Inspired and Developed
Made in USAWe fund, develop, and commercialize start-up companies exclusively focused on various segments of the orthopedic sector.
Our team has extensive medical device experience and networks of relationships that will help our portfolio companies and our investors achieve their goals.
We focus on investing in and developing technologies that improve patient outcomes and reduce cost of implants for the healthcare industry.
All startups companies have two enemies, cash burn and time. GLW has assembled a Research & Development (“R&D”) team which can, and has, “hit the ground running” resulting in projects moving faster than what is usual and customary in our industry. We look for ways to maximize speed to market without sacrificing quality or core competency. Our R&D team has the ability to evaluate a product strategy, frame up ideas and prototype concepts (working closely with design surgeons and internal engineering staff to gather feedback and design input), and then implements product solutions quickly and effectively.
GLW believes that committing assets to the implementation and maintenance of a robust Quality Management System (“QMS”) is the way to “future-proof” our investment in a startup. We are in compliance with FDA 21 CFR part 820 Quality System Regulations with particular focus on: 1) Design Control; 2) Risk Management; 3) Document Control & Records Management; and 4) Supplier Management. Our QMS is overseen by quality, regulatory, and legal professionals with decades of combined experience in medical devices.
Design surgeons are an integral part of our design and development process. We assemble surgeon design teams specifically to each product and collect design and other product input from them. We identify the risks and concerns that surgeon design teams identify and then work systematically to mitigate those risks and address those concerns one after the next. Design surgeons are invaluable to our business strategy as they are the window into our future customer base. This approach, implementing design surgeon know-how from the start of the development process, is one of the key factors that makes investing in medical devices exciting.
Engaging physicians throughout all phases of development, from design concept through prototype development and feasibility, and eventually marketing and educational strategies, allows a GLW startup to provide a laser-focused approach to streamlining the entire process of bringing a product to market. This has vastly improved the speed of development and has shortened the turnaround time of implant design, generation, and manufacture.
We are passionate about our IP strategizing. Does the company have the freedom to operate in that field? What licenses might one need from third parties? We don’t waste money filing patent applications that are not essential to our product portfolio strategy. We restrict applications to those inventions that are worthwhile and those territories where there will have determined there will be a market or where we will be manufacturing. At the same time, we do not have tunnel-vision with respect to our IP strategy; we continuously consider and evaluate territories and markets where we might one day want to operate and do not limit ourselves only to those we are in today.
A successful product design process must proactively consider and account for what is needed for the end goal of manufacturing. We create functional prototypes using design that contemplates at every juncture the relevant manufacturability practices. Investing in scalable manufacturing processes while reducing implant cost is at the core of GLW business model.
Our innovative manufacturing processes do not restrict us in ways that traditional manufacturing currently does. This has given us significant degrees of freedom to allow for innovative designs that have never before been seen in the orthopedic market.
Engagement with end users is also very important to our product development process. Our team has an extensive collective network in the orthopedic and wider medical device marketplace including physicians, operators in manufacturing companies, and operators in distribution companies.
Through our deep network, we can build a vast body of knowledge in a short period of time. Members of GLW have worked diligently to build their relationships within the industry over the course of decades. These relationships make it possible to address and resolve very complex problems simply by making a quick phone call and having an informal conversation with some of the best minds in the industry.
Axel Cremer
Chief Technology Officer
Garret Mauldin
Director, R&D
United States
Christian Lutz
Director, R&D
Europe
Thomas H. Lee, MD
Carbon22 Chief Medical Officer
Lowell Weil, Jr., DPM, MBA
Chairman of the Advisory Board
Keith L. Wapner, MD
Altior Chief Medical Officer
Walter W. Virkus, MD
Chairman of the Advisory Board
Axel Cremer
Chief Technology Officer
Mr.Cremer brings over 15 years of product development, design and management experience in the orthopaedics industry. As senior manager and technical leader at Stryker Orthopaedics, he has led the development of T2 IM nails, Hoffmann 3 external fixation, Pelvis Pro and Axsos 3 plating product platforms. Axel is one of the industry’s leading experts in titanium plating technologies, having spearheaded the global development for the Axsos 3 plating system at Stryker. He also directed Stryker’s strategic relationship with the US Department of Defense and led the engineering efforts to design the Hoffmann external fixation system for the military in order to be prepared to treat casualties in an austere environment. Axel holds over 100 patents and was the primary trauma representative for all Stryker US based interdivisional projects. He was involved in multiple business development evaluations for Stryker and acted as the point of contact for trauma surgeons submitting product development ideas to the company.
Garret Mauldin
Director, R&D
United States
Mr. Mauldin brings over 15 years of experience in the orthopaedics industry. Garret has become adept in the start-up environment with two successful companies; Inbone Technologies bought at 7X investment and SI-Bone going to IPO. He is also one of the industry’s leading experts in total ankle replacements, having developed the innovative Inbone ankle system and responsible for new development with the Salto Talaris and Candence ankles systems. Experience in other industries including automotive, fiber optics, electronics, automation/robotics, manufacturing and military defense has given him the tools to create innovative and highly successful products in their markets. Garret earned both a BSME and MSME from Texas A&M and has over 20 patents in multiple industries.
Christian Lutz
Director, R&D
Europe
Mr. Lutz brings over 20 years of experience in the orthopaedics industry, with vast international and U.S. market expertise. Christian has held various senior R&D management leadership roles at Stryker Orthopaedics (Trauma & Extremities, Spine and CMF). He holds over 25 patents in the specialties of spine and trauma that generate over $800M per year for Stryker. He has successfully managed teams in five international R&D centers that have developed over 20 product platforms including: Trauma – T2 IM nails, Gamma 3 IM nails, Variax plates, Hoffmann external fixation; Spine – XIA system for the thoracolumbar, Solis cage system for the cervical, OIC for the thoracolumbar; and CMF – Universal Neuro II. Christian is a thought leader who speaks at various medical device technology conferences around the world about his experience in developing and inventing new market leading technologies.
Thomas H. Lee, MD
Carbon22 Chief Medical Officer
Dr. Lee has been active in education and research with over 70 peer reviewed publications and was a co recipient for the prestigious Roger Mann Award for best paper for his work with the STAR Total Ankle. He has worked closely with several extremity companies as a design surgeon. His innovative development work has included partnerships with Wright Medical Corporation (Inbone TAR, Infinity TAR, Prophecy CT guided targeting, Valor IM Nail, 3di Fracture Systems, 3di forefoot plating, Claw plating system, Darco Titanium plating system, Charcot frame system), Stryker Corporation (Sonic Anchor system, Jones Fracture Screw system). He has also been an active co-owner in start up Orthopedic companies including Nexa Corporation (sold to Tornier), Darco Corporation (sold to Wright Medical), Therics Biologics (sold to Theken), Bledsoe Corporation (sold to Breg corporation), and Surgical Care Affiliates (sold to Aetna). He is currently active in hospital and orthopedic development within China, India, and Brazil.
Lowell Weil, Jr., DPM, MBA
Chairman of the Advisory Board
Dr. Lowell Weil, Jr. is the CEO of the world renowned Weil Foot & Ankle Institute (WFAI). WFAI has over 20 locations in Chicago, as well as offices in Wisconsin, Indiana, Virginia, Maryland and Texas. He is a founding partner of Foot and Ankle Business Innovations (FABI), a group focused on increasing physicians practice efficiencies and profitability. With his MBA and extensive management experience, Lowell has been involved with surgical and product innovation for his entire career. As the lead U.S. surgeon consultant for Newdeal Technologies (Newdeal), he helped in getting their products to market, spearheading the relationship between Newdeal and Wright Medical. He played a major role in the evolution of Memometal Technologies (MMI), being a part of the design team and generating IP that created the Anchorage plating system. Lowell pioneered and developed what ultimately became the Complete Plantar Plate System (CPR) by Arthrex and is currently a member of the development teams at Treace Medical Systems and Novastep.
Keith L. Wapner, MD
Altior Chief Medical Officer
Dr. Wapner is a Clinical Professor Orthopedic Surgery, University of Pennsylvania where he is the Chief of the Division of Orthopedic Foot and Ankle Surgery and served as Director of the Orthopaedic Foot and Ankle Fellowship Program. He has published 98 peer reviewed articles and authored 41 textbook chapters related to Foot and Ankle Surgery. He has had numerous positions within the AOFAS serving on the Board of Directors of the AOFAS and served as President in 2010. He continues to serve on the Board of Directors of Foot & Ankle International. Dr. Wapner has been involved in product development for over 20 years and has extensive experience in product evaluations and surgeon education.
Walter W. Virkus, MD
Chairman of the Advisory Board
Dr. Virkus is a Director of Orthopaedic Trauma, Indiana University where he is the Associate Professor of Orthopaedic Surgery. He has completed trauma fellowships at the R. Adams Cowley Shock Trauma Center in Baltimore and the Hospital for Special Surgery in New York City, followed by an orthopedic oncology fellowship at the University of Florida. Dr. Virkus provides patients with the latest techniques in treating acute fractures, nonunions, and bone infections. He has been involved in product development for over 15 years and has extensive experience in product evaluations and surgeon education. He speaks regularly at numerous national and international meetings.
We invest in surgeon entrepreneurs with great ideas and provide them with the advice, direction, resources, and funding required to start bringing their product visions to life. We use our shared services business model to create medical device startups and help set their strategies, provide key employees, optimize business development opportunities and raise additional capital. GLW typically invests $500k to $1M in seed round of a company and leads subsequent fundraising round(s) of capital financing needs.
Because of our unique background and expertise, we are able to fund, develop, and commercialize start-up companies with a great amount of confidence and proven talent. This allows us to make investments at earlier stages when valuations are much more attractive. This also typically provides us with larger ownership percentages in companies. This enables us to have a greater role in governance and operations of the companies in which we invest. In the end, by using shared services we are able to mitigate certain risks associated with our investments.
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Let’s create the future of surgery together.