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.

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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.

Overly White Genetic Databases = Decades More Health Disparities

Overly White Genetic Databases = Decades More Health Disparities

ruby.gadelrab

MDisrupt CEO and founder Ruby Gadelrab on how more inclusive genetic databases can reduce health disparities and bring precision medicine to everyone.

The precision medicine problem no one talks about

Precision medicine has long been a promise of the The Human Genome Project (HGP). Humans are 99.9% genetically similar, but it is the 0.1% difference that holds the key to the causes and potential cures of our diseases. The goal of the HGP was that by building genetic databases large enough to allow scientists to see the patterns and variations in the 0.1% difference in our genetics, we could give healthcare providers “immense new powers to treat, prevent, and cure disease” through precision medicine (pharmacogenetics, cancer screening and diagnostics, and much more). However, nearly 20 years later, this promise of better diagnostics and personalized therapeutics is only a reality for those of European descent. That’s because most of the world’s genetic databases consist primarily of genomes from people of European descent – and yet we know that individuals of other ancestries suffer from certain genetic diseases at a much higher prevalence.

So, how did we get here?

3 reasons genetic databases are biased

First, the genome studies conducted that led to building the first genetic databases, the genome-wide association studies (GWAS) were done in the United States and, to a lesser extent, in Europe. A 2009 analysis of the GWAS studies showed that 96% of participants were of European descent.

Second, recruitment of participants in scientific research is notoriously difficult. The faster researchers recruit, enroll, and consent participants, the faster they get the data and can publish. Participants in the GWAS studies were mostly volunteers who lived near well-funded academic institutions, and who had the motivation and the means to travel to those institutions. This resulted in the study populations not being representative of the diversity of the US population. Very few institutions tried or were able to build trust with underserved and underrepresented populations in order to successfully enroll them in the studies. The majority of the studies were conducted by scientists who identified as white. In fact, according to the National Institutes of Health (NIH), only 7% of all NIH R01 Grants were awarded to Black American and Latinx scientists.

During the GWAS era, I worked as the head of international marketing for Affymetrix (now Thermo Fisher Scientific). Affymetrix was a leading manufacturer of microarrays, the technology used to conduct GWAS research. Even back then, we were concerned about the European bias in genetic studies, so my team and I spent 2009 to 2012 traveling around the world meeting with ministers of health and major research institutions, encouraging them to fund and build genetic databases representative of their own populations. Some of these initiatives did eventually take off—notable examples include The Saudi Genome Program, H3Africa and the China Genome Project.

Third, over the last five years, new types of genetic databases emerged from the private sector. More than 26 million people purchased direct-to-consumer genetic tests. While these products have done wonders for accessibility of genetic information, they are also cost-prohibitive for underserved populations and sold by companies that are primarily US-based. This has resulted in new genetic mega-databases that, once again, are biased to people of European descent.

Private sector solutions

Individuals of African descent are highly underrepresented in genetic databases and yet genetic diversity in Africa is higher than any other region in the world. What’s more, African populations have the highest burden of disease due to Africa’s complex population history; large variations in diet; climate; and elevated exposure to infectious disease.

To their credit, some private sector genetic testing companies have tried to address this gaping disparity in genetic databases.

23andMe had the right idea and tried to address the problem through The African Genetics Project, which sought to recruit and provide detailed ancestry results to 23andMe customers of African descent.

The Nigeria-based company 54Gene is also seeking to equalize precision medicine by creating the world’s largest biobank of African genomes, which will be used to build the next generation of diagnostics and therapeutics.

Even so, we have made only marginal improvements in the diversity of our genetic databases. In 2020, a study conducted under the H3Africa Consortium showed that sequencing 426 individuals from 13 African countries resulted in the discovery of over three million novel genetic variants. This implies that we haven’t even scratched the surface of discovering the clinically important variants from those of African and other non-European descent.

5 ways to address health disparities in precision medicine 

So what can be done to address the critical issue of underrepresentation in genetic databases? Here are the key areas that I believe will lead to change:

1. Proactive recruiting.

Genetic researchers should be proactively recruiting underrepresented populations for future studies. This will require some non-traditional methods of recruitment into the studies,including engaging key community stakeholders and building trust in historically mistreated and underrepresented minority populations. Initiatives must also include community outreach and education (e.g., the creation of multilingual recruitment materials). Without this, there is no way we can make precision medicine equitable.

2. Do the right studies.

A continued and concerted effort is needed to conduct studies that address specific underrepresented populations, similar to the methodology in the H3Africa study mentioned above. We must take a systematic approach to ensure that the entire global population’s genetics are appropriately and proportionately represented in genetic databases.

3. Create incentives.

Government funding agencies must build incentives for those who are recruiting and researching diverse cohorts. This includes the rebalancing of research funding for minority scientists.

4. Increase private sector investment in minority founders.

Important efforts to build non-Eurocentric genetic databases may actually come from the private sector, similar to the approaches that 23andMe and 54Gene are taking. However, implementing this on a larger scale would require a significantly increased level of investment into Black American and Latinx company founders, who received only 2.6% of all VC investments in 2020.

5. Build diverse leadership.

Both academia and the private sector must actively recruit diverse leadership teams—not just as entry-level and mid-level managers, but also in leadership roles, in the C-suite, and on boards of directors. Diverse teams are better at decision making, better at brainstorming, and better at creating products that represent a bigger proportion of the population.

We must do better

In 2020 and 2021, the murders of George Floyd, Breonna Taylor, Ahmaud Arbery, and several other Black Americans, along with hate crimes against Black and Asian communities—and in conjunction with the ongoing COVID-19 pandemic—have shone a spotlight on systemic racial disparities and inequities, which are also inherent in our healthcare system. European bias in genetic databases has huge implications for the health of individuals of non-European descent. It has the potential to contribute to decades of health disparities if we continue down this path. Without the changes outlined above, the genetic data we use to create the next generation of diagnostics, disease risk assessments, and therapeutic interventions will continue to make precision medicine available only to those of European descent. If we don’t address this now, history will hold us accountable.

 

At MDisrupt we believe that the most impactful health products should make it market quickly. We do this by uniting digital health companies with experts from the healthcare industry to help them accelerate their time to market responsibly.

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.

Real-world Innovations to Reduce Maternal and Child Health Disparities

Real-world Innovations to Reduce Maternal and Child Health Disparities

Sarah England, PhD

Meet Sarah England, PhD, the
Alan A. and Edith L. Wolfe professor of medicine and vice-chair of research at Washington University School of Medicine’s Department of Obstetrics and Gynecology.

podcast available

Dr. England has devoted her academic research career to maternal and child health, with the goal of reducing disparities and poor outcomes across affected communities. She has been a champion of simple and elegant solutions that, at scale, are poised to make a big impact. Partnering with digital health leaders on innovative solutions can have a global reach and feed into a system where the benefit can be felt across generations.

Maternal and child health disparities today

MDisrupt: Can you describe the current state of health disparities for maternal and child health in the US?

Sarah England: Women of color are not faring well in terms of maternal health outcomes compared to white women. Pregnancy-related death is defined as the death of a woman during pregnancy or within one year of the end of pregnancy; a complication of that pregnancy; or a chain of events initiated by the pregnancy. The statistics are staggering. Black, American Indian, and Alaska Native women are two to three times more likely to die from pregnancy-related causes than white women, according to the Centers for Disease Control and Prevention.

It’s a significant issue and it’s about time that we address it. Many people think it’s due to socioeconomic status, but this is not true. Black women with at least a college degree are still 5.2 times more likely to face these consequences compared to their white counterparts.

Building momentum for change

MDisrupt: How are maternal and child disparities being addressed by the health system and government entities?

Sarah England: Most pregnancy-related deaths are preventable and many of the causes of death can be addressed. Women of color face higher rates of stress associated with situational experiences of racial discrimination in the health system. A well-known example is Serena Williams. She knew that she had a complication from her pregnancy and was not believed by the medical professionals that were caring for her. This happens to Black women more commonly than it does to white women. This is something that we can really address by listening to women during their pregnancy.

And healthcare professionals have to be more cognizant of listening to women of color. Medical schools are developing curricula bringing more attention to issues of this nature. The federal government, especially funding agencies, are realizing that we need to address health disparities more than we have in the past. So the tides are changing. We are realizing that this is not good for the future: In order to reduce the trends in maternal and child health, we have to be much more aware of how we treat patients, how we study them epidemiologically and have a greater focus on those that are carrying the burden of disease.

In summary, we must implement standardized protocols in quality improvement initiatives, especially among facilities that serve disproportionately affected communities We need to identify and address implicit bias in healthcare that would improve patient-provider interactions, health communication, and health outcomes, and there needs to be a greater focus by funding agencies to address racial disparities.

A call to action for digital health leaders

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

Sarah England: There is no shortage of good ideas, but often existing ideas remain stuck in “innovation bottlenecks” as they struggle for attention, funding, or the means of implementation. Healthtech founders can help lift us out of the bottleneck and bridge that gap from academia to commercial.

Fortunately, many digital health entrepreneurs are not only highly innovative but also have a desire to make a social impact. And solutions can be pretty simple. For example, we know that the twelve weeks after childbirth (fourth trimester) is a key window of opportunity to provide healthcare to mothers and babies. However, we often do not focus on the immediate post-pregnancy period. My colleagues and I have talked about getting a mobile unit that could go to underserved or remote areas and check in on new mothers. We could provide women access to services to help their emotional well-being, provide contraception and talk to them about birth spacing, ensure they are getting enough sleep, provide help with medications, and prevent substance abuse, and make sure they have physically recovered from childbirth. This relatively easy solution could make exceptional strides in maternal and child health, especially during this critical fourth trimester period.

Building better and more effective information-gathering systems that connect across all parts of our country is also an area where tech solutions are vital. Many people in remote and underserved communities are routinely left behind. And not all states collect information on race, ethnicity, income, and health insurance status because there are no national standards for data collection and reporting of maternal mortality statistics. Such data are critical for recognizing and understanding disparities, and without them, there has been insufficient accountability for maternal mortality.

Motivating for change

MDisrupt: How do you motivate healthtech entrepreneurs to innovate in maternal and child health?

Sarah England: Investors are interested in companies with broad portfolios and a message around social good. It’s a great time to go into maternal child health for this reason because improving maternal health improves child health and ultimately family health. It’s a feed-forward system that has long-term gains.

Another aspect around innovation is this concept of academia and companies working together to solve big problems. When I started my career, it was really important to be independent and have your own ideas and solutions. Now it’s really gone to “team science” and working with others to move your ideas forward. Also, women are pursuing technological fields. Oftentimes, they have children and raise awareness of this issue and push for robust solutions. There is going to be great innovation in this space in the years to come.

Passion-forward

MDisrupt: What advice can you give to women on their career and personal journeys?

Sarah England: It’s about following your passion. My original career path was cardiovascular sciences, not women’s health. Then I read a paper about preterm birth and felt compelled to connect with people in the field and find out more. I ended up going into a neonatal intensive care unit (NICU) with a friend of mine who was an NICU nurse. I saw a baby who had been born at six months and was being kept alive by multiple machines. It was heart-wrenching. I talked to the mother of the child and she blamed herself, even though the medical professionals didn’t know why she delivered the baby early. It made me realize that we don’t have all the answers, and you need innovative, creative minds in this space. So my advice is to follow opportunities because they may end up changing your course in life and opening up a chance to follow your interests and passions.

For women interested in connecting with other women in health, there’s a group that I’m part of called the Women’s Health Collaborative. The goal of this group is to support women in the field by networking and finding others to connect with who can help you move your ideas forward. You just have to be fearless and be ok not knowing everything. It’s very rewarding when you get to where you want to be.

Parting wisdom

MDisrupt: What parting wisdom can you give digital health entrepreneurs?

Sarah England: First and foremost, we need to raise awareness that maternal health is key for child health, and often the health of the entire family. Addressing maternal health issues has long-lasting health benefits across many generations. Second, you can partner with reproductive health researchers and clinicians. For example, we are partnering with engineers to develop devices needed for the care of women during pregnancy. We are very interested in partnering with other innovators with a sincere desire to improve maternal/child health.

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.

Where is DTC Healthcare Headed? Lessons from 23andMe’s SPAC IPO

Where is DTC Healthcare Headed? Lessons from 23andMe’s SPAC IPO

ruby.gadelrab

MDisrupt CEO and founder Ruby Gadelrab shares her insights in a recent Clubhouse MedTech interview with Henry Peck. Ruby has worked on the commercial side of biotech, healthcare, and digital health for 24 years. She founded MDisrupt to connect digital health innovators to the healthcare industry experts and scientists they need to responsibly accelerate product development, commercialization, adoption, and scale.   

Henry Peck: Let’s talk about 23andMe. What role did you play there and what were the key challenges you were trying to solve for the business?

Ruby Gadelrab: First, some disclaimers—I left 23andMe four years ago. So I’m not speaking on behalf of the company. The opinions are my own as an industry observer.

I was hired at 23andMe just after the FDA had told them they had to temporarily stop selling health products to consumers. My role was to help them figure out some of the non-consumer business models. These included:

  • 23andMe for medical professionals. How do we educate and engage medical professionals on genetics and the reports that 23andMe were providing?
  • 23andMe for educators. Could a genetic test be used to teach university and medical students about genetics, statistics, and ancestry better than a textbook could?
  • 23andMe for research. How could the 23andMe experience be used in a research setting to improve recruitment in population health studies? For example, by giving people interesting data about their ancestry and eventually their health, can we improve recruitment and longer term engagement?

How 23andMe broke new ground

Henry Peck: In your opinion, what makes 23andMe’s product offering so successful and “sticky”?

Ruby Gadelrab: Let’s break this question down into two parts—why is it successful and sticky to consumers, and then secondly why does it have huge potential as a business.

Let’s start with consumer experience. Every aspect of our lives has been digitized through technology. Healthcare is undergoing that same revolution. 23andMe was the first company to work closely with the FDA to create a product that consumers could buy directly themselves that gave them personalized insights from their genetics about their health and ancestry. Over 10 million people bought the product and clearly, ancestry was one of the killer apps, but consumers also had an interest and hunger for health information and trait information.

23andMe made that information really easy and engaging for consumers to understand and interact with. They made the information digestible at an eighth grade literacy level and they explained complex genetics concepts simply enough for people to understand.

23andMe gave consumers the ability to participate in research for causes and diseases that they really care about. During the time I was at 23andMe over 80% of consumers were consenting to research.

Business value

Henry Peck: So what does that mean in terms of value to the business?

Ruby Gadelrab: 23andMe has one of the largest genetic databases in the world, with over 10 million people genotyped and consented to research. An individual genome isn’t really that useful unless it’s paired with phenotype and/or clinical information and aggregated with millions of other genomes so that we can see the patterns and discover new genes that are important for diagnostics and therapeutics.

What’s unique about 23andMe is that the database is recontactable and engaged and the company has the ability to collect additional phenotype data—I believe they currently have over 30K phenotypic surveys completed daily. Effectively, they have built a crowdsourced research platform where you can quickly make novel discoveries which can be applied to building new generations of therapeutics and diagnostics.The value they add to research is clearly recognized by pharma. Drug development is a long and expensive process. That’s because:

  • It takes 7-10 years to bring a drug to market.
  • 90% of drug candidates fail.
  • $2.6B is the average cost of getting a drug successfully to market.
  • It’s incredibly difficult to recruit patients into clinical trials and engage them for the life of the trial.

How do we create efficiencies in this process? The theory is, with the combination of genotype/phenotype data and a recontactable database, can you accelerate the pace of novel drug discovery? Find new drug targets and bring them to market faster? 23andMe has a partnership with GSK where they currently have over 30 therapeutic programs in the areas of oncology, cardiovascular disease, immunology, neurology, and metabolic disease, so clearly pharma sees the potential of such an asset.

4 keys to health product success

Henry Peck: Let’s talk about 23andMe’s recent announcement. How do you think this next step will change the company and their business? Any bold predictions for the future of 23andMe?

Ruby Gadelrab: Despite the numbers, the genetics industry is still in its infancy. And it’s still not a routine part of our healthcare system. Our healthcare system as it stands today is neither about health nor about care—it’s actually a reactive sick care system.

One of the few silver linings of the COVID-19 pandemic is that It showcased the huge gaps in our healthcare system that are ready to be addressed by those who are daring enough to try and disrupt it. Effectively, the pandemic pushed the fast forward button on digital health adoption. And one of the biggest gaps that was revealed is the problem of access.
Everyone from within the health system and outside of it recognizes that it has to change—we have to:

  • Improve access to health information and health services
  • Build solutions that can predict and prevent disease before people ever get sick and deliver the right interventions to the highest risk populations at the right time
  • Have a more holistic view of individuals’ genetics, lifestyle and behavioral data as well as social determinants of health in order to figure out what the right interventions are and who needs them most urgently
  • Develop tools for individuals to have all their health data consolidated in one place.

At MDisrupt we see many digital health companies trying to address some of these challenges. We work with them to identify which problems they are trying to solve that matter to the current healthcare system. So generally for a health product to be successful and gain widespread adoption it has to improve one or more of these four areas:

  • Health outcomes
  • Experience—for patients and for physicians
  • Access to healthcare products or services
  • Reducing healthcare costs.     

When I think about how companies like 23andMe have played a role in this (beyond therapeutics, which we already talked about), here’s what comes to mind:

  • 23andMe has built a platform that provides easier access for consumers to gain insights about their health.
  • They have built an experience for consumers to engage in conversations about their health often before they are patients—and this experience is more engaging than what we currently see from our health systems.
  • The previous generation of genetic tests focused on inherited rare diseases that affect 1% of the population.
  • The next generation of genetic tests will focus on common chronic diseases that affect many of us, such as diabetes, cardiovascular disease, hypertension, and obesity. 23andMe’s genotype/phenotype database gives them the power to develop this new class of tests known as polygenic risk scores.

One caveat to this is that these types of tests are difficult to get to market as hey require huge datasets, the studies are complex because many of the diseases are impacted by lifestyle and behavioral factors, and how these products will get through regulatory is still to be seen.

Why building health products is a marathon and not a sprint

Henry Peck: 23andMe has been one of the flagship companies in direct to consumer (DTC) healthcare. Talk to me more about this space.

Ruby Gadelrab: Building health products is hard, it’s expensive and it takes time. You have to be in it for the long term. It’s hard for a number of reasons.
In healthcare, the user, the influencer, the payer, and the consumer of the product are often completely different stakeholders with completely different incentives, so that’s a really tough challenge.

It’s a really highly regulated space and the regulation is not just per country, it’s potentially per state as well. When you’re thinking about building a health product, you have to think about the regulatory process countrywide and statewide. Your regulatory strategy also deeply impacts your commercial strategy—the type of product you would build for a DTC market is potentially different to what you would build if you want the healthcare system to adopt it.

Unlike tech, in health, you cannot test and iterate quickly. You need to do the studies to generate the evidence that your product is safe, is effective, is clinically useful, and that its economics work, and these studies can take many, many years.

When you start the commercialization process, you have to find your earliest adopters in the healthcare world, which involves building specialized sales teams and deploying expensive KOL (Key Opinion Leader) programs,
Finally, you have to get your product reimbursed and engage the medical community.

Digital health innovators: Don’t skip these steps

Henry Peck: What are the key challenges in DTC? What do you absolutely HAVE to get right in DTC?

Ruby Gadelrab: These three areas are critical:

Regulatory and Evidence Generation
For ANY health product the two things that are most critical are regulatory and evidence generation. No one should skimp on those. If you really want to disrupt healthcare this is the key differentiator. Quite frankly, there is a lot of nonsense out there disguised as health products and your studies and regulatory strategy is what will differentiate you from the nonsense and stop you getting in trouble. The advice I give all digital health companies is to hire a CMO (Chief Medical Officer) even if part time, because they will help you with the evidence generation and staying on the right side of regulatory.

Understand User Acquisition
People underestimate the cost of user acquisition. It’s very expensive to acquire consumers for health products, especially when most people are used to health products being covered by insurance. To be clear, I am a firm believer that there is a self-pay market for access and convenience, but it’s a subset of the market. I see this a lot where companies start out DTC, then realize how hard and expensive it is, and then want to pivot to B2B2C—where they want to work with health systems, employers, providers etc. So, back to my earlier point—to do that you need to make sure you have the right regulatory strategy and have done the evidence generation to allow you to make that pivot.

Bring Healthcare Providers into the Experience
Many DTC companies are improving the access to and experience of health products—and we love this democratization of health products. HOWEVER, part of the consumer experience has to be bringing healthcare providers into the fold. Think about the scenario where a consumer orders a test at home or uses an app or wearable to track their health data and that consumer takes that report to their physicians who has never seen it, has no idea why they ordered it and they ask the consumer, “What is this crazy thing you ordered off the internet?” That ruins the consumer experience.

The way around this is to engage healthcare professionals early on in your product development, so they can help you build products that are clinically useful even if they are for a consumer market. They will be your advocates later. Then, when your product is on the market, provide education for healthcare providers who may see your consumers. Educate them on your product with data and studies. This will massively help with the consumer experience and you won’t spend ridiculous amounts of money calming the naysayers.

Innovators to watch 

Henry Peck: Who are some of the leaders and “up and comers” in the space, in your opinion?

Ruby Gadelrab: It’s companies creating DTC health products that are taking an evidence-based approach that democratize access and improve the experience of healthcare products and services responsibly. And they are even better if they can demonstrate that they can improve health outcomes and reduce healthcare costs.

  • At-home lab testing. I think Everlywell and Modern Fertility are fascinating in that they massively improve the access to and the experience of a traditionally cumbersome process.
  • Liquid biopsy for early cancer detection, particularly patient-initiated (not DTC, but easy access). There are so many digital health companies innovating in this area: Grail, Exact Sciences, Guardant Health, Freenome, just to name a few.
  • Femtech. Women’s health has been neglected for far too long. Everyone thinks Femtech is just about fertility but it goes beyond that into hormone testing, sleep, diet, menopause, endometriosis, and so much more.
  • Apps and wearables that help with at-home patient monitoring. I like OneDrop. It’s a diabetes product that uses a data-driven approach to measure blood glucose levels with coaching and data.
  • Mental and behavioral health apps that combine technology with coaching experts.

Henry Peck: What types of technologies/businesses can we expect to see with the rise of DTC?

Ruby Gadelrab: Some products are DTC and some products are easy-access, where a physician network behind the scenes orders the product. Telehealth is the key technology that can power this. Telehealth and virtual care are big areas by themselves but they also power some of these products that appear to be DTC.

Health data analytics companies are generating huge amounts of data. How do we make sense of it all into something that’s clinically useful?

I think there is also potential for a company to create a space for providers and consumers to learn about digital health products and the evidence behind them. This is one of the things we are working on at MDisrupt.

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.