There are times when physical therapists, occupational therapists, and hand therapists cannot meet the vast diversity of their patients’ needs with existing, off-the-shelf products. In many cases, the products that are available do not fully address the underlying need or simply do not exist.
The challenge is that common prefabricated orthoses, using a “one-size-fits-all” principle, do not account for the complex, three-dimensional geometry of human anatomy. The products may inadequately fit, support, or align the hands, feet, legs, spine, or other areas of the body, so they fail to properly correct alignment or improve movement and function.
Instead of healing, a poorly designed rehabilitation product can cause chafing, pinching, pain, soreness, stiffness, and inhibited function to the point where patients discard the orthoses. The underlying problem is often left unresolved and the patient’s condition may further deteriorate.
In such cases, when experts identify a gap in the market and existing options do not provide a sufficient solution, some leading rehabilitation product firms engage in new product development.
“I believe rehab product manufacturers have an obligation to go above and beyond to design and manufacture innovative new products when there is an identified need that can help patients improve their lives and maintain their independence,” says Mark E. Biehl, President and CEO of North Coast Medical, a global manufacturer and distributor of rehabilitation products. The company sells the branded rehab products they create and distributes a variety of items from other manufacturers internationally in 58 countries.
There are considerable challenges in developing rehab products that reliably meet the clinical needs of the widest range of patients. Today, this requires creating products with a balanced understanding of both the clinical issues that need solving and the sophisticated engineering and product design technology that can foster innovation.
“Some rehab products have a bias towards therapeutic function but lack sound mechanical design. Others are biased towards engineering design but fail to adequately envision the desired therapeutic function,” says Dr. Greg Pitts, who is part of North Coast Medical’s product development team. Dr. Pitts, a Certified Hand Therapist, OTD, MS, OTR/L, CHT, is the Founder and Rehabilitation Director of Lexington, KY-based Commonwealth Hand & Physical Therapy, an outpatient rehabilitation practice that specializes in services for hands and upper extremities as well as physical therapy.
According to Dr. Pitts, developing truly effective rehab products requires expert knowledge of the intricacies of the human body, including bones, joints, and muscles. This clinical knowledge must be thoroughly incorporated into a fully functional physical form with world-class industrial design and engineering. When designers use these complementary skill sets together, each informing the other collaboratively throughout the design process, the sum is much greater than the parts. This facilitates optimal results for the rehab product user.
“Today, what is required to bring greater adaptability to OT, PT, and hand therapy products is a very high-level understanding of human anatomy and function combined with extremely sophisticated industrial design capabilities,” says Dr. Pitts, who instructs at the U.S. Army 7H Upper Extremity Trauma Program and has 33 years of clinical experience. Dr. Pitts previously ran Toyota’s onsite rehabilitation program for 18 years and is a former foundation Chair for the American Hand Therapy Foundation.
According to Dr. Pitts, only an integration of this expertise can enable the creation of a new generation of improved rehab products and easily customizable orthotics that fully support diverse users’ needs and the wide range of functions required.
Integrating Clinical and Industrial Product Design Expertise
To create new solutions, as well as enhance existing items, North Coast Medical taps into the expertise of its in-house product development team, which includes physical, occupational, and hand therapy practitioners. The company often brings in world-class product designers to collaborate on novel designs.
For advanced product development and collaboration, North Coast Medical regularly teams Dr. Pitts with Stephen Samuel, PE, an accomplished product designer with decades of experience. Samuel is President of Design Visionaries, a Silicon Valley-based design engineering firm that has developed products for Fortune 500 companies in the medical, aerospace, automotive, industrial, and consumer sectors including Johnson and Johnson, Applied Materials, GM, Bose Corporation, Snap, and Google.
Samuel has designed rockets and jet engines as an aerospace engineer and is the author of 13 books about computer-aided design (CAD), product life cycle management, finite element analysis, and the innovation process.
Over the past decade, Dr. Pitts and Samuel have worked together to develop a wide range of successful orthotic and ADL products, such as wrist and thumb supports for North Coast Medical.
“When you are designing for the variations of the human body, it can be daunting because the user community is incredibly diverse. However, if you don’t take the users into account, you don’t have anything,” says Samuel.
Samuel says that when working on product development projects, Dr. Pitts’ expertise is extremely valuable because of his extensive knowledge of the anatomy and biomechanics of the hand, including the bones and joints.
“A design is best when it is developed with a deep understanding of the mechanics, math, and science behind it,” says Samuel. “Dr. Pitts is not only a master of the mechanics of the hand but also of understanding patients’ needs.”
Samuel says that Dr. Pitts provides a clear vision of what patients require and his job is to design that into “an optimized mechanical reality.”
“I do not have insight into patients’ bone structure and needs. With Dr. Pitts’ insight, I can create mechanical designs that I believe will be creative, innovative, and groundbreaking – but most importantly create a great experience for the users of whatever we are designing,” says Samuel.
According to Dr. Pitts, the rehabilitation industry is increasingly relying on one-size-fits-all solutions, which can be challenging for both patients and practitioners.
“The problem is that there is not much adjustment you can make with a typical off-the-shelf product when it comes out of the box. You are stuck with that design, and when you design for one, you design for all,” says Dr. Pitts.
To address the need, the team is currently designing a custom hand orthotic for North Coast Medical with an expected release in 2024. The customizable orthotic accommodates an array of variables in hand type, including one of the most difficult to address: differences in individual anatomy.
“Our goal is to provide a customizable hand orthotic that will reliably, comfortably suit the natural differences in people. It will allow a vast array of adjustments to fit their unique, individual anatomy,” says Dr. Pitts.
“As a CAD design master, Stephen Samuel takes our ideas and puts them in motion. With the concept, he opens entirely new pathways to explore, whether different designs, materials, textures, straps, or attachments. He really understands the types of materials an orthotic can use as well as practical factors such as availability and combined function. There is much more to design than you realize; it is a skill set that few people possess,” says Dr. Pitts.
Among the expected user populations, there are many variables to accommodate, including how users will utilize the hand orthotic. This includes not only the individual’s unique skeletal, muscular, and joint structure of the hand but also the purpose and length of the orthotics use. Of course, there will be differences in the user’s size, age, gender, environment, socioeconomic condition, and other factors as well.
Functionally, the orthotic must support the patient’s hand and joints in the correct manner, so the materials and bracing must be reliable, comfortable, and aesthetic.
To accommodate all the required variables, Samuel utilizes “anthropomorphic software” that facilitates tailoring the orthotics design to conform to most variations in the patient’s size, weight, gender, and other factors. The designers and mechanical engineers use the 3D-human-model software to optimize physical human-product interaction. The models provide a great overview of statistical data and simplify using it in a 3D-CAD environment. The software allows him to employ sophisticated parametric modeling, which enables changing the shape of model geometry as soon as the dimension value is modified, saving time in design.
The team also conducts extensive user research at various locations, which consists of substantial observation and questioning of relevant populations.
With all the expert input and data, Samuel sketches the orthotics by hand, then adjusts the design using a high-end computer-aided design system made by Siemens called NX. It’s the same system that NASA and SpaceX use to design rockets. The advanced software is essentially a complete design-to-manufacturing solution that facilitates improving product quality through the use of detailed virtual product models with fewer costly physical prototypes.
Samuel notes the value of the advanced CAD and anthropomorphic software, which streamlines the creation of a hand orthotic with superior fit and function for a wider range of users than off-the-shelf products. With all that the technology offers, expert clinical knowledge and an understanding of end users’ needs still serve as the foundation that superior product development is built upon. Neither skill set in isolation is sufficient to effectively address complex, individualized needs today.
Even with the ability to combine clinical and industrial product design expertise, there is always room for improvement. It is an endless quest to design and deliver greater integration, functional value, and comfort.
As the population ages, the need for more effective, inclusive rehab products will only grow. The ability to keep the population working, functional, and happy will increasingly depend on providers’ ability to create rehab products that meet ever more diverse needs by fully integrating clinical and design engineering skills.
For more information, call 800-821-9319 or visit www.ncmedical.com.