From Clinical Care to Coverage: How a Pitt Graduate Is Helping MedTech Innovation Reach Patients
As a clinician specializing in prosthetics and orthotics for over a decade, Evelyn Rizzo, helped patients work towards their unique mobility goals for independence. “It was really fun for me to get to know someone and see their needs,” said Rizzo.
In this work, Rizzo was limited in what she could do when a potential innovation that would help patients was not covered by insurance, even if it was the best option. At the same time, she saw MedTech companies developing new technologies struggle to prove the value of their innovations to insurance companies.
“During more than a decade in clinical practice, I saw patients denied advanced prosthetic technologies, even if it was on the market for 20 years. Not necessarily because the technology lacked promise, but because the evidence needed for insurance coverage had not been developed or communicated in a payer-relevant way.”
Closing the gap between healthcare innovation and real-world patient access requires evidence that addresses payers', clinicians ', and patients’ questions on technology outcomes. While Rizzo was trying to collect patient outcomes and prove that patients benefit from technologies on the fly, it left her wondering why she needed to look for all this evidence when she should be focusing on the patients.
“I was at a conference when I heard the magic words: health economics and outcomes research, also called HEOR. I thought, Wow! That’s what we need to make sure patients have access to these technologies, and I decided to get a degree in health economics and outcomes research.”
Now, Evelyn Rizzo, CPO, MS-HEOR, a University of Pittsburgh graduate (in the first class of the MS-Prosthetic and Orthotics degree in 2011), is the founder of Mobility HEOR, a patient-centered health economics and outcomes research consulting practice. “I help medical technology startups develop the clinical, economic, and payer-relevant evidence needed to support U.S. reimbursement, adoption, and patient access,” said Rizzo.
Patient Use or Insurance Coverage: What Comes First?
So how are Food and Drug Administration (FDA)-approved devices available in a doctor’s office, but not covered by insurance?
Rizzo explained that while the FDA reviews whether a device is safe and if it does what it says it will do, FDA approval or clearance does not automatically mean that a medical device will be covered by insurance. Medicare and other insurers make separate coverage and payment decisions. Companies need to understand the relevant coding, coverage, and payment pathways and develop evidence that addresses payer requirements.
This means that a health innovation may be available if patients or clients are willing to pay for it before it is covered by insurance. “There is also the need for clients to use them to understand outcomes, and sometimes patients will face out-of-pocket costs when it is available but not covered. That is why it is important that the company build evidence early to prove that it is different than other technology on the market. That is why there are products that health care professionals know about or can access, but insurance won’t pay for,” said Rizzo.
It is a bit of a ‘which comes first?’ scenario: the insurance coverage or the outcomes evidence.
“That is where we can start building evidence as soon as possible,” said Rizzo. Even before there is evidence for a product, Rizzo shares that founders can take certain actions, such as reviewing the current literature to see what has already been reported on the costs, burdens, and outcomes of an innovative product. “This is meaningful information for the hospitals, insurance, and payers. To really know it is really a problem before building a prototype and continuing to innovate, to make sure this is a problem worth a solution for,” said Rizzo.
Applying Lessons Learned from the Pharma Industry
After earning a master's degree in HEOR and while working in MedComms at an agency in New York, Rizzo learned how to develop and communicate clinical and economic evidence to support reimbursement and market access.
“Pharmaceutical companies have much larger budgets, and I wondered how I can bring these rigorous, evidence-based methods from pharma into practical and affordable strategies for MedTech founders. And what MedTech founders can do early, early on to identify this value.”
A few ways Rizzo does this with Mobility HEOR are to review reimbursement codes, identify similar or competitor devices, and conduct early-stage reimbursement assessments, which can help MedTech companies think about and communicate in their pitch decks how their device will be reimbursed.
Rizzo shared that Mobility HEOR now works with both pharma clients and MedTech startups, even in their pre-seed phase. “A lot of startups don’t have a full picture of the population or therapeutic space. “Really defining the patient population can do wonders for your value story”
As a former clinician, Rizzo always has in mind the people who may benefit from the healthcare innovation being explored.
Patient Stories Are at the Heart: Your Evidence Story
Based on her work with MedTech founders, Rizzo sees how many who are passionate about health innovation have had an experience either personally or for someone they love. “They’ve experienced something that shouldn’t happen again; and they see how something different should happen,” said Rizzo.
On the other hand, engineers with ideas for how to make something better may not have provided clinical care, but their ideas are needed. Rizzo asks, “How can the engineers' ideas translate to the patient and healthcare setting?”
While health economics and outcomes research focuses on numbers, costs, and data, Rizzo highlights that patient stories and keeping patients centered in research questions are essential.
“As a clinician, I would make decisions with a patient-first mentality. I think we can take this approach to the beginning of MedTech innovation, to make sure this technology will help the patient.”
Rizzo shared the importance of understanding the patient, as well as who is taking care of the patient and who is paying. “Making sure that when you are entering the MedTech space, that patient stays at the forefront of your mind, innovating, networking with investors, to make sure patient stays there, that’s my clinician’s heart,” said Rizzo.
For those working in MedTech companies, Rizzo advises founders to explore their ideas for HEOR “as early as possible.” Rizzo highlighted, “When you think, ‘I’m going to need an investor, that might be a good signal. Investors will want to know more about the value your innovation will provide and if you’re going to build a prototype or ask people for money, make sure you understand the problem space.”
Rizzo added that a few ways that innovators can start to learn about a problem and potential solutions and outcomes are to first present abstracts and posters, attend conferences, and talk to people working in that space and potential buyers. Investors will ask, “Who will you sell to?” and doing this initial, background exploration will provide a much better idea for investors.
“You need to be at the forefront of your evidence story, understanding your customer and the value you bring to a problem,” said Rizzo.
How AI Can Accelerate HEOR Evidence Synthesis for MedTech Innovation
While uses of AI in the doctor’s office and medicine are still being explored, AI can help accelerate bringing new technologies from concept to patient care in HEOR research.
For example, Rizzo explores using responsible applications of AI to accelerate evidence synthesis and research workflows while maintaining human clinical judgment, methodological rigor, and transparency.
“There are cool tools to help with evidence development and research synthesis such as AI-assisted literature review software. With this software, you can run the search and extract outcomes you are looking for, helping founders begin to explore research questions. They support, but do not replace, expert interpretation of the evidence, and they are a great way to get a first answer,” said Rizzo.
Rizzo shared an example from a project. ”A literature search for one of my projects identified over 2,000 abstracts. Each needed to be assessed for relevance before deciding which papers should undergo full-text review. AI-assisted tools supported that screening process as a second reviewer, while I retained responsibility for the final screening decisions and interpretation of the evidence.”
Conversely, for uses of AI in the doctor’s office, Rizzo proceeds intentionally and said, “With AI, there have been a lot of people coming up with AI products that reduce clinician burden, such as with AI-assisted notetaking or coding. I encourage founders to really understand the patient’s journey, clinical workflow, and care setting, not simply a billing or coding opportunity.”
Bridging the Gap Between Health Innovation and Patient Care
On moving from being a clinician to now helping patients through HEOR consulting, Rizzo said, “I had so much enjoyment seeing patients on a regular basis, but I also had a constant frustration about insurance denials, trying to justify what I saw was so obvious, and having to try things that wouldn’t be best for someone. Once I learned about HEOR, I saw I could impact every single person with that technology in a different way, through helping to support the collection of evidence, so these technologies can have a positive impact.”
While Rizzo shares that she misses seeing people walk for the first time and being part of their lives when they are patients, she hopes that through Mobility HEOR she can help companies address evidence gaps and reimbursement barriers so their technologies have a stronger path to the patients who need them.
With a clinician's heart and experience, a founder’s hustle, the love of learning new things, and knowledge of value, insurance, evidence, and outcomes, Rizzo bridges the gap to help MedTech Innovators understand how to reach patients. Rizzo said, “I’ve helped research and engineering students with abstracts and to understand the patient experience.”
A core element of this work is helping Mobility HEOR clients to truly understand their patients' story and centering the work, value, and offer on the patient. It’s not just about making something new to make money; it’s about getting a healthcare innovation to someone who needs it for a better life.
“The ultimate goal is to make healthcare better for everybody,” said Rizzo.