a specific time period. The capsule dissolves in the stomach and a star-shaped drug delivery system emerges.
The arms of the “star” are made of a polymer that holds the medication and are connected to a central core through degradable linkers. Once the dosing period is complete, the linkers disintegrate, the arms separate, and the entire system safely moves from the stomach into the small intestines, where it passes through the gastrointestinal tract. The platform is being studied with a variety of drugs, including an oral memantine for Alzheimer’s disease.
“Many patients need a loved one or caretaker to help them take oral medication daily, so giving them the ability to take a pill once a week or once a month would positively affect adherence and be hugely impactful on their quality of life,” says Traverso.
Lyndra has raised $240 million to date. One of the therapies they developed to deliver drugs used to treat schizophrenia has advanced to phase-two clinical trials.
Clinical trials are one example of the unique hurdles that medtech startups like Lyndra face on the path to commercialization. Bodies like the U.S. Food and Drug Administration (FDA) and the National Institute for Occupational Safety and Health require strict regulations that need to be met before any medical device, drug, or health care platform can be sold to end users.
“Having an understanding of the regulatory, manufacturing, and business challenges that need to be met to launch a successful product is really crucial. It speaks to the resources that are required to actually be able to execute on these regulations,” adds Traverso. In his first year on MIT’s faculty, Traverso introduced a new class, 2.S988 (Translational Engineering), which aims to introduce these critical elements to students.
Ellen Roche, associate professor of mechanical engineering, is currently trying to determine the regulatory needs for her own startup. In May, she won the grand prize at the inaugural MIT Future Founders Initiative Prize Competition for her pitch.
Roche has developed a minimally invasive technology that occludes the left atrial appendage in patients with atrial fibrillation. The technology, which she developed alongside Professor Jennifer Lewis at Harvard University, decreases the likelihood that blood clots will dislodge, thereby preventing stroke.
“The Future Founders program was invaluable for refining the vision for our company and identifying the correct regulatory and commercialization path to move forward,” says Roche. “Creating a pitch deck forced us to really think through aspects such as our beachhead market, our clinical target population, our funding, and IP [intellectual property] strategy, all the while having access to a network of experts.”
In September, Roche and her team also won the Lab Central Ignite Golden Ticket to support startup founders from traditionally underrepresented groups in the biotech industry.
Both Traverso and Roche have served as instructors for mechanical engineering class 2.75 (Medical Device Design), alongside Professor Alexander Slocum and Nevan Hanumara. The class culminates in a project in which students work with clinicians from Boston-area hospitals and representatives from industry on designing medical devices that address a particular problem. Throughout the class, regulatory experts introduce students to the unique challenges of starting a company or launching a product in the health-care space.
One former student of 2.75, Adam Sachs ’13, co-founded the startup Vicarious Surgical. The company has developed a robotic system that enables minimally invasive surgery. A camera and two robotic instruments enter the abdomen via an incision smaller than the size of a dime. The surgeon can then operate with 360-degree visibility inside a patient’s body.
“Course 2.75 gave me a deep understanding of the entire medical device design process, which was incredibly valuable when we founded Vicarious Surgical. It helped me understand the needs of a user, showed me how to deliver on a product, and allowed me to dip my toes into the process of developing a device from start to finish — much of which I still reference as the company grows and we continue to develop our system,” says Sachs.
Vicarious Surgical, which is based in Waltham, Massachusetts, and currently has just over 200 full-time employees, is in the development process. They have received positive feedback from surgeons regarding their Beta 2 prototypes. After securing the appropriate approvals from the FDA, Sachs and his team plan to bring their product to market for use in hernia and other general surgery procedures.
Traverso sees mechanical engineers, like himself, Roche, and Sachs, as being particularly well-suited to launch medtech startups.
“A huge part of our program is hands-on experience, which we introduce and nurture through many of our course offerings. I think that’s so valuable when you’re developing a device that will be engaging with another human being,” he says.
de MIT News https://ift.tt/JUlN34r
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