From Hal to Wall-E: Artificial Intelligence is transforming the medical device industry

By Rosemarie Szostak, Ph.D., Nerac Analyst

Originally Published November 13, 2018

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Artificial Intelligence


Artificial Intelligence

As creepy as Hal was in “2001: A Space Odyssey” to the cuteness of Pixar’s “Wall-E”, the science fiction community has both unsettled and entertained generations of readers and movie goers. A machine that can perform tasks that normally require the skills of a human being defines the field of Artificial Intelligence (AI) and it is transforming the medical device industry. Investors are pouring money into start-ups in the AI med devices sector at higher rates than the other industries exploiting AI. Since 2013, this segment has raised $4.3B USD in start-up funding.

The holy grail of AI in healthcare is in improving patient outcomes and reducing healthcare costs. The key in medical devices is the development of both diagnostic and treatment tools. However, the primary stumbling block for AI in medical devices has been the FDA. But the regulatory dam finally broke this year.

Fast-track regulatory approval opens up new commercial pathways

“Digital health tools have vast potential improve our ability to accurately diagnose and treat disease. And to enhance the delivery of health care for the individual, making medical care truly patient centric — empowering the individual.”Scott Gottlieb, M.D., FDA Commissioner of Food and Drugs, April 26, 2018

The FDA’s new goal “is to allow developers to efficiently incorporate into their products the latest advances in technology, while focusing FDA’s review on the safety and effectiveness of the higher-risk medical device functions that diagnose or treat patients.”

Three interesting start-ups have received FDA approval this year for their systems.

Cancer diagnostics: Arterys has developed an automated liver and lung AI lesion spotting software saving time and money in analyzing data by a human health care provider.

CT Scanning and stroke: use deep learning to automatically detect and directly alert the on-call stroke physician about suspected large vessel occlusions (LVOs) across their entire stroke network. This happens within minutes, saving both lives and time.

Diabetic retinopathy: IDx-DR technology screens patients for diabetic related blindness without the need for a second opinion from a human expert. This allows the primary care physician to screen a patient and recommend when an eye doctor expert is needed for treatment.

Smartphones for Health Monitoring

Yes, there really is an app for that! The widespread adoption of mobile technologies is opening new and innovative ways to improve health and health care delivery. Both start-ups and technology companies such as Google and Apple are investing heavily in this area. It is important to note that the FDA encourages the development of mobile medical apps that improve health care and provide consumers and health care professionals with valuable health information. Some of these apps, however, are subject to FDA regulation. Mobile apps that transform a mobile platform into a regulated medical device are considered mobile medical apps and are regulated. Generally, these mobile apps use the built-in features such as light, vibration, or camera to perform medical device functions. To date, 300 medical apps have been approved by the FDA.

Some of the more interesting apps are: is a smartphone app that uses the camera and a clinical urinalysis dipstick. The app is as accurate as the standard lab-based urinalysis analyzer and the data is sent directly to the physician and electronic medical records. It has been approved for use in both the US and EU.

QardioCore is a wireless ECG/EKG device that provides a medically accurate electrocardiograph trace for deeper heart health insights that uses a smartphone app to record, track, and store results in a format which can be sent to the persons electronic health records and physician. It is awaiting FDA approval but has been approved in Canada and the EU.

Guardian Connect System is a continuous glucose monitoring system that is imbedded under the skin and wirelessly connects to the patient’s smartphone to record data. This app requires a prescription.

SkinVision is an app that also utilizes the smartphone camera to perform self-checks for skin cancer. SkinVision provides a low, medium, or high-risk indication within 30 seconds and the images can be stored for future reference. It has not yet received FDA approval. Its business model is subscription-based with dermatologists available for review and consultation.

Pear Therapeutics has developed an app called Reset that is the first mobile medical application to help treat substance use disorders (SUD). The Reset application is intended to be used with outpatient therapy to treat alcohol, cocaine, marijuana and stimulant SUDs by prescription only. The device delivers cognitive behavioral therapy to patients to teach the user skills that aid in the treatment of SUD and are intended to increase abstinence from substance abuse and increase retention in outpatient therapy programs.

And Facebook enters Health Monitoring

Therapy bots for mental health care are using the Facebook messaging platform to help people from life coaching to cognitive behavioral therapy and faith-based healing.

How Can Nerac Help?

Is your company ready for this medical technology revolution? Will your products be redundant and displaced by a simple smartphone app? Let Nerac help you navigate and stay ahead of the rapidly changing innovation landscape. We can help you identify opportunities that allow you to capitalize by either acquiring or licensing a disruptive technology that impacts your product line, or reposition yourself in this ever-evolving marketplace.

Don’t be caught short by technological surprise. Nerac is here to help. Contact us here to learn more.

About the Analyst

Rosemarie Szostak, Ph.D.

Rosemarie Szostak, Ph.D., advises companies on technology, patents, innovation and disruptive technology. She has 20 plus years of experience as a thought leader and analyst with broad technical knowledge in chemistry, materials and chemical engineering.

Academic Credentials

  • Post Doctoral Fellow, Chemical Engineering Department, Worcester Polytechnic Institute
  • Ph.D., Chemistry, University of California Los Angeles
  • M.S., Chemistry/Physics, Georgetown University

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