Contract Archives - Healthy News

Worldwide Medical Devices Contract Research Organizations Industry to 2035

DUBLIN, Dec. 28, 2022 /PRNewswire/ — The “Medical Devices Contract Research Organizations Market by Target Therapeutic Area, Scale of Operation, Device Class, Type of Clinical Service Offered, Type of Preclinical Service Offered, and Key Geographies: Industry Trends and Global Forecasts, 2022-2035” report has been added to ResearchAndMarkets.com’s offering.

This report features an extensive study of the current market landscape and future opportunities associated with the medical device contract research organizations market. The study also includes an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this domain.

According to the World Health Organization (WHO), presently, around two million medical devices are available across the globe. Further, just over 35 medical devices received approval by the USFDA, every year. It is worth highlighting that, since 2020, the USFDA has approved around 105 medical devices.

Moreover, the medical devices are expected to capture more than 40{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of the global medtech industry and this value is projected to grow at a steady pace over the coming years. In this context, the number of medical device focused clinical trials have increased at a considerable rate, over the past few years.

However, only a few players engaged in this domain claim to have the technical expertise to carry out in-house clinical research. This can be attributed to the high costs associated with acquiring the required infrastructure and capabilities to carry out research in this domain.

In addition, various regulatory guidelines render medical devices subject to rigorous quality assessments, thereby, making it difficult for firms with limited finances to undertake research initiatives. Specifically, post the onset of the COVID-19 pandemic, there has been a substantial increase in the demand for medical devices as they have the ability to enable early diagnosis, as well as provide non-invasive and effective treatments.

Given the surge in demand for medical devices in the recent past, coupled to the aforementioned constraints faced by developers, a large number of small, as well as well-established, players prefer to outsource a significant share of their respective clinical operations and regulatory affairs management to contract research organizations (CROs). Since 2010, over 75 CROs have been established in this domain.

Further, in order to support the growing demand, medical device CROs have been re-evaluating and bolstering their existing capabilities to offer a wide range of services to their clients. Integration of novel technologies and tools, such as cloud computing, risk monitoring tools, real-world evidence and advanced data analytics, is another key initiative being undertaken by several CROs to distinguish themselves from their competitors.

To enable expansion of their existing capabilities, more than 55 acquisitions and / or strategic alliances have been established by service providers in this market, since 2015. Considering the prevalent trends and projected opportunity associated with the overall medical devices market, we believe that the medical devices CROs market is likely to witness consistent grow, till 2035.

The report features detailed transcripts of interviews held with the following stakeholders:

Lajos Sarosi (Chief Executive Officer and Co-founder, HungaroTrial)
Lee King (Senior Vice President, Business Development and Marketing)
Christopher Rupp (Vice President of Global Marketing and Commercial Operations, NAMSA)
Claus Hemiker (Head, Business Development)
Christian Wolflehner (General Manager, CW Research & Management)
Troy W. Mccall (Chief Commercial Officer, CROMSOURCE)
Nazish Urooj (Senior manager, Medical & Clinical Operations, Metrics Research)
C. Omprakash (Technical Director and Partner, Vyomus Consulting)
Tania Persson (Director of Business Development, A+ Science)
Alexa Foltin-Mertgen (Business Development Manager, AtoZ-CRO)

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

Key Questions Answered

Who are the key players engaged in offering contract research services for medical devices?
Which regions represent the key contract research hubs for medical devices?
What are the key regulatory guidelines, related to medical devices that have been established across various geographies?
What are the key value drivers of the merger and acquisition activity observed within this domain?
What percentage of the medical devices research operations are presently outsourced?
What are the likely future trends in contract research services market for medical devices?
How is the current and future opportunity likely to be distributed across key market segments?
What is the total cost of ownership required to set up a medical device contract research organization?

Key Topics Covered:

1. PREFACE

2. EXECUTIVE SUMMARY

3. INTRODUCTION
3.1. Chapter Overview
3.2. Overview of Medical Devices
3.2.1. Historical Evolution of Medical Devices
3.2.2. Classification of Medical Devices
3.3. Overview of Contract Research Organizations (CROs)
3.3.1. Evolution of CROs
3.4. Role of CROs in the Medical Device Industry
3.5. Types of Medical Device CROs
3.6. Types of Services Offered by CROs
3.7. Advantages of Outsourcing Operations to CROs
3.8. Risks and Challenges Associated with Outsourcing
3.9. Key Considerations While Selecting a Suitable CRO Partner

4. MARKET LANDSCAPE
4.1. Chapter Overview
4.2. Medical Device CROs: Clinical Service Providers
4.2.1. Analysis by Year of Establishment
4.2.2. Analysis by Company Size
4.2.3. Analysis by Location of Headquarters
4.2.4. Analysis by Company Size and Location of Headquarters
4.2.5. Analysis by Area of Specialization
4.2.6. Analysis by Device Class
4.2.7. Analysis by Type of Clinical Operation Service Offered
4.2.8. Analysis by Type of Regulatory Affairs-related Service Offered
4.2.9. Analysis by Type of Additional Service Offered
4.2.10. Analysis by Medical Device Regulatory Compliance Authority
4.3. Medical Device CROs: Preclinical Service Providers
4.3.1. Analysis by Year of Establishment
4.3.2. Analysis by Company Size
4.3.3. Analysis by Location of Headquarters
4.3.4. Analysis by Company Size and Location of Headquarters
4.3.5. Analysis by Type of Preclinical Service Offered
4.4. Medical Device CROs: Standalone Service Providers
4.4.1. Analysis by Year of Establishment
4.4.2. Analysis by Company Size
4.4.3. Analysis by Location of Headquarters
4.4.4. Analysis by Company Size and Location of Headquarters

5. REGULATORY AND REIMBURSEMENT LANDSCAPE FOR MEDICAL DEVICES
5.1. Chapter Overview
5.2. General Regulatory and Reimbursement Guidelines for Medical Devices
5.3. Regulatory and Reimbursement Landscape in North America
5.4. Regulatory and Reimbursement Landscape in Europe
5.5. Regulatory and Reimbursement Landscape in Asia-Pacific and Rest of the World
5.6. Comparison of Regional Regulatory Control
5.7. Concluding Remarks

6. COMPANY PROFILES
6.1. Chapter Overview
6.2. Avania (Formerly known as Factory CRO)
6.2.1. Company Overview
6.2.2. Service Portfolio
6.2.3. Recent Developments and Future Outlook
6.3. Charles River Laboratories
6.3.1. Company Overview
6.3.2. Service Portfolio
6.3.3. Recent Developments and Future Outlook
6.4. CROMSOURCE
6.4.1. Company Overview
6.4.2. Service Portfolio
6.4.3. Recent Developments and Future Outlook
6.5. CSSi LifeSciences
6.5.1. Company Overview
6.5.2. Service Portfolio
6.5.3. Recent Developments and Future Outlook
6.6. Eurofins Medical Device Testing
6.6.1. Company Overview
6.6.2. Service Portfolio
6.6.3. Recent Developments and Future Outlook
6.7. IQVIA
6.7.1. Company Overview
6.7.2. Service Portfolio
6.7.3. Recent Developments and Future Outlook
6.8. Medpace
6.8.1. Company Overview
6.8.2. Service Portfolio
6.8.3. Recent Developments and Future Outlook
6.9. NAMSA
6.9.1. Company Overview
6.9.2. Service Portfolio
6.9.3. Recent Developments and Future Outlook
6.10. Qserve Group
6.10.1. Company Overview
6.10.2. Service Portfolio
6.10.3. Recent Developments and Future Outlook
6.11. WuXi AppTec
6.11.1. Company Overview
6.11.2. Service Portfolio
6.11.3. Recent Developments and Future Outlook

7. MEDICAL DEVICE DEVELOPER AND CRO RELATIONSHIPS: KEY VALUE DRIVERS AND PERFORMANCE INDICATORS
7.1. Chapter Overview
7.2. Definition and Importance of Key Performance Indicators (KPIs)
7.3. Key Considerations for Selection of KPIs
7.4. Types of KPIs
7.5. Comparison of Key Performance Indicators
7.6. Concluding Remarks

8. COMPETITIVE BENCHMARKING
8.1. Chapter Overview
8.2. Assumptions and Methodology
8.3. Competitive Benchmarking by Region
8.4. Concluding Remarks

9. BRAND POSITIONING OF KEY INDUSTRY PLAYERS
9.1. Chapter Overview
9.2. Scope and Methodology
9.3. Brand Positioning Matrix: Labcorp
9.4. Brand Positioning Matrix: IQVIA
9.5. Brand Positioning Matrix: Syneos Health
9.6. Brand Positioning Matrix: PPD
9.7. Brand Positioning Matrix: ICON
9.8. Brand Positioning Matrix: Charles River Laboratories
9.9. Brand Positioning Matrix: WuXi AppTec
9.10. Brand Positioning Matrix: Medpace

10. CLINICAL TRIAL ANALYSIS
10.1. Chapter Overview
10.2. Scope and Methodology
10.3. Medical Devices: Clinical Trial Analysis
10.4. Medical Devices: Analysis by Enrolled Patient Population

11. MERGERS AND ACQUISITIONS
11.1. Chapter Overview
11.2. Merger and Acquisition Models
11.3. Medical Device CROs: Mergers and Acquisitions

12. TOTAL COST OF OWNERSHIP IN MEDICAL DEVICES CONTRACT RESEARCH ORGANIZATION
12.1. Chapter Overview
12.2. Assumptions and Methodology
12.3. Expenditures Incurred by a Medical Device Contract Research Organization
12.4. Total Cost of Ownership of Medical Devices Contract Research Organizations, 2022-2042
12.5. Total Cost of Ownership of Medical Devices Contract Research Organizations: Analysis by CAPEX and OPEX Costs, 2022 and 2042
12.6. Concluding Remarks

13. SURVEY INSIGHTS
13.1. Chapter Overview
13.2. Designation of Respondents
13.3. Types of Services Offered
13.4. Target Therapeutic Area
13.5. Average Number of Annual Projects
13.6. Market Opportunity

14. MARKET SIZING AND OPPORTUNITY ANALYSIS

15. SWOT ANALYSIS

16. FUTURE TRENDS AND OPPORTUNITIES

17. INTERVIEW TRANSCRIPTS

18. APPENDIX 1: TABULATED DATA

19. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

For more information about this report visit https://www.researchandmarkets.com/r/6jr6c5

Media Contact:
Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com

For E.S.T Office Hours Call +1-917-300-0470
For U.S./CAN Toll Free Call +1-800-526-8630
For GMT Office Hours Call +353-1-416-8900

U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716

Logo: https://mma.prnewswire.com/media/539438/Research_and_Markets_Logo.jpg

Cision

View original content:https://www.prnewswire.com/news-releases/worldwide-medical-devices-contract-research-organizations-industry-to-2035—current-market-landscape-and-future-opportunities-301710531.html

SOURCE Research and Markets

TRICARE awards a new healthcare contract with an eye toward lessons learned

Military services relatives members and retirees who use TRICARE will see changes to their healthcare beginning in 2024. The Defense Wellness Company (DHA) introduced its new contract for TRICARE companies on Dec. 22. The new deal for civilian wellness care, known as T-5, will start off in 2024.

Humana Federal government Enterprise and TriWest Healthcare Alliance Company will be the regional contractors, with Humana masking the TRICARE east area and TriWest furnishing coverage to the TRICARE west location.

…

Study More

Armed forces family members and retirees who use TRICARE will see modifications to their health care starting up in 2024. The Protection Well being Agency (DHA) introduced its new deal for TRICARE companies on Dec. 22. The new agreement for civilian overall health treatment, identified as T-5, will start off in 2024.

Humana Governing administration Organization and TriWest Health care Alliance Corporation will be the regional contractors, with Humana masking the TRICARE east area and TriWest giving coverage to the TRICARE west location.

The combined $138 billion deal will provide shut to 10 million patients in the well being community. With the new agreement, the Protection Office replaces Wellbeing Internet Federal Providers with TriWest Health care in the western TRICARE region

The contractors perform with DHA in furnishing health care, and combining the resources of the contractor and the military’s immediate health-related treatment program to deliver wellbeing, professional medical and administrative assistance products and services to services users, retirees and eligible family members customers or dependents. Though energetic obligation servicemembers get immediate, no charge wellness care, companies for their dependents and for retirees are contracted to industrial healthcare companies. DHA said the new contracts will supply beneficiaries increased supplier community versatility, increased telehealth appointments, and far more productive referral transfers between the two regions.

Humana and Wellness Net gained the contract for providers in 2016 right after a approach that generated nine protests, all of which ended up sooner or later denied. DHA expected protests owing to the massive sizing of the agreement. The agency had proactively requested the Authorities Accountability Place of work and other acquisition gurus to appear around the method prior to award in an exertion to head off protests. DHA needed to forestall complications immediately after a 2009 contract award for TRICARE generated protests that delayed implementation of the contract for close to 3 a long time.

While the contract was supplied in a competitive bidding procedure, only two bids had been submitted, assuring them both equally a agreement and no prospect of protests.

In addition to a change of supplier, the T-5 agreement also helps make a alter to the make-up of the regions. The new boundaries of the two locations will shift Arkansas, Illinois, Louisiana, Oklahoma, Texas and Wisconsin from the eastern to the western area. All those six states will provide about 1.5 million beneficiaries into TriWest Healthcare’s location.

“Moving these six states into the west area will generate a extra even balance to the TRICARE inhabitants each regional contractor manages. The go will also streamline processes and standards for each regions,” claimed a statement from TRICARE.

Even though some of the earlier variations to the application brought about significant problems for beneficiaries, TRICARE hopes that with a yr constructed in for transition, this next modify will present a better expertise. The changeover period of time begins Feb. 1.

“Transition planning time is scheduled for one entire year. This is to guarantee health care shipping is ready for all 9.6 million beneficiaries on day just one of the new contract,” TRICARE explained.

In 2016, TRICARE moved from a 3 area administration to the two latest regions. United Healthcare missing the location and unsuccessful to get the contract renewed. Difficulties riddled the ensuing rollout of the T-2017 deal. Individuals reported being dropped from TRICARE rolls, having their payment info lost and seeing referrals backlogged. Introducing to the confusion, DHA amplified the cost of co-pays in the course of that transition period.

The terms of the new contract are value-moreover-award-payment, business-mounted-rate and set-cost sort contract with the integrated 12-thirty day period transition interval. It then moves to eight a person-12 months solution periods for health care supply, as well as a changeover-out time period. This deal also consists of incentives and performance assures.

Navy services companies such as Armed service Officers Association of The united states lobbied DHA previous year to decrease disruptions to sufferers throughout the changeover and make positive new contractors have satisfactory networks to treatment for beneficiaries. The team lifted considerations that the contracts emphasized worth-based service to the probable detriment of individuals.

Outlook on the Medical Devices Contract Research Organizations Global Market to 2035

Dublin, Dec. 19, 2022 (GLOBE NEWSWIRE) — The “Medical Devices Contract Research Organizations Market by Target Therapeutic Area, Scale of Operation, Device Class, Type of Clinical Service Offered, Type of Preclinical Service Offered, and Key Geographies: Industry Trends and Global Forecasts, 2022-2035” report has been added to ResearchAndMarkets.com’s offering.