Written by Josh Tolkoff
The most common reason for the commercial failure of a start-up entity is not having a compelling clinical need. What exactly is an “unmet need”? An unmet need is something more than an incremental improvement, and once it exists in the market it will make a substantial change for the better.
How do we find the unmet need? The most effective method in finding a compelling need is to observe current clinical practices or work with healthcare practitioners who can observe for you. Invariably, the open-minded, objective observer will know, recognize and discover many suboptimal outcomes. Examples such as procedures that cost the healthcare system more in time and money than necessary, or make the procedures performed by trained healthcare professionals less successful, and of course – things that cause unnecessary morbidity or mortality to the patient.
How do we develop a broad need statement? We often see in our B-BIC grant applications that the researcher has selected their strategic clinical or research focus area. Often, they have developed a technical solution to an existing problem. In addition, they may have confirmed with a few colleagues that their solution solves a real problem. While this is a great beginning, this is not adequate to assure that the presumed need is worthy of years of work to bring a commercial solution to market! Understanding, screening and finding the unmet need is a necessary process of studying the problem.
For example, a need statement that asserts, “a catheter that won’t get infected” isn’t enough. Do you mean all catheters or just urinary or intravenous (IV) catheters? If so, do you mean short-term or long-term catheters? Is the problem equally worthy of solving if it’s for infants in the hospital or the intensive care unit adult patient? Is the problem really the catheter, or might there be broader ways of looking at the clinical requirement? What about ways to deliver or drain fluids that don’t need a catheter at all? What about a special light source that can kill any bacteria that gains access to the catheter via the insertion site?
Think about the fundamental objective of the device, therapeutic, process, procedure, diagnostic, etc. and broaden your thinking about innovative ways to completely change the nature of the problem. In this way, more compelling and broad-based solutions can be considered that meet the compelling need.
Cardiac pacemakers traditionally have been designed as a small battery/electronics unit placed under the skin in the chest or abdomen and attached electrical leads conducting the electrical signal from the pacemaker battery through the cardiac anatomy to tip electrodes embedded in cardiac tissue. Companies have worked for years improving the leads which tended to wear out, had insulation failures due to fatigue, developed thrombus and created clots. A typical need statement might have been, “better pacemaker leads”, or “less thrombogenic leads”, or “longer lasting insulation on leads”. One company asked the more fundamental question, resulting in a broader need statement, “Means to provide an electrical signal to the heart tissue”. They developed a miniature pacemaker, so small that the battery, electronics, and electrodes are a single unit that would be implanted in the heart using a catheter introduction system.
The broader need statement allowed the innovators to consider game-changing solutions, even in a product that has been in use for over 60 years.
Observe, write down problems, broaden your thinking to develop need statements. Then talk with many stakeholders (patients, clinicians, hospital administrators, hospital purchasing agents, insurance providers, etc.) to better understand the need, and determine what kind of solutions would fit in the current clinical environment.