Tom Sudow: Why isn’t My Digital Health Innovation being Accepted by the Market?

New article by Tom Sudow on MoneyInc

  Read original post on MoneyInc…

Shh… I want to tell you a secret, the answer to unlock your world of commercialization of your  new digital health technologies, your entry into a $51.3b market. So, why can’t you get past the gatekeepers and decisions makers with digital health innovations?

The world of medical innovation revolves around the diagnosis and treatment of patients. How does your product greatly improve patient care and patient outcomes? With this caveat – your innovation must be significantly better than the current gold standard of treatment at a greatly reduced cost. It must improve patient outcomes, while taking cost out of the system. How does you innovation improve the continuum of care? As an example, you sensor which can measure a parameter does not mean the parameter greatly improves the continuum of care or is of true value.

Two things to always remember about healthcare innovation – it is highly regulated by the FDA and most payments are in the form of reimbursements and reimbursements for the most part are fixed. So, the hospital or doctor will receive a fixed payment for a service and if costs are added, they can lose money. Losing money is a No NO in most businesses and healthcare is no different.

So you still think that you have a breakthrough innovation, it must meet three criteria to be taken seriously-

  1. It must be scientifically proven, for the medical world that will mean proof. Evidence based decision making places a high priority on the use of scientific evidence from well-designed and conducted research. Medicine is based on science and requires empirical support to prove the value of the innovation. The innovation will need to go through some rigor to prove its scientific data. You cannot rely on anecdotal evidence.
  2. It must be medically relevant it has to change the standard of care and improve how the disease state is treated, by greatly improving care. Again this will need to be proven. Further it will require a strong business case. How does your device improve the continuum of care and greatly improve clinical outcomes? Marginal improvements are not going to make it.
  3. The innovation must be commercially viable. You need to be able to prove you can make money following all of the development and that market is robust enough to produce sales. Further, that you are not selling a commodity but have something of real value which address a large market need. You need to understand the supply chain and how to access that supply chain. And you must be able to show that it has passed all regulatory hurdles – you have an approved product. Last, you must demonstrate there is third party reimbursement available for your product or that someone will pay for it out of their pockets.

These are the bars that you will have to achieve. Understand the need that you are trying to solve and understand if your solutions solves the specific problem or gap in the continuum of care. Work with medical professional to understand their needs and their current process and let them help you determine how your innovation truly solves their problem.

Unlike the IT world, disruptive innovation in healthcare tends to be more evolutionary than revolutionary. Clayton Christensen, who wrote the book on Disruptive Innovation, notes “Health care may be the most entrenched, change-adverse industry in the United State. The innovations that will eventually turn it around are ready, in some cases-but they cannot find backers.”

With this understanding, where are important trends to understand in digital health?

The only way to satisfy the opportunities in the healthcare industry is by proving – scientifically validity, medical relevance, and commercial viability. It is not about anecdotal data, it must be scientifically proven and that remains the key for entry into the industry.