Summary of Clinical Trials Technology Event on November 5th, 2019

We had a great event last week on clinical trials.  A big thanks to our speakers:  Carrie Northcott of Pfizer, Melissa Naylor of Takeda, and Wendy R. Sanhai of Deloitte.  Also thanks to our host RightPoint Boston and our event partner the Healthcare Businesswomen’s Association.

Event with Carrie Northcott, Melissa Naylor, and Wendy Sanhai at RightPoint Boston.

Here are ten takeaways from the discussion:

  • Digital endpoints have many advantage over traditional clinical endpoints in clinical trials. Data can be collected 24/7and can be randomized by time. Measures can be continuous which is more effective at assessing quality of life. Digital endpoints can take away the burden on the patient to make repeated clinic visits which also reduces the trial cost. Digital endpoints can also help make sure that trial participants aren’t downplaying their reported symptoms or practicing for tests in advance of clinic visits.
  • Digital endpoints include data collected from a growing variety of devices. Some of the devices discussed include thermal radiography sensors and accelerometers for itching and scratching, mobile apps for measuring cognitive ability, wearables to measure the motions of Parkinson’s, image recognition of facial expressivity, tracking social phone interactions in schizophrenia, and detection of pill taking.
  • New digital endpoints need to be validated in comparison to traditional clinical measures. One challenge is that the original clinical measures may not be very useful or accurate in comparison to the new digital measures. Another challenge is that the digital data sets are often huge (4 terabytes of data per study is typical). So the initial phase of a trial exists only to validate the new technology with the targeted population and a control group and won’t include drugs or other treatment.
  • Digital measures can be especially valuable for conditions that involve difficult to measure cognitive changes like Alzheimers and Parkinson’s. The collection of large sets of data from multiple sensors and devices that interact with patients give hope for the discovery of more effective ways to measure early stages of the disease.
  • When choosing a device for data collection, it’s important to keep in mind that most people don’t live in Boston or Silicon Valley. People may be uncomfortable using technology, may have no wireless connectivity at home, and can’t be relied upon to keep batteries charged. It’s often the best practice to choose a devices with no screen and no connectivity that can be dropped at the clinic at the end of the trial period to extract the data.
  • There’s an important trend in clinical trials to become more patient centered. This is increasingly leading to sharing a participant’s data with them at the conclusion of a trial. Sharing data too soon isn’t recommended because it can lead people to change their behavior and skew the trial results.
  • Security is a growing area of concern. Many technology companies are new to healthcare and don’t have experience with the rigor of a regulated environment. One example includes a technology company in the midst of a clinical trial that was infiltrated by hackers who threatened the company with ransom. Since the company had no cybersecurity policy, they lacked the means to notify trial participants of the threat to their health.
  • Another rising issue is data privacy and ownership. As the big tech companies of the world become involved in healthcare and come into contact with the FDA, there will need to be changes to the way they have previously handled privacy. One way the FDA is addressing this is through their Center of Excellence for Digital pre-certification program which consists of a background check on companies to demonstrate they have a good track record.
  • Biotech companies working with technology vendors have a different set of challenges. Many vendors will try to keep their algorithms proprietary as a black box which makes validating the data more difficult. In other cases, vendors will want to publish early training data that shows initial signs of success, which is misleading if the data hasn’t yet been validated. Another area of concern are the statistical impacts of software that is modified during the course of a study or trial, for example an algorithm or the underlying software OS.
  • We are at a point in time when the rising costs of clinical trials are at a pace to become unsustainable. Digital endpoints offer an opportunity to bring down the cost of trials while increasing their effectiveness.

Hosted in partnership with the HBA

Summary of the Digital Chronic Care event (2019)

Event hosted by HealthTech Build on October 1st, 2019

  • Michael Sturmer, SVP Health Services Segment, Livongo
  • Maria-Louisa Izamis, Innovation Program Director, Philips
  • Piali De PhD, Founder & CEO, Senscio Systems
  • Patricia Bloom MD, Clinician Investigator, Massachusetts General Hospital
  • Jonah Comstock (Moderator), Director of Content & Editor in Chief, HIMSS Media

A little nudge can dramatically change a person’s health for the better.  Many people with diabetes only check their blood sugar levels once a day. This may miss moments of dangerously low levels at other times.  A simple nudge to adjust the time of their glucose check, as described by Michael Sturmer of Livongo, can improve health outcomes through a technology platform that incorporates a human touch.

A panel of digital chronic care experts discussed the challenges of providing high quality care for people with chronic conditions at a HealthTech Build event moderated by Jonah Comstock of HIMSS.

The obstacles for chronic care can perhaps best be understood through the concepts of episodic care and continuous care, as described by Piali De of Senscio Systems.  In episodic care, people get sick and visit a hospital or clinic, get diagnosed, and are given a plan for treatment. After the visit, there is typically little engagement with clinical staff and further treatment becomes the responsibility of the patient.

By contrast, continuous care involves the patient at home, at work, or in the hospital.  To do continuous care properly, there needs to be a way of monitoring the patient remotely and engaging with them frequently.

In the United States today, the healthcare system is built around the model of episodic care.  Most physicians lack the resources to follow up with their patients which may number in the thousands.  And financial incentives are mostly aligned around a fee-for-service model of visits and procedures which discourages an ongoing relationship with the patient.

Episodic care is particularly a problem for people with multiple chronic conditions who have complex needs that require additional engagement from clinical providers, as explained by Patricia Bloom MD of Mass General.  People with liver disease are often dealing with drug and alcohol addiction and socioeconomic factors. They may arrive at the hospital with a serious condition that is treated before being discharged back into an unsupportive environment.

The consensus of the panel was that an effective solution should incorporate both technology and a human care network.  

The technology components include remote monitoring through connected glucose monitors or blood pressure cuffs, algorithms and artificial intelligence that automatically identify and alert about patient problems, and interfaces for engagement between the patient and clinical care team.  The human element includes a central point of contact that may be a health coach or social worker in combination with a clinical team of nurses and physicians and other specialists.

The good news is that digital chronic care is moving forward quickly.  Newly public companies like Livongo are reaching hundreds of thousands of patients, new companies like Senscio are bringing together the newest technologies for patient care, hospitals like Mass General are adopting digital systems to better care for chronic conditions, and multinational companies like Philips are integrating a diverse set of monitoring products to work across institutions.

Piali De of Senscio described founding a company to serve aging parents with multiple chronic conditions.  The goal of Senscio is to gently guide people toward better care without taking away autonomy. The Senscio platform collects large amounts of data in the home and uses artificial intelligence to identify patient problems and escalate if necessary to a human care network.

Dr Patricia Bloom explained her experience as a physician for patients with chronic liver conditions.  Hospitalized patients would spend weeks to get on the perfect regimen and receive education, but after discharge there would be little or no contact unless the patient reappeared at the hospital.  To address this, her team has implemented the PGHD Connect remote monitoring system from Partners HealthCare to remotely track the health of liver patients. A member of her team regularly observes the patient monitoring results and can make a phone call to the patient if there is a problem.

Michael Sturmer of Livongo spoke about how the Livongo model is centered around the patient to deliver better outcomes while lowering costs.  As someone who previously spent years on the payer side of the industry, he detailed the challenges of breaking into the market from a financial perspective.  Some of Livongo’s earliest customers were large employers who had the funding to add to their employee benefits. During this time, Livongo was able to calculate a return on investment based upon  lower utilization of outpatient services in the short term and improvements to patient health that led to utilization of lower severity services in the long term.

Maria-Louisa Izamis described how Philips has many products for digital chronic care including devices for us in clinical settings and at home.  The large reach and scale of Philips has allowed them to standardize across hospitals and encourage sharing of algorithms between sites with the goal that patients can walk into different institution and receive similar benefits to their care.

While can anticipate that the healthcare system will move slowly, there are positive signs that things are headed in the right direction. Livongo’s success metrics are a model for the industry, Medicare has opened new paths for reimbursement for ongoing services like remote monitoring, and employers and payers are increasingly experimenting with patient-focused models.

And we can expect technology to continue at a rapid pace to deliver smaller and cheaper home monitoring devices, improved sensors, more sophisticated algorithms to pinpoint patient problems and guide clinical decisions, and new voice and video interfaces for communications between patients and providers.

Summer Liquidity Networking Event

Join us to raise a glass for this summer’s recent healthtech IPO successes. 2019 has been a milestone year for the healthtech sector, and we look forward to this trend continuing.

The companies going public this summer include:

Livongo – Technology for personalized tracking and actionable feedback for people with chronic conditions. LVGO (NASDAQ).

Phreesia – Automation of patient intake process. PHR (NYSE).

Healthcare Analytics – Data analytics technology for healthcare providers. HCAT (NASDAQ).

We hope this infusion of funds into the sector will accelerate the path to improved patient outcomes and effective care.

When: Tuesday, August 13th at 6pm

Where: Ned Devine’s in Faneuil Hall (inside on 2nd floor)

This summer party is a joint effort by several Boston collaborators in HealthTech, including…

New digital health research site Exits and Outcomes

The Boston team (formerly RaizLabs) of Rightpoint Healthcare and Medicine

The Boston life sciences team of investment bank Outcome Capital

Apple Research Kit – Boston with Behavioral Health Innovators

Recap of 4/10/19 Event: Understanding the Digital Revolution in Medical Devices

By Matt Gross

If a ride-sharing app can detect when a passenger is having a heart attack, should that app be allowed to notify clinical staff?  That scenario was among the challenging digital health topics tackled at a recent HTB Boston event by experts from Boston Scientific, Medtronic, Analytics 4 Life, and Outcome Capital.

While digital technologies are starting to make a significant impact in many sectors of healthcare, market data indicates that we’re still in the earliest days with a steep growth curve ahead (source: Outcome Capital).

That growth will occur across a variety of healthcare sectors.

From the viewpoint of David Feygin of Boston Scientific, digitization will come first to areas with significant data flows or where there are frictions that need to be addressed.  Examples include the digitized capture of medical imaging with AI, telehealth, clinical trials, and population health.

For Geoff Dacosta of Medtronic, the surgical division is his area of focus for digital change.  Many companies are starting to digitize surgery from robotics to machine learning. One of the fundamental challenges is distilling actual surgery into bytes and voxels and compressing actions into a format that’s accessible to machines for the development of surgical algorithms.  Once digitized, surgery data can be supplemented by biologic and genetic data. Another area of surgical practice with great potential to benefit from digital technologies is post-operative recovery. New post-operative algorithms for regimen and prescriptions can be personalized to target treatment to an individual patient’s specific surgery.

Continue reading “Recap of 4/10/19 Event: Understanding the Digital Revolution in Medical Devices”

April 2019 – Understanding the Digital Revolution in Medical Devices

HealthTech Build is hosting a unique discussion about changes in the MedTech landscape with leaders from Boston Scientific, Medtronic, and more. Join us for this free event!

When: Wednesday, April 10th, 6:000 – 8:00PM
Where: WPI Seaport, 303 Congress Street, Boston

Eventbrite - Understanding the Digital Revolution in Medical Devices

Join representatives from leading MedTech companies to understand the role technology is playing in the next generation of medical devices. The discussion will cover emerging trends in business and science as medical devices and digital technology converge.

This event is intended for entrepreneurs and leaders from MedTech businesses who want to navigate the business and regulatory complexities of the MedTech space. This event will also be of interest to developers, medical researchers, clinicians, data scientists, and more.

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Recap of 2/5/19 Event: Innovation at the FDA and the MyStudies App

By Matt Gross

Nobody knows better than the FDA that gathering real world evidence is challenging.  A new initiative called FDA MyStudies offloads the burden of technology infrastructure while making participant engagement as easy as checking an Instagram feed or ordering an Uber.

Last week at HealthTech Build in the Boston Seaport an interactive audience learned how this new open source software initiative is now freely available for implementation by any research team.

To understand FDA MyStudies, it’s perhaps easier to walk through a scenario.  Imagine a team of researchers who are investigating the association between levels of physical activity and prediabetes.  They want to study a population of 1000 people at risk and measure their activity over the course of several months.

Once their study plan is approved, the research team decides to send an invitation to a list of patients from their institution who have expressed interest in research.  These patients receive an invitation on their phone by text message containing an enrollment token and a link to download the app which has been branded with the institution’s colors and logo.  

Continue reading “Recap of 2/5/19 Event: Innovation at the FDA and the MyStudies App”

FEBRUARY 2019 – Innovation at the FDA: Introduction to MyStudies, An Open Source App and Platform for Patient Research

Join us for our kickoff event for 2019!

When: February 5th, 5:30 – 7:30PM
Where: WPI Seaport, 303 Congress Street, Boston
Space is limited and pre-registration is required – Register Now

Join us for networking and a cutting-edge discussion of the FDA’s new open source research app platform called MyStudies. This new digital platform, announced in November 2018, enables researchers and developers to adapt MyStudies technology to advance new ways to access and use data collected directly from patients—with the necessary controls in place to ensure patient privacy, compliance with regulations and assist with safety monitoring. Data can be collected from a variety of sources, such as patient-generated and provided data including in home-use settings, or from data gathered from other sources, such as mobile device and external sensors.

Hear from Harvard Pilgrim Health Care and Boston Technology Corporation, two of the companies contracted by the FDA to create the open-source HIPAA and FISMA compliant platform that will encourage the development and use of mobile health technology for real world evidence collection and patient engagement. The open source code that serves as the foundation of the MyStudies platform, as well as specifications for a secure patient data storage environment, were developed through a collaboration with Harvard Pilgrim Health Care Institute, LabKey and Boston Technology Corporation. Continue reading “FEBRUARY 2019 – Innovation at the FDA: Introduction to MyStudies, An Open Source App and Platform for Patient Research”

NOVEMBER 2018 – Software as a Medical Device

Join us for our kickoff event for the HealthTech Boston group of Mobile Monday Boston.

A new era for digital therapeutics:  Medical treatments that incorporate software running on patient’s personal devices are starting to gain widespread acceptance.  Several new companies are building treatment pipelines of mobile apps that can be prescribed and reimbursed by insurance.  Meanwhile the pharmaceutical industry is producing a steady stream of companion apps that can integrate with devices in the home for drug delivery and data collection.

The FDA and Software as a Medical Device (SaMD):  The medical community and FDA are responding favorably to this trend.  Earlier this year, the FDA rolled out a pre-certification program for software as a medical device to address the needs of software developers who typically operate at a timescale of weeks instead of years.  In their words, an “agile regulatory paradigm is necessary to accommodate the faster rate of development and potential for innovation in software-based products.”

Join us for an open discussion with: Ashley Mateus (Akili Interactive), Greg Stern (Sanofi), Jeremy Gilbert (Pear Therapeutics), and Carlos Rodarte (Volar Health) about the latest developments in digital therapeutics and Software as a Medical Device (SaMD).

Continue reading “NOVEMBER 2018 – Software as a Medical Device”

Recap of 5/23/16 Event: Mobile Technology for the Ebola Epidemic in West Africa

Here is a recap from our event on Mobile Monday May 23rd.  Many thanks to Microsoft for hosting us.


Dimagi CEO Jonathan Jackson
Partners in Health, Specialists Ermyas Birru and Aaron White
VitalWave, Senior Technical Advisor, Jonathan Payne

Some key use cases for mHealth are contact tracing over time, training health workers (quickly) in symptom identification, and data sharing across countries in a secure and legal way.

Introduction of a new technology during a healthcare crisis is generally a bad idea.  That’s why new tech usually arrives as a crisis is trailing off.  The reason is that it takes time for the people on the ground to determine what the requirements are (in the ebola epidemic, this was contact tracing).  Another reason for lag time is it can take time for funding to come through and then organizations to get set up locally.

Continue reading “Recap of 5/23/16 Event: Mobile Technology for the Ebola Epidemic in West Africa”