Fifty years of Biomedical Engineering and Collaboration New Perspectives on What's Possible

The Biomedical Engineering department formally became a joint department of the U-M College of Engineering and the Medical School in 2012, just five years before celebrating its 50th anniversary in 2017. But the spirit and impact of the collaboration that spurred its founding five decades ago continue at an ever-increasing pace today.

At the heart of the Department’s many collaborative efforts lie clinicians’ desire to offer new and better solutions to their patients and engineers’ passion for applying their knowledge to solve important health and medical problems.

Take Jacqueline Jeruss, MD, PhD, a surgical oncologist who treats benign and malignant breast disease. An investigator focused on breast cancer biology, she’s also an associate professor of BME. “Once a patient becomes metastatic, that’s when what I as a surgeon can offer to patients falls into the background.”

That disheartening situation led Jeruss to ask, “If I can’t help these patients anymore through my surgical practice, what can I do in the lab?”

The answer: Quite a lot. Jeruss works with William and Valerie Hall Chair and Professor Lonnie Shea (the two also are married) to better understand the cellular changes that lead to metastasis and to devise new methods for detection.

Drs. Jeruss, Shea, and other collaborators have been working to engineer pre-malignant niche sites – areas in other parts of the body that are “primed” to shelter and nurture metastatic cancer cells. Engineered niches offer opportunities to observe how and where cancer cells travel, paving the way for new detection systems and therapies to thwart the process.

What enables such collaboration? “The real opportunity here is having a top-10 engineering school and a top-10 medical school co-located,” Shea says.

“Michigan is very unique in that it’s an incredibly collaborative environment, not just within a department or division but across the schools and colleges,” adds Dr. William Roberts. “It’s very simple and easy to pick up the phone and call someone in BME, talk about a problem and start to develop a research relationship.”

“It’s very simple and easy to pick up the phone and call someone in BME, talk about a problem and start to develop a research relationship.”William Roberts M.D.

Foundation of collaboration

The seeds of collaboration between what is today the BME department and the U-M Medical School were sowed in the 1960s. At the time, faculty from both schools were already working together on joint projects such as nuclear imaging, prosthetics, and signal processing in neurons.

Other early research included electrophysiological studies by Daniel Green that informed our understanding of how humans see in changing light. The work of Clyde Owings, who held appointments in both Pediatrics and BME, led to specialized medical care of abused children, including through the Child Abuse and Neglect Clinical and Teaching Services program he established.

A testament to the many joint projects between the Bioengineering Program and the Medical School, during a difficult time for the Program in the late 1970s, two Bioengineering faculty with Medical School appointments launched a letter-writing campaign. More than 20 distinguished faculty from nearly a dozen medical specialties responded by sharing their strong support.

Among the many fruitful research efforts of that era were development of the “spherocentric knee,” an early ball-in-socket, rather than hinge, design that more closely imitated typical human knee motion by David Sonstegard, Herbert Kaufer, and Larry Matthews. Groundbreaking work by Dr. Robert Bartlett on a new system – extracorporeal membrane oxygenation – provided life support to infants and children with acute respiratory failure. The now famous “Michigan probe,” a multi-channel neural probe still widely used in brain research, was developed by Kensall Wise and David Anderson.

Seeking opportunities

Further cementing collaboration in the early 1990s, then Bioengineering Program Director Charles Cain encouraged faculty from the College and the Medical School to propose joint research to the Whitaker Foundation. Their efforts resulted in a Special Opportunity Award in 1994.

Building on its success, two years later the newly formed BME department – thanks in no small part to Cain’s continued efforts – won a $3 million Whitaker Foundation Development Award to support its growth and continued collaborative work.

Research at the time included co-development of gene-activated matrix technology for wound repair by Steven Goldstein and Jeffrey Bonadio and in situ tissue engineering, which has become an important research technology. Work by Lawrence Schneider on the biomechanics of automotive injuries has led to improved crash-test dummy design and vehicle occupant safety, and advances in ultrasound and multimodal imaging by Paul Carson have led to improved imaging safety and effectiveness.

Creating a sustainable and translational model

With the aim of advancing promising joint engineering and medical research projects from the laboratory to market to clinical settings, in 2005, the Department won a $5 million Wallace H. Coulter Foundation Translational Research Partnership Award, one of only nine universities in the country to do so.

Matthew O’Donnell, BME chair from 1999 to 2006, was thrilled about the award. As he said in the Department’s history, Biomedical Engineering at Michigan: A Product of Vision and Persistence, “…how wonderful, especially for our junior faculty, to be exposed to a world where you don’t just write papers, you put out a device or process or new molecule that people will actually use in the clinic.” The program provided funding for four collaborative clinician-engineer teams in its first year alone.

Four BME department chairs gather for the 50th-anniversary celebration in September 2017. Left to Right: Doug Noll, Charles Cain, Lonnie Shea, and Matt O’Donnell. Photo: Brandon Baier.

Five years later, given its strong track record, U-M received an endowment through the U-M Coulter Partnership for Translational Biomedical Engineering Research. This time, U-M was one of only six universities nationwide to receive the $10 million endowment, with an additional $10 million in matching funds from the College of Engineering and the Medical School.

Coulter projects have led to impressive results, including 14 start-up companies that will no doubt have a positive impact on patients. For example, Charles Cain, J. Brian Fowlkes, Timothy Hall, William Roberts, and Zhen Xu have been developing a non-invasive ultrasonic technique to treat severe congenital heart disease in newborns as well as many other conditions.

“It was an organic thing that evolved,” said Cain, founding BME chair, of his and other long-standing collaborations. “There were [clinical] problems that needed a solution.”

Ever-increasing breadth, depth and impact

Since the early 2000s, collaborative research has expanded continuously. Other game-changing work over the past two decades includes:

  • Intravascular diagnostic ultrasound techniques to detect lipid pools within atherosclerotic plaque by Matthew O’Donnell.
  • Improved functional MRI techniques for brain imaging to improve speed and reduce distortion by Douglas Noll.
  • Advances in image reconstruction for multiple imaging modalities and a low-dose CT scan method that reduces radiation exposure by Jeffrey Fessler.
  • Mechanistic studies to improve ultrasound diagnostics and therapies, including drug and gene delivery by Cheri Deng.
  • Development of optical molecular imaging and diagnostics, including a new optical spectroscopy method to diagnose pancreatic cancer by Mary-Ann Mycek.
  • Creation of a “5-D protein fingerprint” by David Sept and Michael Mayer to provide insights into neurodegenerative diseases such as Alzheimer’s and Parkinson’s disease.
  • Development of modular micro-tissues and biomaterials that direct cell phenotype in order to regenerate bone, cartilage, and blood vessels by Jan Stegemann.

Education to support collaboration and innovation

Enhancements to the BME curriculum over the years are ensuring students receive the training to follow in the footsteps of so many interdisciplinary engineering and medical researchers. Several design courses round out the common BME core. These include Biomedical Instrumentation & Design (BME 458), in which students design an instrument to take electrophysiological measurements, Biotechnology and Human Values (ENG 100), in which students design a new diagnostic test, and the senior capstone design course, BME 450, in which students design and test a prototype for actual stakeholders.

Broadening “bench to beside” translation, the design curriculum has been further bolstered with a year-long graduate course, BME 599, created by Aileen Huang-Saad to expose students to the full innovation process, including commercialization. Rachael Schmedlen introduced a year-long senior capstone design course (BME 451/452) and a clinical-needs-finding course (BME 499). Andrew Putnam created a new course in computer modeling in design (BME 350).

The Department also launched a new medical product development master’s concentration in 2015. Headed by Jan Stegemann, the program was designed to teach students how not only to design a medical device but to address the many regulatory, intellectual property and reimbursement-related factors involved in successfully bringing new products to a competitive market.

In addition, 2015 brought new clinical immersion and experiential learning opportunities to students through greater support for device prototyping, a collaboration with the Medical School’s Clinical Simulation Center, a Clinical Peer Mentors program and the Medical Device Sandbox. All offer the chance for BMEs and medical students and clinicians to work together – ultimately toward improved patient care and safety.

A novel “instructional incubator” course, launched by Huang-Saad in 2016 continues to build on the collaborative nature of biomedical engineering practice by having students themselves create several new short courses. Courses piloted in 2017 included 3D printing and prototype development, biological signaling in neural tissue, and computational modeling for drug development (See the related story: BME-in-Practice: Iterative curriculum design).

Cameron Louttit instructs students.
BME student Cameron Louttit instructs students on proper pipetting technique in Building a Tumor, an Introduction to Tissue Engineering.

Poised for a new era

With 12 new faculty hires in the past three years, BME is well positioned to address both intractable and new health and medical challenges with a next-generation arsenal that includes precision health (molecular imaging and diagnostics, gene and drug delivery, and histotripsy), data analytics (systems biology and multiscale modeling) and regenerative medicine (brain-machine interfaces, immune therapeutics, cell transplantation).

Explore all of the BME research by area, clinical application, or technology used.

In this last area, BME’s David Kohn is co-leading U-M’s Regenerative Medicine Collaborative, comprised of more than 150 faculty across campus. The groundswell recalls BME’s earliest days, when the department was a burgeoning program, its growth and stature fueled by a vision that blurred disciplinary boundaries. The momentum continues, offering clinicians, engineers, and students alike the opportunity to improve lives.

Dr. Parag Patil is a neurosurgeon who works closely with BME’s Cindy Chestek on brain-machine interfaces and welcomes those opportunities. “Engineering helps because when I’m doing my clinical work, I’m always thinking about ways to make things better,” he says.

Zhen Xu, too, is excited by the prospect of opportunity and change. “I hope one day we can tell patients that we can actually remove your blood clots or remove your tumor noninvasively,” she says.

And Dr. Jeruss describes the “renewed sense of optimism about what I can offer to patients. One of the most wonderful things that’s come out of this whole process for me is a new perspective on what’s possible for us to do in our lifetime.”

“One of the most wonderful things that’s come out of this whole process for me is a new perspective on what’s possible for us to do in our lifetime.”Jacqueline Jeruss, M.D., Ph.D.

A Better Way to Connect Arteries How Coulter’s Newest Licensed Product Is Making Its Way from the Classroom to the Clinic

When reconstructive surgeons repair a breast after mastectomy or a severely injured leg after a car accident, they often move tissue harvested from one part of the body to another using microsurgical techniques. A new device developed at U-M and supported by the Coulter Translational Research Partnership Program will make it possible to connect arteries in the transferred tissue to those at the repair site in just minutes with a few easy steps. The device, called the arterial everter, looks like a thin silicone pen with a flexible steel spine. It was developed as an accessory for the market’s leading product for connecting vessels, the GEM Microvascular Anastomotic Coupler from Synovis Micro Companies Alliance, enabling it to work as well on arteries as it currently does on veins.
The Arterial Everter & Synovis Coupler
The arterial everter was developed at U-M to allow Synovis’ GEM coupler to connect arteries as easily as it connects veins. To use the coupler, a surgeon slides two cut vessels through a pair of plastic rings, secures each vessel’s end to a series of metal pins, and then clips the rings together. The everter allows surgeons to spread the more muscular arterial walls over the rings and push them securely onto the pins. Credit: Jeffrey Plott

This enhanced usability has long been on many mircosurgeons’ wish lists because of the coupler’s speed, ease of use, and effectiveness in re-establishing venous blood flow from transplanted tissue. However, arteries’ more muscular walls have made them hard to maneuver on the coupler (see image above). This typically requires them to be meticulously hand-sewn and adds significant time to surgery.

Overcoming this barrier, say the everter’s developers, was made possible by the rich ecosystem of biomedical innovation at U-M – one that has taken the device down a carefully crafted pathway, from classroom challenge to Coulter project to industry license.

Bringing Your Problems to Class

This innovation began as an increasing number have in recent years – as a classroom project. U-M’s Plastic Surgery Section Chair Paul Cederna, MD, has long been familiar with the time-consuming and technically demanding nature of hand-sewing tiny, 1 to 3 millimeter arteries in complex tissue transfers. But he’s also a professor of biomedical engineering and knew this was an ideal problem for U-M’s engineering design students.

So, Cederna brought the problem to ENG 490/ME 450, a multidisciplinary design and manufacturing course co-taught by Mechanical Engineering Professor Albert Shih, PhD, to see what solutions might emerge. Cederna further upped the odds of success by convening a crack support team: Jeffrey Plott, then a PhD student in Shih’s lab, to serve as a product-development mentor, plus two fellow U-M plastic surgeons, Associate Professors Adeyiza Momoh, MD, and Jeffrey Kozlow, MD, for clinical guidance, prototype testing and feedback.

The team presented the problem, advised the students and was soon rewarded with a number of potential solutions. By the course’s end, the leading contender could successfully evert artery walls over Synovis’ existing coupler.

Though a breakthrough in function, the design developed in class involved more moving parts than was ideal in the operating room. But, in it, the team saw the seeds of a winning device. With input from the surgeons and students, Plott continued streamlining the concept. When he arrived at a pen-like tool that could spread the cut end of an artery and affix it to the coupler, the team knew they were onto something.

 

Developing the Everter
The challenge with using the coupler on arteries is that their muscular walls are hard to spread over the device’s rings, often popping off one anchoring pin as the next is attached.
In the class design, a catheter balloon stabilized the artery while a plunger-type tool (yellow) pushed its ends onto the coupler pins all at once. Credit: ENG 490 student team The next version was a rigid plastic tool with a telescoping dilation mechanism and channels that could accept the coupler’s pins with a single push. Though streamlined, it required precise surgical alignment to avoid bending the pins. Credit: Jeffrey Plott The latest design is a flexible tool with a tapered silicone tip that can spread the artery onto the coupler’s pins from almost any angle. The pins pierce through the artery and into the silicone without bending, and the tool’s shaft can be angled as needed. Credit: Carolyn McCarthy

Tapping Coulter, Engaging Industry

Cederna approached his contacts at Synovis to gauge their interest in a product with the potential to enhance the coupler’s usability and – since it would now be ideal for both types of vessels – boost its sales. With their interest piqued, his next call was to Coulter.

“I’d worked with Coulter in the past and knew our team would benefit from their expertise in translating products to the clinical arena,” says Cederna. “I also knew we’d need funding for animal studies to confirm the device could do what we thought it could do.”

Recognizing the everter’s potential, Coulter took the unusual step of submitting the project for approval outside its traditional funding cycle. “This project was unique in a number of ways,” says Managing Director of U-M’s Coulter Program Thomas Marten. “It offered a simple, elegant solution to a clear clinical need. It was an accessory to an existing, market-leading device. And it promised to improve patient care, reduce time under anesthesia and decrease surgical costs. With all this and an industry partner engaged, we were eager to maintain the team’s momentum.”

Coulter approved the project, and its funding allowed Plott and the team to further refine their prototype, generating a device that was easy to both use and manufacture. They knew they’d nailed it when the team connected model arteries in minutes.

Coulter also helped the team engage with Synovis and its parent company, Baxter, to design a pilot animal study to provide the safety and efficacy data the company would need to consider licensing the everter.

The resulting Coulter-funded trial involved plastic surgeons Adeyiza Momoh and Ian Sando, MD, in cutting and reconnecting the femoral arteries in a large-animal model, one side using the everter-coupler combination and the other using traditional hand-suturing. After the initial cases showed that the everter-coupler technique attached the vessels securely without damaging their walls, maintained unobstructed blood flow, and reduced procedure time from more than 20 minutes to just five, Coulter invited representatives from Synovis and Baxter to see the results.

“That was a big day for us,” says Synovis President Michael Campbell. “It’s one thing when you see an idea on the blackboard; it’s another to see that it works. We were excited.”

So much so, that with support from the U-M Office of Technology Transfer, Synovis has just licensed the everter and plans to continue developing it for market.

Product of an “Innovation Ecosystem”

The everter is a great example of how multiple aspects of the U-M environment can come together to support biomedical innovation, says Bryce Pilz, director of licensing for the Office of Technology Transfer. “Projects at U-M benefit from schools that are top in their respective areas, have great researchers, and have also invested heavily in commercializing research, with programs like Fast Forward Medical Innovation at the Medical School, the Center for Entrepreneurship at the College of Engineering, and the Coulter Program that spans both.” Along with Tech Transfer, these programs are part of a rich support system that educates faculty about commercialization and helps develop projects to the point that they’re ready for industry.

Coulter is a critical component of U-M’s biomedical innovation ecosystem that helps educate faculty about commercialization and develop projects to the point that they’re ready for industry.

Coulter’s role in this ecosystem is offering financial resources, connections and expertise in product development and regulatory planning to help investigators evaluate their technology’s market potential and develop a product that will be attractive to investors.

“With the everter,” says Pilz, “Coulter helped the team engage Synovis in preclinical research to de-risk the technology to the point that the company was prepared to license it and invest its own resources in getting the product cleared by the FDA and into the marketplace.”

Such support is essential, says Paul Cederna, in bridging the vast but underappreciated gap between an idea or device developed in the academic world and one that is teed up for industry. “Programs like Coulter are essential in helping us span the ‘valley of death,’ where you’ve created something that works beautifully in the lab but dies while you’re trying to get it into the clinic,” he says. “They not only fund experiments, but things like market analyses and business plan development – activities that granting agencies just don’t invest in.”

It’s this kind of support, he says, that combines with U-M’s extensive collaborations across medicine and engineering to make biomedical innovations like the everter possible.

Results from the everter study were recently published in the Journal of Reconstructive Microsurgery. In addition, the device has won national recognition in the Create the Future Design Contest and with a Baxter Young Investigator Award.

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Funding for the arterial everter was provided by the Coulter Translational Research Partnership Program. The program provides funding, expertise, and comprehensive support to accelerate the development of U-M technologies into new products that improve health care. Details at: coulter.bme.umich.edu.

The U-M-Coulter Partnership A pivotal program helps catapult promising biomedical technologies from the lab to the marketplace

by Aimee Balfe

The 1990s saw the rise of a new term that would reshape biomedical engineering and academic medicine in the years to come — “translational” research.

Driven by funders’ desire to bridge a gap between basic research and clinical application, it encouraged biomedical scientists to more directly impact human health by taking their work “bench to bedside.” In doing so, it suggested that the end-game for academics could just as reasonably be a high-impact journal article as a medical product poised for commercialization.

Perhaps no program at U-M played a greater role in institutionalizing this approach within the College of Engineering (CoE) and Medical School than the Coulter Translational Research Partnership Program.

Launching a Program – and a Mindset

The process began in 2005, when then-BME Department Chair Matthew O’Donnell led a successful pitch to the Wallace H. Coulter Foundation for its $5 million Translational Research Partnership Award in Biomedical Engineering.

The award supported research teams co-led by engineers and clinicians in developing promising health-related technologies that could be translated from the lab to the clinic via the marketplace. It offered individual project grants within a coaching framework designed to help participants think early-on about their technology’s path to commercialization.

“I was personally very excited about Coulter,” says O’Donnell. “It allowed me to marry my two loves, industry and academics. I thought how wonderful, especially for our junior faculty, to be exposed to a world where you don’t just write papers; you put out a device…that people will actually use in the clinic.”

“I thought how wonderful, especially for our junior faculty, to be exposed to a world where you don’t just write papers; you put out a device…that people will actually use in the clinic.”Matthew O’Donnell

O’Donnell’s enthusiasm spread quickly among the faculty and was sustained by his successor, Douglas Noll. In its first five-year funding cycle, the U-M Coulter Program supported 19 projects ranging from engineered ACL replacements to optical detection of pancreatic cancer to custom, 3D-printed biodegradable scaffolds for skeletal reconstruction and bone regeneration. The work yielded four start-up companies that garnered $25 million in funding. But just as importantly, the award provided a mechanism for cooperative translational research between the CoE and Medical School — an approach that was reinforced in 2012 when Biomedical Engineering became a joint department of both entities.

Endowment and Enhanced Support

The program’s success also positioned U-M for an even larger award — $10 million from the Coulter Foundation that was matched by the CoE and Medical School, yielding a $20 million endowment to support translational projects in biomedicine. U-M was one of only six universities nationwide to receive this award.

That was in 2011. Since the endowment, the Coulter Program has funded another 30 projects (see examples) and has ramped up its coaching in an effort to ensure the technologies it supports stand the best chance of making it to market through a license to an established company or start-up.

“Coulter is so much more than a funding entity,” says Tom Marten, managing director of U-M’s Coulter Program. “We’ve evolved to the point where we now guide projects through the same elements of new product strategic planning and development that are used in industry.”

“Coulter is so much more than a funding entity…We’ve evolved to the point where we now guide projects through the same elements of new product strategic planning and development that are used in industry.” Tom Marten

This happens even before funding decisions are made. Coulter has recently launched a program for its finalists, called the Coulter College Commercializing Innovation planning program, or C3i. It provides expert analyses of each project’s regulatory and competitive landscape, as well as market research in which target users evaluate the proposed product. The program also leads each team through eight weeks of structured homework guided by industry mentors matched to their project.

The result of this work is a “blueprint report” for each project that systematically examines its potential market; likely challenges; characteristics necessary to be sustainably adopted; as well as the research, intellectual property, and other milestones that must be met to make the product attractive to investors.

“By the time we go through this process, both Coulter and the teams have a clear sense of their project’s commercialization potential,” says Marten. This robust planning also means that the winning teams are able to hit the ground running, using their funds to implement the strategy they developed, and pressure-tested, through C3i.

Of course, all of this is possible because of Coulter’s reach and deep connections. “We have relationships with top industry executives, medical device serial entrepreneurs, regulatory specialists, and venture capitalists — many of whom are on our oversight committee — so we can provide expert mentoring to help faculty reach their hand-off goals.”

The projects funded since the endowment have yielded 7 start-ups, $30 million in outside investment and one license to industry. But Marten believes that with U-M’s talent pool, its culture of collaboration and innovation, and the resources provided by the Coulter Program, Tech Transfer, MICHR and others, there is even more success to come.

Highlighted Projects:

HistoSonics

Non-Invasive Precision Surgery

One of the earliest Coulter-supported projects involves histotripsy, a non-invasive surgical technique that uses the mechanical, not thermal, properties of focused ultrasound to precisely destroy target tissue without damaging surrounding structures. Coulter catalyzed a team of academics and businesspeople that launched a start-up around the technology and supported an intellectual property analysis that helped attract venture capital. The company, HistoSonics, has since secured more than $25 million in funding, developed a prototype device, conducted first-in-human clinical trials for enlarged prostates, and is now pursuing additional applications, such as liver cancer.

Slit-Stent

Lacrimal Drainage Device

One of Coulter’s more recent projects aims to help patients with excessive tearing. Traditional treatment involves creating and temporarily stenting a new drainage canal. But current stents don’t drain, so symptoms persist until the stent is removed months later. The Coulter program connected U-M oculoplastic surgeon Alon Kahana, MD, with Jeffrey Plott, a PhD student in ME/BME Professor Albert Shih’s lab. Plott solved the problem in a single day by cutting slits at key places in an existing lacrimal stent to create a patentable new “Slit-Stent” concept. The Coulter team, Kahana, and Plott are now collaborating with a leading manufacturer of lacrimal stents to modify one of their existing FDA-approved stents to create the Slit-Stent. The manufacturer has committed to running this product through its FDA-validated pre-clinical testing processes, which is required for an investigational device exemption (IDE) that U-M will file with the FDA. With the IDE in place, Coulter will fund a Slit-Stent clinical trial at U-M in late 2017 to generate the proof-of-concept data needed for a licensing arrangement.

NeuromaMend

Surgical Tool to Treat Neuromas

While working on a way to amplify nerve signals for prosthetic limb control, a U-M team that included BME Assistant Professor Cindy Chestek, PhD, and Plastic Surgery Section Chair and BME Professor Paul Cederna, MD, discovered a technique to treat neuromas. Neuromas are disorganized bundles of nerves that form when a nerve is severed; amputees suffer greatly from them, and they’re notoriously difficult to treat. However, Cederna developed a manual surgical procedure to wrap the severed nerves in a “cap” of harvested muscle tissue to relieve the pain. To make the procedure widely available, he sought a way to make it less time- and skill-intensive. Coulter funded development of a surgical device prototype that automates the procedure and allows surgeons to harvest the muscle, grab the nerve, and slide the muscle over the nerve in as little as five minutes. With support from Coulter, the team was able to demonstrate the functionality of the device in animal studies and secure a licensing agreement with Michigan-based RLS International. RLS will finalize development, and it hopes to file for FDA approval and bring the tool to market within two years.

Have A Great Biomedical Innovation That Could Improve Patient Care? Apply to the Coulter Program beginning Nov. 1st 2016

The UM Coulter Translational Research Partnership Program “Coulter Program” is pleased to announce the 2017 Call for Proposals.

 

Proposals will be accepted beginning November 1, 2016. The deadline for proposal submission is February 15, 2017.

 

The Coulter Program funds collaborative translational research projects between Engineering and Clinical faculty co-investigators. The goal of the program is to accelerate development and commercialization of new medical devices, diagnostics, and other biomedical products that address unmet clinical needs and lead to improvements in healthcare. Projects are actively supported and mentored by Coulter Program Management and a team of industry-experienced experts who proactively work to accelerate Coulter Program objectives. Coulter Program objectives and metrics for success involve developing new product concepts to the point of partnering with industry or forming start-up companies with follow-on investor funding to commercialize new products envisioned from translational research efforts. Coulter funding (typically $100,000 range for 1 year) does not require a departmental funding match or cost-sharing of salaries.

 

Distinctive aspects of the Coulter Program include business assessment work that dovetails with technical milestones for each project. Specific benefits to each project include:

  • New product planning support
  • Business development support
  • Market research
  • Regulatory guidance
  • Follow-on funding guidance
  • Mentorship from the Oversight Committee
  • The C3i Commercialization Planning Program

 

For more information, visit http://www.bme.umich.edu/coulter or download Coulter proposal instructions and application forms here: http://bme.umich.edu/research/coulter/process/apply/

 

For questions, please contact Thomas Marten, Coulter Program Director, at tmarten@umich.edu or (734) 647-1680.

UM Coulter Translational Research Partnership Program Awards 4 Projects for 2016-2017 Funding

The UM Coulter Translational Research Partnership Program “Coulter Program” is pleased to announce its funding selection for FY 2017.

The Coulter Program funds translational research projects between Engineering and Clinical faculty co-investigators. These projects aim to develop medical devices or other biomedical products with the goal of new company formation or a technology license to industry partners. Throughout the funding period and beyond, teams receive a high level of guidance and support for new product planning, market opportunity evaluation, patent filing, prototype development, regulatory strategy planning, and sourcing for follow-on funding or licensing.

For the FY 2017 funding cycle, four projects were selected for funding:

Cryo-Anesthesia for Intravitreal Injections

Current anesthetic procedures prior to intravitreal injections are uncomfortable and painful for patients, increase procedure time, and can increase the occurrence of ocular surface bleeding. Retinal Specialist Cagri Besirli, MD, PhD, and Mechanical Engineer Kevin Pipe, PhD, have developed a handheld device that delivers thermoelectric, contact cooling to the ocular surface as a rapid anesthetic for performing painless intravitreal injections in less time. This project also received Coulter funding last year for the  FY16 cycle. During their first year of Coulter funding, the team developed their first prototype and conducted device safety testing to determine optimal parameters for safe use. The team received IRB approval for a first-in-human (FIH) study which they initiated at the Kellogg Eye Center. With this second year of Coulter funding, the team will refine their current prototype using FIH study outcomes, design for manufacturability changes, and professional market research feedback. Regulatory consultation leading to a Pre-Submission meeting with the FDA will pave the way to a second clinical study funded by Coulter to demonstrate improved patient-reported outcomes and reduced anesthesia times compared to standard-of-care anesthesia methods. This project will likely lead to an exciting start-up company to commercialize the device.

 “Slit-Stent” Lacrimal Drainage Device for the Treatment of Epiphora Due to Insufficient Drainage

Oculoplastic surgeons treat epiphora, or excessive tearing, by surgically creating a new tear drainage system and placing a lacrimal stent to allow healing. Current stents take up space in the newly created tear drainage system, and patients do not experience relief from epiphora until the stent is removed 3-6 months later. Oculoplastic Surgeon Alon Kahana, MD, PhD, teamed up with Mechanical Engineers Albert Shih, PhD and Jeffrey Plott, to develop the “Slit-Stent”, a lacrimal stent constructed to facilitate drainage of tears through the stent after placement, which will provide patients immediate symptomatic relief. With Coulter funding, the team will pursue an Investigational Device Exemption (IDE) and conduct a clinical study to demonstrate that “Slit-Stent” provides improved symptomatic relief from epiphora while maintaining mechanical integrity and having no significant difference in infection risk compared to standard stents. Positive clinical study outcomes will provide a strong position for licensing of the technology to an existing ophthalmic medical device company.

Dynamic Arterial Morphology Analysis for Prediction of Intradialytic Hypotension

Intradialytic hypotension (IDH), a drop in blood pressure that cannot be compensated for by vasoconstriction, occurs in 20-30% of all hemodialysis sessions. This sometimes leads to session abandonment and fluid overload as patients are not able to be adequately dialyzed. Emergency Medicine Physician Kevin Ward, MD, Mechanical Engineer Kenn Oldham, PhD, and Computational Medicine and Bioinformatics Associate Professor Kayvan Najarian, PhD, have developed a small, wearable, noninvasive monitor that predicts the onset of IDH during hemodialysis and provides a warning to dialysis clinic staff, allowing them to implement countermeasures to prevent the hypotensive episode and continue the dialysis session. With Coulter funding, the team will build prototype devices to obtain clinical data on patients undergoing dialysis in the U-M Acute Dialysis Unit to refine and optimize the prediction algorithm. The goal of the study is to demonstrate the ability to predict IDH within 2 minutes of onset with 80% sensitivity and specificity. Positive results from this clinical study on the ability to predict IDH will greatly accelerate development and licensing to a commercial partner.

Miniaturized HemoRetractoMeter (mHRM) Blood Coagulation Diagnostic

Blood coagulation is a critical hemostatic process that must be properly regulated to maintain the delicate balance between bleeding and clotting. Coagulation diagnostics using whole blood thromboelastography measurements are rapidly gaining clinical acceptance, but commercially available systems are significantly limited by their size, cost, inter-assay variability, and significant user intervention. Emergency Medicine Physician Kevin Ward, MD and Mechanical Engineer Jianping Fu, PhD, have developed a small, inexpensive, easy-to-use and maintain, near point-of-care whole blood thromboelastography device (mHRM) that provides equivalent results to commercially available thromboelastography devices in less time. With Coulter funding, the team will improve the mHRM manufacturing method, conduct clinical testing to verify mHRM reliability on samples with known coagulation profiles, and demonstrate equivalency of the mHRM to commercially available thromboelastography devices. Positive results from this clinical study will strongly position this technology for commercial partnering with existing companies in the coagulation monitoring space.

See http://bme.umich.edu/research/coulter/ for more information about these newly funded projects. For more information about the Coulter Program, contact Thomas Marten, Coulter Program Director, at tmarten@umich.edu.  Look for the next Coulter Call For Proposals in late Fall 2016.