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Biologics, MIS, Robotics: Why Surgeons Say to Prioritize These Technologies

We often rely on surgeon voices to reveal certain trends that the industry is moving toward (or away from), as well as certain opportunities that exist for device companies.

To provide you with this guidance and insight as you focus on your 2019 priorities and prepare for the American Academy of Orthopaedic Surgeons Annual Meeting, we looked back on some of the surgeon interviews conducted throughout the last two years to examine what they had to say about the direction of the industry and critical orthopedic topics. Here’s a recap on the topics of biologics, minimally invasive surgery, robotics and value-based implants.

What is exciting you about orthopedics, right now?

Patrick Sweeney, M.D., Founder of Center for Minimally Invasive Surgery, ConnectSx and Flow-FX | Interviewed in 2018
It’s clear that orthopedic knowledge and surgical skills have grown in many separate silos over the years and there will be significant advantages to integrating these areas, both for the patient and the profession. The possibilities created by this will be extensive.

Also, the amazing progress in biologic development coupled with the increasingly important problems of osteoporotic fractures, antibiotic resistant infections and the associated economic costs lead us toward precision delivery of medication through implants as an answer to many of these issues. Some of these solutions will be as useful in the developing world as in the developed. For example, chronic osteomyelitis imposes a huge economic burden on patients in the developing world, to whom we may be able to offer a cheap, technologically simple treatment.

Finally, the device distribution system as well as procedure knowledge delivery is ripe for modernization. The economic gains from this will lower the overall cost of healthcare.

What opportunities and challenges lie ahead for minimally invasive spine surgery (MISS)? What is the role of device companies in its progression?

James Marino, M.D., Founder of NuVasive and Trinity Orthopedics | Interviewed in 2018
The opportunities are virtually limitless, particularly as the interventions become more biologically mediated and less mechanically driven. Ultimately, cost containment or preferably cost reductions are mandated by our socio-political climate, for the foreseeable future. For example, personal entertainment expenses can increase at double-digit rates, but the cost of care for various specific surgical diagnoses must remain flat or retract with the burden of increasing healthcare access to an increasingly aged population. 

Degenerative spondylolisthesis, for instance, cannot remain a diagnosis treated with open decompression and segmental fixation in our senior population. The cost of the primary procedure is too high and the complication rates are difficult to justify, given the frequency of this diagnosis in our elderly population that is surviving well into their ninth decade and beyond. MISS intervention will solve this problem, and even more attractive would be early biologic intervention that prevented the progression of disease prior to significant symptom onset.

Device companies have numerous challenges to overcome to ensure that they first survive and then hopefully thrive. Ultimately, the advancement of MISS innovative solutions is a requirement for all spine device companies, because that has been the trend in all surgical disciplines for at least the last 40 years. This is particularly true for the smaller entities, as they can only garner attention, acquisition or significant market share if they conceive, develop and introduce novel MISS procedures and enabling instrumentation.

Unfortunately, in recent years, medtech is not regarded by the investment community to be as attractive as biotech and pharma, so small innovative spine entities find it nearly impossible to raise money to support MISS innovation. Larger spine entities rely on the innovation of smaller companies to sustain their technology pipeline (through acquisition of the smaller innovators) and ultimately provide the competitive edge for their future. I believe it is in their own self-interest for larger profitable companies to expend a substantial portion of their profits on investments in smaller spine entities (as “strategic partners”). These larger companies need to fill the investment gap associated with the exit of venture capitalists from medtech in general and particularly spine, as the “well was poisoned” with the abysmal failure of prior motion technology investments.

What do you realistically expect to see next in the use of robotics and sensors? What does the future mean for device companies, and how will implant design evolve as robotic, sensor-based and computer assistance technologies advance?

Martin Roche, M.D., Founder and Chief Medical Officer of OrthoSensor | Interviewed in 2018
The progression of tactile electronics, augmented visual reality devices and robotic automated processes will drive this integration in the next five years. We need to incorporate data-driven artificial intelligence to select the patients appropriately, and then customize the procedure to the individual patient with algorithmic machine processing. The surgeon still wants to operate, but if this technology makes the procedure more consistent, efficient and generates improved outcomes, the patients will request it and surgeons will utilize the data to potentially develop the next surgical procedures and personalized implants.

I have had the good fortune of working with hundreds of engineers over the last 20 years. The evolution from plastic and metal processing has really accelerated in the orthopedic sector. Teams now consist of biomechanical, biomedical, bioenergy, bioinstrumental, biomaterial, electrical, medical imaging, software and robotic system engineers. The early integration of clinicians, rehabilitation and economic experts is now critical. The future will then extend into bioengineering, in which the bioimplants will challenge the molecular and genomic aspects of disease in a personalized manner.

The data from all of these processes will revolutionize orthopedic care into defined pathways, with predictable outcomes. The next-generation technologies may define and regulate a disease process through stem cell and regenerative processes. Through all this rapid evolution, the clinician must take a leadership role. The successful innovators will focus on bridging the human experience into this technological evolution.”

What market forces are driving value-based healthcare? What do engineers and their executive leaders at companies of every size in orthopedics need to learn and embrace about value-based implants?

Peter Althausen, M.D., Chairman and Treasure of Orthopaedic Implant Company | Interviewed in 2018
The majority of orthopedic devices have now become commodities. Devices coming to market today have not demonstrated improved outcomes, yet carry hefty price tags that are unaffordable for the majority of hospitals and patients. Clearly there’s no winning argument to pay more for devices that do not improve outcomes. Furthermore, the overwhelming majority of these new and expensive implants are approved by FDA through the 510(k) process, which by definition means that the device is “substantially equivalent” to similar devices on the market and in use today. Health insurance companies and the government are now realizing this fact, creating market forces that are driving better value for our healthcare dollars.

Companies must accept that the value-based market is here to stay. Generic medication has done wonders for saving patients money. While a specialty plate or nail might prove to be beneficial for outlying indications, the majority of devices used in the most common cases for internal fixation are generic in nature and should be priced accordingly.