2013 CTSI Annual Pilot Awards to Improve the Conduct of Research

To facilitate the development, conduct or analysis of clinical & translational research

An Early Translational Researcher’s Framework for Health Economics Evaluation

Proposal Status: 


Economic considerations are important in determining the development and use of a new technology in any scientific field. This is particularly true in healthcare, where overall spending in the U.S. is at an unsustainably high rate, thus making cost consciousness imperative in the development of new technologies. Researchers who desire to translate new understandings of disease mechanisms into commercially viable methods of diagnosis, therapy and prevention often neglect or struggle to incorporate health economics into the assessment of the potential value of their innovations. We propose to develop a framework for health economics evaluation, with insights, tools and relevant case studies, specifically targeted to support the research and development goals of early translational researchers. The primary objectives of the framework are:

  • to highlight some key economic factors that lead to the adoption or rejection of new technologies into clinical practice, and
  • to help researchers better frame the potential economic value of their innovations

Supporting an Unmet Need

In the Catalyst Award Program at UCSF CTSI, early translational researchers receive targeted advice on product development and commercialization strategies, in addition to seed funding. These key insights, provided early in the translation process, have often led researchers to significantly recalibrate their research and development goals and approach to maximize the potential clinical and commercial success of their innovations. Health economics and cost-effectiveness are consistently raised as critical issues in the potential success of new technologies reviewed in the program. A complete economic evaluation of any proposed technology is far beyond the goals and capabilities of the program. However, an accessible framework that  provides key insights, tools and case studies to help researchers understand the contributing factors to the economic evaluation and adoption of new technologies, would be invaluable.


An Initial Pilot Project Focused on Medical Devices

Since the proposed framework will be driven by a limited number of case studies, we will maximize its value by initially developing and validating our approach for medical devices. If successful, a similar approach will be used to develop frameworks for therapeutics, diagnostics and digital health technologies, with the expectation of shared and technology-specific elements within each framework.

We will leverage the knowledge of key experts in health economics and policy as well as  technology adoption at UCSF. Additional independent experts in health economics, cost-effectiveness, reimbursement, and new technology assessment will also be identified and consulted.

  • Pilot Evaluation: A panel consisting of UCSF and external experts will initially be convened to discuss how early translational research projects can be best evaluated using the limited resources available to researchers. The panel will recommend and evaluate up to 5 medical devices whose development and successful (or failed) clinical adoption can be used to highlight important aspects of health economics.
  • Draft Development: The output of these reviews will be translated into the first draft of a framework for economic evaluation and is expected to include case studies, methodologies, templates, and resources.
  • Rapid Testing: This draft framework will be pilot-tested with 5 UCSF researchers involved in medical device projects that have been reviewed by the Catalyst Program. Their experience with the framework and their resulting economic evaluations will be assessed and discussed by the expert panel.
  • Finalize: The results and assessment of the pilot study will be used to develop a final framework for broader distribution.
  • Distribution: The final framework will be distributed through the Catalyst Award Program, The Center for Healthcare Value, and other CTSI and UCSF channels, other CTSA network channels, and outreach to relevant publishers, etc.

Short and Long-Term Success Metrics

The short-term success of this approach and of the framework will be determined by the results of the pilot study and the content of future Catalyst Award applications. Long-term success will be measured by the ability of researchers to better understand and incorporate economic factors into their translational projects. Project tracking and feedback mechanisms within the Catalyst Award Program will be used to monitor and evaluate such measures.



This project will be seeking to include a multidisciplinary group of health economics stakeholders, including key researchers at the Institute for Health Policy Studies at UCSF, health economists, reimbursement and technology evaluation experts. Lisa Schoonerman and Ruben Rathnasingham, who will lead the project, have extensive healthcare product development and commercialization experience. This pilot project, focused on medical devices, will require a budget of $15,000 for consultants, meeting expenses, production and promotion.


Intriguing, but you may need to be more specific about what it is you want investigators to better understand as they develop their early translational discoveries.  For example, you talk about 'economic value' but I'm unclear what exactly you mean.  Do you mean that you will be providing tools for investigators to understand how their intervention will or will not provide value were it to be successful (benefit/cost)? 

Mini, thank you for comment. You make a great point. We will work to better articulate our objectives over this open improvement phase.

Investigators generally appreciate the value and importance of a cost/benefit analysis. What is not as broadly understood is the many factors that contribute to ‘cost’ and ‘benefit’, and how these factors potentially affect the decision to adopt new technologies into clinical practice. Our goal is to develop a framework that provides key insights and tools to improve this understanding, and empower early translational researchers to ask the right questions that will guide them in maximizing the clinical and commercial success of their innovations.

This looks very intereting and will be a new service for UCSF investigators.  Once you are ready to start providing the consultation, please consider partnering with Consultation Services.  We could assist in the promoting, provide on-line request forms and track the scope of consultation over time.

Alice, thanks for your comment. Our hope is that this framework will inform researchers of some of the economic considerations that go into the decision to develop and commercialize a product. The framework may help them with a preliminary assessment of their projects, but most importantly, it will empower them to think through potential challenges and opportunities, and reach out to the many resources at UCSF, such as the new Center for Healthcare Value, for feedback. In that regard, we would love to get your support on any resulting consultations.

I agree that this would be a very useful tool for projects that are aiming to improve health care value.

It would help to provide a little more information about the conceptual framework for what you are proposing. For example, what are the dimensions of the key inputs and outputs?  Who are potential experts at UCSF and elsewhere that could be tapped to provide input in these areas.  It will also be important to specify from which perspective you will be forming the economic analysis/model... e.g. the health care organization that adopts the device, the insurance company that pays for the device, society at large, or the company that will be formed to manufacture and sell the device?


Thank you for your thoughtful comment and insightful questions.

As you mention, the idea of providing translational researchers with a resource to help them better understand the role of health economics in the development and commercialization of their innovations would be very valuable. We see this question arise in most of the projects we review in the Catalyst awards program.

However, we also understand the broad scope of this issue, and the proposed pilot framework will necessarily be limited in scope to:

  • a resource targeted to medical device researchers (one of the four categories in the program: devices, diagnostics, therapeutics, and digital health)

  • a pilot resource built on the needs of a small, but representative number of UCSF medical device research projects

  • a resource that provides sufficient information and insights for researchers to understand the perspectives of key stakeholders, and to help them begin adopting these perspectives into their research projects.

Potential key inputs: A set of inputs will be initially proposed and then prioritized by the expert panel. They will include clinical and market need, target indication and market size, product claims, estimated product development resources, impact on risk/benefit profile, existing solutions, reimbursement profile,  delivery profile, and other factors that key stakeholders consider, and are accessible to researchers at UCSF.

Potential key outputs: key stakeholders, their objectives and dependencies. Top level description  of health economic assessment methods and tools used by key stakeholders. Case studies that highlight how these tools are used. The output may take the form of decision trees, flowcharts and interactive workbooks.

Potential UCSF experts include leaders at the Center for Healthcare Value and the Institute of Health Policy Studies, such as yourself, and others, who can not only help guide the creation of the resource, but also how it is delivered. We also hope to engage with key decision makers at the Medical Center. Outside UCSF, we will involve leaders from the medical device industry, and representatives of private and public payors. We have engaged with some potential panelists through our work at CTSI, and our first task will be to identify individuals who are available to help.

Most of the researchers we work with are not primarily focused on improving health care value. They are often driven by the effectiveness of their innovations and the potential to improve health. The impact of health care value on the development, adoption and delivery of the innovation is often misunderstood or ignored. Our goal is to engage these early researchers by positioning health care value as a key factor in determining the likelihood that their innovations will get the required support at every point in the research, development, commercialization and delivery value chain. We believe that this approach will require the identification and some consideration of the perspectives of all key stakeholders.

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