BioMatters - Special Medical Devices Edition

IN THIS ISSUE:

10 MICHIGAN’S UPPER PENINSULA IS HOME TO A THRIVING MEDICAL DEVICE COMMUNITY ABLE MEDICAL DEVICES

12 TAKING ENGINEERING TO HEART PACKAGING COMPLIANCE LABS

22 NOW! TEST FOR ENDOSCOPES HEALTHMARK INDUSTRIES

26 MICHIGAN: A LEADER IN LIFE SCIENCES INNOVATION MEDC

SPECIAL EDITION

A magazine showcasing Michigan’s biosciences industry

MEDICAL DEVICES Michigan’s Medtech Cluster

MONEY DOESN’T INSPIRE GREAT IDEAS. GREAT IDEAS INSPIRE MONEY. ENTREPRENEURSHIP & INNOVATION MEDC is here to help bring great ideas to life, right here in Michigan. We’ll help you gain access to investors, expose you to SmartZones, Michigan’s network of regional tech incubators, and connect you to local university resources.

Whether you’re a one-person startup or and access to capital that can help your business grow.

Learn more at michiganbusiness.org/entrepreneurship

PRESIDENT’S MESSAGE Michigan’s medical device sector is a leader in the global medical technologies (medtech) marketplace as well as one of the key economic drivers in the state.

As one of the largest medtech clusters in the U.S. it has flourished for decades and earned a reputation for innovation in the medical products field to improve health care and people’s well-being.

Michigan is committed to developing, growing and promoting our medtech cluster. And we have a robust ecosystem to sustain it.

Businesses looking to start, expand or relocate in Michigan will find a supportive community of like-minded partners in the public, private and nonprofit sectors who are passionate about working in the medtech sector and bringing their lifechanging products from idea to market. Moreover, a dense network of suppliers offering everything from design to engineering to precision manufacturing and so much more, is at their fingertips. So are the needed professional providers versed in medtech regulatory, clinical trials, intellectual property protection, and other essential service areas.

This issue of BioMatters® provides a mere glimpse of Michigan’s medtech

“Businesses looking to start, expand or relocate in Michigan will find a supportive community of like-minded partners”

community and everything it has to offer. The stories describe the diversity of unmet medical needs that companies are targeting with their innovative products, product development expertise and advanced manufacturing prowess.

Michigan’s low business costs and taxes, coupled with a skilled workforce (engineers/STEM graduates and trades), world-class academic institutions with national-leading public R&D expenditures and numerous leading health systems, offers an ideal backdrop for a flourishing medtech cluster.

MichBio, as the statewide association representing the interests of Michigan’s medtech community and the broader biosciences industry, welcomes you to learn more. We’re ready to talk to you about how Michigan’s assets and capabilities make the state well-equipped to meet all of your medtech needs.

Sincerely,

STEPHEN RAPUNDALO, PHD President and CEO, MichBio

BIOMATTERS ® | MEDICAL DEVICES SPECIAL EDITION

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THE DISRUPTORS WHAT ARE THE BIG THINKERS DOING TO CHALLENGE CONVENTIONAL DRUG DEVELOPMENT?

MEET SANATH Sanath Ramesh was determined to track down the resources needed to repurpose a drug for his son Raghav’s ultra-rare disease. This determination led him to apply his experiences as a software engineer and empower the rare disease community with his collaborative platform, the OpenTreatments Foundation.

Find out how his software platform is now giving hope to other rare disease patients and how Charles River’s partnership is helping more patients get to treatment.

Watch Sanath’s story at

MeetTheDisruptors.com

every step of the way.

MichBio is the biosciences trade association for the state of Michigan. Our goal is to drive the growth of the state’s bio-industry through advocacy, education, connections, and supportive resources.

PREMIUM MEMBERS GOLD

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Stephen Rapundalo, PhD President and CEO Alisha Brown Editor Director, Marketing and Communications Elizabeth Morgan Foster Director, Membership and Operations Nancy Marcotte Manager, Finance

MichBio 3520 Green Court, Suite 175 Ann Arbor, MI 48105-1175 734-527-9150 info@michbio.org michbio.org Designer: Daina Fuson Designs Printer: Progressive Printing © Copyright Michigan Biosciences Industry Association, DBA MichBio

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MICHBIO BOARD OFFICERS

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CHAIR Ken Massey, PhD Wayne State University Senior Director, Venture Development Technology Commercialization VICE CHAIR Kevin McLeod C2Dx Founder, President and CEO

PRESIDENT AND CEO Stephen Rapundalo, PhD MichBio President and CEO SECRETARY Robert Donofrio, PhD Neogen Corporation Vice President, Food Safety R&D TREASURER Vacant

MICHBIO BOARD DIRECTORS Sean Callaghan Medbio Inc. President

BRONZE

Lola Eniola-Adefeso, PhD University of Michigan University Diversity and Social Transformation Professor of Chemical Engineering Christine Haakenson, PhD IDT Ann Arbor Director of Operations Charles Hasemann, PhD Michigan State University Assistant Vice President for Innovation and Economic Development

PATRON

Jamie Kemler, MBA, CLP, RTTP Stryker Corporation Vice President, Intellectual Property Business Strategy Anna Langerveld, PhD Genemarkers, LLC President and Chief Scientific Officer Ken Massey, PhD Wayne State University Senior Director, Venture Development Technology Commercialization Kevin McLeod C2Dx Founder, President and CEO

Emily Miner, MS Terumo Cardiovascular Group Senior Vice President, Global Quality and Regulatory Fredrick Molnar, MBA Michigan Economic Development Corporation Vice President, Entrepreneurship and Business Development Dave Morin Impellia President and COO Ron Perry, MBA Emergent BioSolutions Vice President and General Manager Stephen Rapundalo, PhD MichBio President and CEO Tom Ross Grand River Aseptic Manufacturing President and CEO John J.H. Schwarz, MD Former U.S. Representative Uma Sharma, PhD MMS Holdings Chief Scientific Officer

BioMatters® is published bi-annually to showcase Michigan’s bioscience industry. Much of the content is submitted by MichBio member companies. Interested in submitting an article or advertising in a future issue? CONTACT ALISHA BROWN AT ALISHA@MICHBIO.ORG. BIOMATTERS ® | MEDICAL DEVICES SPECIAL EDITION

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TABLE OF CONTENTS

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Impact Felt in Every Heartbeat

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Michigan’s Upper Peninsula is Home to Rugged Innovation and a Thriving Medical Device Community

Terumo Cardiovascular

Able Medical Devices

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Investing In and Evolving Products to their Fullest Potential

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Taking Engineering to Heart

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30 Years of Innovation in Marquette, Michigan

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Michigan Medical Devices: By the Numbers

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Creating Device Components that are Unseen Yet Ubiquitous

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After the Elevator Pitch

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NOW! Test for Endoscopes

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Serving as a Guide for New Product Development

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Michigan: A Leader in Life Sciences Innovation

C2Dx

Packaging Compliance Labs

Resolve Surgical Technologies

MichBio

Scherdel Medtec

Emerging Companies

Healthmark Industries

in2being, LLC

MEDC

BIOMATTERS ® | MEDICAL DEVICES SPECIAL EDITION

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TERUMO CARDIOVASCUL AR

Impact Felt in Every Heartbeat

BY STEPHANIE SORENSON, MANAGER, MARKETING COMMUNICATIONS, TERUMO CARDIOVASCULAR

Terumo Cardiovascular saves lives through mission-driven innovations.

When a child is born, it is one of the happiest moments in a parent’s life. But for some, the unthinkable happens – the child is born with a congenital heart defect, and without urgent treatment the result will be fatal.

Surgeons and teams of healthcare professionals work quickly to correct the problem, using their precision touch to mend a heart that is the mere size of a walnut.

And alongside these skilled clinicians are the medical devices carefully engineered to serve as the patient’s heart and lungs, and continuously monitor the body’s vitals during surgery. Working together, clinicians and innovative technologies give patients the best possible care and a second chance at a bright future.

These are the life-saving technologies imagined and manufactured by Terumo Cardiovascular.

Terumo Cardiovascular is a global medical device manufacturer headquartered in Ann Arbor, Michigan. The company specializes in manufacturing and distributing medical devices for cardiac and vascular surgery with an emphasis on cardiopulmonary bypass, intra-operative monitoring, and vascular grafting.

Its products are used every day in a wide range of critical procedures affecting patients from babies that are only days-old to adults of all ages; procedures like pediatric congenital defect repairs, coronary artery bypass grafting

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and valve replacements, heart transplants and surgeries for peripheral artery disease. Today, heart teams in cardiac surgery centers around the world choose products made by Terumo Cardiovascular.

The driving force behind Terumo Cardiovascular technologies is its mission: Working together, we help save one more life, today and every day.

“If you were to ask any Associate about what motivates them in their work, you’ll almost always hear the same reply: Patients,” says President and CEO Robert DeRyke.

“So many of us have been personally touched by the impact of cardiac surgery, whether through family, friends, and even through our own medical needs. We know just how much people rely on our products to receive life-saving care, and it inspires us to continually bring new solutions to the cardiovascular market.”

Terumo Cardiovascular shares a long and impactful history in healthcare as part of its parent company Terumo

TERUMO CARDIOVASCULAR

Perhaps now more than ever, Terumo Cardiovascular is harnessing its commitment to quality care to navigate the unprecedented challenges of the COVID pandemic.

Corporation, which celebrated its 100th Anniversary in 2021. Terumo Corporation began with the development of its first product, a clinical thermometer, in the 1920s. Since then, it has grown to become one of the largest medical device companies in the world, with more than 28,000 employees providing medical devices and services in more than 160 countries.

“Terumo’s long-term view and contributions to healthcare have been incredibly important to our own business. We have 100 years of legacy and are preparing for the next 100 years, not just the next 1, 3, or 5,” says DeRyke. “We are in the business of saving lives, and our ability to serve both healthcare professionals and patients through our mission, vision and values is what distinguishes us in the market.”

Perhaps now more than ever, Terumo Cardiovascular is harnessing its commitment to quality care to navigate the unprecedented challenges of the COVID pandemic. As the needs of healthcare professionals and patients change, Terumo is pivoting to develop more dynamic and datacentric solutions.

“Even before COVID, we recognized that the needs of the market were shifting. A new generation of professionals is approaching the helm, professionals who expect data mobility, effortless user experience and communication integrations across care paths,” says DeRyke. “The pandemic has both reinforced and accelerated our investment in those kinds of innovations and we are excited to help define next-generation care that will save and improve more lives.”

While the company ramps up product development, it maintains its position as one of the leading clinical support resources for perfusion practices. It’s team of certified clinical perfusionists serves customers around the globe, providing experiential training for new and seasoned perfusionists. Remote and on-demand educational training has become paramount in the COVID era, keeping healthcare professionals connected with the latest clinical best practices.

“While we are a medical device manufacturer, we choose to take a more comprehensive approach to serving our customers,” says DeRyke. “Sharing knowledge, exploring unique situations and cases, and demonstrating the latest techniques can elevate healthcare professionals’ skills and ability to optimize patient outcomes.”

Whether through its innovative technologies or educational programs, Terumo Cardiovascular will continually strive to deliver meaningful impact to help save one more life, today and every day.

TERUMO-CVS.COM

BIOMATTERS ® | MEDICAL DEVICES SPECIAL EDITION

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ABLE MEDICAL DEVICES

Michigan’s Upper Peninsula is Home to Rugged Innovation and a Thriving Medical Device Community

BY ADAM PALTZER, VICE PRESIDENT OPERATIONS & SENJA WAHLMAN, SALES ACCOUNTS MANAGER, ABLE MEDICAL DEVICES

For more than 30 years, the medical device community in Marquette County, Michigan has been growing and evolving. What was once a single medical device manufacturer is now a cluster of twelve companies with physical or remote representation in the region involved in device manufacturing, design, development, and regulation.

Community Culture: Longevity, Collaboration, and Innovation

Among those twelve companies is Able Medical Devices — a leader in medical device manufacturing and development, providing standard and complex instruments and implants to orthopedic, dental and cardiothoracic OEM partners.

The Upper Peninsula in Michigan is one occupied by people — like those at Able Medical - who have chosen to be part of a community that uses its rugged natural environment to fuel innovation. Demonstrated by the deep and longlasting industries in the region, including mining, natural resources, and advanced manufacturing, the community culture is one of hard work, diligence, and collaboration. A stalwart of those industries, with a 150-year track record for embracing opportunity and growing long-term value, is the J.M. Longyear Company. Longyear is a privately held entrepreneurial asset management company that brings longevity and sustained growth to its holdings — including Able Medical Devices.

The Able Medical team brings decades of knowledge in developing and manufacturing OEM and direct-to-market products. That first-hand experience helps the team to truly understand what their customers need to drive innovation and provides an in-depth understanding of regulatory and quality requirements, manufacturing precision and clinical

That rich history, culture, and the burgeoning industry — with knowledge and expertise in biomechanics, materials science, advanced machining techniques, and the ever-changing regulatory environment - creates synergy around innovations that will make treating patients safer and more effective.

This community creates a network of sales, manufacturing, and R&D professionals, as well as connections with orthopedic surgeons and Key Opinion Leaders (KOL’s) which link Marquette County companies to the innovative technologies, critical intelligence, and market opportunities required to sustain growth.

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acumen, and vast market knowledge. The dedicated engineering team and world-class manufacturing staff support projects from concept to full production launch.

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ABLE MEDICAL DEVICES

CAPABILITIES Able Medical develops and manufactures a full range of implants and instrumentation, utilizing an integrated quality system. The experienced team partners with OEMs to develop and produce solutions for the complex assemblies required for medical device innovation, while product development and sales teams identify ways to be innovative in existing markets. In 2021, the Able team developed the Valkyrie Thoracic Fixation System, the market’s first single-use, radiolucent plating system, designed to span the osteotomy and close the sternum after open heart surgery.

CORE COMPETENCIES INCLUDE: • Plates • Screws • Rods and Hooks • Interbody Devices

• Connectors and Assemblies • Monolithic instruments • Complex instrumentation

EQUIPMENT Intentional Culture: The ABLE Way Utilizing two decades of collaboration, the Able team developed a scalable process based on best practices and experience. The Able Way allows the team to make smarter decisions, increase speed to market and ensures the best possible quality in products and services.

The model has proven to be so effective, it has been expanded and guides many aspects of company operations including hiring, equipment purchases, planning, and most importantly, culture.

That intentional culture at Able Medical Devices inspires and focuses the entire organization.

The company’s mission and vision create the foundation for its guiding principles - six ideals that make commitments to customers, culture and community – and its operating mechanisms – like the Able Way - are the tools used to reinforce that culture. Together, it all creates an engaged and satisfied workforce and drives business success.

As experts in medical device machining and precision, Able Medical has an extensive equipment list to meet machining needs. Using Lean Principles, projects are delivered on time while exceeding quality standards. Material experience ranges from various grades of steel, aluminum alloys, Cobalt Chrome and Titanium to polymers such as phenolic, UHMWPE, and PEEK. MACHINING CAPABILITIES • 9-axis Swiss Turning

• Multisensor CMM

• Multi-axis machining

• Complex Assembly

• Wire EDM

• Laser Marking

• Laser & GTAW welding

• Passivation/finishing

QUALITY POLICY Able provides quality services and products in accordance with its Guiding Principles and Operating Mechanisms and is committed to a quality management system that complies with applicable regulations, continuously improves, and meets customer needs.

QUALITY OBJECTIVES • Defect-free products and services are shipped/ provided to customer • Solutions meet customer needs • Continuous improvement is practiced in QMS processes • Establishment/Maintenance/Continuation of ISO 13485 Certification

ABLEMEDICALDEVICES.COM

BIOMATTERS ® | MEDICAL DEVICES SPECIAL EDITION

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C2DX

Investing In and Evolving Products to their Fullest Potential

BY SARAH HOLLINGSWORTH, DIRECTOR OF MARKETING, C2DX

C2Dx, Inc is a privately held medical device company based in Kalamazoo, Michigan with a unique business model. Founded in early 2019 by industry experts, C2Dx continues to build its business from the strong foundation of its initial acquisition of the STIC Intra-Compartmental Pressure Monitor from Stryker.

Seeing success from giving this product dedicated attention has provided the opportunity to invest in additional acquisitions while continually evolving to ensure that healthcare providers have the devices, technology and service they need.

The company is led by a team of medical device industry executives with over a century of experience managing growth-oriented teams across the globe. The company was founded on two principles: 1) continue the legacy of the STIC Pressure Monitor and 2) grow its offering by investing in other valuable products.

“Since its introduction over 30 years ago, the product has been cited in numerous articles and papers due to its clinical effectiveness, accuracy, and reliability,” said Kevin McLeod, founder, president and CEO of C2Dx. “While at Stryker, I had the pleasure of being intricately involved with building the legacy and growth of this product and wanted to carry it on.”

The STIC Pressure Monitor is a convenient, compact, reliable unit for both an immediate and/or continuous reading of compartment pressure. It was designed to aid in the diagnosis of compartment syndrome, which occurs when excessive pressure builds up within a muscle space in the body, often the lower leg or forearm. “There are very few emergencies in orthopedics- compartment syndrome

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is one of them,” said Dr. Christopher LeBrun (Orthopedic Trauma Surgery, Shock Trauma Center at University of Maryland Medical Center).

One common diagnostic method is clinically assessing the patient using the 5 P’s (pain, pallor, pulselessness, paralysis, paresthesia). Statistically, this method performs poorly when used as a diagnostic tool. Studies have proven sensitivity rates as low as 13-54% using this method, while the STIC Pressure Monitor yields sensitivity rates of 94%. In addition to its clinical success, the STIC Pressure Monitor has become known for its rapid set-up, accuracy, convenience, and cost effectiveness.

Through the success of the STIC Pressure Monitor, C2Dx has been able to make additional acquisitions while evolving its business practices to better support both its customers and community. The current C2Dx product portfolio highlights the company’s unique acquisition strategy of integrating industry-trusted products with untapped potential that could benefit from the team’s go-to market talents and innovative methods.

The second product line, also from Stryker, was the T/ Pump Localized Temperature Therapy System. The T/Pump provides localized controlled warming and cooling temperature therapy with multiple treatment cycle

C2DX C2DX

“At C2Dx, we aim to be a place where people, products, and ideas flourish.

By investing in our people and community we all benefit”

options for customized pain relief and patient comfort.

It is often used for orthopedic conditions; acute injuries, chronic pain, and muscle strains, as well as skin trauma, burns, contusions, and other localized pain diagnoses, such as arthritis and neuritis. Similar to how C2Dx started, they are using this opportunity to put a dedicated team in place to focus on T/Pump, learn more about the needs of its customers, and provide leading service.

T/Pump isn’t the only product contributing to C2Dx’s recent growth. In addition continued partnership with Quintree, the first telemedicine platform that integrates with providers’ existing diagnostic equipment, C2Dx announced its most recent expansion with the acquisition of Hemostatix, effective in early 2022.

Elegantly simple, the Hemostatix Thermal Scalpel seals blood vessels as they are incised—effectively cutting and coagulating simultaneously. The surgically sharp blade enables surgeons to make precise anatomical dissection and achieve immediate hemostasis resulting in maximum visualization and superior surgical control. Formerly known as the Shaw Scalpel, the thermal scalpel features a 5-layer laminate composition of copper and stainless steel.

With the Hemostatix Thermal Scalpel in hand, surgeons can prioritize surgical safety with no muscle excitation, reduced blood loss, and contribute to the move toward a smoke-free operating room.

The additional acquisitions have allowed C2Dx to not only grow its team, but also support the development and job growth of local organizations by transitioning manufacturing processes to the U.S. from overseas. “At C2Dx, we aim to be a place where people, products, and ideas flourish. By investing in our people and community we all benefit,” said Kevin.

Although C2Dx recently closed on its latest acquisition, the company already has its sights on future product lines and companies that could integrate into its business model.

Whether it’s a product spinout from a large company’s portfolio or an up-and-coming technology, C2Dx will continue to develop its robust product portfolio.

C2DX.COM

BIOMATTERS ® | MEDICAL DEVICES SPECIAL EDITION

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PACK AGING COMPLIANCE L ABS

TAKING ENGINEERING TO HEART

BY CASSIE PETERSON, MARKETING, MANAGER, PACKAGING COMPLIANCE LABS

Packaging Compliance Labs has been through four major expansions in its history including, adding a lab, doubling its office space, and creating a mock surgical facility. Co-founders Matt Lapham and Ryan Erickson recognize the significance — and the seriousness — of their upward trajectory. Lapham noted, “We never want to lose sight of the people who need the medical products we work with.”

Seeing the heart lay on ice while the ECMO (Extracorporeal membrane oxygenation) machine sustained the patient’s life and the surgeon implanted the valve was sobering. Yet, it helped Erickson prepare for upcoming projects engineering packaging for emerging technology in prosthetic cardiac devices.

The medical device packaging engineering, validation lab, and contract manufacturing firm works hard to protect its small-business, customer-centric mindset from the pitfalls of big business. Lapham stated, “We are fortunate to work with global leaders and major corporations, but we also work with small startups and OEMs. Every one of those clients is in the business of bringing life-improving or life-saving products to people and families. We honor that reality with our clients.

Internally, we have a continuous improvement culture that keeps us mindful.”

Back in Michigan, Erickson reported that it had been meaningful to reflect on the young patient’s new hope for the future and how her family must have felt. He went on to tell his team that the experience had driven home the weight and significance of their work. After hearing the story, it was easy for the team to agree that every strict quality assurance measure they follow is worth the effort.

Taking Quality to Heart When Ryan Erickson, Vice President of Engineering, attended an open-heart surgery at a northeast Ohio hospital, he had the opportunity to experience the full journey of a life-saving device, like those for which he designs packaging systems every day.

Scrubbed and gowned, Erickson had listened intently as the cardiovascular surgeon explained that the open-heart surgery would repair a congenital heart condition that had not only severely affected the patient’s quality of life but had also been a looming threat to her life altogether. The surgeon explained that the procedure would replace a defective aortic valve with a prosthetic valve.

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Within hours, the young patient, with a fully functioning heart, was wheeled to recovery with a new chance at a healthier, more active life.

Additionally, Erickson’s experience observing that procedure cemented the importance of understanding real surgery situations, patient needs, provider expectations and more.

Since that visit, PCL (Packaging Compliance Labs) has launched a new Usability Evaluation service and mock surgical facility to ensure its packaging and manufactured products meet the highest quality standards and maintain a patient- or end-user focus.

PACKAGING COMPLIANCE LABS

Even PCL’s in-house training programs emphasize the human side of the medical device equation, whether lab or engineering. Quality Manager and Senior Packaging Engineer Ryan Ott noted, “We hammer the message home that whether designing a joint replacement package or running a transit test, oversights could hurt someone—and that someone could be your mom, your grandma, your child or brother.”

Coincidence and Consequence Erickson added that just as his operating room visit was so inspiring, it brought to mind a past project that had hit close to home in the opposite way.

He recalled, “A client distributed a wide variety of popular health care products. That client was outsourcing the packaging of this product line, as happens all the time, and had received some negative reports. Those reports led them to enlist PCL to research and investigate the potential problems.”

“It just so happened that around that time, a PCL family member had cause to use these products and had ordered them online.

When they arrived, the PCL employee saw the products and was alarmed to see multiple failures and defects in the ‘sterile’ packaging. Confiscating the products, our team member advised the family member to seek a substitute.”

Erickson continued, “Examining those products in the PCL lab, our findings showed a flagrant disregard for quality control something that was confirmed upon visiting the outsourced facility. We don’t usually see the actual products we test. In this case, timing was everything and, unfortunately for the client, the concerns reported were valid.”

“We had product from the marketplace, we’d confirmed the failures, and our investigative visit to the outsourced facility fueled our report and recommendations to help our client restore their quality standards — starting with severing the relationship with the careless, non-compliant vendor.”

It is stories like these that make the day-to-day work feel worthwhile and exciting. Packaging Compliance Labs is proud to be part of the MI Bio community!

PKGCOMPLIANCE.COM BIOMATTERS ® | MEDICAL DEVICES SPECIAL EDITION

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RESOLVE SURGICAL TECHNOLOGIES

30 Years of Innovation in Marquette, Michigan

BY PAT NICHOLS, PRINCIPLE, SUN UP COMMUNICATIONS ON BEHALF OF RESOLVE SURGICAL TECHNOLOGIES

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RESOLVE SURGICAL TECHNOLOGIES

Innovation is often inspired by need. Frustrated by the limitations of monofilament wire for back surgeries, Dr. Matthew Songer, a Marquette, Michigan-based orthopedic surgeon, embarked upon a mission to build a better implant.

Relying on his clinical experience, as well as an academic background in mechanical engineering, Dr. Songer successfully developed the Songer Cable, a system of stainless steel or titanium cable that can be adjusted and secured with a single instrument.

to-revenue advantage that their competitors can’t match.”

This breakthrough innovation led to the 1992 founding of Pioneer Surgical Technology in Marquette to manufacture the cable and, in the years that followed, other spinal and orthopedic implants and instruments. After three decades of medical advances, company evolution and growth, the recently rebranded company, Resolve Surgical Technologies, has stayed true to its innovative roots.

Today, it designs, develops, and manufactures metal and polymer implants and instruments for orthopedics, spine, and cardiothoracic applications.

Also, a competitive advantage for Resolve Surgical Technologies: a largely Michiganeducated talent base that appreciates the quality of life in the Upper Peninsula. Marquette, an outdoor adventure mecca on the shores of Lake Superior, has been an ideal home for the company, supporting significant growth over the past decade. Marquettebased University of Northern Michigan and Michigan Technological University, based in nearby Houghton, continue to be primary sources of engineering and technical talent.

The company has also continued to advance its business model as an original equipment manufacturer (OEM), developing and manufacturing products for distribution by other medical technology companies. Resolve Surgical Technologies has honed and expanded its processes, providing collaborative R&D and design, rapid prototyping, vertically-integrated, high quality manufacturing process and end-to-end product lifecycle and regulatory management.

The company’s recent return to independent operations under private ownership has been a catalyst for increased investment to accommodate market demand – investment that includes advanced equipment and infrastructure. The 110,000-square foot vertically-integrated plant and office facility, which operates 24-hour shifts, now employs more than 250 individuals, making it one of Marquette’s largest employers. The additional capacity is expected to support customer account growth and expansion in the coming years.

Megan Osorio, recently named the president of the company, says that the close customer relationships and comprehensive approach set Resolve Surgical Technologies apart. “We establish long-standing partnerships with our customers, which include some of the leading medical technology providers in the industry,” she explains. “This approach has been successful in freeing up their time and resources so they can focus on their innovation and growth priorities.”

Jason Sandstrom started with the company as an NMU engineering intern in 2004 and today leads its research and development team. “Our company has changed over the years, and technology and techniques continue to evolve,” he explains.

That business model has stood the test of time. Two of the company’s original customers continue to work closely with Resolve Surgical Technologies, expanding and scaling their product development. “In a typical medical technology company, the product development process takes four years or more,” Osorio explains.

“Because of our systems, business processes and expertise, we can typically accelerate that to 18 months.

That provides our partners with a quality and speed-

“What has stayed constant is a mission that matters. We all continue to be inspired by our role in making implants and instruments that improve people’s lives.”

RESOLVESURG.COM

BIOMATTERS ® | MEDICAL DEVICES SPECIAL EDITION

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MICHIGAN

A LEADING MEDICAL DEVICE STATE SAMPLE COMPANIES IN MICHIGAN’S MEDTECH CLUSTER

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MICHBIO: BY THE NUMBERS

STATEWIDE EMPLOYMENT*

INDUSTRY IMPACT*

338

MEDTECH ESTABLISHMENTS

12,106

BILLION

ECONOMIC IMPACT

MEDTECH JOBS

TOTAL MEDTECH EMPLOYMENT IMPACT

$87,086

$14

34,975

AVERAGE MEDTECH SALARY

LARGEST MEDICAL DEVICE STATE

$279.2 MILLION

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MEDTECH VC INVESTMENT 2016-19

*TECony/omBIO Report, The Bioscience Econyom: Propelling Life Saving Treatments, Supporting State & Local Comunities, 2020, https./w: bi.o org/sites/default/ les/2020-06/BIO2020-report.pdf

BIOMATTERS ® | MEDICAL DEVICES SPECIAL EDITION

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SCHERDEL MEDTEC

Creating Device Components that are Unseen Yet Ubiquitous

BY DREW JELGERHUIS, BUSINESS DEVELOPMENT MANAGER, MEDICAL, SCHERDEL MEDTEC

Springs are the engine in almost all drug delivery devices. They provide the energy to propel restorative and life-saving medicines from a device, through a needle, and ultimately into a patient. Despite being an essential and ubiquitous component in these devices, springs are unseen and rarely considered – except by those who make them.

world’s first diesel engine. In the next century, Scherdel innovation brought the best technology in springs to automotive production and advanced engineering for events in Formula 1 racing and beyond. By 1985 Scherdel was positioned to expand internationally to meet customer demands around the globe. Now – after more than 130 years from that first set of piano strings – Scherdel sets the standard for processing metallic wire and strip for springs and stampings in multiple industries.

Scherdel Medtec is a global supplier of technical springs and stampings for the medical device industry. The company has been working with the top drug delivery OEM’s in the world for decades providing technical expertise during development and manufacturing excellence during serial production.

The company’s rich history and deep expertise in high precision technology and innovative manufacturing set the stage, and a strong foundation, for the beginning of the Medtec division in 2014. Currently, Scherdel Medtec designs and manufactures 100’s of millions of springs and stampings that are critical to drug delivery devices the world over. Scherdel’s customers supply life-saving medicines and Scherdel springs provide the energy required to deliver those medicines to patients.

While Scherdel currently has facilities in 12 countries and produces over 6 billion springs annually, the company had a humble beginning. In 1889 Sigmund Scherdel began producing piano strings using his wire drawing mill. By 1893 his offerings had expanded and, notably, Rudolf Diesel experimented with springs from Scherdel in the

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Located in Muskegon, Michigan, Scherdel Medtec North America is the most recent evidence of growth in the

SCHERDEL MEDTEC

Medtec division. The Muskegon facility serves US, Canadian, and Mexican customers with a broad range of engineering, design, prototyping and production capabilities. The Michigan team can produce tension, torsion, spiral, and compression springs.

Additionally, their capabilities include stampings, metal/ plastic assemblies as well as complex bending and manufacturing projects.

In addition to production, Scherdel has the expertise and tools necessary to work alongside development engineers and provide valuable simulations, engineering support, calculations, testing, and prototyping. Medical devices, and specifically drug delivery devices, have long development cycles and need technical expertise early in the process – involving a partner like Scherdel lowers the cost for development and, eventually, manufacturing.

Partnering customers can take advantage of Scherdel’s extensive research and development team, and resources that allow the OE access to material databases, coating technologies, cleaning options, testing resources, and prototyping for feasibility and optimization.

NOT LOST ON THE COMPANY IS THE UNIQUE PRIVILEGE IT IS TO MAKE VALUE-ADDED COMPONENTS FOR LIFE-GIVING DEVICES. SCHERDEL PRODUCES COMPONENTS FOR: Insulin Pens: Compression springs provide both force for drug delivery, as well as a return mechanism for the delivery button.

Auto Injectors: Constant force and power springs provide consistent high force for higher viscosity drugs. Rolled housings are complex bent and stamped components that are then clenched or laser welded to provide ‘needle shield’ removal.

Scherdel can assemble these components into plastic housings to add value for the manufacturer.

Safety Syringe: Precision bending and stamping components, as well as compression springs are used in these devices.

Inhaled Medication Devices: Specialty springs including compression and wave springs are used, as well as electronic connecters in some ‘smart’ connected devices.

Scherdel Medtec is thankful to provide crucial medical components to the people who need them – even if those components are mostly unseen.

MEDTEC.SCHERDEL.COM

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AFTER THE

ELEA V TOR PITCH EagleView Imaging, Inc. develops augmented reality technologies to make surgery easier and safer.

In the United States, brain tumor surgeries cost over $1 billion annually. One third of all brain tumor patients go on to develop complications, which increases their costs by 3-5 times that of the non-complicated patients while reducing their quality and longevity of life. EagleView Imaging’s 3D augmented reality environment makes the complex process of planning brain surgery more intuitive and precise. With EagleView’s tool, surgeons can directly interact with a 3D representation of the patient’s anatomy and plan a surgery in a 3D environment that reflects the reality they will face in surgery instead of mentally reconstructing the 3D shape from 2D images. As the result, the surgeons will be better prepared and more confident during surgery and patients will have fewer complications.

Compared with competing products, EagleView’s patent pending solution is easier to use, does not cause dizziness in the user, and can be well integrated into a surgeon’s workflow at an affordable price.

To date, several pilot sites, including Henry Ford Hospital and Detroit Medical Center, have already begun to use the company’s early product for resident training and patient consultation. EagleView has also already received purchase orders from early adopters. More hospitals are in the pipeline of finalizing the purchase agreements.

The company has been supported by angel investment and SBDC business acceleration funds. In addition to continuous sales to early customers, the company plans to finalize the product features, extend the technologies to other platforms, and file FDA approval.

EAGLEVIEWMEDICAL.COM

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Michigan continues to be a leader in advancing biosciences research and commercialization, thanks to its rich pipeline of intellectual property. A whole new crop of startups are germinating in the state, which is good news for the regional cluster of established companies that are focused on innovation in therapeutics, medical devices, healthcare technologies, clinical diagnostics and agri-/industrial biotechnology. Renewal is crucial to sustaining and growing an innovation cluster. All the way around, Michigan bioscience businesses are truly improving the quality of life for patients and consumers.

Advanced Interactive Response Systems (AIRS) is an FDA registered company and has launched their Moisture Exchange Tubing (MET). The MET incorporates an antibacteria tubing that humidifies oxygen for six months.

The tubing is portable and takes water particles from the air to humidify the oxygen, so that it mimics the user’s environment. The tubing has a universal end that attaches to all standard oxygen equipment.

In addition, AIRS is currently working on a 510k filing for the FDA for their Oxygen Flow Monitor (OFM). Once FDA clearance is granted, the OFM will be available for purchase. The OFM attaches to any oxygen system to monitor the flow of oxygen and the patients SPO2 with

heart rate. The OFM works with an app that remotely monitors the data and can alert the user and caregiver of any issues.

These innovative products are beneficial to oxygen patients in all settings, including hospitals, long-term care facilities and home care situations. AIRS products are uniquely designed to be portable, reliable and userfriendly, with a focus on improving quality of care and life for oxygen users.

AIRS is a woman-founded and Michigan-owned company focused on respiratory care solutions.

OXYGENALARMS.COM

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Advancing Precision Medicine Through Genomics To learn more visit: www.genemarkersllc.com/clinical-testing or reach out to info@genemarkersllc.com

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IN2BEING, LLC

IN2BEING, LLC

What does a pioneer on the Oregon Trail have in common with someone trying to get a new product to market? They both need a guide—someone who knows the road, who will walk alongside them and will help overcome the many challenges and obstacles along the way. in2being, LLC, Michigan’s leading medical and life science product development firm, is that guide.

The road to a fully commercialized product is a long one, in2being, LLC can be your guide.

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Michigan: A Leader in Life Sciences Innovation

BY MARKETING AND COMMUNICATIONS, MEDC

Focused on engineering, testing, research and specialized design services, the state is paving the way for the next generation of life sciences industry innovation, from discoveries in medicines and vaccines to medical device technology.

Over the past 150 years, Michigan has built a proud legacy of discovery and impact within the life sciences industry by honing its academic R&D ecosystem and rich manufacturing talent base to ensure the technologies, products and pharmaceuticals of the future are discovered, developed and made in Michigan.

Michigan’s manufacturing prowess, top 10 medical device manufacturing workforce and core of world-class companies make the state a top-tier location for medical device innovation. Businesses throughout the Great Lakes State manufacture surgical, optical, dental and other devices used in preventing, diagnosing and treating diseases and other medical conditions.

The proud home to 275 medical device and life sciences firms, including household industry names such as Pfizer and Stryker and exciting upstarts like Tetra Therapeutics, Michigan is among the top ten in the nation for number of industry companies it houses compared to the entire U.S. Additionally, according to the Michigan Venture Capital Association’s 2021 Annual Research Report, the life science and information technology sectors continued to be the focus of capital deployment in 2020. Of the startups that

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MICHBIO | michbio.org

received venture funding from Michigan venture capital firms in 2020, 34 percent were life science companies.

From Fortune 500 companies to innovative startups, Michigan is increasingly competitive throughout the nation for developing, testing and deploying new medical device technologies.

Michigan companies also stepped up in a big way to help combat the COVID-19 pandemic. Pfizer, part of Michigan’s $28 billion life science industry, produced and distributed the first of three vaccines from one of the most technically advanced sterile injectable pharmaceutical facilities in the world. Genemakers, headquartered in Kalamazoo, pivoted from its genomic services to offer COVID-19 testing; the firm grew from 10-15 employees to more than 50, while forming relationships with seven Michigan pharmacies, several universities and more than 30 skilled nursing facilities. Meanwhile, Grand River Aseptic Manufacturing (GRAM) manufactured Johnson & Johnson’s COVID-19 vaccine in early 2021 out of its Grand Rapids facility.

“We are fortunate in West Michigan to have access to a robust life sciences ecosystem that has allowed us to continue leveraging a highly skilled talent pipeline,” said Tom Ross, President and CEO of GRAM.

MEDC

From startups to global companies, Michigan is home to several leaders in the life sciences space.

“When we recruit, there are great people in Michigan that have the skills that we need, and these are very technical positions that require a good amount of education, training and development. There is no doubt that our company’s growth and success has been made possible because we call Michigan home.”

With research expertise and highly ranked degree programs in medicine, biological science and other disciplines, Michigan is paving the way for the next generation of life sciences industry innovation, from discoveries in medicines and vaccines to medical device technology. Michigan’s University Research Corridor (URC) continues to lead other peer clusters across the U.S. in medicine and biological science. The URC is the No. 1 cluster for undergraduate and advanced degrees in medicine and biological science, and the only cluster of its peers to offer a doctorate in osteopathic (DO) program; in addition, Michigan ranks No. 10 in the nation for biomedical engineering graduates.

From startups to global companies, Michigan is home to several leaders in the life sciences space.

In 2020, Perrigo, a global self-care provider based in Dublin, Ireland, announced it would be locating its new North American Corporate Headquarters on the Medical Mile in Grand Rapids. The city’s growing reputation as a leader in medical and life sciences innovation was one of the key reasons Perrigo chose Grand Rapids as the home of its new headquarters. Breaking ground in 2021, the new headquarters is expanding Perrigo’s presence in west Michigan, which includes more than 4,000 employees at its offices and manufacturing facilities in Allegan and Ottawa counties.

“Our commitment to consumer self-care remains steadfast, and so too does our commitment to West Michigan,” said Perrigo President and CEO Murray S. Kessler. “What is especially exciting about our future North American Corporate Headquarters in Grand Rapids is the location within the world-renowned Medical Mile, which will allow Perrigo to leverage the expertise of healthcare and innovation thought leaders who share our passion for making self-care accessible, affordable and effective for all.”

Meanwhile, Fifth Eye, a startup company out of Ann Arbor, has developed technology to interpret a patient’s electrocardiogram and detect future instability before a patient shows any signs of distress. In 2015, the founding team at Fifth Eye received an award from the Michigan Translational Research and Commercialization Program (MTRAC) Life Sciences Innovation Hub at the University of Michigan. By accessing this early funding, Fifth Eye was able to meet critical milestones as it built out the technology and prepared for spin out as a start-up company. In February 2022, Fifth Eye announced the FDA provided clearance to market its second-generation clinical decision support software, the analytic for hemodynamic instability (AHI) system, to hospitals across the country.

Whether it’s producing life-saving vaccines or developing life-saving technologies, Michigan continues to pave the way as a leader in life sciences industry innovation.

MICHIGANBUSINESS.ORG

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Breakthroughs that change patients’ lives

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Where Law Meets Science.

Dykema: Protecting Great Ideas Across the Globe When it comes to protecting your IP assets, Dykema delivers on your priorities. For insightful legal counsel, smart representation and strategic business advice, Michigan’s biotechnology and life science companies turn to Dykema.

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Meet Your New Lab! Founded in West Michigan, Symbiote provides a wide selection of innovative products that will help outfit your space with mobile, modular furniture for years to come. Contact design@symbiote.com today to request a quote or more information. symbiote.com

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WHO WILL STAND UP TOGETHER FOR PATIENTS? SPARTANS WILL. healthsciences.msu.edu

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