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.

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.

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

Community Culture: Longevity, Collaboration, and Innovation

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.

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.

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.

ABLEMEDICALDEVICES.COM

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.

• Plates • Screws • Rods and Hooks • Interbody Devices • Connectors and

Assemblies • Monolithic instruments • Complex instrumentation

EQUIPMENT

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.

• 9-axis Swiss Turning • Multi-axis machining • Wire EDM • Laser & GTAW welding • Multisensor CMM • Complex Assembly • Laser Marking • 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.

• 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