The orthopaedic industry has been in a steady state of incremental to slow product advancements. I anticipate that will change in the near future. There are a host of factors playing into what I believe will be a decade of rapid and radical change, and savvy device companies will be ready to respond to new market needs.
So, what forthcoming changes can we anticipate in surgical techniques, indications, technologies and regulations? Here are seven shifts that device companies should consider when choosing new product development initiatives.
In almost every healthcare market outside of orthopaedics, medical devices incorporate electronics and sensor technologies; even the Internet of Things inundates the market with health monitoring devices. An opportunity exists in orthopaedics to incorporate smart implants that are capable of providing diagnostics, health status and other alerts to the patient and their physician.
To prepare to sell in this market, it’s imperative to learn what is possible with electronics. Consumer electronics shows and niche conferences on medical sensors and implantable devices are great places to learn about the latest innovations. Once companies are aware of electronic advancements, they can determine which products are suitable candidates to convert into smart devices that may provide additional, useful information, thus changing the industry paradigm.
With the increase of additive manufacturing technologies for implants occurring in parallel with enhanced imaging capabilities and robotic-assisted surgery, I believe there will be a portion of the market that will move away from standardized implant sizes.
Patient-specific implants are becoming a cost-effective solution. This shift will improve outcomes and reduce inventory and fabrication costs. OEMs should consider investing in these new technologies, particularly additive manufacturing using titanium. Spinal implant companies use this technique, and the potential exists to make hip stems, tibial trays and reconstructive plates quickly enough to be used in these larger markets.
Used in parallel with advanced imaging techniques and precision robotic-assisted surgery, the advantages will become obvious, increasing demand by both surgeons and their patients.
Less Invasive Surgery
Adoption of new, less invasive surgical techniques can provide quicker recovery times, lower risk of infection and improved outcomes. The orthopaedic industry is moving in this direction, but this segment of the market is likely to grow rapidly as new surgical approaches are established.
Collaboratively developed designs with easy-to-use instruments will be the most successful solutions. Surgeons know best what works in the O.R., and engineers know how to translate visions into reality. So, manufacturers should continue to brainstorm ways to perform open surgeries in less invasive manners, and then begin to prototype and test these approaches in the laboratory to be a leader in this market shift.
At universities and in labs, much research is delving into the development of new materials for healthcare—everything from antibacterial films to resorbable and porous implant constructs that work with the body to regrow bone. Some of these materials will likely replace our current use of monolithic titanium and other metals, rendering them outdated relics of a prior era. Imagine a porous ceramic hip stem that allows the ingrowth of the patient’s bone, or a resorbable scaffolding that degrades over a couple of years until what we see on a radiograph is just the femur, perhaps with a ceramic femoral head the only visible remnant.
In addition to bone, new materials have emerged for ligaments, muscle and other soft tissues, some of which could fundamentally change our vision of reconstructive procedures. These new technologies are far enough along that they are entering the market in niche applications. Coupled with additive manufacturing, these new materials hold promise. Thus, it’s time for manufacturers to begin investigating which of their products would be enhanced by a change in material or fabrication technique.
Tissue Engineering & Regrowth
As with new materials, significant strides have been made in tissue engineering. Some species, like dogs, can grow a new meniscus. Others can regrow tails or limbs. Even humans can regrow ribs, livers, nerves, muscles and blood vessels, so it is likely that researchers will learn how to regrow other tissues, like bone and cartilage. We’re learning how to use advanced imaging techniques and additive manufacturing to “print” replacement organs, some even with early success in vascularization of that tissue. We’re also learning ways to have patients grow their own replacement tissue and organs, so I believe in the near future we’ll unlock the secrets to helping the body repair itself.
Bone, in particular, is a good candidate tissue. It has a well-understood and defined remodeling and growth process, a good blood supply and a fracture healing response that we already use for spinal fusion and cementless fixation procedures. Using these known features of bone, researchers will soon be able to stimulate bone to repair itself.
The need for orthopaedic fixation will still exist, but the design of those implants, including their materials, will change, as will methodology around how we provide care.
Data and Evidence-Based Medicine
The days of measuring outcomes based on clinician inspection of radiographic results, patient surveys and survivorship at a certain number of years are coming to an end. The future is about quantifiable data and evidence-based decision making based on that data. Spinal fusion has been under FDA scrutiny for several years for lack of evidence on how/why the procedure works and whether it has better outcomes than more conservative approaches. Thus, this segment of the orthopaedic industry is one of the first to invest in research that will provide these answers through new diagnostic tools, new ways of collecting data and the use of data science.
Data science is the use of machine learning (artificial intelligence) to eliminate bias and improve interpretation of data. For instance, rather than rely upon the experience of a surgeon to interpret a radiograph, a machine can be taught to read it based upon exposing the machine to the interpretations and conclusions of human experts in the field. After 1,000 or more exposures, a machine can form consistent, top-quality interpretations that are independent of the availability of an experienced expert. This means that patients will receive the best advice from their healthcare provider on such questions as whether or not they can return to normal activities, whether there’s a hairline fracture in the joint or if another, more expensive imaging technology is needed to determine a diagnosis.
Data science will also be an important factor in the adoption of smart implants. Today, everyone is inundated with data. This makes it more difficult, if not impossible, to draw conclusions when faced with thousands to millions of pieces of information. Thus, algorithms that can consolidate and interpret this data to provide concrete answers are a critical part of the solution.
I believe that the increased use of data will lead to fewer overall procedures, coupled with a demand by regulatory bodies and patients for more quantitative proof of favorable outcomes. This is a desirable result on many fronts, as it will reduce unnecessary costs, improve the quality of healthcare and outcomes and create a more standardized approach for various conditions.
Longer Time to Market, More Comprehensive Regulatory Requirements
We already anticipate significantly longer regulatory pathways for the EU when Medical Devices Regulation (MDR) is implemented in 2020. There will be many hurdles to overcome, as the weaknesses and flaws in this new regulation are discovered and corrected. In the long run, I believe it will be an asset for everyone. This is the first regulation that provides transparency to all parties, including the patient, about the performance of individual medical devices. Those manufacturers with superior devices, those who are first to the market and those who have done their clinical testing, post-market surveillance and data analysis will be the most successful. This differs from the current model, which favors the largest players with the most comprehensive suite of products.
I expect that FDA will follow suit and adopt many of the regulatory guidelines of MDR once it is more established. FDA is also working on its own changes, many of which are focused on data science and the need for evidence-based medicine. In addition, the agency is streamlining its 510(k) clearance procedures by eliminating loopholes for new products based purely on predicate devices, and making it easier for novel devices to be introduced to the market.
Considering surgical techniques, indications, regulations and technologies together as a whole, expect to see significant changes in orthopaedics over the next decade. OEMs that anticipate and adapt to these changes can expect to grow and prosper.
Dr. Deborah Munro is the President of Munro Medical, a biomedical research and consulting firm. She recently is Senior Lecturer in Mechanical Engineering and Lead for Minor in Medical Engineering at University of Canterbury in New Zealand. Dr. Munro has worked in the orthopaedic medical device field for almost 20 years and holds numerous patents, mostly in the area of spinal fusion. She taught mechanical and biomedical engineering at the University of Portland for eight years, where she also founded a Master’s in Biomedical Engineering program. Her current interests include developing new medical device solutions for companies and assisting them in their regulatory compliance efforts. She can be reached by email.