Biodesign course offers hands-on medical device experience

One of the greatest challenges facing a company in the medical device industry is also the most basic: making a product that people actually need.

This simple step is all too easily forgotten by fledgling biomedical engineers. Every year, numerous products are designed not because the public needs them, but simply because they are compelling engineering puzzles. The biomedical startup companies that fall into this trap doom themselves by producing expensive, elegantly designed products that have no market. The company has no return on its investment, and soon, no future.

Dr. Saurabh Biswas, a biomedical engineering professor at Texas A&M University, is training the next generation of Aggie engineers to avoid this deadly trap. He has helped pioneer a new biodesign course that teaches students with a future in the medical device industry to start not with an interesting design, but rather the rigorous process of examining public needs — a method that will massively increase these students’ impact in the workforce.

Over the two-part biodesign program, students gain hands-on experience working on faculty-led medical device projects, supported by structured training in both design and commercialization.

“Traditionally, an engineer comes up with the design and says, ‘I have a great product. Will you buy it?'” Biswas said. “Research has shown very clearly now that most of these startup companies who try to commercialize things like this fail, but not because they run out of money or have bad teams. Mostly, they fail because they’re trying to bring something to market that no one cares about.”

The biodesign method begins by assessing the needs of all those who will interact with the finished product — from patients and parents to medical professionals. This critical step, called “needs-finding,” makes up the entire first half of the two-part course.

“There are many stakeholders in the world of healthcare. If you don’t talk to any of them before you come to market, you’re going to fall flat on your face,” Biswas said. “Before you even reach the physical design of the device, this class will teach you to understand the process. First, identify the stakeholders and their needs, then go out and talk to people. The design starts later.”

The young field of biodesign originally began as a training program fellowship created by Stanford University for industry experts in 2001. Texas A&M’s biodesign course brings this method into the classroom. While only in its second year, it is already empowering engineering graduate students to rethink how they approach design.

In Biodesign I, students are given an open-ended topic. For Rachel Schober, who took the class last year, it was “airway clearance.” Armed with nothing but a general term, students set out to identify and rigorously interview stakeholders, from patients and medical professionals to insurance adjusters.

“Nothing compares to actually speaking to somebody face-to-face,” Schober said. “Engineers might be able to build a great design once the specifications are written out, but somebody needs to be able to write them. They have to acquire the user needs and present them in a way that is translatable, both on the customer and development side. You have to go in humble and ask people to tell you about their experiences, such as what products, devices and treatments they use. What is the prescription process like? Is it like pulling teeth to get a doctor to prescribe the treatment? These are things you would never find in an academic paper.”

In Biodesign II, students are tasked with turning the needs that they’ve identified through months of rigorous interviews into a design for a biomedical device. The shift between semesters introduces a certain amount of chaos. Student teams may be reshuffled in the wake of departures, plans may be shifted significantly, and topics may morph in response to new opportunities. These variables prepare students for the tumultuous design process of real-world companies.

“The primary goal of the engineering graduate program is to prepare students for industry, such as R&D roles, customer facing roles like product management, product marketing, and regulatory,” Biswas said. “The biodesign class is focused on teaching them the process of pipeline product development.”

Alumni of the class are already applying the skills they learned to the medical device industry.

“Actually seeing how an idea can be dismantled the second you take it to physicians is fascinating and really opens your eyes to always double check with the patients, doctors, insurance companies and investors,” said Lucas Esnaola, a graduate of the new course who now works as a quality systems and validation engineer at Corveus Medical. “You will need to check before you get too deep into the process.”

This hands-on experience, complete with the chaos of reshuffled teams and forced restarts after dead-end designs, prepares students in ways that traditional classes cannot. While only in its second year, the course is already paying dividends. Not only has the number of enrolled students tripled, but one of the class’s projects proved so promising that the university awarded it two years of funding to support its completion.

“For anybody who has any interest in business at all or the customer side of things, I think the biodesign courses are one of the best experiences you can have,” Schober said. “It’s not a lecture class, it’s very hands-on. I loved being the bridge between the customer and the technology.”