A human-centered design approach

ASU professor awarded $3M NSF grant to introduce students to ethical engineering, manufacturing of biomedical devices


October 6, 2022

Leila Ladani is on a mission to cultivate a human-centered mindset to guide the design and manufacturing of biomedical devices and implants.

Ladani, a professor in the School for Engineering of Matter, Transport and Energy, part of the Ira A. Fulton Schools of Engineering at Arizona State University, is among pioneering biomedical engineers advancing the understandings of how devices can be used more effectively in clinical settings.
ASU Professor Leila Ladani looks at a sample of a biomedical device with a student in a lab. ASU Professor Leila Ladani (left) works with student Carol Lu in her research lab to develop a biomedical device to determine the presence of cancer in tissue margins during a lumpectomy, which will streamline the cancer removal process and reduce the need for re-excision. Photo courtesy Leila Ladani Download Full Image

Ladani was recently awarded a $3 million grant from the National Science Foundation Research Traineeship Program to develop a new biomedical device manufacturing training program at ASU. Her project, Design and Manufacturing of Medical Devices and Implants: Cultivating a Human-Centered Mindset, will connect engineering students with health care professionals and patients to introduce them to the ethical principles, laws and policies associated with the development and use of biomedical technologies. 

“We want to put the users right at the forefront of innovation because the users are patients or clinicians,” Ladani says. “We want to make sure that what we are designing and manufacturing is something that they can actually use, with the mindset that human society is very complex.”

Ladani was also recently nominated by ASU Provost Nancy Gonzales to participate in the ELATES leadership development program at Drexel University. The program is designed to support senior female faculty members and allies of all genders in STEM-related fields to hone their leadership effectiveness. Ladani was one of only 30 people to be selected for this year’s nationwide cohort. Over the course of the yearlong fellowship program, she will attend multiple in-person and online meetings with peers as each attendee develops an institutional action plan to advance a mission of their choosing.

Closing the gap between knowledge and public service

During the process of developing her own biomedical device, Ladani discovered a knowledge gap between biomedical engineers and the communities they serve.

In collaboration with Mayo Clinic and one of its well-known surgical oncologists, Dr. Barbara Pockaj, Ladani is developing a device to determine the presence of cancer in tissue margins during a lumpectomy – the surgical removal of a portion, or “lump,” of breast tissue, typically as a treatment for a malignant tumor or breast cancer.

ASU Women and Philanthropy is funding the development of the device, which will streamline the cancer removal process and reduce the need for re-excision. 

With the intention of using the device in the operating room during surgery, Ladani realized the complexity of the clinical setting may not allow her current design to be used efficiently.

“We needed to make sure the device could detect the location of the cancer accurately and make it easy for the doctors to be able to read the results while they were operating. I figured out that there’s a big gap in theory and practice,” Ladani says. “We develop these innovations in the lab, but we don’t really know what makes a device effective unless we have a close connection with the medical side.”

Motivated to improve the experience of innovators who might encounter similar situations, Ladani began developing a program that would introduce STEM students to the nuances of device manufacturing. Program team members include faculty at ASU, including Katina MichaelJafar RazmiKaushal RegeKaren AndersonJean Andino and Rick Hall, as well as Dr. Steven J. Lester, a cardiologist, professor of medicine, and founder and chief medical officer of the Mayo Clinic-Arizona State University MedTech Accelerator

The team’s new biomedical device manufacturing program is built on a set of multidisciplinary and convergent research areas, which also builds on the strong relationship between ASU and Mayo Clinic and the Mayo Clinic and Arizona State University Alliance for Health Care. 

“This endeavor represents an important facet in ASU’s quest for excellence in which achieving a convergence of disciplines is a key imperative,” ASU President Michael Crow said in support of the program. 

Dr. Rafael Fonseca, chief innovation officer at Mayo Clinic, also strongly supports Ladani’s project.

“Training engineers who understand the practical limitations of their discoveries and inventions is critical in advancing solution-oriented discoveries,” Fonseca says.

Engaging students in the mission

To effectively engage students in STEM with the medical aspects of their disciplines, they will connect with Mayo Clinic providers and key collaborators who are interested in the students’ prospective biomedical technologies or devices to shadow them for a semester. 

“This process helps create a foundation for truly use-inspired technology development,” Lester says. “The program is a wonderful example of the collaboration between Mayo Clinic and ASU, which work together to create an intellectual ecosystem with expertise from every area of health care.”   

Through the program’s curricular components, including applied and experiential learning and entrepreneurial activities, students will develop their ideas for biomedical devices. Then, under the guidance of experts, students go through the processes of disclosure and filing patents, involving all the steps necessary to commercialize their innovative products. 

The goal is to help students develop a sustainable, scalable product, taking into consideration legal, regulatory, compliance and reimbursement issues. The entrepreneurial focus opens the possibility for some of the students’ ideas, leading them to establish their own medical device companies.

The program also provides support for doctoral students through stipend and tuition coverage. 

As a part of the project, Ladani is creating a new structured mentorship program for students at all levels. The Graduate-Undergraduate Mentorship program will give graduate students opportunities to spend a summer mentoring undergraduate students interested in developing their own devices. 

Ladani and her team are also developing new courses to acquaint students with the ethical and regulatory aspects associated with medical devices and implants. The program will also include components like seminars, orientations, retreats and presentations from guest speakers in industry and academia. 

Though doctoral students will spend only two years in the program, the community they build during their time as participants is intended to last a lifetime.

“These students will have a breadth of understanding in several different areas that will impact their design work,” Ladani says. “With the information they gain, they will be more equipped to start their own companies to create devices as well as jobs.”

The program will enable students to design next-generation medical technologies that enhance care delivery and patient outcomes.

Doctoral students from all engineering disciplines are encouraged to apply via an online portal set to launch in spring of 2023. Interested students can contact Ladani at ladani@asu.edu.

Hayley Hilborn

Communications specialist, Ira A. Fulton Schools of Engineering

 
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Former Olympic soccer goalie Briana Scurry shares her story at ASU event

October 6, 2022

Panelists noted how Title IX, which is celebrating its 50th anniversary, paved the way for players like Scurry

Briana Scurry pulled out her gold medals from the 1996 Olympics and 1999 World Cup.

The "girls," she called them.

“Can I trust you?” she asked the audience at the "Title IX and Global Football" panel put on Tuesday by Arizona State University’s Global Sport Institute and the new Sport Humanities initiative in The College of Liberal Arts and Sciences.

As heads nodded, Scurry handed the gold medals to spectators in the first row and said to pass them around.

“They’ve never been dropped,” Scurry said. “So be careful.”

The medals represent the pinnacle of sport and Scurry’s career as goalkeeper for the United States’ Olympic soccer and World Cup teams. But Scurry said they also represent the progress women’s sports — and, in particular, soccer — have made thanks to those teams and Title IX, which is celebrating its 50th anniversary this year.

“Title IX was obviously a gateway for me,” Scurry said. “Without Title IX, I’m not here talking to you because Title IX was the legislation that started everything. … It was the best ally I could have ever possibly gotten.”

Tuesday’s event, which was moderated by Victoria Jackson, a sports historian in ASU’s School of Historical, Philosophical and Religious Studies, had two halves, so to speak.

For the first 90 minutes or so, attendees watched part of Scurry’s documentary, titled “The Only,” and heard Scurry talk about her time on the Olympic and World Cup teams. The second half featured questions from the audience and a six-person panel that included ASU soccer players Alexia Delgado and Nicole Douglas, and Lindsey Mean, an associate professor in ASU’s School of Social and Behavioral Sciences.

Any soccer fan of a certain age remembers Scurry's time on those U.S. soccer teams, which included Mia Hamm, Abby Wambach and Brandi Chastain, who famously ripped her jersey off after making the game-winning penalty kick in the 1999 World Cup final against China.

In addition to proving that women’s soccer could fill NFL stadiums across the country (the World Cup final was played before more than 90,000 fans at the Rose Bowl in Pasadena), Scurry and her teammates initiated the long fight for the U.S. women’s national team to receive equal pay with the men’s national team, a fight that was finally won in May of this year.

“I’m very excited about the equal pay collective bargaining agreement,” Scurry said. “Somebody came up to me and said, ‘Why are you so excited? Only 30 to 40 people are affected by this.’ No. This is a watershed moment. Now, every other federation in every country, and not just for soccer, can look at this and say, ‘We can do something like this.’

“I’m very, very proud to have been a part of that; to be a on a team whose legacy created that."

The documentary, which can be viewed on Paramount+, sprung from Scurry’s book “My Greatest Save.” In the book and movie, Scurry addressed the discrimination she experienced because she was a Black lesbian and the dark turn her life took — including thoughts of suicide — when a concussion she suffered in April 2010 forced her to retire and live for 3 1/2 years with memory loss, insomnia, poor balance and chronic pain.

Scurry said the book and documentary were cathartic.

“The analogy I make is that your life is a house, and the different rooms are different chapters of your life,” she said. “Sometimes you have rooms that you go in all the time. And sometimes you have rooms that you haven’t been in for a while that are dark and padlocked and you don’t want to go in there.

“But I felt like I had to go in those rooms to be completely honest, to be able to impact everyone who reads the book and watches the documentary.”

Scurry said she never felt discrimination from her coaches and teammates on the women’s national team. But she believes the media — and some sports companies — viewed her differently because of her race and sexuality.

“What I realized after the fact was the media had problems with the way I looked and the fact that I was gay,” Scurry said. “That was a bit of an eye opener and something I had to reconcile and realize because I always felt my color was never going to be anything that held me back.”

Scurry also told the audience, which included girls youth soccer teams from around the Valley, about how hard her life became after suffering her concussion.

“It completely changed my life,” she said. “... I became depressed, I had anxiety and I was suicidal in 2013. I talk (in the documentary) about standing on the edge of a waterfall thinking of going over, and I can’t swim. I knew I wouldn’t survive it if I did, and what kept me from doing it was the thought of my mother being told her daughter was gone.”

A medical procedure eventually relieved Scurry’s pain, and she said the experience was a lesson in resilience.

“Hopefully, people can realize that even professional athletes, all of us as human beings, have ups and downs, but you have to persevere through it, even if it gets really difficult or you’re hanging on by a thread,” Scurry said. “Just keep hanging in there because someone is probably coming to help.”

When the panel convened, Paola Lopez Yrigoyen, a former player for several teams in Mexico, said she appreciates the impact Scurry and her teammates had in showing young women they can be equals, both on and off the field. In Mexico, she said, that’s not the case.

More than a dozen teams were fined in September 2021 for colluding to impose a cap on the salaries of female soccer players, and despite the fact Mexico hosted the women’s World Cup in 1971 and went to the finals, a women’s professional league wasn’t established until 2017.

“It’s a shame we didn’t get to clap for our heroes,” she said. “How can you do that when Title IX in Mexico is non-existent?”

Douglas, ASU’s all-time leading goal scorer, said she encountered a different type of resistance when she started playing soccer at the age of 4 in London.

“I started playing on my twin brother’s team,” Douglas said. “I played with him for two years, and I’d get remarks from parents on the other team and from boys on the other team saying, ‘Why is this girl on this team? Why is she playing? She can’t play soccer.’

"My twin brother supported me and said girls can do this, too. That made a major difference in my life.”

Scurry said hearing the stories from Lopez Yrigoyen, Douglas and Delgado, who also grew up playing in Mexico, made her appreciate once again the significance of the Title IX legislation.

“I spend so much time supporting women’s soccer in the United States that I don’t hear how it is in Mexico or England. So thank you for that,” Scurry said. “It was very eye opening. It makes me feel even more fortunate and blessed that we do have Title IX here. It really has made such an amazing impact.”

Top photo: Two-time Olympic Gold medalist and former U.S. women’s soccer goalkeeper Briana Scurry speaks during an event on Title IX and global football at Sun Devil Stadium in Tempe, Arizona, on Oct. 4. Photo by Samantha Chow/Arizona State University

Scott Bordow

Reporter , ASU News