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Minimally invasive surgical (MIS) products are a staple of today’s spine company portfolios. In anticipation of new devices to be launched at the NASS Annual Meeting, we asked James F. Marino, M.D., a thought leader in MIS and founder of companies NuVasive and Trinity Orthopedics, about the technologies.
BONEZONE: What are your thoughts on the current state of minimally invasive spine surgery?
Dr. Marino: While a number of progressively less invasive techniques are gaining popularity and have provided iterative advances in reduction of blood loss, infection rates and post-operative length of stay, these gains have generally occurred with greater surgical challenge to the surgeon and increased patient and physician x-ray exposure. In general, the field has not provided dramatic alterations of intensity of care (inpatient to outpatient conversion, open to percutaneous incisions), and the cost benefits/ROI associated with generally more expensive minimally invasive spine surgery (MISS technology) are not overtly evident (except perhaps to the advocates of these techniques).
BONEZONE: What opportunities and challenges lie ahead for MIS?
Dr. Marino: 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. 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 health care 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.
BONEZONE: How can surgeons capture these opportunities?
Dr. Marino: As in all human endeavors and industries, there are leaders and followers. Our most creative colleagues must familiarize themselves with evolving developments in procedural enabling disciplines, such as molecular biology, materials science and applied physics, so that they can incorporate advances in these disciplines in novel biologic and electromechanical surgical interventions. All great advances begin with the imagination and astute observations of an inventive mind, and invention is simply imaginative problem solving.
For the non-innovative surgeons, it’s important to pay close attention to the “fringe elements” that promote new concepts in MISS. These practicing colleagues must challenge the innovators to provide initial scientific justification for their ideas and then support a measured objective process for evaluating the outcomes of these new techniques. Avoid irrational adoption. I can remember NASS meetings in which one could not get into the lecture hall, packed with colleagues expressing unbridled enthusiasm for new and scientifically unsound technology (remember intervertebral disc thermal modulation, or “cooked discs”?). In my opinion, the theory and science was lacking or incomplete at best, and the advocates as well as the audience were insufficiently objective and lacked healthy skepticism.
BONEZONE: What is the role of device companies in the progression of MIS?
Dr. Marino: 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.
When I started NuVasive and first suggested the trans-psoas approach to the lumbar spine, we had no idea how important this MISS approach would be for the company and the field at large. The company, and those such as myself, had much to learn about the demands of this procedure and some of the lessons were very painful. Eventually the merits of the procedure proved to be worth the “costs” associated with development, and it became the bedrock platform for a very successful company.
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.
BONEZONE: What most excites you about the spine industry today?
Dr. Marino: It would have been hard to imagine how MIS techniques in the extremities would supplant so many of the open orthopaedic procedures I learned as an intern or resident 35 to 40 years ago, not to mention the completely new associated diagnostic and therapeutic interventions. We can and should expect that the same level of innovation will occur in the spine. There are no limits to what might be realized when a curious and imaginative mind, one well versed in the pathophysiology of spine disorders and aware of increasing understandings associated with biologic processes, advances in material science, and innovations in applied physics peers into the future!
