Categorically and fundamentally, ST is novel—novel in its underlying theory, novel in its mechanism of action, and certainly novel in its results. Some people believe that it’s “too good to be true.” In which case it’s easier to dismiss it than adopt it, particularly if it challenges status quo thinking and might have an impact the economics of that status quo.
When my business partner, Dave Farley, MD, and I ordered our first ST device and opened our first pilot clinic in February 2014, we did not intend to try to seek exclusivity for the technology. Yes, we thought we might have the basis of a better business model, but we had three initial priorities:
- To prove the technology actually worked as well as we hoped it did. Since then, we have learned so much and actually believe that it is better than the studies and other outcome stories previously illustrated. But we know with equal certainty that it has to be done the right way—there are clearly more effective ways of treating patients and consistency in outcomes that are born solely from understanding, learning, and following the right protocols of care and delivery.
- To figure out a pricing model that would make therapy affordable despite a lack of insurance coverage, and still allow us to build a viable company. This was a learning process, but we have done this in a creative way, which probably could not be replicated in any other care environment. Therapy is affordable and accessible, and the company has a sustainable revenue model.
- To see if we could create a foundation upon which we could eventually scale the solution more broadly. After years of clinical practice and many hundreds of patients treated in our pilot operations, we have done the work, put in the time, and learned by doing it, giving us confidence and knowledge about what works and what doesn’t. Our business solution, though equally novel to the innovative device we use, creates a strong foundation for scale and growth.
A New Business Model for a New Therapy
Even before Dave and I opened Radiant Pain Relief Centres, I had already concluded that we needed to create a new business model if we were to effectively commercialize the technology. I had witnessed firsthand a few years of impressive outcomes, and also heard positive reports from clinicians, other demos, and clinical studies.
As a result, I began to believe that the primary issue holding back ST was not product viability, but the model through which it was distributed. This realization got me thinking and exploring the obstacles, examining whether it was possible to engineer a solution that could overcome or mitigate these obstacles.
Broadly speaking, the obstacles fell into three categories:
FDA Clearance
When the former licensee took ST through the FDA clearance process, they wanted to save time and money. To make this novel, innovative therapy comprehensible to the licensing board, they categorized it with TENS therapy, naming the ST machine “Scrambler Therapy MC-5A TENS Device.” This facilitated the process, but confused people as to what ST actually is.
This confusion hindered doctors’ understanding of the therapy of and made it difficult to secure a level of insurance reimbursement commensurate with the actual cost of treatment. ST doesn’t fit into doctors’ understanding of chronic pain treatments (the mechanism is different) and it doesn’t fit into insurance companies’ understanding of legitimate treatments (it’s more expensive but more effective than TENS). These factors mean that ST was at a disadvantage from its inception.
Economics and costs of delivery.
In the years that I was associated with the former licensee, the retail price, (the price that a clinician paid for an ST device) fluctuated considerably. When I began marketing the technology, the retail price was around $80,000. Over the years, the licensee increased this price to more than $100,000.
Had there been demand for ST, this price might have been viable. In practice, the high price further stymied sales. For mainstream physicians, a retail price in the six figures and no viable insurance reimbursement is a difficult combination of factors. For a clinician to justify a fairly high-ticket price to buy a device, and to make money with ST, they’d have to be very comfortable with cash-model businesses, selling, marketing, and overcoming objections. Not only do physicians generally not have the time to do this, they typically lack both the appetite and the skillset to do it.
Physicians’ training, perspectives, and biases.
Physicians trained primarily in biochemistry receive most of their formal education in understanding drugs and the mechanism of action of drugs in the body. They are not typically trained in biophysics—so they find it challenging to immediately understand a biophysical therapy approach such as ST. Therefore, they find it much easier to dismiss it as “snake oil” or to wait and see how the technology evolves.
Few physicians are entrepreneurial. Few are sales and marketing oriented. And few are true early adopters. If they happen to be any of these things, the healthcare system, operating environment, and institutional rigidity—which all influence how they practice—make it very difficult for them to act in that manner. The combination of a costly piece of equipment that physicians aren’t trained to understand, a therapy that sounds too good to be true, and an economic model that makes little sense, make ST a difficult technology to market in traditional ways.
The good news, I realized, is that because no one owns chronic pain, no one could effectively own this novel therapy. The way was clear for me to create an entirely new delivery model. A model that resolved the licensing concerns because it put me and Dave in a position to educate patients directly on the value of ST. A model that addressed the economic challenges by allowing patients to pay by subscription. A model that sidestepped the objections of physicians by taking ST directly to patients.