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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.”

Collaboration between Project MESA and Washtenaw Community College’s Advanced Fabrication Program

M-HEAL’s Project MESA has been finalizing its design of a portable gynecological examination table for use in rural mobile clinics in Nicaragua. In addition to improving the design’s comfort, durability, and clinical features, they have been working to simplify manufacturing of their product. The group connected with Amanda Scheffler, a welding instructor at Washtenaw Community College (WCC). She donated her time to weld the team’s fifth iteration of their prototype, and after hearing their mission to reduce cervical cancer morbidity in low-resource settings, she wanted her students to get involved. She teaches the Advanced Fabrication course at WCC, and she wanted her students to have the chance to apply their manufacturing skills from the classroom in a meaningful way. Her students have been designing and building three welding fixtures for Project MESA’s portable table, which can be used for quicker and simpler assembly of the devices. This partnership has provided both the WCC and UM students with the unique opportunity for cross-collaboration between engineers and manufacturers, with both groups learning from each other while working on a project geared towards improving global healthcare. In the future, they hope to continue this relationship in optimizing the manufacturing of the tables so that more of MESA’s devices can reach their target communities.

From: Erik Thomas (erikmich@umich.edu), M-HEAL, Project MESA Lead.

Image: Amanda Scheffler and one of her students welding Project MESA’s fifth prototype of their portable gynecological examination table in December 2016.

M-HEAL’S Project MESA Wins $25K from Ford C3 Prize supports distribution of team’s portable exam table in Nicaragua

ANN ARBOR— A team of U-M students is one of seven across the country to win $25,000 in the 2016 Ford College Community Challenge (Ford C3). Project MESA was recognized for their efforts to improve women’s health in rural Nicaragua through a portable gynecological exam table they designed for use by mobile health workers traveling to remote villages.

The team, which is comprised largely of BME undergraduates, is part of Michigan Health Engineered for All Lives (M-HEAL), the U-M student organization that brings biomedical engineering to underserved communities around the world.

Project MESA was an ideal match for Ford C3’s focus on student-driven projects that address pressing community needs in a sustainable way through the disciplines of engineering, business, and design.

The student-run project aims to reduce rural Nicaragua’s high mortality rate from cervical cancer by designing a portable, sterile, and professional table that helps women feel more comfortable consenting to a sensitive exam, while improving diagnostic accuracy through proper positioning. In the absence of the device, women are often examined by healthcare workers on beds or kitchen tables.

From its start, Project MESA had its sights set on sustainability. Catalyzed by a needs assessment among local healthcare providers in 2010, it was born of market demand. Through four iterations, the table has been refined to more fully meet the needs and preferences of providers and patients.

The team’s current focus is on sustainable production and distribution. Members traveled to Nicaragua in May to meet with healthcare partners for feedback on their most recent prototype and to begin discussions with local manufacturers about piloting in-country production of the table.

“This grant will allow team members to stay longer in country to try building the table with the local manufacturers we’ve identified…”– Erik Thomas

This testing and potential scale-up of local production is capital-intensive and will receive a significant boost from the Ford C3 funding. “This grant will allow team members to stay longer in country to try building the table with the local manufacturers we’ve identified,” says Project MESA co-lead and BME senior Erik Thomas. “We’ll be able to identify which parts of the table are easy to make there and which parts aren’t so easy. We plan to bring those insights back and design something that’s easier to produce, so that we can approach larger contract manufacturers to scale things up.”

The team hopes to leverage its partnerships with local groups to identify one with a stake in the table’s success to spearhead its distribution. They envision a portion of the proceeds supporting each level of the supply chain to foster sustainability.

Project MESA co-lead and proposal author Katherine Chen says the team is grateful for Ford C3’s support and credits their success with a highly motivated student team and a vigorous support network of faculty and volunteer advisors and Nicaraguan partners.

For more information:

M-HEAL: mheal.engin.umich.edu
Project MESA: mheal.engin.umich.edu/projectmesa/
Ford C3: fordblueovalnetwork.org/ford-college-community-challenge

BME Students Triumph in Michigan Business Challenge

BME medical product development graduate student Walker McHugh (MSE ’17) hopes the device he’s helping bring to market will transform treatment in the intensive care unit.

Called MicroKine, the microfluidic sensor enables doctors to determine quickly and from only a drop of a patient’s blood which cytokines are causing a hyperinflammatory state that can lead to organ failure.

After working on the product and the science behind it for more than a year in the lab of his advisor, Pediatric Critical Care Professor Timothy Cornell, MD, McHugh proposed using the MBC to explore the path to commercialization.

Cornell agreed, and McHugh teamed up with business student Caroline Landau (MBA '16) to form a company, PreDxion, based on an initial application for the device: monitoring cancer patients receiving chimeric antigen receptor T-cell (CAR-T) therapy. CAR-T uses a patient’s own immune cells which have been genetically engineered to recognize a specific protein on tumor cells. Once reintroduced into the body, these cells seek out and destroy the patient’s cancer.

Though this treatment has had promising results, a potential downside is that a patient’s immune system can overreact, producing a flood of inflammatory cytokines which can quickly lead to organ failure. MicroKine can determine in just 30 minutes which cytokines are out of the normal range, allowing doctors to prescribe the specific anti-cytokine medication that matches those elevated in the patient.

The technology has already achieved proof of concept. In late 2014, Cornell’s lab received an emergency use exemption from the FDA to use the device in a patient experiencing cytokine release syndrome in late 2014. The case was a success, and the team began envisioning a larger impact.

That’s what impelled McHugh to throw his hat into the MBC. He hoped to use its structure – the deadlines, the coaching from Zell Lurie, and partnership with a business student – to explore potential markets, walk through financial models, and flesh out a business plan.

Their work has paid off; the team won $30,000 in the MBC, which they will add to awards from The Coulter Foundation and U-M’s Michigan Translational Research and Commercialization for Life Sciences Program, to continue down the path to commercialization. One of the challenges, says McHugh, is that the product is in a new, niche area of the companion diagnostic space, so the FDA and potential drug-company partners need to assess how to approach it. Ultimately, PreDxion hopes it can structure a pharmaceutical-company partnership that could open the door to cooperative clinical trials and marketing efforts.

McHugh is hopeful that the technology will one day be a game-changer. “Things haven’t changed much over the last 25 years in terms of how we treat organ failure in the ICU,” he says. “We’re are still largely limited to supporting the failing organs. By targeting the inflammatory processes that are actually driving that dysfunction, we hope MicroKine will bring personalized medicine to the ICU.”
Other contributors to MicroKine include Professor Katsuo Kurabayashi and postdoc Pengyu Chen.

Taking fourth place in the MBC social impact category is a team from M-HEAL (Michigan Health Engineered for All Lives), the U-M student-run organization that brings biomedical engineering to global health work.

The team, which includes several BME undergraduates, used the competition to evaluate its plans to scale up work on a portable gynecological exam table for use by mobile health workers traveling to remote villages.

Evolution of Project MESA portable exam table prototypes: A (2011 original); B (2013 with stirrups), C (2014 with adjustable backrest), D (2016 with integrated backpack).

Called Project MESA, the team has been working with partner clinics and NGOs in Nicaragua since 2010 on iterative designs for the table. They hoped to use the MBC to test their assumptions about producing and distributing the table on a larger scale to make a bigger impact on healthcare delivery.

Project MESA’s business lead, Katherine Chen, says the coaching was invaluable in helping these mostly engineering students think more critically about issues such as customer preferences, pricing strategies, and business models. “Originally, we designed the product to be produced in the U.S. with the idea that it should be repairable with locally available materials,” she says. “But through customer discovery, we learned that most clinics don’t have the resources to do repairs, so we’ve decided to design the table to be more durable in the first place. In addition, we assumed that a distribution channel in Nicaragua would be hard to manage, but the MBC judges encouraged us to explore that option.”

With $1,200 in prize money from the MBC, the team returns to Nicaragua in May to, among other things, talk with local machinists and distributors; delve into how clinics make their purchasing decisions; assess potential market size; develop new partnerships; and solicit feedback on the newest iterations of the table, which better address durability, portability, aesthetics, and patient positioning.

Chen says the MBC is a great resource for BME design students. “Developing the business plan really helps you define your end goal and determine if it’s financially and logistically feasible,” she says. “It helps you gain an even stronger sense of direction for your design.”

Project MESA’s co-lead is BME student Erik Thomas; other members include: Maya Ben-Efraim, Val Coldren, Bansili Desai, Sabrina Deutsch, Samantha Fox, Hannah Heberle-Rose, Steven Houtschilt, Christina Khouri, Jaime Landsman, Lillian Lantis, Jennifer Lee, Siri Manam, Andrea Mathew, Keely Meyers, Kyle Morrison, Molly Munsell, Madhu Parigi, Monica Patel, Maddie Price, Bharathi Ramachandran, Jen Spiegel, Alejandra Vaquiro Valencia, Shreya Wadwhani, Eldy Zuniga.