• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    Transporting Treatment: An Examination of Tubing Technologies

    Outward Appearance: Reviewing Surface Treatment Options

    Face to (Virtual) Face: Telemedicine Now and Post-Pandemic

    Voices for Medtech: AdvaMed and MDMA Leaders Share Thoughts

    Digitize Your QMS via an Enterprise Cloud Platform
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Top News
    NeuroLogica Debuts Next-Generation SmartMSU with OmniTom Elite

    IZI Medical Products Launches Fully Automatic Quick-Core Auto Biopsy System

    Seed Grants Awarded to Five Proposals for Pediatric Medical Device Development

    Iterative Scopes Announces IBD-Focused Scientific Advisory Board

    Vicarious Surgical, D8 Holdings Corp. Combine Operations in $1.1 Billion Deal
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Transporting Treatment: An Examination of Tubing Technologies

    Outward Appearance: Reviewing Surface Treatment Options

    Face to (Virtual) Face: Telemedicine Now and Post-Pandemic

    Voices for Medtech: AdvaMed and MDMA Leaders Share Thoughts

    Digitize Your QMS via an Enterprise Cloud Platform
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Home Is Where the Heart (Valve) Is

    CGM: Digital Health Meets a Very Large Opportunity

    Biomechanical Engineer, Heal Thyself

    Optimizing MIM in Medical Device Manufacturing

    PPE and Diagnostics: Sourcing Domestically and Speeding Time to Market
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    Forefront Medical Technology

    Medbio LLC

    Creganna Medical, part of TE Connectivity

    PTI Engineered Plastics Inc.

    maxon
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Fiber Optics Introducing New Cleanliness Requirements for Medical Electronics

    EMS Providers Valued for Product Customization, Medical Certification Expertise

    Three Future Trends and Opportunities in Quality Assurance

    Adopting a Data-Driven Quality Model

    Digital Transformation for Quality and Manufacturing
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Medicoil

    K-Tube Technologies

    Forefront Medical Technology

    Medbio LLC

    Creganna Medical, part of TE Connectivity
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • Podcasts
    • Resources
    • eBook
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Columns

    How Digital Health Fits into the Medtech Mold

    Healthcare will need to adopt digital technologies that streamline and enhance connectivity.

    Related CONTENT
    • Real-World Medical Device Hacking Tales
    • Fiber Optics Introducing New Cleanliness Requirements for Medical Electronics
    • FDA Grants De Novo Clearance to Medtronic’s GI Genius Model
    • Acutus Medical Receives FDA Clearance of AcQCross
    • Portable Medical Devices Market to Reach $100 Billion by 2027
    Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors04.01.21
    The digital health era is well underway. Since its beginnings at the turn of the millennium, the industry’s digital transformation has spawned the development of computerized and artificial intelligence-based tools for disease diagnosis, treatment, and management. With virtual and telehealth opportunities bolstered by the pandemic, the pace of healthcare’s digital transformation is only expected to accelerate over the next decade as digitally connected technologies change the paradigm of deliverable care.

    The definition of “digital health,” however, can vary widely. There are many categories that fall under this umbrella, including:

    Wearables: Some of the current trendy items in this category include watches, patches, rings, necklaces, and textiles.

    Digital Therapeutics: Defined by Wikipedia as “evidence-based therapeutic interventions driven by high quality software programs to prevent, manage, or treat a medical disorder or disease.”

    Software as a Medical Device (SaMD): The International Medical Device Regulators Forum specifies SaMD as software intended to be used for one or more medical purposes that perform these functions without being part of medical device hardware.

    Artificial Intelligence (AI) and Machine Learning (ML) in SaMD: AI is the science, engineering, and development of intelligent machines, especially intelligent computer programs. ML is an AI technique used to design and train software algorithms to learn and act on data. Current deployment of AI/ML in medtech include imaging systems, monitoring solutions, and surgical planning software.

    Cybersecurity: The use of technology to manage and mitigate risks for medical devices that are exposed to threats through the internet or other forms of connectivity.

    Digital mHealth: Not every medical app is considered a SaMD. There are many apps that seek to improve overall well-being by providing patients and clinicians important health information.

    Digital Health Information IT: The framework used to manage health information across multiple electronic systems and devices, as defined by the U.S. Food and Drug Administration (FDA).

    Medical Device Data Systems (MDDS): Hardware or software products intended to transfer, store, convert formats, and display medical device data, according to the FDA.

    Medical Device Interoperability: The ability to safely, securely, and effectively exchange and use information among one or more devices, products, technologies, or systems (per the FDA).

    Telehealth and Telemedicine: The American Academy of Family Physicians broadly defines telehealth as electronic and telecommunications technologies and services used to provide care and services at a distance. Telemedicine is the practice of medicine using technology to deliver care at a distance. A physician in one location uses a telecommunication infrastructure to deliver care to a patient at a distant site. Telehealth is different from telemedicine in that it refers to a broader scope of remote healthcare services than telemedicine. Telemedicine refers specifically to remote clinical services, while telehealth can refer to remote non-clinical services.

    Personalized Medicine: Wikipedia’s definition is “a medical model that separates people into different groups—with medical decisions, practices, interventions and/or products being tailored to the individual patient based on their predicted response or risk of disease.”

    Digital Health Communities: Online platforms that enable consumers, caregivers, and clinicians to share stories and develop solutions across the healthcare system.

    Many of these categories did not exist (at least in a meaningful way) 20 years ago. The development of digital health shows the medtech industry continues to evolve and change in ways that have yet to be fully understood. Nevertheless, digital health has had a significant influence on the medtech sector. Its impact on businesses can vary, though, depending on the category. A detailed look at the specific entrepreneurial effects and best practices for some of these categories follows.

    Wearables: Patient monitoring companies are now most likely a remote patient monitoring (RPM) organization as well. RPM providers must be particularly vigilant about technological performance, consumer adoption, clinical workflow integration, and reimbursement challenges.

    Digital Therapeutics (DTx): Establishing a foothold in this newer category of patient solutions can be tricky. Start with funding—there are huge amounts of money being invested in this category. Last year’s $18.5 billion acquisition of Livongo (a chronic condition management platform) by Teladoc has certainly highlighted the attractiveness of this space. Some current examples of competitive companies in this area include Omada, Virta Health, Biofourmis, and Pear Therapeutics. Even though these companies tackle different patient issues, most of the common DTx solutions involve patient education, data tracking and analytics, coaching, and some type of sensor.

    AI/ML: Companies in the robotics space (or considering entering it) should “up their game” with some type of AI or ML component. AI/ML is now rapidly growing within many medical segments, including imaging, endoscopy, diagnostics, and digital surgery. This is a capability that can be developed alone or with a partner. There are many non-medtech companies with AI/ML capabilities that would make ideal partners.

    Cybersecurity: Devices containing software have already been impacted by this issue. And many a C-suite executive has lost sleep over this matter. Earlier this year, the FDA appointed its first cybersecurity chief to help build out the Center for Devices and Radiological Health’s (CDRH) cybersecurity programs, public-private partnerships, and premarket vulnerability assessments. The director will service a one year term as an expert-in-residence at the CDRH as well as at the nascent Digital Health Center of Excellence, which launched last fall. No company can eliminate every threat but the best efforts should be made to minimize or reduce cybersecurity risks.

    Digital Health IT: Historically, this was an area left for HIS (hospital information systems) or RIS (radiology information systems). In today’s drive for interoperability, digital health IT is nearly every company’s business. Finding a way for products to drive data into a hospital or clinic’s EMR system has evolved from being a competitive advantage to a customer expectation. Finding solutions to ensure products can provide data across platforms will continue to be increasingly important in the future. Companies not already working on this issue will have to quickly make up for lost time, as it’s clear the healthcare industry will continue its momentum to move into the 21st century.

    Telehealth and Telemedicine: Not every medical device company participates in this area today but thanks to the global pandemic, more may be willing to venture into this area. Telehealth/telemedicine allows patients to seek treatment without exposing themselves to hospital- or clinical environment-based pathogens. For clinicians, the technology helps improve efficiency and allows them to care for more patients. Institutions that adopt telehealth/telemedicine solutions are securing their financial futures. Thus, medical device companies would be wise to rethink their “clinical use” stories for current products. Solutions meant for the hospital or clinic may now be better marketed directly to the patient (consumer). Such a switch would require different sales techniques and an emphasis on patient education.

    Digital Health Communities: Like it or not, these online platform communities are here to stay. Patients, care givers, and clinicians use these platforms to discuss products, therapies, and other solutions in an open environment. The question is, will medtech firms embrace it or ignore it? These online forums will undoubtedly impact companies, even those whose products are used only in hospitals. Smart companies with hospital or home-based products that will benefit patients suffering from diabetes, atrial fibrillation, cancer, and other conditions are finding ways to become involved in these community discussions. An informed consumer can be a great advocate. Therefore, medtech companies should think about products that ultimately benefit patients and ways to constructively inform them about these solutions. Educating patients without insulting them or selling to them will create immense value in both the product offerings and future business.

    Certainly, there are many different aspects to digital health that can affect medtech businesses in various ways. And while it is still evolving, the industry’s digital transformation will create opportunities for companies as patients demand instant access and in-depth, real-time data on their health. In the decades ahead, healthcare will need to adopt digital technologies that streamline and enhance connectivity, and foster communication and engagement between patients, providers and payers. The path ahead is clear—medtech companies just have to be brave enough to follow it. 


    Florence Joffroy-Black, CM&AA, is a longtime marketing and M&A expert with significant experience in the medical technology industry, including working for multi-national corporations based in the United States, Germany, and Israel. She currently is CEO at MedWorld Advisors and can be reached at florencejblack@medworldadvisors.com or at www.medworldadvisors.com

    Dave Sheppard, CM&AA, is a former medical technology Fortune 500 executive and is now focused on M&A as a managing director at MedWorld Advisors. He can be reached at davesheppard@medworldadvisors.com
    Related Searches
    • Digital Health
    Related Knowledge Center
    • Digital Health
    Suggested For You
    How Can a Device End User Aid in Cybersecurity? How Can a Device End User Aid in Cybersecurity?
    What Could Medical Device Hacking’s Future Look Like? What Could Medical Device Hacking’s Future Look Like?
    Real-World Medical Device Hacking Tales Real-World Medical Device Hacking Tales
    Fiber Optics Introducing New Cleanliness Requirements for Medical Electronics Fiber Optics Introducing New Cleanliness Requirements for Medical Electronics
    FDA Grants De Novo Clearance to Medtronic’s GI Genius Model FDA Grants De Novo Clearance to Medtronic’s GI Genius Model
    Acutus Medical Receives FDA Clearance of AcQCross Acutus Medical Receives FDA Clearance of AcQCross
    Portable Medical Devices Market to Reach $100 Billion by 2027 Portable Medical Devices Market to Reach $100 Billion by 2027
    BD Receives 510(k) Clearance for Pristine Catheter BD Receives 510(k) Clearance for Pristine Catheter
    Vicarious Surgical Appoints CFO and Chief Legal Officer Vicarious Surgical Appoints CFO and Chief Legal Officer
    Nagarro Achieves ISO 13485 Certification Nagarro Achieves ISO 13485 Certification
    MICRO Expands with New Facility in Costa Rica MICRO Expands with New Facility in Costa Rica
    Qosina Announces Expanded Portfolio for Bioprocess Single-use Systems Qosina Announces Expanded Portfolio for Bioprocess Single-use Systems
    Endologix Acquires PQ Bypass Endologix Acquires PQ Bypass
    Elixir Medical Begins Study of Metallic Implant for CAD Treatment Elixir Medical Begins Study of Metallic Implant for CAD Treatment
    A Digital Stethoscope & Digital Health—A Medtech Matters Podcast A Digital Stethoscope & Digital Health—A Medtech Matters Podcast

    Related Columns

    • Chronic Disease | Digital Health | Patient Monitoring
      CGM: Digital Health Meets a Very Large Opportunity

      CGM: Digital Health Meets a Very Large Opportunity

      Continuous glucose monitors (CGMs) are one of the most formidable diabetes management tools to be developed in decades.
      Maria Shepherd, President and Founder, Medi-Vantage 04.01.21

    • Digital Health
      Five Themes to Watch as Digital Health Takes Center Stage

      Five Themes to Watch as Digital Health Takes Center Stage

      Here are five themes to watch in the sector, including what life sciences developers and investors should know about the current deal-making landscape.
      Stephen W. Bernstein, Partner, McDermott Will & Emery 03.03.21

    • Digital Health
      Digital Health Delivers During a Year for the Ages

      Digital Health Delivers During a Year for the Ages

      Internet of Medical Things technologies have emerged as the key enabler of a much more holistic and complete disease-state management toolbox.
      Brad Womble, Senior Director of Strategy, Marketing, and Mergers & Acquisitions, Jabil Healthcare 11.04.20


    • Digital Health
      What’s Apple Been Up To in Healthcare?

      What’s Apple Been Up To in Healthcare?

      Apple is building its bench with teams of physicians and engineers creating software and hardware to address the healthcare market.
      Maria Shepherd, President and Founder, Medi-Vantage 07.21.20

    • Digital Health
      The Rise of Digital Medical Devices and Implications for the Supply Chain

      The Rise of Digital Medical Devices and Implications for the Supply Chain

      ...
      Tony Freeman, President, A.S. Freeman Advisors LLC 07.21.20

    • Digital Health
      Hospital Advances in Digital Health Medical Technology

      Hospital Advances in Digital Health Medical Technology

      It's been stated, “What the world would have taken five years to achieve was accomplished in five weeks,” regarding virtual care and the U.S. population.
      Maria Shepherd, President and Founder, Medi-Vantage 06.04.20


    • Digital Health
      To Build or To Buy? In Data Analytics, That Is the Question

      To Build or To Buy? In Data Analytics, That Is the Question

      As companies undertake new types of analytics projects that require new skills beyond simple sales reporting, it’s worth revisiting the “build vs. buy” question
      Maria Kliatchko, Principal, ZS 03.04.20

    • Digital Health
      The Next Medtech Frontier: Digital Health and Home Healthcare

      The Next Medtech Frontier: Digital Health and Home Healthcare

      U.S. health systems want to find ways to reduce costs; however, the shift to treating patients at home instead of admitting them to a hospital is new.
      Maria Shepherd, President and Founder, Medi-Vantage 01.29.20

    • Digital Health | R&D & Design
      Speed Up or Risk Stepping Down: The New Reality of the Connected Healthcare Development Cycle

      Speed Up or Risk Stepping Down: The New Reality of the Connected Healthcare Development Cycle

      Digital health and connected devices are an extraordinary new tool for delivering on improving patient outcomes.
      Joe McBeth, VP Global Supply Chain, Jabil Healthcare 01.29.20


    • Digital Health
      An Update on Digital Health

      An Update on Digital Health

      ...
      Maria Shepherd, President and Founder, Medi-Vantage 11.04.19

    • Contract Manufacturing | Digital Health | Software & IT
      Connecting the Dots in Medical Device Outsourcing

      Connecting the Dots in Medical Device Outsourcing

      ...
      MPO Staff 07.30.19

    • Digital Health | Neurological
      A Breakthrough for the Nightmarish Effects of PTSD

      A Breakthrough for the Nightmarish Effects of PTSD

      ...
      Sam Brusco, Associate Editor 06.13.19


    • Digital Health
      AI in Healthcare: Where Are We Now?

      AI in Healthcare: Where Are We Now?

      ...
      Maria Shepherd, President and Founder, Medi-Vantage 06.13.19

    • Cardiovascular | Diagnostics | Digital Health | Patient Monitoring
      Cardiac Care on the Can

      Cardiac Care on the Can

      ...
      Sam Brusco, Associate Editor 04.03.19

    • Digital Health | Patient Monitoring
      Converging Goals: How a Focus on the Patient Drives Stronger Healthcare Partnerships

      Converging Goals: How a Focus on the Patient Drives Stronger Healthcare Partnerships

      ...
      Vicki Anastasi, VP and Global Head—Medical Device and Diagnostics Research & Real World Evidence Late Phase Research, ICON 04.03.19


    Trending
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • Survey: Remote Patient Monitoring To Match Or Surpass In-Patient Within Five Years
    • Device Designed To Permanently Replace Failing Human Hearts
    • 5 Ways Plastics Revolutionized The Healthcare Industry
    • Top 10 Trends In The Medical Device And Equipment Industry
    Breaking News
    • NeuroLogica Debuts Next-Generation SmartMSU with OmniTom Elite
    • IZI Medical Products Launches Fully Automatic Quick-Core Auto Biopsy System
    • Seed Grants Awarded to Five Proposals for Pediatric Medical Device Development
    • Iterative Scopes Announces IBD-Focused Scientific Advisory Board
    • Vicarious Surgical, D8 Holdings Corp. Combine Operations in $1.1 Billion Deal
    View Breaking News >
    CURRENT ISSUE

    April 2021

    • Transporting Treatment: An Examination of Tubing Technologies
    • Face to (Virtual) Face: Telemedicine Now and Post-Pandemic
    • Outward Appearance: Reviewing Surface Treatment Options
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    AstaReal Astaxanthin Ingredient Receives U.S. Patent Approval
    Study on Kemin’s DailyZz Botanical Blend Uncovers Sleep Quality, Next-Day Performance Benefits
    FDA’s Dr. Cara Welch Opening Speaker at the 9th AHPA Botanical Congress
    Coatings World

    Latest Breaking News From Coatings World

    Stahl Launches NuVera
    PPG Acquires Automotive Coatings Manufacturer Cetelon
    Jebsen & Jessen, Innospec Sign Distribution Agreement
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    NeuroLogica Debuts Next-Generation SmartMSU with OmniTom Elite
    IZI Medical Products Launches Fully Automatic Quick-Core Auto Biopsy System
    Seed Grants Awarded to Five Proposals for Pediatric Medical Device Development
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Resilience Acquires Ology Bioservices
    RDIF, Hualan Ink COVID-19 Vaccine Deal
    Kintor, Visum Enter COVID-19 Manufacturing Partnership
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Bésame Cosmetics Unveils Marilyn Monroe Collection
    Procos Opens U.S. Office
    Weekly Recap: HipDot Reese’s Makeup Collection, Cosmoprof Worldwide Bologna Postponed & More
    Happi

    Latest Breaking News From Happi

    Jergens Launches Mother’s Day Campaign
    Fragrance Creators Association Celebrates P&G Executive
    Jeen International Celebrates Its 25th Anniversary
    Ink World

    Latest Breaking News From Ink World

    Kumon North America Adds Speedmaster XL 106 from Heidelberg
    SE-DA Invests in Kornit Presto S
    Acrylic Resins Market Worth $21.9 Billion by 2025: MarketsandMarkets
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    TLMI reveals Eugene Singer Award winners at Virtual Spring Summit
    Monadnock Paper Mills joins SGP
    ACTEGA helps converter reach sustainability goals
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Andritz to Supply Elliptical Cylinder Pre-Needler in France
    Ahlstrom-Munksjö to be Delisted from Nasdaq Stockholm
    Radienz Living Introduces Sustainable Products
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    First Surgeries Completed With Globus Medical's CREO ONE Robotic Screw
    BioMagnetic Sciences Names President and CEO
    Mainstay Medical Launches ReActiv8 in Australia
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Virtual ASMC 2021 Spotlights Advanced Semiconductor Manufacturing Excellence
    LG Display Cuts Down CO2-eq Emissions by 3 Million Tons in 2020
    European Commission's Innovation Radar Acknowledges 3 ARMOR Innovations

    Copyright © 2021 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login