• 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
    Pharmaceutical Focus: A Look at Combination Products

    The Printed World: Additive Manufacturing in Medtech

    The Lost Year: 2020 Year in Review

    Extrusion Evolution

    Little Big Parts: Micromolding Under the Microscope
    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
    FineHeart Successfully Tests Wireless TET System

    Apria Healthcare Settles Whistleblower Lawsuit

    OraSure’s OMNIgene·ORAL Device Included in COVID-19 EUA Amendment

    Remote Patient Monitoring Market Set to Surpass $645 Million by 2025

    4C Medical Technologies Completes $10 Million Over-Subscribed Convertible Note Financing
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Pharmaceutical Focus: A Look at Combination Products

    The Printed World: Additive Manufacturing in Medtech

    The Lost Year: 2020 Year in Review

    Extrusion Evolution

    Little Big Parts: Micromolding Under the Microscope
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Fixing Face Mask Form and Function

    The Heart of the Matter: Trends in Cardiology

    Virtually the Same? The Challenges of Online Conferences

    Digital Health Delivers During a Year for the Ages

    Advanced Technology for Staking and Swaging Medical Plastics
    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
    Spectrum Plastics Group

    Concise Engineering

    Qosina Corp.

    maxon

    MW Life Sciences
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Meeting Critical Ventilator Product Requirements Amid Pandemic

    Impact of COVID-19 on the Medtech Supply Chain

    Finding the Upside to a Challenging Year

    Preparing Your Design Controls for FDA Approval

    A 'Trial and Error' Approach to Micromolded Parts
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    MW Life Sciences

    Spectrum Plastics Group

    Unicep

    Element

    Medicoil
    • 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

    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.

    Speed Up or Risk Stepping Down: The New Reality of the Connected Healthcare Development Cycle
    Joe McBeth, VP Global Supply Chain, Jabil Healthcare01.29.20
    This is a very exciting time to be in healthcare, as technology and digital healthcare capabilities continue to transform the industry. Connected health devices—things that can track patient compliance or provide insights on how well a drug is being metabolized or provide monitoring of a patient’s biomarkers—are opening up tremendous opportunities for future product iterations, as well as disease-state product platforms. In a 2018 survey—Connected Health Technology Trends1—Jabil canvassed more than 200 healthcare decision makers and determined that all of them had plans to develop and bring to market a connected health device. The medical industry has one primary goal: improve patient outcomes. Digital health and connected devices are an extraordinary new tool for delivering on this objective.

    The Jabil survey responses demonstrate confidence that healthcare is shifting from being primarily reactive to becoming more proactive, preventative, and patient-focused. The Internet of Things (IoT), long a “hot” trend across other industries, is now impacting healthcare, with almost three out of four healthcare executives predicting Internet of Medical Things (IoMT) healthcare devices will be disruptive to product lifecycles within three years. According to Deloitte, remote patient monitoring, enabled by connected health technology, will result in healthcare being able to reach more people and with greater ease, increasing value- over volume-based care, and empowering patients to take better control of their lives, thereby improving quality of life.2

    Sounds like a market with vast potential and a healthy level of buy-in from key decision makers, right? There are, however, real challenges to the production of connected healthcare solutions. Historically, due largely to a sometimes burdensome and lengthy product development cycle, healthcare lags behind other connected industries.

    Let’s break down that product development cycle—by the numbers—based on survey responses:
    • Almost half reported their connected healthcare product development cycles range from 18 to 36 months.
    • Within that cycle, it was larger companies that were particularly hard-pressed to complete a cycle in a year or less.
    • Only 2 percent of larger companies (more than 5,000 employees) reported that 12 months was an adequate time frame for completing a product development cycle—compared to 15 percent of smaller companies (1,000 to 5,000 employees).
    Part of the urgency to speed up the product development cycle stems from the expectations set by the rapidly iterative cycles that have become the norm in consumer electronics. The public receives shiny new communications devices with great fanfare year over year; it’s no wonder they expect healthcare to keep up.

    What’s a healthcare manufacturer to do? A good place to start is to examine the most significant factors currently slowing down the product development cycle, then determine what measures can be taken to meet those challenges.

    Healthcare Product Development Cycle: The Delays
    Healthcare solutions are, by their nature, held to a higher standard than, say, consumer electronics; a smartphone software glitch doesn’t carry the life or death consequences an inaccurate diagnosis or poor treatment method might. It follows that, overall, the healthcare industry is more risk-averse, which can lead to hesitancy when undertaking a culture-shifting acceleration of a company’s production cycles. Unlike other connected solutions, such as in the home or building industries, for example, which can be experimented with and adjusted to some degree, connected healthcare has no margin for error. Rather, it is required out of the gate to be as calculated and precise as possible.

    The worst-case result of an inefficient, slow-moving product development cycle is that product does not reach the market. I have seen companies abandon healthcare projects more frequently than consumer electronics due to concerns over the intense focus on technology and feasibility studies, as well as human factors. According to the survey, one in five companies that produced a healthcare solution that solved technology, production, and compliance issues had to retract it.

    Ninety-five percent of survey respondents admitted to facing manufacturing challenges, although only 17 percent of participants deemed manufacturing problems as the most daunting challenge in developing their connected health solutions. The top manufacturing challenges shared were high manufacturing costs, a lack of sufficiently sophisticated enabling technologies, and sourcing issues, driven by the often-volatile electronic components market.

    Component shortages present as significant a challenge to connected healthcare as they do to other connected industries; one in four survey respondents cite this as a major handicap of concern. Lead times of 500 days to obtain components such as capacitators and resistors create barriers for in-production devices, as well as for new designs utilizing legacy components. Cost becomes a real factor, as the product development cycle will become more expensive the longer production is held up, sometimes simply for lack of a 15-cent part. A vicious cycle is created, in which component shortages delay a new product launch to market, which in turn discourages the manufacturer from future investment in new product launches.

    Consider another “by the numbers” perspective; based on survey responses:
    • Only 3 percent of companies have reached the certification stage of their connected devices’ product development cycle…
    • ...while 13 percent have reached testing.
    • Only 16 percent have successfully launched a complete product.
    • Overall, 60 percent of companies have not yet delivered a connected healthcare product at all or are still in early testing of a prototype.

    Why? Certainly, we can infer impact from all the issues already discussed. But these numbers speak somewhat more directly to momentum. There are measures manufacturers can initiate to gain traction with their connected healthcare product development process and help make it more efficient and effective.

    Smooth the Way with the FDA
    One way to shorten the connected healthcare product lifecycle is to look at working with government agencies [e.g., the U.S. Food and Drug Administration (FDA)], as leveraging a resource rather than as another delay to market launch. Consulting the FDA is a given for most U.S. healthcare manufacturers—more than 60 percent of survey participants said they produce healthcare solutions that require FDA approval. Early engagement with government agencies, working with them to identify risks and concerns, then addressing these early in the development lifecycle, can go a long way toward acceleration of the regulatory approval process for connected devices.

    Realize the Potential of Partners
    Establishing a partnership can be an effective measure for a company to gain a new area of expertise and push its connected health solutions forward. Among survey respondents, manufacturing companies with prior expertise in connected devices were perceived to offer the most potential benefit. Next in line, at 63 percent, were technology partners with cloud and data privacy expertise. Nearly half of survey respondents saw the value of partners with expertise in government processes who can assist in cutting through confusing, lengthy regulatory processes.

    Conclusion
    The lag in connected healthcare is understandable; as noted earlier, people’s lives may depend on this technology. That doesn’t mean we shouldn’t keep pushing to make the process smoother to get more connected healthcare devices into the market. The potential benefits to patients are too great; connected healthcare can allow doctors to monitor their patients remotely, detect symptoms of illness or medical conditions before they become serious (through predictive analytics), and give patients more control over their own health.

    Rather than asking, “Can we afford the risk of pushing innovative healthcare solutions?” I urge manufacturers to ask, “Can we afford the risk of NOT offering innovative connected health solutions?” Speeding up the healthcare product development cycle is a good place to start in improving, and potentially even saving, millions of lives. 

    References
    1. http://bit.ly/mpo200190
    2. http://bit.ly/mpo200191

    As VP of global supply chain management for Jabil Healthcare, Joe McBeth oversees the Jabil division’s supply chain operations, including inventory control, strategic sourcing, supplier development, and supply chain creation. An enthusiastic challenger of assumptions, McBeth has proven to be exceptionally adept at managing the complexities of supply chain management, providing Jabil clients with the insight and guidance required to navigate the lightning-fast market changes, unpredictable resources, and sometimes baffling compliance and regulatory requirements of today’s healthcare market. Prior to his current role, McBeth helped build the broader global supply chain organization within Jabil, overhauling a previously decentralized organization into a highly efficient, regionally based, global program. His ongoing input and direction has been integral to the development of Jabil’s InControl platform, the company’s state-of-the-art supply chain decision support solution. McBeth began his career with Jabil in 1993 as a manufacturing supervisor. In addition to earning his bachelor’s degree from Michigan State University, McBeth graduated with an MBA in Materials Logistics Management from MSU’s Eli Broad College of Business. 
    Related Searches
    • u.s. food and drug administration
    • fda
    • devices
    • product development
    Related Knowledge Center
    • Digital Health
    • R&D & Design

    Related Columns

    • 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

    • Contract Manufacturing | R&D & Design
      Trends for Medtech Contract R&D and Manufacturing

      Trends for Medtech Contract R&D and Manufacturing

      Over the past 10 years, medtech manufacturers from startups to giants have grown their levels of outsourcing to contract R&D and manufacturing partners.
      Maria Shepherd, President and Founder, Medi-Vantage 09.01.20

    • 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

    • R&D & Design | Surgical
      Sparking Innovation as We Struggle to Find the New Normal

      Sparking Innovation as We Struggle to Find the New Normal

      The goal is to find the best ideas to support orthopedic patients adjusting to additional pain and immobility while they wait for elective surgeries.
      Dawn A. Lissy, Founder & President, Empirical 06.04.20


    • R&D & Design
      Disposable Design: Consider All Interfaces

      Disposable Design: Consider All Interfaces

      The disposable component is becoming more challenging as products get smaller and more complex.
      Will DeMore, Mechanical Engineer, Key Technologies Inc. 06.04.20

    • R&D & Design
      Why Outsourcing Is in: Piecing Out Projects Makes Sense

      Why Outsourcing Is in: Piecing Out Projects Makes Sense

      Getting outside help is a trend both large and small medical device companies are following as outsourcing engineering services continues to gain traction.
      Dawn A. Lissy, President & Founder, Empirical 04.01.20

    • R&D & Design
      Top 10 Considerations for Medtech Inventors

      Top 10 Considerations for Medtech Inventors

      If you or your employer is interested in protecting an invention, then filing a patent application may be the way to go.
      Ryan Connell and Doug Portnow, Schwegman Lundberg & Woessner 04.01.20


    • R&D & Design
      Supercharge Medical Device Innovation Using Effective User Preference Studies

      Supercharge Medical Device Innovation Using Effective User Preference Studies

      User preference and evaluation studies have been a mainstay design tool for medical device development for decades.
      Philip Remedios, Principal, Director of Design & Development, BlackHägen Design 04.01.20

    • 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


    • R&D & Design | Testing
      FDA Guidelines for Employing X-ray Inspection in Medical Device Development

      FDA Guidelines for Employing X-ray Inspection in Medical Device Development

      Different materials exhibit different radiopacity as a function of material composition (i.e. atomic weight) and thickness.
      Gil Zweig, President, Glenbrook Technologies 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

    • R&D & Design
      Perfecting Drug Delivery Device Design

      Perfecting Drug Delivery Device Design

      Unlike medical products that just need to work, drug delivery devices must also consider intuitiveness, usability, and how it makes the user feel when operated.
      Bryce G. Rutter, Ph.D., Founder & CEO, Metaphase Design Group Inc. 11.04.19


    Trending
    • Cytotron Gains Breakthrough Status To Treat Breast, Liver, And Pancreatic Cancers
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • 5 Ways Plastics Revolutionized The Healthcare Industry
    • Hardy Diagnostics Releases Rapid Test For COVID-19
    • Top 10 Trends In The Medical Device And Equipment Industry
    Breaking News
    • FineHeart Successfully Tests Wireless TET System
    • Apria Healthcare Settles Whistleblower Lawsuit
    • OraSure’s OMNIgene·ORAL Device Included in COVID-19 EUA Amendment
    • Remote Patient Monitoring Market Set to Surpass $645 Million by 2025
    • 4C Medical Technologies Completes $10 Million Over-Subscribed Convertible Note Financing
    View Breaking News >
    CURRENT ISSUE

    November/December 2020

    • Pharmaceutical Focus: A Look at Combination Products
    • The Printed World: Additive Manufacturing in Medtech
    • The Lost Year: 2020 Year in Review
    • 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

    BGG Obtains U.S. Patent on AstaZine Natural Astaxanthin for Heart Function During Exercise
    Qualitas Health/iwi Raises $10 Million in Investment Round
    Aker BioMarine Expands Krill Portfolio with Novel Protein Hydrolysate
    Coatings World

    Latest Breaking News From Coatings World

    Huntsman Finalizes Acquisition of Gabriel Performance Products
    PPG Completes COLORFUL COMMUNITIES Project at School in A. Bangsaothong Samutprakarn, Thailand
    dar-tech, inc. Becomes U.S. Midwestern Distributor for ZS Interpolymer
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    FineHeart Successfully Tests Wireless TET System
    Apria Healthcare Settles Whistleblower Lawsuit
    OraSure’s OMNIgene·ORAL Device Included in COVID-19 EUA Amendment
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Valeo Pharma Appoints President, COO
    Metrion, LifeArc Extend Neuroscience Alliance
    Grifols Begins COVID-19 Plasma Treatment Trial
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    JLo Beauty Launches at Sephora & Amazon
    Unilever and Alibaba Group Join Forces
    Redken Unveils Acidic Bonding Concentrate Range
    Happi

    Latest Breaking News From Happi

    A Surge in Interest for Supplements & Vitamins
    Manscaped Expands Further in Europe
    Color Street Gives Back
    Ink World

    Latest Breaking News From Ink World

    dar-tech, inc. Becomes U.S. Midwestern Distributor for ZS Interpolymer
    Techkon USA, Konica Minolta Partner
    Alon Bar-Shany Appointed Chairman of Highcon Board
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Exhibitor registration opens for virtual.drupa
    FTA planning in-person Forum & INFOFLEX
    Fortis Solutions Group achieves SGP certification
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Super Strong Inks Survive Tough Environments
    Ontex Honored for Mask Production
    TFP Acquires PV3 Technologies
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    OrthoPediatrics Expands Agent Network in Three European Countries
    Studies Show FlareHawk Expandable Cage Delivers Favorable Fusion, Patient Outcomes
    Rapid Recovery Protocol Can Lead to Increased Range of Motion After TKA
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    UDC Subsidiary Adesis' Website Wins 2020 MarCom Platinum Award
    Roadsimple Modernizes Warehouse Ops with Zebra Technologies
    Graphene Flagship Launches Redesigned Website

    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