Using Digital Health Tools to Strengthen the Doctor-Patient Relationship

Using Digital Health Tools to Strengthen the Doctor-Patient Relationship

Arti Thangudu

Meet Arti Thangudu, MD, an endocrinologist pioneering a new model of patient care.

podcast available

Dr. Thangudu is a triple board-certified physician and endocrinology, diabetes, and thyroid specialist at Complete Medicine. She takes an evidence-based approach to care, focusing on the patient and their lifestyle, and uses a membership-based model of practice.

Putting the doctor-patient relationship first

MDisrupt: Tell us how you turned from practicing physician to physician-entrepreneur.

Arti Thangudu: I completed my endocrinology fellowship at the University of Pittsburgh Medical Center. When I graduated, I landed my dream job as an attending physician at the largest endocrinology private practice in the world. I had tons of patients and was seeing more than 30 a day.

I came into medicine to take care of people, and I chose endocrinology because it’s very relationship-based. But with 30-plus patients a day, that relationship is broken down. I thought, “Is this what I see myself doing for the rest of my life?”

In this fee-for-service model, doctors get rewarded for seeing more patients. The quality of care does not get rewarded. Better-quality care takes more time. And it’s not what the healthcare system wants us to do. The incentives are for us to see more patients and order more tests because that brings more money into the system.

I just wasn’t about that. And so I started my practice, Complete Medicine, which strives to break down the barriers to healthcare that I saw in the insurance-based model.

MDisrupt: What is your clinic trying to solve?

Arti Thangudu: The breakdown of the relationship between physician and patient and the lack of pricing transparency. For example, you go to a doctor and you have no idea how much you’re going to pay or how much your insurance is going to cover. And you get a bill two weeks later, another bill two months later, another bill three months later. And they’re all way higher than you expected. My practice is membership-based. Patients have unlimited visits. They can call me, they can text me, they can email me between visits. We can do virtual visits, we can do phone visits.

And our prices are transparent. The patient knows on day one how much they’re going to pay. We have negotiated cash pricing on labs and imaging. Patients can use insurance if they want to, but our prices are usually about one-tenth of what they would be with insurance. And there are no surprise bills.

The patients have better outcomes when they’re working with a physician they can trust and lean on and reach out to when they’re having trouble. So with my diabetes patients, we’ve had stellar outcomes—lots of patients coming off insulin, reducing their need for medication, just getting overall healthier, because good care delivers good outcomes.

Lifestyle medicine: caring for the whole patient

MDisrupt: What is lifestyle medicine?

Arti Thangudu: Lifestyle medicine integrates evidence-based nutrition, exercise, management of stress, sleep hygiene, cessation of bad habits. When I was in private practice, I noticed that people weren’t getting better. As an endocrinologist, I knew that nutrition and diabetes go hand in hand. During my endocrinology fellowship, nutritional training, for me, was 30 minutes with the dietician. That is insufficient for any doctor, especially somebody trying to call themselves a diabetes expert.

I realized that if I was going to create a more patient-centered practice, nutrition had to play a big part. And so I got certified in nutrition. And I also got board-certified in lifestyle medicine. These are all such important things that are bypassed by traditional medical training. When you can teach a patient why they should make lifestyle changes, and can be there to support them, they’re much more likely to make the changes and get themselves to better health.

A life-changing digital health tool

MDisrupt: How do you incorporate digital health tools into lifestyle medicine for your patients?

Arti Thangudu: The majority of my patients have diabetes. We use continuous glucose monitoring (CGM). And it has been fantastic. With these CGM devices, we can see the patient’s blood sugar in real time. So I can see exactly what their blood sugars have been doing all day, and they can too. And they don’t have to use a fingerstick anymore.

Studies have shown the more times a patient takes a blood sugar, the better control they have, but more importantly, the better quality of life they have. And so now with these CGM systems, they can input what they ate. You can see exactly how foods, exercise, and sleep affect them and the patient gets real-time feedback.

I have informally studied my own patients. This is not a randomized controlled study. But I did a small study on patients whose intervention was continuous glucose monitoring and lifestyle coaching. And those patients dropped their hemoglobin A1c by 2% after three months. That’s like a 50% reduction in their risk of complications from diabetes. It’s also cost-effective. Every 2% somebody decreases their A1c, it saves the healthcare system at least $4,000 per year—although it could be much more than that. And in that little study, 75% of my patients who were taking insulin were off of insulin by the end.

It’s a huge improvement in quality of life, health, and cost. Can you imagine using this little tool, and then you go from four shots of insulin a day to none, just by changing your lifestyle? That’s really motivating.

Making digital health better

MDisrupt: What are some of the biggest challenges in digital health?

Arti Thangudu: One is the evidence base. There are a lot of at-home lab tests, or testing that you can order online direct-to-consumer. They say they’re evidence-based, but then when somebody who’s a physician or scientist reads that evidence, they can recognize that it’s not at all evidence-based.

A lot of healthtech products are done in a silo and the physician is practicing in a silo. There’s no connection between the patient’s physician and the technology. And physicians don’t know how to interpret the data given to the patient from these tech solutions. If the physician can’t help interpret the data, it makes the patient lose trust.

If there’s a solution that wants to be really big, we need to get the patient’s physicians on board. Or the tech companies need to have a physician that they can send patients to who understands that tech. If we work together as physicians and a digital health team, we can make these products all the more robust and meaningful for patients. Digital health has so much potential—we can’t alienate doctors from it, because it’s the future. We, as physicians, have to get on board, and we have to make these digital tools usable by both patients and physicians. We can do so much together.

MDisrupt: What is your dream digital health tool for lifestyle medicine?

Arti Thangudu: If we could integrate the continuous glucose monitor plus our patients’ dietary and exercise logs, and then create an AI-sourced daily feedback model for them, supported by a health coach or nurse and into the clinical model—with the physician in that same team—that would be amazing for patients with diabetes. I know there are tools getting pretty close to that, but it seems like still there’s a bit of limitation with the physician being part of the team.

Doctors and patients as allies

MDisrupt: What will the doctor-patient relationship look like in 10 years?

Arti Thangudu: My hope is that we, as a community, recognize the value of that relationship. And we as patients and physicians fight to get it back, because doctors and patients are on the same side.

Patients feel frustrated. They’re rushed through their appointment and they blame the doctor because that’s the person in front of them. We need to take a step back and say, “Well, the system is making this doctor have to see 35 patients a day to keep their office open.”

If that same doctor could be in a situation where they saw 12 patients a day, would they be able to deliver better care? The answer, 99.9% of the time is, absolutely. I’ll tell you a story. I consult for a company that takes care of retired police and fire. I have more time to take care of these patients because it is not an insurance-based clinic.

I saw a patient for hypothyroidism and pre-diabetes. After I spent 20 minutes with her, taking a really thorough history, she said, “Doctor, I have to tell you something. You’ve seen me before.” And I was like, “Really? When?” And she said, “In your old clinic. It was really rushed—I must’ve spent three minutes with you. I never went back because the experience was so bad.” I was horrified! I said, “I hope I can make it up to you.” She said, “You already have. I recognize that you were put in a bad situation. Now I’m really excited to be on this journey with you.”

The same doctor can be put in a bad situation or a good situation, and that’s going to affect the care they provide. And so for things to improve in the future, the system really, really needs to change. We as doctors and patients need to recognize that the system isn’t necessarily helping us and maybe move outside of the system until the system decides to catch up. And really be our own advocates.

At MDisrupt we believe that the most impactful health products should make it to market quickly. We connect digital health innovators to the healthcare industry experts and scientists they need to responsibly accelerate product development, commercialization, adoption, and scale.

Our experts span the healthcare continuum and can assist with all stages of health product development: regulatory, clinical studies and evidence generation, payor strategies, commercialization, and channel strategies. If you are building a health product, talk to us.

And check out our blog and services!

How Precision Medicine Can Transform Healthcare

How Precision Medicine Can Transform Healthcare

Bernard Esquivel

Meet Bernard Esquivel, MD, PhD,
a leader in precision medicine.

podcast available

Dr. Esquivel is a clinical immunologist-allergist and international business leader with expertise in developing new markets in genomics and precision medicine. He’s the founder and president of the Latin American Association of Personalized Medicine, ALAMP.

A passion for precision medicine

MDisrupt: Tell us how you turned your passion for precision medicine into a career.  

Bernard Esquivel: During my medical training, I learned about the role our genetic information can play in influencing disease development. Once I started practicing medicine, I tried to start testing my patients, and understanding their genes, and then find a way to implement that into my workflow.

That’s when I noticed that, number one, it was very hard to find [genetic] tests. Number two, it was very hard to access the information needed to understand and clinically implement decisions based on that information. And number three, my colleagues thought that I was talking about Star Wars or some dark science.

So, facing those barriers, back in 2014 a colleague of mine and I founded the Latin American Association of Personalized Medicine (ALAMP). The aim was to share knowledge to foster the implementation of precision medicine.

I interacted with a lot of key opinion leaders (KOLs) globally from different fields of precision medicine. And I learned how they were implementing precision medicine, pharmacogenomics, cancer molecular testing, health wearables, and so on. Long story short, for the last 12 years I’ve been 100% into precision medicine, to find a way to bring these fantastic new tools closer to the patients.

Precision vs. personalized medicine

MDisrupt: How do you define precision medicine, and how do you see it as different from personalized medicine?

Bernard Esquivel: If we use the definition that cancer.gov has for precision medicine, it’s a form of medicine that uses information about a person’s own genes or proteins to prevent, diagnose, or treat diseases. But I think there are missing parts to this definition. One of them is “predict.” That’s where I believe precision medicine is heading: to predict, by using data from patients, subpopulations, larger groups, and N-of-1s, and using new technology such as machine learning, to predict how a patient will respond.

Also, precision medicine is not only about genetic information anymore. For example, there are different “omics”—metabolomics, epigenomics, nutrigenomics, proteomics, and also the social determinants of health that are crucial as well. Personalized medicine is specific to the patient.

Getting precision medicine adopted

MDisrupt: What are some obstacles to a widespread adoption of precision medicine?

Bernard Esquivel: The first barrier is the way we run clinical trials. We need to continue following an evidence-based approach, meaning we need to show clinical validity, clinical utility, clinical actionability, and so on. But precision medicine is unique because you may be talking about a single individual with a lot of data points.

The second barrier is about implementation and clinical actionability. For example, in pharmacogenomics, some genetic variants of CYP450 enzymes may impact how the patient will respond to certain medications. You need to take that to the next level: “What can I do next? Is there any other option for that patient? Are there clinical guidelines to help me to customize the dose for that specific patient?” That’s clinical actionability.

The third barrier is, precision medicine needs to be user-friendly for the provider as part of our day-to-day tools. If we don’t implement precision medicine data sets into the clinical workflow, it’s going to be a hard stop.
And last but not least is cost-effectiveness. We need to show that it makes sense to invest in the molecular testing and technological platforms that we need.

MDisrupt: When do you see us being able to bring all that information together to give an individualized view of the patient?

Bernard Esquivel: Within the next five years. I think we are getting there in terms of connectivity and data management. The milestone for the next five years is going to be about ethics—how those corporations are going to be managing, handling, and protecting your information as a patient.

Pharmacogenomics (PGx) in precision medicine

MDisrupt: What’s the ideal implementation of PGx in the health care delivery model?

Bernard Esquivel: Pharmacogenomics is a fantastic example of how precision medicine has evolved. One of the barriers has been the lack of standardization. We need to be sure that our [variant] coverage is as similar as possible in order to compare apples to apples.

The other one is about how you interpret that data, the phenotyping calls. How are you calling [a particular] genetic variant and what are the clinical implications? Several organizations are doing outstanding work trying to tackle those problems. And I strongly believe that champions of pharmacogenetics are and will continue to be the pharmacists.

PGx success

MDisrupt: Is there an example of a health system that has been successful in implementing a PGx program?

Bernard Esquivel: Yes, several. St Jude’s Hospital has been a pioneer in implementing PGx into the electronic medical record and having expert pharmacists help other providers implement it. Also Mayo Clinic with its center for individualized medicine.

The Netherlands is a fascinating example of a countrywide PGx implementation. They use a single electronic medical record for the entire country. They already have a specific PGx piece that will follow the patient wherever they go. They’re publishing data on how they are saving money countrywide by using pharmacogenomics.

How digital health innovators can improve precision medicine

MDisrupt: When you think about precision medicine, what could digital health innovators do more of and what are they not doing enough of?

Bernard Esquivel: Number one will be having a smooth workflow in terms of integration. Then, once you’ve got all those data sets, how are you going to start organizing that information? You need to allow new technologies such as machine learning to start making predictive models, then [integrate] that information with genomics, microbiome, exposure, behaviors, clinical tests, even patient contributed data. And then find ways to connect all that to clinical information and deliver it to the final user. I know it sounds hard, but many people are working on this right now.

MDisrupt: What advice would you give a founder interested in precision medicine solutions?

Bernard Esquivel: Have the right experts working with you. If you don’t make that investment at the beginning, it’s going to be way more expensive “learning during the flight.”

With the right team on board, I recommend three pillars: Number one, the regulatory landscape—look into the regulatory requirements, talk about your idea with the regulatory agency.

Then, invest in developing the right evidence behind your product. And number three is clinical actionability: You can go-to-market with the minimal viable product, but you need to always be thinking of how this information will trigger action from the clinical standpoint.

Healthcare’s future

MDisrupt: What do you think the health system is going to look like in 10 years?

Bernard Esquivel: We know that the way we are spending money in healthcare is not working. So everything will change into value-based care and precision medicine will play a critical role there.

At MDisrupt we believe that the most impactful health products should make it to market quickly. We help make this happen by connecting digital health innovators to the healthcare industry experts and scientists they need to responsibly accelerate product development, commercialization, adoption, and scale.

Our expert consultants span the healthcare continuum and can assist with all stages of health product development: This includes regulatory, clinical studies and evidence generation, payor strategies, commercialization, and channel strategies. If you are building a health product, talk to us.

MDisrupt’s CEO: Lessons from our 2nd Year & Trends for 2022

MDisrupt’s CEO: Lessons from our 2nd Year & Trends for 2022

ruby.gadelrab

MDisrupt is celebrating its second anniversary this week, and we’re speaking with the company’s founder and CEO, Ruby Gadelrab, about what she’s learned and where digital health is headed.

podcast available

Solving the three pain points

MDisrupt: First, tell us about your path to founding MDisrupt.

Ruby Gadelrab: I spent 24 years in healthcare on the commercial side and eventually landed at 23andMe, as VP of commercial marketing. In three years there I really caught the bug for consumerized healthcare and digital health. I left 23andMe to help the growing number of digital health companies that were forming, and consulted for twenty-five of these companies back to back. I learned that these companies, as they bring their products to market, all have the same three pain points.

We built MDisrupt to help them overcome those pain points, which are:

  • How can digital health innovators access trusted health care operators who can help them build and commercialize their products?
  • As soon as a health product gets to market, how does a digital health company find its earliest clinical users? Who are those innovators within the healthcare system that are willing to try products early on?
  • How to quickly generate evidence to convince the variety of stakeholders that need to be convinced?

Our mission is to help the most impactful digital health products get to market quickly and responsibly.

Today, as we embark on our third year, I want to say a huge thank you to everybody who’s been involved in MDisrupt. We’ve built a network of over 200 health industry experts on demand. We’ve worked with over 40 clients already. And we have this network of incredible advisors who have been guiding us every step of the way. I could not be more grateful to the experts in our network, the clients who have trusted us with complex challenges, and the advisors who have guided us every step of the way.

MDisrupt: What are some lessons you’ve learned in growing MDisrupt through its second year?  

Ruby Gadelrab: The top lesson is around trust. A few weeks ago, I interviewed Dr. Shantanu Nundy on Clubhouse and he said, “Healthcare moves at the speed of trust.” It’s all about trust with your clients, your community, your team, and your advisors.

Secondly, you have to build a team that shares your mission and can fill in your knowledge gaps. We’ve built a really incredible team to augment what I know and push the company forward.

The third lesson is the complexities of fundraising, which we started in the last couple of months. We’ve had some amazing interest so far, but fundraising is hard—and it’s really hard as a brown, female, first-time founder. But I’m really optimistic, because we’ve had some great traction and we see ourselves as building a scalable platform that can really help digital health companies accelerate their path to market.

Healthcare innovation is not optional—it’s an absolute necessity. 

MDisrupt: What have you learned from MDisrupt’s health experts that has surprised you?

Ruby Gadelrab: I’ve been marketing and selling to scientists and physicians my whole career. Today, we are at an inflection point. Everybody I speak to is united in saying that innovation in healthcare is not an option anymore. It’s an absolute necessity.

There is a lot of focus on finding solutions around access to health care, improved health outcomes, simplified delivery of services, transparency, and convenience. And one of the challenges is, How do we build these solutions in an evidence-based way?

The incentives for each type of stakeholder are very different. For providers, it’s about maximizing their time, creating solutions that fit into their clinical workflows, and improving their patients’ experience. For payers, it’s about the economics. For patients, it’s about how to access healthcare simply, conveniently, and transparently. And for the digital health companies, it’s about scaling quickly and being the first disrupters in a very complex market.

The big challenge is, How do we create solutions that address the incentives for everybody in that ecosystem? How do we do it cost effectively, responsibly, and in a way that scales? These are the challenges I think we’ll see solved over the next 10 years.

A new breed of clinician

MDisrupt: What are some characteristics of the people who have joined MDisrupt this year? 

Ruby Gadelrab: A lot of the experts who have joined us have experience in building health products. That’s one of the key features of the MDisrupt health expert network—it’s made up of people who have done this before and really understand the challenges.

We’re also seeing a new breed of clinician. These clinicians have been in practice for many years, and see the need for change through innovation. They want to get involved with digital health companies, they want to be medical advisors, and they want to have a say in building products and in how the products are presented to their peers.

These physicians hold the power to change the healthcare system from within. I want to help them understand their power, so they can work with digital health companies so we can get those solutions into healthcare faster.

Secrets of digital health success

MDisrupt: When you look at successful digital health companies, what are they doing right? 

Ruby Gadelrab: First, they engage clinical experts early and often throughout the process of developing a health product.

Second, they take their regulatory and evidence generation very seriously. They don’t skip steps, and they go very deeply into figuring out the appropriate regulatory path and generating the right evidence to convince the various stakeholders.

Third, they build balanced teams. Building health products requires careful orchestration between technical, commercial, and clinical teams, and I think some of the best companies we’ve seen have got a great balance between those three areas.

MDisrupt: In our webinar next week, we’re talking about why it can be important, early on, for a digital health company to hire a chief medical or scientific officer. What’s your view on that? 

Ruby Gadelrab: It’s really important. It helps you build the right product from the start, and save a ton of time and money by not making mistakes. For example, we see a lot of companies who have a technology, and they’re trying to back it into a problem—but it doesn’t actually solve a clinical problem. So having people who really understand clinical workflows and what physicians are looking for can add huge value.

Physicians are some of the most skeptical audiences in the world, but they listen to their peers. And I think chief medical officers, chief scientific officers, and medical affairs teams are really the key to communicating with those communities. Even if it’s a part-time role, chief medical officers are worth their weight in gold and can be the difference between success and failure in getting a health product adopted.

The need for standards

MDisrupt: What are some of the biggest challenges you see in the digital health industry as a whole?

Ruby Gadelrab: There was an article out recently from IQVIA that said there are 350,000 digital health apps in the market, and 250 new ones come out every day. How do we, as consumers or providers, know what’s good? There is no systematized way of identifying what the standards are. If you have a choice of five different genetic tests, which one is right for you? So I think there need to be some standards and transparency around the standards. And I think it’s really important that we bring some of the clinicians along with us in that journey around how that data is generated, how they use it in their clinics.

One thing we would like to do over time is to develop the standards for digital health—to organize the world’s digital health products by performance and create transparency, so people can make the right decisions.

The final challenge is around the cost and time it takes to commercialize a health product. In the consumer world, we can build and commercialize and scale a product within five years. In healthcare, it’s different—the evidence generation by itself takes longer, and the amount of time and the cost in convincing the stakeholders to get widespread adoption is much longer. I think it’s important for innovators to be realistic about what it takes to scale a health product.

Looking ahead

MDisrupt: What do you think is in store for digital health in 2022?

Ruby Gadelrab: I wish I wasn’t saying more COVID solutions, but it will be more COVID solutions because we’re not nearly out of the pandemic yet. With the delta variant, there are going to be more options for testing. I hope over the next year or so, we’ll be thinking about some of the back-to-work solutions for COVID. And I see more healthcare from home solutions, whether that be at-home testing, remote patient monitoring, telemedicine. Many chronic conditions are a function of lifestyle and social determinants of health, so I see a lot of solutions coming around mental health, cancer, cardiovascular disease, addiction, and diabetes.

MDisrupt: This time next year, what do you think we’ll be saying about MDisrupt?

Ruby Gadelrab: I think we will have built out our community of experts to be even bigger and broader. We will have served more truth-seeking clients who are bringing game-changing innovations to healthcare. I think we will have raised our first institutional funding and we’ll hopefully be celebrating with our investors at that point. And I think we will have some new solutions for our digital health clients around how they find their earliest clinical adopters and how they generate evidence. I hope we’ll be celebrating all of that!

At MDisrupt we believe that the most impactful health products should make it to market quickly. We help make this happen by connecting digital health innovators to the healthcare industry experts and scientists they need to responsibly accelerate product development, commercialization, adoption, and scale.

Our expert consultants span the healthcare continuum and can assist with all stages of health product development. This includes regulatory, clinical studies and evidence generation, payor strategies, commercialization, and channel strategies. If you are building a health product, talk to us.

Making the Patient Experience Better

Making the Patient Experience Better

Jennifer Swoyer, DO

Meet Jennifer Swoyer, DO, who leads the family medicine residency program at AMITA Health Adventist Medical Center in La Grange, Illinois.

podcast available

Dr. Swoyer is a family physician who has been in practice for over 20 years. Her passion lies in teaching and clinical medicine, helping underserved populations, and improving access to health and wellness programs.

Health consumers driving change

MDisrupt: How is the traditional family practice evolving to meet the demands of health consumers?  

Jennifer Swoyer: Family medicine is evolving quickly, as are most aspects of medicine. For primary care providers, the pandemic shed new light on how we need to integrate technology to improve the quality of care for our patients.

For example, telehealth has been around for a while, but with the pandemic, there were changes that allowed us to be able to integrate it better. The beauty of telehealth is that we were able to screen patients differently, do follow up visits more easily, and stop limiting patients to the schedules that we set. We were able to be much more flexible in making sure that patients got the care that they need and deserve—and this is here to stay.

Technology to engage patients and improve health

MDisrupt: It’s been estimated that there are somewhere between 200K to 400K avoidable, preventable deaths each year in the US. How can physicians partner with health innovators to improve those stats?

Jennifer Swoyer: For medical professionals, preventing deaths is always our goal. Technology, depending on how it’s utilized, can really become a team approach between the provider and patient. The best thing about point-of-care technology is that the individual who has the disease or condition being monitored now has a daily opportunity to understand their own health. That allows me to do a better job as a provider and it becomes more of an opportunity for us to prevent bad outcomes. There are many examples of where we can use these technologies to help this partnership work better.

When we talk about population health and social determinants of health, we’ve seen the healthcare landscape change over the last few years. Healthcare systems have consolidated services to try and create one-stop shopping experiences: If you need to go see your provider, you can also get your X-ray and your labs, everything done in one location. This is really great and improves convenience. When health systems moved to single locations, however, they removed a lot of the providers that were in the community and consolidated them, reducing some of the access. Having mobile clinics that go out to shelters or large church organizations is an amazing outreach opportunity where you can reach a large population and then connect them with technology.

A call to action

MDisrupt: Many in the MDisrupt audience are entrepreneurs who have access to capital, technology, and engineers to build solutions. How can we help?

Jennifer Swoyer: Digital innovators are focusing on important problems that we need to solve, but to truly solve problems requires the right input. Providers in an urban setting, for example, may bring up a very different set of needs than providers in a rural setting. Engaging entrepreneurs and digital thinkers to incorporate views from many types of providers will help align how technology is utilized and ultimately change the trajectory of patient care.

What physicians need from digital health  

MDisrupt: As a provider, what do you see as the most important components of a digital health product?

Jennifer Swoyer: I look at digital health products through two different lenses: patient-forward technology and physician-centered technology. In terms of patient-forward, I look for technology that is usable by the patient and builds ownership and accountability, which will then help me, as the provider, help them manage their health differently. If the technology is physician-centered then it really needs to be technology that is going to help physicians do their jobs better by improving patient outcomes, more easily meeting quality measures, and saving time. Ideal solutions will improve patient satisfaction and physician well-being.

Meeting patients where they are

MDisrupt: Is there something you’ve changed your opinion on since you started practicing medicine?

Jennifer Swoyer: There can be numerous factors that contribute to individuals being successful in managing their genetic predisposition and lifestyle-created conditions. I’ve realized that my job is to work with someone where they are to get the best results and not necessarily focus on all the things that they need to do. For example, when we talk about obesity or diabetes, we focus on the type of diet and exercise you need. Those are things I will continue to talk about, but you have to look at where someone is in their life and what they are facing on a daily basis. If your meal supply is supplemented by a food pantry, you no longer have the same control over the foods you eat. We need to make sure the solutions we are providing and the advice that we are giving work with the individual’s social needs. This is the piece where I have changed the most. I ask questions very differently. I try to work with people where they are and help them get to where they should be.

Bringing healthcare home

MDisrupt: How will traditional health systems do things differently to adapt to a new model of healthcare?

Jennifer Swoyer: We’re all connected all the time now. Continuing to utilize the tools that almost everyone has—a cell phone, an iPad, a laptop—is part of where we need to start. The healthcare landscape is going to continue to change, and it should. Hospitals will be for the sickest patients and people who are less sick will—I hope—no longer be hospitalized and instead will be home-monitored remotely through digital tools.

Providers who are not in an acute setting like the emergency room, but who are part of a primary care practice, will be linked into how the followup gets done and will have access to daily technology for that individual.

As a family medicine physician, I still see patients in the hospital. Patients will ask me,”How long am I going to continue to feel tired?” I always give my math, which is not scientific but is founded on my experience: Every day you spend in the hospital is a week of recovery. We could do better by recuperating at home in our own beds if we could be monitored.

Advice for innovators

MDisrupt: What advice would you give a founder who wants to create tools for better health and wellness?  

Jennifer Swoyer: Most physicians go into medicine because we love what we do. It’s an art and a passion. I want to help people be well. I’m most willing to adopt technologies that help me improve my patients’ health, and reduce burnout. It’s critical to look at who is the adopter of the technology and whether it will help me provide better care. Can that adoption of technology ensure that my billing and collections are better? You don’t want technology to be an additional burden on an already-busy life and schedule.

At MDisrupt we believe that the most impactful health products should make it to market quickly. We help make this happen by connecting digital health innovators to the healthcare industry experts and scientists they need to responsibly accelerate product development, commercialization, adoption, and scale.

Our expert consultants span the healthcare continuum and can assist with all stages of health product development: This includes regulatory, clinical studies and evidence generation, payor strategies, commercialization, and channel strategies. If you are building a health product, talk to us.

Are Telemedicine and Virtual Care Here to Stay?

Are Telemedicine and Virtual Care Here to Stay?

Aditi U Joshi

Meet Aditi U. Joshi, MD, MSc, chair of the telehealth committee for the American College of Emergency Physicians and former senior advisor of acute care telehealth at Thomas Jefferson University Hospital.

podcast available

Dr. Joshi has worked in telehealth for over eight years, most recently leading Thomas Jefferson University Hospital’s on-demand telehealth program. She holds an assistant professorship in the Department of Emergency Medicine at Thomas Jefferson. Dr. Joshi is a champion of health innovation and has a passion for training students and residents about how technology is fundamentally transforming how we interact and care for patients.

An early adopter of telehealth

MDisrupt: How did your passion for health innovation and specifically telehealth evolve?

Aditi Joshi: I graduated residency in 2009 and started my career in a busy emergency department. After a few years, I had symptoms of burnout and decided to try something different. I found an advertisement for Doctor on Demand and decided to apply. This was in 2013 when they were just beginning. I was one of their first doctors and eventually became the assistant medical director. During my time there, I helped develop best-practice protocols to ensure patients were getting a quality visit.

In 2015, Thomas Jefferson University started a huge enterprise-wide telehealth program that piqued my interest. I eventually joined Jefferson in the department of emergency medicine and was the medical director of our telehealth program. My role here has been interesting because, as an academic center, there’s room to try new things. This is also encouraged by our CEO, Dr. Steve Klasko, who has a commitment to health innovation, creating home-based health care, and improving health equity. The team here has expanded and achieved a number of things like a direct-to-consumer program, a triage program in our emergency department, and telehealth education. We also have a telehealth fellowship for post-residency training.

MDisrupt: What is the difference between telehealth and telemedicine?

Aditi Joshi: Telemedicine is the actual service between the patient and the provider. Simply, it’s direct care or a medical encounter. The term telehealth is much broader because it’s not only the services but also includes preventive maintenance, follow-up, and the regulatory portions of telehealth. It’s a more relevant, all-encompassing term. In the future we’re going to realize that telemedicine, or telehealth, is just going to be part of healthcare and the “tele” is going to go away. We may call it virtual care, but eventually, it is just going to be healthcare.

Bringing telehealth to more people

MDisrupt: What are some of the challenges and solutions of adoption in telehealth?

Aditi Joshi: Reimbursement tends to be the biggest reason that clinics and hospitals have shied away from telehealth. It was viewed as an added amount of work without being able to charge for it. With the Emergency Care Act, telehealth got reimbursed to a much broader degree. In respect to that, telehealth visits cost less for both patients and payers. Of course, the caveat is sometimes we need to send patients to a higher level of care because not everything can be done via telehealth. When I first started out, there wasn’t much engagement by either clinicians or patients in telehealth. Patients would pay out of pocket for these types of visits—a limiting factor for many people. As more payers have adopted telemedicine, whether it’s a contract with companies that supply direct-to-consumer telemedicine or a hospital system, it has continued to evolve.

A second challenge is cost. The setup costs to cover technology can be prohibitive for small practices or hospitals that can’t buy the necessary software and hardware. With the realization that telehealth needs to be integrated into the future of healthcare, it’s important to consider the cost to establish these services.

Internet connectivity and access to phones and smart devices is a third major challenge. During the pandemic, there were a number of people in Philadelphia who could not access our platform due to connectivity and technology access. Given the dire emergency situation, my colleagues applied for a grant to do targeted outpatient testing via a mobile van. There’s a second round of grants that focuses on access and expansion of devices and internet connectivity. It’s probably the first time the government has really put that much money into this type of health innovation.

In the future, we’re going to have to figure out how we access rural areas. Today it’s being done with local community interventions such as setting up kiosks or enabling people to access the internet by coming to libraries and community centers.

How innovators can make a difference

MDisrupt: Many in our audience are digital health innovators who have access to capital, technologies, and engineers to build solutions. What could we do better and what are we not doing enough of?

Aditi Joshi:  It has been a beautiful thing to see how many people are committed to trying to improve healthcare with all of the digital health solutions that are out there.

When it comes to innovating in healthcare, it can be very complicated, so at the very least you have to understand the healthcare system and how it works.

The biggest complaint from clinicians is that health innovators don’t understand hospital workflows and so they create solutions that make it harder for us to get our jobs done. Physicians are overburdened, so adding something that isn’t useful or efficient or that can’t be reimbursed ends up being a problem. Some ways to get around this are really understanding what your solution is and ensuring that what you’re creating is solving a problem in the first place. I will say that speaking to clinicians early on is a really good idea—with the caveat that we don’t always know the right solution. It’s great to get people who are outside of medicine to innovate, but it’s important to have someone onboard, like a chief medical officer or an advisor, who understands how clinicians practice and how patients respond or use the solution.

MDisrupt: What advice would you give a founder who is interested in telehealth solutions and improving patient care?

Aditi Joshi: First and foremost, understand what you’re trying to solve and get the right team around you—people who work in a similar fashion and have similar goals. I usually give this advice to residents or medical students, but it also works for anybody who is starting a company or has an innovation.

When I started out in telehealth, I really enjoyed it. I kept saying yes to things. I said “yes” to being the assistant medical director, at Doctor on Demand. I said “yes” to Jefferson. And here at Jefferson, every time there was a new program where people came to us and said they want to try this telehealth solution, our department would say “yes” and then we would do it. It didn’t always work! We have a lot of programs we never brought to fruition, but every time we went through the thought process and the workflow it became easier and easier. Now if a health innovator were to ask me, “Can you set up a process to do this type of program?” I would say, “Absolutely!” I can do that because I’ve had practice through trial and error.

Telehealth, ten years out

MDisrupt: What will an interaction with the health system look like in ten years?

Aditi Joshi: I love this question because this is my favorite thing to work on. At the American College of Emergency Physicians, where I’m chair of telehealth, we have a task force looking into how we are going to define emergency medicine for the next five to 10 years because of telehealth.

First, there’s going to be a lot of home-based healthcare for patients with both acute and chronic disease. We’ll be able to use the emergency medical system for acute care and deliver a lot of what we can do in the emergency department at people’s homes. We can also employ more cross-consults which will allow patients to access specialists. We’ll be able to observe patients at home and take better care of them.

There’s also going to be better health literacy once we figure out how to make it palatable. We need to uncomplicate the terms we sometimes use in medicine, so patients can have more control over what they’re doing and what they understand for their health care. The future is going to rely on more individual practice and giving patients the ability to understand and improve their health along with us will be essential.

Medical education is going to change significantly for medical students, residents, and care providers. We’ll also have to continue to understand how smartphones are optimized to work in the healthcare space. They are part of our daily life and we need to make them part of our healthcare, too.

At MDisrupt we believe that the most impactful health products should make it to market quickly. We help make this happen by connecting digital health innovators to the healthcare industry experts and scientists they need to responsibly accelerate product development, commercialization, adoption, and scale.

Our expert consultants span the healthcare continuum and can assist with all stages of health product development: This includes regulatory, clinical studies and evidence generation, payor strategies, commercialization, and channel strategies. If you are building a health product, talk to us.

4 Things Digital Health Innovators Need to Know about Compliance

4 Things Digital Health Innovators Need to Know about Compliance

Deb Somerville

Deborah Somerville is a seasoned compliance expert with deep experience in healthcare and digital health environments. She’s held leadership positions at Everlywell, Genomic Health (now part of Exact Sciences), and Genentech, among others. Here, she shares four important lessons about the emerging area of compliance as it relates to digital health companies.

1. Gray areas are the norm.

Laboratory-developed tests (LDTs) have “regulatory discretion” with the FDA, which means that the FDA tends to pass off regulation of these tests to the Center for Medicare and Medicaid Services (CMS). That leaves lots of question marks for digital health.

Digital health founders sometimes think that bringing in a compliance officer will get them a quick answer to the question of “Can we do this?” But there are not a lot of legal precedents or enforcement activity in our space. Market access for digital health is a murky soup—a lot depends on who you are marketing to. A compliance expert can help you clarify what is possible; sometimes you need to take a matrix approach to sort out exactly what applies to your product.

2. Compliance matters after an FDA clearance.

The agencies are saying “Tell us what you’re doing, and keep really good records, because we are all figuring this out.” For example, it’s important to set up a system to track communications. You don’t want to rely only on a verbal agreement. Transcribe all phone calls so you have a permanent record, send them back to the FDA, and say “Did this capture our conversation?”

It’s a requirement to track adverse events, including when the authorization is an emergency use authorization (EUA). The FDA is also interested in usability data, which is information beyond what is required for authorization. It helps with your relationship with the FDA to keep a database. For example, how do people feel about at-home tests? Do they sit on the kitchen counter for several days before they get mailed? What do the instructions say, and does feedback indicate they are easily followed?

Something else about working with regulators: If you make a mistake, and can show that there was a process and internal controls in place for decision making, and after the fact realized you didn’t use super-great judgment in reaching your decision—chances are the regulators won’t be extremely harsh. This was generally the case in life sciences overall, and now we are seeing this in digital health, too. And, it’s important to be proactive when you do discover such a “miss.” Self-disclosure is key.

3. Seize opportunities to influence emerging requirements.

Privacy, for instance, is one area where this is possible: The use of AI is expanding, and the ethical use of data derived by AI is a significant area. Will there be more regulation in this area? Changing regulations? It’s a great time for digital health innovators to get in and mold that regulation, for example, by lobbying, or by joining with other companies to respond with a white paper.

4. Expect a healthy tension between compliance and marketing.

For example, when you’re going through the FDA authorization process, once the FDA is familiar with a product, they will say, based on the product’s intended use, “Ok, this product will be called XYZ.” And it might be a very long name, which for a marketing person might be challenging to use in various media. But in this instance there is no room for negotiation—that is just how the FDA works.

In other instances, as a compliance professional, to find the best path forward I first have to think like a business person. Social media is a great example: How can we say what needs to be said in that media where we may have only a tiny bit of space? The way I think it through is, “What is the risk that I’m protecting the company from? How likely is that risk to be exploited? Can I quantify it—i.e., worst case, what would be the cost to the company? How much wiggle room—if any—do we have to take on a bit more risk?” The decision will be made by consensus of the executives, and rightly so, but the recommendation comes from the compliance person. As a team, we must be aligned to achieve our objectives, so education is a factor in that equation, too.

At MDisrupt we believe that the most impactful health products should make it to market quickly. We help make this happen by connecting digital health innovators to the healthcare industry experts and scientists they need to responsibly accelerate product development, commercialization, adoption, and scale.

Our expert consultants span the healthcare continuum and can assist with all stages of health product development: This includes regulatory, clinical studies and evidence generation, payor strategies, commercialization, and channel strategies. If you are building a health product, talk to us.