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.

Continue reading “April 2019 – Understanding the Digital Revolution in Medical Devices”

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.

Speakers:

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”