M-HEAL + Mentors = Design Progress

by Kim Roth

The student-run organization M-HEAL, Michigan Health Engineered for All Lives, has a laudable, and ambitious, mission: to design healthcare solutions in collaboration with international partners to positively impact global health.

Today, with over 100 members on more than nine teams working on projects for communities worldwide, it’s no surprise M-HEAL has grown significantly over the past decade.

With growth has come increased interest among members to pursue the College’s Multidisciplinary Design Minor, which enables M-HEAL students to pursue academic credit for their project work. The trend has highlighted the need for additional mentorship to help students take their projects and products to the next level, so designs can be finalized, manufactured, and adopted by end users.

“Given the large number of design teams and students interested in the Multidisciplinary Design minor and the diversity of M-HEAL projects, students are best served if they can reach out to industry experts to help them navigate many of the key aspects of solution development – ideation, design, quality, risk management, and even business development,” says Aileen Huang-Saad, M-HEAL faculty advisor since 2007, assistant professor in biomedical engineering, entrepreneurship and engineering education.

The need has led to a budding mentorship program with medical device manufacturer Stryker Corporation. Following a successful pilot with Stryker Principal Engineer, Bill Hassler, and U-M mechanical engineering and design science graduate student, Michael Deininger, in the Winter 2016 semester, the program expanded quickly.

In Fall 2016, six Stryker engineering mentors – Bruce Henniges, Mitch Baldwin, CliffLambarth, Brian VanderWoude, SteveCarusillo and Dan McCombs – began working with several M-HEAL teams, offering dozens of students access to experts with industry experience and technical skills demanded by the complex design process. With the success of the program, M-Heal students added a local business mentor, Randy Schwemmin, in Winter 2017.

Teams typically meet with mentors via Skype every two weeks to discuss progress, challenges, and next steps. Both mentors and mentees are benefiting in big ways, and the model program is expanding to other industry participants as well.

“It’s so critically important our students have this input,” says Huang-Saad. “The more resources they can draw upon to help them design better products, the better they’re able to meet the needs of their intended end users. The teams’ mentors have helped them make great progress toward their respective goals.”

Stryker mentor Bill Hassler worked with Project MESA, a portable gynecological exam table for use in Nicaragua.

“Working with bright, motivated students who are doing good work for people who need help was an honor, and it was gratifying to see that my experience could have a positive impact and help them become even more knowledgeable and enthusiastic about their project,” – Bill Hassler

“Working with bright, motivated students who are doing good work for people who need help was an honor, and it was gratifying to see that my experience could have a positive impact and help them become even more knowledgeable and enthusiastic about their project,” says Hassler.

Getting to know those motivated, bright students also introduces the company to promising talent and aids recruitment efforts. “It’s a real win-win-win,” he adds. “The program has a very good vibe around here.”

 

Team: PeriOperative

Mission: To provide low-resource settings with a sustainable, user-friendly warming device to keep patients at a stable core body temperature during surgery while also reducing the risk of infection.

Mentor:  Bruce Henniges

Next stop: Dominican Republic, May 2018

Members of team PeriOperative, Elizabeth Seeley, Estefania Rios, Hannah Soifer, Adam Burdo, Brian Qian, and Tejaswini Hardas, (left – right) with their Stryker mentor Bruce Henniges (center).

The team is currently prototyping and finishing the design of its second iteration warming device. Using input from clinical partners in the Dominican Republic, the team has been testing new ideas for the next prototype. The team’s regulatory group is investigating CE Mark designation and performing risk analysis, according to PeriOperative team member Hannah Soifer, rising senior and former M-HEAL secretary.

Team PeriOperative worked with Stryker mentor Bruce Henniges, senior director of advanced development, who helped with the risk analysis. “This was new territory for the team this semester, and Bruce spent a lot of time explaining the best way to go about conducting it,” says Soifer. He also helped the team with schematics to make a constant current source, “something we hadn’t known how to do before,” she adds.

Working with its Stryker mentor, the team “made faster progress because we were guided in the right direction from the get-go and our potential mistakes were caught early,” Soifer says. “Bruce brought an incredible knowledge base in all areas of design and development, and he always gave us advice or resources we hadn’t known about.”

 

Team: Project MESA

Mission: To design a portable gynecological exam table to help improve cancer screening and better monitor pregnancies in women at high risk of complications

Mentors:  Dan McCombs, Cliff Lambarth, Randy Schwemmin

Next stop: Nicaragua, May 2017

Four members of M-HEAL’s Project MESA help a nurse try on their gamma prototype of a portable gynecological examination table at their partner clinic of Santa Lastenia in Nicaragua. Credit: Jennifer Lee

The team is currently working on its sixth prototype. Members will return to Nicaragua this spring to meet with its clinical partners and get additional feedback on two prototypes, each with different features, so it can solidify the design. Members will also get feedback on two prototype tables it previously delivered, which have been in use with patients in-clinic, according to team member Samantha Fox, a rising junior.

During the 2016-’17 academic year, Stryker mentor Cliff Lambarth, senior principle engineering product manager, helped the team uncover some key design flaws and find solutions.

“He really forced us to think about design decisions we’d made and their justification. He analyzed our design – and pushed us to analyze it – and opened our eyes to changes we needed to make,” Fox says.

“His experience and technical knowledge made him able to immediately see things we didn’t, and he also emphasized justifying our decisions. We have really good documentation now of the decisions we made and why, and that’s going to help us move forward,” she adds.

 

Team: Solar Fridge

Mission: To design an absorption refrigerator that uses solar energy to help rural health clinics and traveling health workers keep vaccines at a consistent, desired temperature.

Mentor:  Steve Carusillo

Next stop: Dominican Republic, August 2017

Team Solar Fridge with their prototype design. From left to right: Ayana Dambaeva, Adam Racette, Michelle Ruffino, Austin Friedant, Christine Hathaway , Aidan Connolly, Saswat Sahoo, and Daniel Bruni.

The team has been designing and building a prototype that could be built by users on site and running evaporation tests. Members will travel to the Dominican Republic this summer to conduct a needs assessment in a local community, recommended by M-HEAL alum Hope Tambala (Chemistry, ’15), now serving as a Peace Corps volunteer in the country.

The team worked with Stryker mentor Steve Carusillo, vice president of research and development technology, who has been helping the technical team test components and develop ideas for redesigning the device for the new stakeholder community, according to team member Michelle Ruffino, rising senior.

“It’s been a very valuable interaction,” Ruffino says. “About two weeks ago I was telling Steve about issues a sub-team was having – we’re not getting enough heat transfer from the copper pipe to the condenser – and he told us to try thermal epoxy. We bought some, tested it, and we’re very likely going to implement it. It’s inexpensive and easy to use. It’s that kind of real-world expertise and experience that helps us so much,” she adds.

 

Team:  The Initiative

Mission: To reduce infant mortality with a low-cost warmer that combines kangaroo care with an infant incubator.

Mentors:  Brian VanderWoude, Mitch Baldwin

Next stop:  Ethiopia, August 2017

 

Members of The Initiative, (left to right) Elizabeth Zwier, Elizabeth Zwier, Meghna Menon, David Chang, and Connor Yako, show Stryker mentor Brian VanderWoude (right) how to properly wear the kangaroo mother component of their hybrid infant incubator.

The team recently completed its third prototype, which includes a heated mattress, a bassinet, and a wearable wrap to hold the infant against the parent. Members plan to travel to Ethiopia this summer to further evaluate the hospital environment, conduct usability studies, and meet with its community partners.

Working with Stryker mentors “definitely helped speed up our project timelines,” said team lead Connor Yako. Mentors provided technical expertise, including feedback on materials and manufacturability, as well as big-picture input. “Having that industry experience helped us avoid power consumption and other problems we might have encountered down the line; it helped us pick the right paths early on.”

Excited by the opportunity to improve access to healthcare in a developing area of the world, Brian Vanderwoude, principal engineer with Stryker, said the team’s “creativity and resourcefulness were apparent” despite limited resources. “They weren’t intimidated by challenges, and they were really open to learning.”


Improving medical devices Collaboration by design

Image caption: Clare Donohue at Medical Device Sandbox redesign session. Credit: Lauren Stuart.

by Kim Roth

The design of health-related and medical devices directly impacts patient safety, and engineers and clinicians designing, and using, medical devices depend upon each other’s expertise.

A new experiential learning opportunity at U-M, the Medical Device Sandbox (MDS), helps both BME students and health care learners, including medical students, residents, nurses, and other health providers, collaborate across disciplines to improve device design and, ultimately, patient safety.

“Interprofessional collaboration and shared learning between BME students and health care learners is absolutely critical to designing and using medical devices in the clinic that are effective and safe for patients,” says John Gosbee, MD, a lecturer in the Departments of Biomedical Engineering and Internal Medicine and a human factors engineering and patient safety consultant.

“Interprofessional collaboration and shared learning between BME students and health care learners is absolutely critical to designing and using medical devices in the clinic that are effective and safe for patients,” -John Gosbee

Gosbee conceived of the MDS and, working closely with colleagues, BME Professor Jan Stegemann and BME Lecturer Rachael Schmedlen, has held more than two dozen MDS sessions to date.

The guided, structured, and interdisciplinary sessions begin in a simulated patient examination or hospital room at either the U-M Center for Experiential Learning and Assessment or the Clinical Simulation Center. Gosbee presents the group – typically four to six BME students and four to six medical learners – with a realistic scenario that involves the use of a medical device.

Guided by the instructor, the students identify potential design flaws, use errors, and safety issues.

During a recent session, Gosbee asked a participant to climb on and off the examination table, just as doctors routinely ask patients to do. The other students observed. Gosbee continued to prompt students with probable scenarios – the patient has a twisted ankle, the patient is short, the patient’s hands slip on the paper as they try to climb on.

BME students and health care learners constructing prototypes of their redesign ideas. Credit: John Gosbee and Jennifer Lee.

Next, the group brainstorms possible solutions. In the case of the exam table, students suggested moving the step to the side of the table, adding an extra step, and adding handrails.

Interactivity is key. Instead of simply talking about or sketching the changes they would make, students use prototyping materials – items such as foam core, scrap fabric, glue, and tape – to build a three-dimensional representation of their ideas. Participants then share their ideas with the group, and Gosbee helps them synthesize takeaway lessons.

Sessions have included a range of devices and scenarios, including layperson use of an automated external defibrillator, a pulse oximeter found in a first responder’s medical bag, and a medication organizer a patient would use at home.

Students also have brought course projects to the sessions, for example, a liver biopsy simulator from BME 450 and an existing and redesigned EKG device, brought by internal medicine residents.

The MDS name, fittingly, refers to sandbox mode in gaming, where players are freed from the usual rules and constraints.

“Bringing learners from these two disciplines together has transformative potential,” says Gosbee. “Having a creative physical and intellectual space where this kind of interaction can take place brings everyone closer to their shared goal of safer, more effective devices.”

To date, about 100 medical learners and 136 BME students – from BME 450, 452, 499, 599, and M-HEAL – have participated. BME undergraduate Jennifer Lee (’17) played an important role in organizing and running sessions and ensuring as many BME students as possible participated.

BME students who have taken part in the MDS have said it’s helped them think more about patient safety and usability testing as a crucial part of the design process – and that working with health care learners was a key way to better incorporate their expertise.

Other students said they no longer felt resigned to work with products as they currently exist and felt empowered by the redesign process.

In the words of one participant, “Redesign is an outlet for change.”

The MDS has been supported by the Third Century Initiative at U-M and by the National Institute of Biomedical Imaging and Bioengineering of the National Institutes of Health under Award Number R25-EB019898.