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Contract Regulatory Affairs Management Market for Medical Devices, 2019-2030

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The ‘Contract Regulatory Affairs Management Market for Medical Devices, 2019-2030’ report features a detailed study on the current landscape of contract service providers focused on regulatory affairs management for medical devices. – PowerPoint PPT presentation

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Title: Contract Regulatory Affairs Management Market for Medical Devices, 2019-2030


1



Contract Regulatory Affairs Management Market for
Medical Devices, 2019-2030
  • Roots Analysis

https//www.rootsanalysis.com/reports/view_documen
t/med-dev-regulatory/282.html https//www.rootsana
lysis.com/
2
Overview
  • According to the World Bank, more than 50,000
    different types of medical devices are currently
    being used on a daily basis in healthcare
    facilities across the globe. In 2018, the global
    medical devices market was estimated to have
    reached a net worth of approximately USD 450
    billion. It is also worth noting that, since
    January 2018, the USFDA approved over 130 medical
    devices. However, a relatively large proportion
    of developers lack the resources and technical
    expertise required to handle regulatory filings
    and effectively manage the processes associated
    with procuring marketing authorizations from
    regional regulators. Moreover, keeping up with
    evolving regulatory guidelines, rising costs of
    legal advice and increasing effort required for
    preparing of technical documentation, is
    difficult for companies with limited finances. In
    addition, establishing reimbursement strategies
    for medium to high-risk devices is also a
    complicated process and innovator companies
    usually do not have the expertise to deal with
    payers and insurance providers. According to a
    recent report, 68 of medical device companies
    reports prepared and submitted by in-house
    players are either rejected or were reported to
    have multiple major gaps in their clinical
    evaluation report (CER) and supporting evidences
    by the notified bodies. In fact. in a survey
    published in the 2016 edition of Global Medical
    Device Supply Chain, regulatory requirements were
    highlighted among the primary areas of concern
    within the medical device value chain.
    Furthermore, the implementation of highly
    stringent regulatory guidelines, specifically for
    devices posing medium to high risk to consumers,
    render them subject to rigorous quality
    assessments.

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Scope of the Report
  • The Contract Regulatory Affairs Management
    Market for Medical Devices, 2019-2030 report
    features a detailed study on the current
    landscape of contract service providers focused
    on regulatory affairs management for medical
    devices. The study features an in-depth analysis,
    highlighting the capabilities of the various CROs
    engaged in this domain, across different regions
    of the globe. Amongst other elements, the report
    includes
  • A detailed review of the current market landscape
    of the medical devices regulatory affairs
    outsourcing market, featuring a list of over 400
    CROs engaged in this domain, and detailed
    analysis based on a number of relevant
    parameters, such as year of establishment, size
    of employee base, geographical location, device
    class (class I, class II, and class III), type
    and size of clientele (medical device developers,
    medical device manufacturers, medical device
    research organizations, and others), types of
    services offered, (A regulatory management
    services (such as legal representation, notified
    body selection, project registration and clinical
    trial application, regulatory writing and
    publishing, regulatory document submission,
    product labelling related service, gap analysis,
    technical dossier set-up, vigilance medical
    device report, risk management-related services),
    B additional services (such as biostatistics,
    consulting, clinical operations, post-marketing
    activities, quality assurance, reimbursement,
    training)), region(s) of operation wherein the
    company is offering regulatory management
    services, and popular therapeutic area(s).

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  • A detailed discussion on the need for regulatory
    review / oversight across different stages of the
    medical devices supply chain, with emphasis on
    the optimization of the supply chain using
    upcoming tools / technologies (such as artificial
    intelligence, big data analytical, blockchain,
    internet of things and others).
  • An elaborate discussion on the various guidelines
    established by major regulatory bodies for
    medical device approval across North America (the
    US, Canada and Mexico), Europe (France, Germany,
    Italy, Spain, the UK and rest of Europe),
    Asia-Pacific and rest of the world (Australia,
    Brazil, China, India, Israel, Japan, New Zealand,
    Singapore, South Africa, South Korea, Taiwan, and
    Thailand). The report also features an insightful
    multi-dimensional, heat map analysis, featuring a
    comparison of the contemporary regulatory and
    reimbursement scenarios in key geographies across
    the globe.
  • Elaborate profiles of popular players that
    specialize in offering end-to-end regulatory
    services for medical devices across key
    geographies (North America, Europe and
    Asia-Pacific). Each profile features a brief
    overview of the company, including information on
    company headquarters, year of establishment,
    number of employees, and therapeutic area
    expertise, financial information (if available),
    detailed description of service portfolio, and an
    informed future outlook.
  • A benchmark analysis, highlighting the key focus
    areas of small-sized, mid-sized and large
    companies, comparing their existing capabilities
    within and beyond their respective peer groups,
    providing a means for stakeholders to identify
    ways to gain a competitive edge in the industry.
  • An elaborate discussion on the various
    outsourcing business models adopted for
    regulatory affairs management, along with an
    insightful Harvey ball analysis of key
    considerations that need to be assessed by
    industry stakeholders while selecting a CRO
    partner.

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Contents
  • Chapter Outlines
  • Chapter 2 provides an executive summary of the
    insights captured in our research. It offers a
    high-level view on the current state of the
    medical device regulatory affairs management CROs
    market and its likely evolution in the
    short-midterm and long term.
  • Chapter 3 is a general overview of the various
    types of CROs that offer services to the medical
    devices industry. It provides a brief
    introduction to the concept of CROs, featuring a
    discussion on the historical evolution of
    contract research services market in this domain.
    Further, it elaborates on the need for
    outsourcing in this domain, along with the
    various partnership models that have been adopted
    by CROs and medical device developers. In
    addition, the chapter highlights key points that
    developer companies need to consider for
    selecting a suitable contract research services
    provider for regulatory management services. It
    also features a detailed list of regulatory
    management services offered by contemporary CROs,
    along with a discussion on the various challenges
    within the market.
  • Chapter 4 includes a detailed discussion on the
    need of regulatory review / oversight across
    different stages of the medical device supply
    chain. It also emphasizes on the various factors
    that are likely to impact the performance of the
    medical device supply chain, along with
    strategies that are likely to assist in improving
    visibility in the supply chain. Subsequently, the
    chapter provides information on optimization of
    the supply chain using upcoming tools /
    technologies (such as artificial intelligence,
    big data analytical, blockchain, internet of
    things and others).
  • Chapter 5 features a discussion on the various
    guidelines established by major regulatory bodies
    for medical device approvals

9
  • For additional details, please visit
  • https//www.rootsanalysis.com/reports/view_documen
    t/cell-therapies-supply-chain/260.html
  • or email sales_at_rootsanalysis.com
  • You may also be interested in the following
    titles
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    Manufacturing Market (3rd Edition), 2019-2030
    (Focus on AAV, Adenoviral, Lentiviral,
    Retroviral, Plasmid DNA and Other Vectors)
  • Global T-Cell (CAR-T, TCR, and TIL) Therapy
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  • Contact
  • Gaurav Chaudhary
  • 1 (415) 800 3415
  • 44 (122) 391 1091
  • Gaurav.Chaudhary_at_rootsanalysis.com
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