The Unmet Clinical Need
Written by Paul Tessier
A common refrain heard by healthcare entrepreneurs is that they should focus on satisfying an “unmet clinical need,” however there is no universal definition of the phrase, “unmet clinical need.” Even established companies and public healthcare agencies, who use the concept of an unmet clinical need to assist in developing product roadmaps and healthcare policy, respectively, frequently struggle to gain consensus. The reason is that there are degrees of need, and the perceived importance of a need varies across the many stakeholders in the healthcare ecosystem.
It is generally agreed upon that there are three essential elements to consider in assessing an unmet clinical need; adequacy/availability of treatments, disease severity or burden, and size of the affected population. Related to the adequacy of treatments is the benefit of a newly proposed solution over the current treatment. Payers and value assessment committees are typically not willing to pay for an incremental increase in benefit over the existing standard of care. Diseases with high severity (e.g., morbidity & mortality) and high burden (e.g., frequency & cost of hospitalization) tend to get more attention and are considered more attractive needs to address. Lastly, the size of the affected population typically relates directly to the size of the business opportunity and impact of the product.
While healthcare entrepreneurs strive to have a positive impact on patient care, achieving that goal is only possible if they are addressing a “business-viable” unmet clinical need. This is where the product addressing the unmet clinical need can result in a profitable product-line or business. Patients, clinicians, and payers may be the target customers for your product. Still, you have other “customers” to satisfy as well – namely granting agencies and investors who will be looking at the business viability of your plan.
Not every unmet clinical need is a business-viable unmet clinical need. However, it is still essential to start your entrepreneurial pursuits by assessing unmet clinical needs. There is tremendous opportunity in many fields of healthcare for new devices, diagnostics, and therapeutics.
A new device that significantly improves efficiency and reduces costs, such as allowing treatment to move from in-patient to an out-patient procedure, will be welcomed by patients, clinicians, and payers alike. However, a new device that provides only incremental improvements will likely be challenging to get past value assessment committees or adopted by clinicians.
A new diagnostic test will be embraced if it enters a clinical domain and market that was unserved or poorly served, and it improves the quality of medical decision-making and treatment. However, a new diagnostic test may be limited in acceptance if there is no effective treatment to implement when a diagnosis is made with the new test or if the cost of the test is too high.
A new drug that improves treatment and patient outcomes in an underserved clinical domain and market is likely to be adopted quickly. However, a new drug may be adopted slowly, even in a poorly served market, if it is crowded with established standard treatments. Treatment guidelines, conservative physicians, and payors may require that patients exhaust existing treatment options before trying the new drug.