The Tech Between Us Podcast: The Rise of Digital Therapeutics Part II.

Jessica Miley

18 Dec, 2023

The Tech Between Us Podcast: The Rise of Digital Therapeutics Part II.

In part II of the Mouser podcast episode, Dr. Smit Patel continued discussing the evolving landscape of digital therapeutics and its impact on healthcare highlighting several key insights into how digital solutions are reshaping medical treatments and the regulatory environment surrounding them.

artificial intelligence

- Biomedical Devices

- electrical engineering

- Medical Devices

FDA's Approach to Digital Health Solutions

The United states Food and Drug Administration (FDA) strategy towards digital health solutions is function-based, focusing on the device's functions rather than hardware or software components. This approach allows for a more flexible and efficient regulatory process.

Digital therapeutics are categorized as either class one or class two medical devices, depending on the level of risk they pose. They often follow a 510K pathway for approval, streamlining the process compared to traditional hardware-based medical devices. The speed of clearance through this pathway depends on the intended use and the risk to the patient.

The FDA assesses digital health products based on the risk level to the patient, irrespective of whether the product is software or hardware. This risk-based categorization ensures that the appropriate approval pathway is applied.

The Digital Medicine Society (DiMe) has developed resources to aid entrepreneurs and engineers in digital therapeutics companies. These resources include an interactive tool and flow chart that consolidate over 30 guidances and multiple policies, simplifying the navigation through regulatory landscapes.

Artificial Intelligence (AI) and Machine Learning (ML) algorithms are increasingly being utilized in digital therapeutics, extending beyond radiology to the prevention and management of diseases. These technologies are proving to be crucial in enhancing efficiencies and clinical applications across the healthcare sector.

Innovations in Medical AI

A notable example of innovation in medical AI is Caption Health's cardiac AI software, which was the first of its kind to be granted approval early this year. This breakthrough demonstrates the significant potential for innovation and evolution in the field of medical AI.

In conclusion, the podcast with Dr. Smit Patel offered valuable insights into the dynamic world of digital therapeutics. It underscored the importance of regulatory adaptability, the growing role of AI and ML in healthcare, and the resources available to those venturing into this promising field. Listen to part 1 here.

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Smart Skin Patches and Noninvasive Medical Sensing

Status and evolution of intelligent skin patches, enabled by flexible hybrid electronics, going from a single wired sensors to complex wireless multi-function capability. Learn about trends, archirectures and challenges from a manufacturer's point of view to understand how to design for production.

Khasha Ghaffarzadeh

fromTechBlick

25 Jul, 2023

Biomedical Devices

- Medical Devices

- Printed Electronics

- wearable

- wearables

As part of the TechBlick (wwww.TechBlick.com) series we invited Wladimir Punt from Molex to tell us about how hybrid printed electronics can enhance function and manufacturing of wearable medical sensors. Here you wll learn about the trends, archirectures and challenges. Wladimir and his team at Molex are very well placed in this field, having had the opportunity to develop, prototype, and mass produce many wearable medical sensors over the years. This article was originally published on TechBlick here.

The advance of electronics miniaturization is opening new frontiers in Medtech, including in the field of adhesive skin patches. In the past, a skin patch might contain a single wired sensor. But today’s smart skin patches incorporate a broader range of functions. Hybrid printed electronics permit a variety of electronic devices and noninvasive sensors to be affixed to a thin and flexible substrate, enabling designers to integrate sensors, microcontrollers, wireless connectivity and batteries into a capable, durable and connected device.

Whether in a clinical or home setting, this enables far more comprehensive patient monitoring. Adding enhanced capabilities to lightweight and flexible skin patches allows patients to go about their day while they (or their healthcare provider) monitor vital signs or activity noninvasively. There is tremendous potential for this flexibility to improve patient monitoring and make it simpler, more comfortable and more accessible.

The Evolving Need for Connected Medical Sensing

The demand for mobile, connected and noninvasive medical sensing capabilities is growing. During the COVID-19 pandemic, the need for hospitals and clinics to monitor patients remotely became clear. This capability did more than allow doctors to track their patients’ vital signs while maintaining social distan

Image: This image shows examples of MAGENTA prototypes fabricated with a “shape memory alloy” spring and an elastomer, and how their sizes compare to that of a one cent coin. Credit: Wyss Institute at Harvard University

Wasting muscles built back better

Programmable mechanically active adhesive makes muscles stretch and contract, preventing and enabling recovery from atrophy

Benjamin Boettner

fromHarvard University

15 Nov, 2022

Biomedical Devices

- healthcare

This article was discussed in our Next Byte podcast.

The full article will continue below.

Muscles waste as a result of not being exercised enough, as happens quickly with a broken limb that has been immobilized in a cast, and more slowly in people reaching an advanced age. Muscle atrophy, how clinicians refer to the phenomenon, is also a debilitating symptom in patients suffering from neurological disorders, such as amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), and can be a systemic response to various other diseases, including cancer and diabetes.

Mechanotherapy, a form of therapy given by manual or mechanical means, is thought to have broad potential for tissue repair. The best-known example is massage, which applies compressive stimulation to muscles for their relaxation. However, it has been much less clear whether stretching and contracting muscles by external means can also be a treatment. So far, two major challenges have prevented such studies: limited mechanical systems capable of evenly generating stretching and contraction forces along the length of muscles, and inefficient delivery of these mechanical stimuli to the surface and into the deeper layers of muscle tissue.

Now, bioengineers at the Wyss Institute for Biologically Inspired Engineering at Harvard University and the Harvard John A. Paulson School of Engineering and Applied Sciences (SEAS) have developed a mechanically active adhesive named MAGENTA, which functions as a soft robotic device and solves this two-fold problem. In an animal model, MAGENTA successfully prevented and supported the recovery from muscle atrophy. The team’s findings are published in Nature Materials.

With MAGENTA, we developed a new integrated multi-component system for the mechanostimulation of muscle that can be directly placed on muscle tissue to trigger key molecular pathways for