Medicine in Michigan

The Absorb GT 1 stent disintegrates in the body within three years.

The Absorb GT 1 stent disintegrates in the body within three years.

By Ilene Wolff

From using a virtual reality headset to distract hospitalized kids from pain, to educating the next generation of doctors working in community settings where medical care is increasingly rendered, Michiganders are embracing technology and innovation to improve the health of the state’s residents and economy.

All this activity has attracted the attention of investors, advocates and policymakers who increasingly support the med tech ideas originating within the state.
 

Adding tech for healing

At the University of Michigan C.S. Mott Children’s Hospital in Ann Arbor, Mich., J.J. Bouchard, digital media manager and certified child life specialist, distracts sick children and helps other kids work on moving better with virtual and augmented reality.

“At first it was escape,” says Bouchard of using the technologies that bend and enhance reality, “but always with the intent that there are health benefits lurking in the background.”

For example, Bouchard recalls a child waiting in line to use a virtual reality headset that could take him on a rollercoaster or a ride in a submarine. The boy was curled up in a corner with pain that registered nine on a scale of one to 10. Once the child started using the headset, though, he began smiling and laughing.

“That for me just shows dramatically how this technology can affect patients,” says Bouchard.

In the therapy room, physical and occupational therapists at Mott use virtual reality (VR) to encourage children to move in a virtual world — sitting up straight on a balance ball, reaching, touching, walking and using a wheelchair in ways they may not ordinarily do.

Augmented reality, like the Pokemon Go game, uses an Android or iOS-equipped phone or tablet, an app and specially equipped pictures to create a magical digital window that layers a digital world on top of the real one. For example, kids with an augmented reality book can point to a lion and hear him roar.

Meanwhile, heart doctors at St. John Hospital & Medical Center in Detroit are treating patients using the nation’s first stent that, while not virtual, is dissolvable.

The Absorb GT 1 stent disintegrates in the body within three years and is designed to solve multiple problems with existing plain metal and metal drug-eluting stents (that are coated with medicine to prevent scar tissue from forming in an artery), says Dr. Hiroshi Yamasaki, director of St. John’s interventional cardiology program.

Permanent stents inhibit the ability of an artery to adjust to the body’s demand for increased blood flow during exercise. They also limit options if future therapy is needed, says Yamasaki. For instance, permanent stents make re-treating the same area, whether with stenting or a bypass graft, extremely difficult, if not impossible. The dissolving stent is particularly good for younger people who may need re-treatment in the future.

The Absorb stent is made of a dissolving polymer similar to that used for dissolvable stitches and emits a drug to inhibit clot formation. 

At Henry Ford Hospital in Detroit, urologist Dr. Mani Menon uses high-intensity, focused ultrasound, a technology recently cleared by the U.S. Food and Drug Administration to treat prostate cancer in a new way.

Traditionally, physicians treat the entire prostate regardless of where the cancer is.

“It’s been an all or nothing phenomenon,” says Menon. “That’s a very, very good approach, but it’s not how we treat other cancers.” 

The new approach treats just one of the two lobes of the prostate with cancer, if the disease involves just that half of the gland.

Menon wants to see if his approach controls cancer better, and if it also reduces or eliminates unwanted side effects like urinary incontinence and sexual dysfunction.

To aid in the fight against prostate and other cancers, Beaumont Hospital in Royal Oak, Mich., expects to start treating patients at a new, $40-million Proton Therapy Center in spring 2017.

Proton therapy is an alternative to traditional X-ray radiation therapy, and has two important advantages, says Dr. Craig Stevens, chief of radiation oncology. Unlike X-rays, which damage healthy tissue when they travel through and beyond their target, a proton beam stops at its destination. Also, therapeutic X-rays can’t be repeated if they fail to kill all the cancer in a treated area, or if a cancer recurs at the same spot. Proton therapy can.

“The ability of protons to deposit more energy directly into the tumor makes this an ideal treatment option for many patients, especially those with tumors close to vital organs,” Stevens says. “For children, those most vulnerable and susceptible to the damage of traditional radiation therapy, proton therapy offers less radiation exposure and fewer side effects.”

Beaumont expects to draw up to 400 patients a year from Michigan, Ohio and Ontario for proton therapy.
 

Adding medical to the shop floor

As in stock portfolios, diversification reduces risk for manufacturers. While reducing risk and offering stability, diversifying into medical manufacturing is also challenging. Royal Oak Medical, in Rochester, Mich., a successful spinoff from the defunct Royal Oak Industries, makes hardware for spinal fusion surgeries.

Even with help from Medical Main Street, a collaborative group of universities, health systems and businesses in Southeast Michigan, initial contact with the U.S. Food and Drug Administration was filled with uncertainty. 

“The first visit by the FDA was a nightmare, but the second was better and the third even better,” says Matt Kroll, former president of and current consultant to Royal Oak Medical.

Meeting ISO 13485 certification requirements was expensive. The company paid a consulting firm from Austin, Texas, $400,000 to help implement a quality management system that led to ISO certification, an important credential for medical manufacturers. The process took several months, Kroll says.

Certifying for ISO 13485 was a lot easier for Firstronic, an electronic circuit board assembler. The company didn’t need to hire a consultant because Anthony Bellitto, quality director, had previously implemented requirements for the certification in multiple facilities before hiring in at the Grand Rapids, Mich., company.

Eric Icard, senior business development manager at The Right Place in Grand Rapids, a regional economic development corporation, says diversifying into medical manufacturing requires changes in many processes to get ISO certification for traceability of devices and overall documentation of the manufacturing process.

“I think you have to be committed to it,” he says.

Having existing relationships with medical-related original equipment manufacturers is another factor that helped Firstronic. John Sammut, president and CEO, Bellitto and others in management worked together at EPIC Technologies of Rochester Hills, Mich., a business similar to Firstronic. While there, they worked with Medtronic, Siemens Healthineers and Bayer HealthCare, among others.

Christophe Sevrain, former president of Delphi Medical in Troy, Mich., an automotive supplier that diversified into the medical devices industry, says that while the FDA’s regulatory environment and connections in the national and international medical industry are huge hurdles to scale, other stumbling blocks include requirements for low-volume manufacturing for automotive suppliers who are used to high-volume work, and a lack of capital.
 

Life sciences advancing

After almost 15 years of trying, Michigan’s life sciences sector has a plan that may help it to advance as a cohesive industry.

The plan, entitled “Michigan Bio-Industry Roadmap 2016”, has already drawn bipartisan support in Lansing, Mich., since its release in February, says Stephen Rapundalo, president and CEO of MichBio of Ann Arbor, Mich., one of the roadmap’s partners. A bill sponsored by a Democratic lawmaker is pending to reinstate an R&D tax credit that was eliminated in the revamped Michigan Business Tax in 2012. 

A Republican-sponsored bill has been proposed to create an angel investor tax credit in an effort to lure more venture capital money to the state. Rapundalo says he’s hopeful for positive movement on the two bills in 2017.

Also, industry representatives visited lawmakers in Lansing in May and testified to state capital committees about the industry’s priorities.

All of these activities have Rapundalo thinking positively.

“I think the reason I’m more hopeful of this go-round is that in many respects this plan is more comprehensive than the original one,” he says, referring to a plan MichBio drafted for Lansing in the early 2000s. Rapundalo says the efforts to create in Michigan the life sciences hubs that already produce jobs and sustain economic growth in cities like Boston have gotten further than ever before.

Michigan is strong in academic infrastructure, medical device manufacturing and organizations that conduct clinical trials, according to the roadmap. Along with those strengths are multiple needs, including forging stronger ties among entities within the industry, educating and attracting talent, securing investment and promoting the sector, in addition to enacting public policy that supports it.

Jeff Mason, executive director of roadmap partner Michigan’s University Research Corridor, reinforces the strength of the state’s academic infrastructure by pointing out that of $2.1 billion in annual R&D funding, 60 percent, or $1.1 billion, is earmarked for the life sciences.

Some of that life sciences research money leads to devices, pharmaceuticals and apps that form the basis of new businesses that contribute to Michigan’s economy.

“The pace of ideas spinning out from the faculty and researchers has been accelerating for the last decade,” Mason says.

His group’s collaboration with MichBio and two Detroit-based partners, Business Leaders for Michigan and the Data Consulting Group, represents a whole that is greater than the sum of its parts, he says, and makes them all stronger as a result.

“We’re going to continue to talk about the importance of this sector of our economy to policy makers, the business community, legislators and the general public,” says Mason.
 

Training doctors in the community
With three new medical schools opening in the last five years, and increased enrollment at several other institutions, Michigan is graduating hundreds of new doctors.

These doctors, combined with no new federal money for hospital-based postgraduate residencies, raise the question of who will provide specialty training to the new M.D.s. In recent years, about 500 new doctors nationwide haven’t entered a residency upon graduation because there was no space for them.

“It’s a serious problem,” says Dr. Tsveti Markova, associate dean for graduate medical education at Wayne State University School of Medicine.

Markova is part of two groups in the state, MI-DOCS and the Area Health Education Center, working to solve the problem. She expects Michigan to start working on residency curriculum changes in 2017 toward a model that focuses more on the ambulatory setting, reflecting trends in where healthcare is increasingly delivered. This shift should alleviate or solve the residency problem in the state.

The efforts to step up the number of graduating M.D.s came in response to a nationwide call 10 years ago from the American Association of Medical Colleges (AAMC) to address a projected shortage of primary care and specialty physicians. Up to 95,000 new doctors will be needed by 2025, according to the AAMC.

Dr. John M. Dunn, president of Western Michigan University, says, “The data with respect to the shortage of physicians as we think of future generations is alarming.”

In Michigan, the Oakland University William Beaumont School of Medicine opened in 2011, and has graduated 115 doctors in the first two classes; the Central Michigan University College of Medicine opened in 2012; and the WMU Stryker School of Medicine opened in 2014. The latter two schools have yet to graduate M.D.s.

CMU’s medical school has a preference for students from within the state — about 80 percent are from Michigan — and focuses on choosing students who have a strong interest in primary care and psychiatry, says Dr. George Kikano, dean of the medical college. Like many other states, Michigan has a shortage of primary care doctors, he says. Psychiatrists specializing in addiction medicine are needed in answer to the epidemic of pain killer addicts.

“Our focus is to graduate students in Michigan for specialty shortages,” Kikano says.

In addition to the new medical schools, Wayne State University increased its class size from approximately 260 in 2005 to up to 300 in 2006, in response to the AAMC’s call. Since then, most years WSU has admitted about 290 medical students.

Michigan State University College of Human Medicine began to expand its medical school in 2007, increasing the entering class from 100 to 150 students until 2010. That’s when MSU opened the Secchia Center for medical education in Grand Rapids, Mich., and increased enrollment to 200 entering students. At the time of the initial expansion in 2007, the college had about 400 students; enrollment is now double that, or about 825 students.