Assessing the viability of future medical technologies can be a complex task, as it involves considering various factors such as scientific advancements, regulatory frameworks, ethical considerations, economic feasibility, and societal acceptance. This provides a general framework for assessing viability.
1. A solution to what? Successful transformations solve a problem, although sometimes the problems are not recognized until the innovation has been widely deployed. Unfortunately, many times a new device has been invented that may perform a function well but there is no problem that it solves. So the first questions should be: what problem does it solve; what is the need? Is the problem growing and what is the size of the need? Look at the competitive landscape and whether there are similar innovations already available. How does this innovation compare to existing solutions?
2. Does it work and is it safe? Documenting efficacious outcomes requires research such as a clinical trial, which shows significant and consistent positive change. Whether it means improved patient health, reliable or more precise diagnoses, reliable predictors, or sharper and detailed data are available for diagnosis. Look at the evidence supporting the innovation, including clinical trials, case studies, and other research. Is there sufficient evidence to support the effectiveness and safety of the innovation? It is important that outcomes are measurable and consistent and that it meets positive outcomes as intended. What are the adverse effects? Documenting any harm or negative side effects to the patient, the providers or the health system. Finally, will it do it at least as well as other current alternatives?
3. Accessible User-friendly is a well-worn phrase that is very significant for technology. Innovations are nothing without the ability of users to use them. Testing with user feedback is the only way to ascertain whether the innovation is relatively easy to use for the intended customers, whether it be doctors or patients. For elderly or disabled patients such testing is even more important.
4. Ethics It’s important to consider the ethical implications of the technology, including issues related to privacy, data security, and equity.
5. Is it a cost, neutral, or a revenue? Cost is a critical factor in all of healthcare. Costs include the purchase of the technology, the cost of installation and, if applicable, the cost of integrating with existing systems, work flows, and software. Ongoing costs include the related cost of provider services as well as annual maintenance and licensing costs. Of course, who pays for the costs is important. Insurance, health system, providers, and patients could cover some of all of the costs. Measured it with the revenue created. Ideally, the initiative with generate cost savings. Will the innovation be financially viable and create net cost savings for the system, the provider, or the patient? Will the results be achieved faster than other alternatives?
6. Market potential. Given an acceptable price point and regulatory approval, what is the potential market? A great solution to a niche problem in medicine will impose a ceiling on potential sales and revenue. High cost for a product that has limited usefulness can prove to be fatal.
7. Financing. Going from an idea to transforming medicine takes more than a pencil and paper. How much will it cost to make this a go for the early, medium, and final stages of the effort. It’s not enough to cover the costs of the software or equipment. Coving ongoing costs of provider services and maintenance is often what makes an innovation a success. Acceptance by health systems and health providers requires payment for their services. Payment by insurers, employers or consumers requires assurance that the innovation works well, is a better alternative than existing services and can generate revenue. Consider the long-term sustainability of the innovation, including its economic viability. Identify them with supporters recruited and efforts to convert those in opposition.
8. Will they let it? Some of the best ideas with medical technology have been derailed by a lack of understanding of government regulations. The lack of approval by FDA, violation of established state medical and pharmaceutical board practices rules are a few of the stumbling blocks hindering sincere efforts to transform medicine. A better mousetrap will never come about if laws and regulations stand in the way. Who are the champions? Who or what loses with such transformation? What enemies will it create and do they have the ability to thwart the initiative?
9. You can build it but will they come? Consumer/patient acceptance is often a combination of the product’s recognized worth, usability, trust, and reliability. Consider the perspectives of various stakeholders, including patients, healthcare providers, payers, and other relevant groups.
10. How fast can you grow? Failure by success is a real problem in technology innovations. It is not unusual for a company to fail because there is no ability to ramp up to meet a surge in demand. What’s the plan for moving from start-up to rapid growth?
11. Will it change healthcare? Consider the potential impact of the innovation on patient outcomes, healthcare delivery, and the overall healthcare system. How will it change/improve current practices? Any significant shifts in the way healthcare is delivered can be welcomed or opposed, by various stakeholders.
It’s important to note that assessing the viability of future medical technologies is an ongoing process, and factors influencing viability can evolve over time. Therefore, continuous monitoring and reassessment of technologies as new information emerges is essential.
An important goal of the Transformational Healthcare Initiative (formerly the Partnership for Artificial Intelligence, Automation and Robotics in Healthcare) is to be a change agent to anticipate, conceptualize, identify, and foster next generation technology innovations leading to the transformation of the existing healthcare system. Assessing medical technologies role requires a framework in which to judge breakthroughs and the potential to go from idea to reality. This summary includes some of the critical areas that will be used.