• 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
    Adding Fabrication Capabilities: Additive Manufacturing for Production Parts

    Delivering the Goods: The Evolving World of Combination Products

    Anxious Undertones: The 2019 Year in Review

    From Art to Science: The Changing Face of Extrusion

    Exact Science: A Micromolding Roundtable
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Top News
    FDA OKs Roche's Nasal Swab MRSA Test

    Philips & Paige to Deliver Clinical-Grade AI Applications to Pathology Labs

    Eye Test for Parkinson's Gains Breakthrough Designation

    Biomerics Forms New Business Unit

    J&J's New Monofocal IOL for Cataract Patients with Astigmatism
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Adding Fabrication Capabilities: Additive Manufacturing for Production Parts

    Delivering the Goods: The Evolving World of Combination Products

    Anxious Undertones: The 2019 Year in Review

    From Art to Science: The Changing Face of Extrusion

    Exact Science: A Micromolding Roundtable
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    From Genome Sequencing to the World’s First Portable MRI

    An Update on Digital Health

    ‘If You’re Reading This, You Need to Be at This Meeting’

    Five Steps for Succeeding Globally in Medtech

    Unlocking Market Doors with Real-World Evidence
    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
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    Command Medical Products Inc.

    Aran Biomedical

    Pulse Systems

    Halkey-Roberts Corporation

    Carclo Technical Plastics
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Understanding Key Processes for Mixing APIs with Silicone

    How to Minimize Color Variations in Your Medical Device

    Don’t Touch: Gesture Tech Is Reshaping How We Interact with Devices

    Revenue-Based Financing: A New Form of Growth Capital

    Pre-Filled Safety Syringes and the Self-Administration Trend
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Zeus

    RJG Inc.

    FUTEK Advanced Sensor Technology Inc.

    S-Y-M Products Company

    K-Tube Technologies
    • 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
    • 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
    Online Exclusives

    How Value-Based Healthcare Affects Medical Device Development

    Manufacturers need to employ new methods and tools to maximize the effectiveness of their efforts in bringing new devices to market.

    How Value-Based Healthcare Affects Medical Device Development
    Related CONTENT
    • Study Probes Utility of Continuous Noninvasive Hemoglobin Measurement With Masimo SpHb
    • Masimo and PositiveID Announce the U.S. Release of TIR-1
    • CHLA/USC Researchers Design Novel Micropacemaker
    • The Impact of Changing Healthcare Economics on Device Design
    • Velano Vascular Board of Directors Welcomes Two New Members
    Vicki Anastasi, VP and Global Head, Medical Device and Diagnostics Research, ICON12.17.18
    Value-based healthcare (VBHC) models are poised to transform everything from how patient care is delivered to how treatments are priced. An analysis by United Healthcare estimated that at the end of 2018, more than $65 billion will be tied to value-based contracts. Furthermore, as the movement gains momentum, the adoption of value-based care is projected to account for about 59 percent of healthcare payments by 2020, according to Aetna 2018 Health Care Trends Report.

    Unlike traditional models where care is considered to be the treatment a patient receives at the time he or she sees a healthcare provider, VBHC models consider care to be a long-term affair that stretches from the first doctor visit to months, or even years after the treatment was first delivered. This encourages providers to consider the long-term outcomes and costs of a treatment or medical device.

    VBHC follows the idea that payments for services are linked to the clinical and cost outcomes for treating a defined patient need, condition, or episode of care—as opposed to the volume of the provided services. Policymakers believe that holding healthcare providers accountable incentivizes improvements that will ultimately produce better individual patient and population health outcomes at a lower overall cost.

    To achieve success in a VBHC market, device manufacturers will need to work with providers to control costs, while demonstrating value in terms of improved patient outcomes through new types of evidence. Manufacturers will need to share product performance data to providers that offer a complete solution to the procedures in which their devices are used. What’s more, they need to integrate themselves further in the healthcare delivery system.

    For device manufacturers, the challenges that come with the shift to VBHC are a marked departure from how the relationship between device manufacturers, payers, and providers has been conducted in previous years.

    Value Can Mean Many Things
    Aligning the many definitions of value that each stakeholder holds is the biggest challenge in the transition to value-based healthcare. Patients and physicians might put the highest value on individual clinical efficacy and convenience. On the other hand, payers and governments may not consider these as important as cost and population health impact.

    An example that illustrates the misaligned definitions of value is the 90-day episode-of-care bundled payment for joint replacement surgery. A provider group that is getting a flat-rate bundled payment might be reluctant to spend more on a costlier joint replacement implant, when there is a cheaper alternative readily available, even if the expensive implant can potentially reduce the patient’s healthcare costs over the subsequent 20 years. Therefore, the short-term financial incentive on the part of the provider is not aligned with the patients’ long-term best interests, in addition to the long-term treatment cost implications for the healthcare system.

    The key to success is to ensure the many definitions of value align across stakeholders, especially with payers, who have the most sway in decisions. It is important to determine what benefits accrue to whom and over what time frame, and then to focus on those benefits when establishing a target market or during price negotiations.

    A fundamental shift needs to occur when considering value. For instance, factoring value into clinical trial design should occur earlier in the product lifecycle and in balance with other aspects of a patient's care. A stakeholder value mapping process can help identify what various stakeholders value and over what time frame that value is returned. Manufacturers can use this map to assess the market potential of devices in development and guide evidence generation and actions that foster alignment of incentives for all stakeholders, so that they all can realize the value they expect.

    Putting a Price on Value
    To ensure devices achieve success in the marketplace, manufacturers need to work with providers to control costs. Provider groups may attempt to circumvent the high price of a more expensive, but better performing, product by negotiating a lower price point from the manufacturers. Also, providers may turn to insurers to make a deal that pays the provider more for using a specific device because its higher upfront cost can be offset by lower treatment costs over future years.

    In other cases, patients may be asked to pay the extra cost of a non-standard device or diagnostic, since payers reason patients would pay for a device that provides an improved outcome over the standard option.

    Regardless of what cost-reducing method is chosen, payers will continue to hold providers accountable for delivering better patient outcomes at a lower overall price. This could cause device manufacturers to consistently and aggressively lower the price of their products to remain a viable and attractive option for providers.

    However, lowered pricing places cost pressures on device manufacturers, who could see lower margins on their devices as a result of operating in a VBHC system. While achieving profitability may become more challenging, manufacturers have the opportunity to increase sustainability and improve patient outcomes by changing how they approach device development. For example, carefully assessing, planning, and coordinating with a range of potential stakeholders will be required to generate higher margins.

    As detailed earlier, to counteract the potential decline in margins, device manufacturers need to incorporate steps to address value earlier in the product lifecycle. Traditionally, clinicians write study protocols that maximize clinical data collection, and an economist’s valuation of the device occurs late in the development process. This leaves the economist little time to gather and analyze data, which can significantly impair a new device or diagnostic’s survival in an already tough market.

    Proving New Is More Than Better
    In the past, to clear lower risk devices under the FDA 510(k) or CE mark process, it was necessary to demonstrate that the new device was equivalent to a previously approved device, but no clinical outcomes evidence was required for Class I and Class II devices. Currently, under VBHC, buyers and regulators are requiring more evidence of clinical effectiveness and cost impact of new treatments to ensure they are getting their money’s worth.

    As a result, device manufacturers will need to provide evidence that a product not only works, but also generates offsetting savings or patient benefits that make it worth the extra cost if it is a premium price over similar products.

    In addition, from the provider’s perspective, claiming a device is equivalent to an older device means its worth is no more than the older device. So, for truly innovative devices, manufacturers must consider the worth of investing in a pre-market approval program that gathers detailed clinical evidence and cost impact information, at the same time, to provide the innovative device an edge once it is available on the market. Therefore, clinical and economic data are essential to developing a value-based case for higher payment.

    mHealth Helps to Gather Evidence
    Showing the long-term benefits of novel devices requires new types of metrics and data gathering methods. For example, data from mobile health technologies (mHealth)—which includes mobile sensors for detecting clinical signs and patient activity; mobile apps for running diagnostic quizzes and reporting symptoms; and telemedicine applications that run on smartphones, tablets, and other electronic devices—can be transmitted wirelessly, enabling continuous monitoring of patient progress or therapy adherence.

    Using mHealth and other innovative technologies can generate the evidence needed for manufacturers to demonstrate value in several ways. The litany of mobile sensors can generate continuous streams of data on vital signs such as blood pressure, blood sugar, and heart rate. mHealth can also identify changes in patient outcomes of which they themselves may not be aware, such as increased activity due to relief of chronic pain.

    Perhaps the most important information that mHealth technologies bring to light are data for real-time patient activity, which show how a therapy impacts patient outcomes, especially those that are difficult to document through periodic clinical visits, such as the ability to walk to the grocery store or care for themselves or others.

    Moreover, diagnostic and telemedicine apps can keep patients in communication with clinics, creating scenarios where healthcare providers can discharge patients earlier after surgery, since they’ll be monitored in a home setting and still be in close contact with the provider in the event there are complications.

    Conclusion
    Moving forward, the implementation of VBHC models means manufacturers will need to demonstrate clinical efficacy and cost impact of new devices—especially earlier in the development process—to ensure products benefit patients, while outweighing any extra costs. mHealth technologies have the potential to document the value of treatments more effectively and efficiently, helping manufacturers to increase treatment value, while presenting a persuasive case to payers. Despite the challenges, the rewards of value-based care can be high for manufacturers, as they can help patients to have more timely access to innovative medical technologies.

    Partnering with a CRO that has a proven track record in clinical evidence generation, economic modeling, and commercialization expertise can help throughout the stakeholder value mapping process and ensuring a new device can have a good market impact.


    Vicki Anastasi is vice president and global head, Medical Device and Diagnostics Research at ICON plc. She provides leadership to create and foster priority relationships in the medical device and diagnostic marketplace, developing customized programs to meet medical device client needs. She has over 25 years of experience in the medical device industry, with over 15 years specifically focused on global medical device strategic consulting. Prior to joining the company in 2007, Anastasi held senior management roles for medical device companies focused in orthopedics, cardiovascular, general hospital, and general surgical devices. In diagnostics, she held senior positions at companies involved in the development of infectious disease and genetic-based products. She is actively involved in medical device industry groups, including Advamed, MDIC, and MassMedic, where she regularly speaks and participates in medical device focused panels and discussions.
    Related Searches
    • patient
    • forward
    • apps
    • it
    Related Knowledge Center
    • Digital Health
    Suggested For You
    Simbex Simbex
     FDA Clears Masimo RD Sensors With Improved Accuracy Specifications for SET Pulse Oximetry FDA Clears Masimo RD Sensors With Improved Accuracy Specifications for SET Pulse Oximetry
    Kent Systems Kent Systems
    The Regulatory Outlook for 2019 The Regulatory Outlook for 2019
    New Blood Test Detects Early Stage Ovarian Cancer New Blood Test Detects Early Stage Ovarian Cancer
    Qosina Adds New Bonded Extension Lines to Its Inventory Qosina Adds New Bonded Extension Lines to Its Inventory
    The Top 10 Medical Innovations for 2019 The Top 10 Medical Innovations for 2019
    Former Deutsche Bank Securities Executive Joins Masimo Former Deutsche Bank Securities Executive Joins Masimo's Board of Directors
    Velano Vascular Board of Directors Welcomes Two New Members Velano Vascular Board of Directors Welcomes Two New Members
    The Impact of Changing Healthcare Economics on Device Design The Impact of Changing Healthcare Economics on Device Design
    CHLA/USC Researchers Design Novel Micropacemaker CHLA/USC Researchers Design Novel Micropacemaker
    Masimo and PositiveID Announce the U.S. Release of TIR-1 Masimo and PositiveID Announce the U.S. Release of TIR-1
    Study Probes Utility of Continuous Noninvasive Hemoglobin Measurement With Masimo SpHb Study Probes Utility of Continuous Noninvasive Hemoglobin Measurement With Masimo SpHb

    Related Online Exclusives

    • Digital Health | Software & IT
      6 Ways Machine Learning-Enabled Virtual Assistants Can Serve Doctors and Patients

      6 Ways Machine Learning-Enabled Virtual Assistants Can Serve Doctors and Patients

      Automating trivial and repetitive tasks.
      Nadejda Alkhaldi, Innovation Analyst at Itransition 11.20.19

    • Diagnostics | Digital Health | Neurological | Software & IT
      An App-solute Symphony of Digital Health Solutions

      An App-solute Symphony of Digital Health Solutions

      Thirteen entrepreneurs competed on the Medica Connected Healthcare Forum stage for cash prizes.
      Sam Brusco, Associate Editor 11.20.19

    • Digital Health | Electronics | Software & IT
      Four Ways AI Can Be Used in Medtech

      Four Ways AI Can Be Used in Medtech

      Utilizing the capabilities of AI and machine learning.
      Colin Gelfer, SVP Industries and Solutions, Atrium 11.19.19


    • Digital Health
      Four Ways Telehealth is Revolutionizing the Healthcare Field

      Four Ways Telehealth is Revolutionizing the Healthcare Field

      Why healthcare providers need to adopt telemedicine.
      Alexis Schomer, Co-Founder & COO of Expy Health 10.18.19

    • Digital Health
      The Benefits of Blockchain

      The Benefits of Blockchain

      How blockchain is revolutionizing the health tech space.
      Vadym Vorobiov, Chief Technology Officer of Solve.Care 10.16.19

    • Digital Health | Patient Monitoring
      Easy Breezy: IoT Guarding Lung Health

      Easy Breezy: IoT Guarding Lung Health

      Approaches to IoT and mobile apps that address acute lung concerns.
      Veronika Vartanova, Mobility Researcher at Iflexion 10.15.19


    • Diagnostics | Digital Health
      Enabling the Safe Delivery of Virtual Healthcare

      Enabling the Safe Delivery of Virtual Healthcare

      Transforming healthcare administration and delivery.
      Kevin von Keyserling, Chief Strategy Officer at Keyfactor 09.17.19

    • Cardiovascular | Digital Health | Software & IT | Surgical
      Gaming Through Surgery: Apps Prepare Clinicians for Challenging Cases

      Gaming Through Surgery: Apps Prepare Clinicians for Challenging Cases

      A video game app can be leveraged to introduce healthcare professionals to challenging procedures for a variety of clinical application areas.
      Sean Fenske, Editor-in-Chief 08.08.19

    • Digital Health | Patient Monitoring | R&D & Design
      The Nuances of Using Gamification in Healthcare

      The Nuances of Using Gamification in Healthcare

      Game mechanics are being used to motivate patients in creative new ways.
      Sudipto Sur, Chief Technology Officer at Reflexion Health 07.12.19


    • Contract Manufacturing | Digital Health | Software & IT | Surgical
      6 Trends Reshaping Medical Equipment Manufacturing

      6 Trends Reshaping Medical Equipment Manufacturing

      Medical device manufacturers and end users alike must keep an eye on current industry trends in order to prepare and adapt.
      Megan Ray Nichols, Science Writer; Editor, Schooled By Science 05.30.19

    • Digital Health | Patient Monitoring
      Remote Patient Monitoring: The 21st Century Approach to Treating Chronic Disease

      Remote Patient Monitoring: The 21st Century Approach to Treating Chronic Disease

      Employing real-time monitoring technologies to the chronic disease protocol, patients are empowered to become a part of addressing their own medical concerns.
      Waqaas Al-Siddiq, Founder and CEO, Biotricity 05.30.19

    • Diagnostics | Digital Health | Patient Monitoring
      4 Factors Leading to the Growth of IoT in Healthcare

      4 Factors Leading to the Growth of IoT in Healthcare

      The Internet of Things within medicine provides an array of benefits to all industry stakeholders, while challenges still exist.
      Akshay Malunjkar, Team Lead—Healthcare Research, The Insight Partners 05.17.19

    • Digital Health | Software & IT
      Telemedicine Stands to Offer New Horizons to the Healthcare Solutions Landscape

      Telemedicine Stands to Offer New Horizons to the Healthcare Solutions Landscape

      High-speed internet, affordable smartphones, and standardized phone operating systems have added an unexpected dimension to the idea of telemedicine.
      Saipriya Iyer, Global Market Insights 04.04.19

    • Digital Health | Patient Monitoring | Software & IT
      The Impact of mHealth on the Global Healthcare Fraternity

      The Impact of mHealth on the Global Healthcare Fraternity

      mHealth is making steady progress as the technology has simplified healthcare for all.
      Shikha Sinha, Global Market Insights 03.20.19

    • Digital Health
      Is VR the Solution for Addressing Chronic Pain?

      Is VR the Solution for Addressing Chronic Pain?

      Imaginary worlds that create an environment for positive thinking can substantially impact the affect pain has on a patient.
      Michelle Silverpen, Contributing Writer 02.19.19


    Breaking News
    • FDA OKs Roche's Nasal Swab MRSA Test
    • Philips & Paige to Deliver Clinical-Grade AI Applications to Pathology Labs
    • Eye Test for Parkinson's Gains Breakthrough Designation
    • Biomerics Forms New Business Unit
    • J&J's New Monofocal IOL for Cataract Patients with Astigmatism
    View Breaking News >
    CURRENT ISSUE

    November/December 2019

    • Adding Fabrication Capabilities: Additive Manufacturing for Production Parts
    • Delivering the Goods: The Evolving World of Combination Products
    • Anxious Undertones: The 2019 Year in Review
    • View More >
    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    International Scientific Society Calls for Omega-3 Blood Testing in Future Research
    Pharmactive Affron Saffron May Help Relieve Depression Symptoms
    Warmer Temperatures Could Lead to Concerning Levels of Arsenic in Rice
    Coatings World

    Latest Breaking News From Coatings World

    Cristo Rey High School Educator Named 2019 Axalta All-Pro Teacher of the Year
    Michelman Makes United Way of Greater Cincinnati’s List of Top 25 Corporate Campaigns
    BCF: Coatings Industry Reports Record Improvement in Waste, Recycling, Accident Rates
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    FDA OKs Roche's Nasal Swab MRSA Test
    Philips & Paige to Deliver Clinical-Grade AI Applications to Pathology Labs
    Eye Test for Parkinson's Gains Breakthrough Designation
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Almac Awarded $1M BMGF Grant
    Vivera Pharma, Parexel Ink Clinical Services Agreement
    MedPharm Triples Capacity at RTP Site
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    WWP Wins Three NJPEC Awards
    Cat-Themed Beauty Collection to Launch in Japan
    Pantone Names Classic Blue the 2020 Color of the Year
    Happi

    Latest Breaking News From Happi

    Lip Lab Opening in Brooklyn
    Raining Rose Expands Exec Team
    Scott’s Sells Personal Care Production Site
    Ink World

    Latest Breaking News From Ink World

    ePac Flexible Packaging Expands into Asia Pacific Market
    Haney, HP Developing Sustainable Fashion Packaging for Heron Preston
    Addipel Moves to New HQ, Expands Production Facility
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    HP teams with Haney for sustainable packaging
    Tags & Labels Printing adds Heidelberg’s Versafire EP
    Austrian converter installs first Nilpeter press
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Thrace to Relocate U.S. Capacity
    FiltXPO Speaker Line-Up Announced
    Nölken Incorporates Sustainable Wipes Packaging
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Orthofix Appoints New Spine Business Leader
    Viant to Halt EtO Sterilization at Michigan Plant by End of Year
    Synaptive Medical's Modus V Expands Into Spine Market
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    IDTechEx Show! Announces Graphene Award Winner
    OE-A Continues to Bring Future of Printed Electronics to CES 2020
    Avancis, Smit Thermal, HZB, CNRS, Solliace Team for Higher Efficiencies in CIGS

    Copyright © 2019 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.