This complete program has been built to supply you with a comprehensive understanding of the important elements of professional medical creating, with a specific target on health care products.
Crafting for medical equipment has its personal unique skill set and, with important regulatory adjustments in the field, all all those associated in clinical composing face a challenge to assure they have the essential abilities and sources to fulfil the necessities of the new regulation.
Less than the direction of our pro trainers, you will understand how to get ready a doc that is linguistically and stylistically acceptable and understand the successful use of visual things these as tables, graphs and move charts. The programme will study the information and composition of the CER – an integral portion of the submission process, and assure that you are fully informed of what a Notified Overall body is on the lookout for in your medical analysis.
Useful workout routines and dialogue will consolidate mastering, and practical guidelines and strategies from experts in the field of health-related producing and clinical gadgets will improve your awareness.
Who Need to Show up at:
Health-related gadget pros responsible for getting ready, creating and completing a CER
Clinical writers generating studies for health care machine brands
Regulatory affairs staff associated in preparing scientific documentation
Medical machine personnel who need a fundamental knowing of what is needed when drafting scientific stories for their merchandise
Deal analysis organisations (CROs)
R&D specialists
Key Subjects Covered:
Overview of composing and enhancing files
Substantive and technical aspects
Looking at logic, textual content circulation, wordiness and precision
On the lookout at the particulars these types of as language enhancing, abbreviations and acronyms
Making ready a very clear information for the intended reader
Polices applicable to the medical analysis of a clinical unit
Introduction to the European Health-related Product Regulation (MDR)
Direction documents for scientific evaluations – what is expected?
Notified Human body expectations
Producing regulatory paperwork
Do different audiences and documents need different techniques?
Corresponding with the authorities
Systematic literature searches for the CER
Powerful lookup procedures
Selecting on what source information is expected
State of the artwork
Features of English
Common glitches in English that really should be avoided
Transient overview of vital punctuation details influencing this means and readability
Improving readability – be variety to your reader
Structuring texts
In phrases of language, how perfect do regulatory files need to be?
Framework and material of the CER
What is needed to meet up with the regulation?
Contents of a CER
Conducting a medical analysis
CER case research workshop
Choosing on what source facts is needed
Introduction to other clinical gadget medical regulatory documents
At the close of each and every 12 months, we have a habit of hunting back again at classes discovered, the ups, the downs, the is effective. And like in 2020 and 2021, the COVID-19 pandemic and related scarcity of healthcare equipment just take heart phase in our reflections as a community. Even now the US Food and drug administration continues to update its prolonged “Medical Unit Shortages In the course of the COVID-19 Public Well being Emergency” list. But this yr, not all is horrible. In point, the Food and drug administration taken off goods from that record as opposed to introducing much more in its hottest update on December 12th,1 indicating an enhancement in situations at the very least in the United States.
Sadly, we cannot say the same for our pals in the EU, who are now dealing with a second wave of healthcare products shortages. And this time, it may possibly be self-induced.
The EU’s new Healthcare Devices Regulation (MDR) arrived into drive just past yr and changed various directives that experienced been in position given that the 1990s.2 Provided the leaps and bounds the earth has produced in the healthcare equipment industry in the 21st Century, the MDR likely supplies a a lot-wanted update to improved replicate existing requires. However, the changeover has been fulfilled with significant increasing pains, additional exacerbated by the even now-ongoing COVID-19 pandemic.
How It Commenced:
The Fee had already prepared for an eventual overhaul of its health care products regulatory framework in as far back as 2009.3 On the other hand, in 2010, French authorities uncovered that Poly Implant Prothèse (PIP), the world’s third largest supplier of breast implants at the time, experienced been employing industrial-grade gel alternatively of medical-grade, creating the implants additional probably to rupture and end result in irritation and scarring.[4] As a end result, PIP’s founder was sooner or later located responsible of fraud and sentenced to four decades in jail.5
Pushed by the scandal and the actuality that PIP’s defective implants experienced handed regulatory muster because of to loopholes, the Commission established out to introduce even greater safety specifications and stricter certification processes.6 This resulted in the MDR, which was adopted by the European Parliament and the Council in 2017 with ideas for it to go into impact in 2020.7
Early 2020, however, marked the commence of the COVID-19 pandemic and the resulting global medical units lack. The Parliament and Council acknowledged the great importance of maximizing availability of health care methods in light-weight of these developments and adopted the Commission’s proposed just one-calendar year hold off in implementation of the MDR.8
How It’s Going:
Next the a person-calendar year delay, the MDR arrived into power on Might 26, 2021, demanding manufacturers, importers, and distributors to conform to the new heightened rules for both equally new and aged products upon the expiration of any existing certification. Having said that, the improved specifications of the MDR have correlated directly with amplified expenditures for businesses, reportedly by 3-10 instances, foremost a lot of to simply drop merchandise from their choices as a substitute.9 In addition, even for companies deciding upon to deliver their merchandise into conformity, the time it requires to get certification for items has also amplified noticeably, sometimes from months to a long time.10 The consequence has been a substantial lack of health-related equipment, specifically those people for rarer ailments that businesses no more time locate worthwhile.
The Commission has acknowledged this difficulty, nevertheless it cites the ongoing COVID-19 pandemic and Russia’s war against Ukraine as root causes as an alternative, and programs to consider an extension of deadlines for firms to conform to the MDR.11 While the strategy is not formally tabled nonetheless, the tentative proposal sets new staggered deadlines: 2027 for “high risk” gadgets and 2028 for “low risk” units.12 The Wellbeing Commissioner more famous in her remarks on December 9th that these new deadlines should really be issue to nonetheless-undisclosed disorders, as “[o]nly products that are risk-free really should advantage.”13 Last but not least, the tentative proposal totally eliminates the Could 2025 provide-off day, therefore stopping waste of units previously on the market.14
The proposed modification to the MDR is established for thought at the commencing of the new 12 months. Really should the amendment be adopted, whether yet another deadline extension will solve the challenge at hand or basically punt the problem further down the line will stay to be observed.
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
Producing healthcare gadgets that do their work opportunities properly is one detail – having people today to engage and use them appropriately around time is really one more, says Oscar Daws, co-founder and running director, Tone Item Structure.
Regardless of whether we use professional medical devices or not, most of us are utilised to being ‘assisted’ by technological innovation. No matter if it’s the telephone we use to organise our life, the specs we use to see, or the smartwatches we use to monitor our conditioning activities. We can’t imagine existence without them.
And however the human response to health-related technological innovation is hugely diverse, with choose-up and adherence a challenge the world more than. It’s not for the reason that the kit does not function. It does ‒ medtech merchandise have to be rigorously analyzed and verified to be clinically efficient. But the human context isn’t generally absolutely regarded as. How men and women interact with med-tech drops off the list of priorities as innovators and producers emphasis on efficacy and negotiate the myriad obstacles and laws that appear with the territory.
There are important psychological and actual physical challenges that designers will have to defeat to convince persons to engage with medtech. It could be that the product is complicated to use. Or that it’s cumbersome and inconvenient. Or that we panic working with it improperly. Or that it embarrasses us. Or that it helps make us really feel outdated and sick.
It is only by digging deep and understanding the human response that we’ll find why individuals are prepared to put on headphones all day, for illustration, but the the greater part of grownups who would gain from a hearing support refuse to don a person. Or why 83{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of men and women who are prescribed sleep apnoea devices take them off midway through the night time. Most are bulky, hideous and noisy, and annoying for clients and partners. Transforming the design and the materials could improve adherence, ease psychological issues and make improvements to the over-all user knowledge. Following all, it does not issue how excellent a medtech products is, if men and women really don’t interact with it and use it correctly, it’s not going to get the job done as well as it could.
It is the exact same with selected drug shipping and delivery gadgets. A lot of of them are technically complicated, frightening and uncomfortable, which is concerning considering they’re administering essential, usually highly-priced medications. Resolving this with a thorough thought of style and UX elements would account for a portion of improvement expenditures ‒ which helps make the condition even additional baffling.
Engagement-very first pondering
This is the sweet spot wherever designers can move in and administer medtech CPR. Successful products structure can tap into the psychology of patient conduct and communicate medtech positive aspects to the end consumer in a innovative and empathetic trend.
Medtech ought to be straightforward to use and integrate with day-to-day life, like brushing your tooth or showering. It also has to be reliable and make people experience in management of their overall health wants, specially when there’s no healthcare skilled current. And it should really address any socio-situational worries. If a medtech product appears to be like a piece of ‘regular’ engineering rather of screaming out the term ‘assistive’, it can help easy about connected stigmas.
Element of the problem is that for so long, people living with sure problems have been regarded as ‘patients’ right before they’re observed as ‘people’, but that’s starting up to transform. And with that shift in considering will come the option to use methods far more normally related with shopper-targeted merchandise.
This transfer toward a additional shopper-centric technique has noticed us search to sport-like functions, behavioural science, covetable wearables: each and every resource in the box to create activities to drive engagement and enhance adherence. So, when headway is being designed, we could do so a lot more ‒ it’s continue to not a priority for numerous developers.
The knowledge-driven agenda
Some of the biggest issues right now surround the selection of facts. Huge-scale well being data has a good deal of worth, but there are essential discussions to be had all around privacy and ownership. Tracking and analysing data about a patient produces a clearer picture of that person’s wellbeing, and that details can be shared with the needed experts. But that requirements to be conveyed to the person in the suitable way. Several individuals are genuinely and rightly concerned about knowledge breaches, so style and design demands to reassure on security and make distinct the added benefits.
It’s fascinating to see how sturdy style and design can get a practical professional medical gadget and make it aspirational. Get athletics-engineering company Supersapiens – it took a continuous blood-glucose watch made for diabetics and reworked it into a effectiveness-improving system for athletes by way of style, gamification and intelligent communication. It demonstrates the electrical power of structure and communication approach in shifting perceptions, and cutting down stigma – all though generating a myriad of data which can be valuable for clinicians, scientists and most importantly the close user.
The pandemic turbo-boosted everyone’s romance with knowledge collection and its uses. In the United kingdom, an NHS get hold of tracing application captivated plenty of criticism above privateness and complex general performance. Folks in the United states experienced identical fears. While technically more healthtech than medtech, it is a pertinent illustration for the reason that the solution lay with designers. Prioritisation and investigation of person perceptions and user expertise may well have built it distinct that major challenges existed prior to start.
Folks failing to just take their treatment as prescribed is an age-aged issue, and the medtech industry is evolving to deal with that. But, as we transfer toward a environment where persons consider additional duty for their personal health and wellbeing, it would make feeling to devote time and power in putting their needs very first to guarantee that low engagement and adherence charges turn into a detail of the past.
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
The implementation of Regulation (EU) 2017/745 on medical devices (MDR) was discussed on the second day of the meeting of the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) on 9 December 2022. The European Commission proposes to extend the transition period currently foreseen in the MDR for devices certified in accordance with the Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMDD) through legislative amendment of the transitional provisions of the MDR. The extension of the transition period would be in the form of a staggered approach based on the risk classification of devices.
The transition period foreseen in the MDR provides that the deadline for recertification of medical devices in accordance with the regulation is 26 May 2024. A broad range of stakeholders, including the medtech industry, consider this timeline to be unattainable and have called on the European Commission to extend the recertification deadline. This extension would be based on the risk classification of devices and would mean that devices certified in accordance with the MDD and the AIMDD will remain on the market in the European Economic Area (EEA) after the end of the currently applicable transition period.
The European Commission proposes the following targeted legislative amendments:
Extension of the transitional provisions foreseen in the MDR based on the risk class of each device.
26 May 2027 for high-risk (Class III and Class IIb) medical devices
26 May 2028 for medium- and low-risk (Class IIa and Class I) medical devices
Elimination of the sell-off date of 26 May 2025 for medical devices that are already available on the EEA market to prevent safe medical devices from being removed from the market.
EU Commissioner for Health and Food Safety Stella Kyriakides noted that the proposed amendments would apply solely to medical devices that are safe for patients.
Following discussion with the health ministers of the EU member states, Kyriakides acknowledged the need for interim measures in relation to CE certificates of conformity previously issued for medical devices that have expired or will expire soon.
Shortly after the EPSCO meeting concluded, the European Commission published a position paper prepared by the Medical Device Coordination Group. The purpose of the position paper is to ensure a uniform approach to the application of market surveillance measures to bridge the gap between the expiration of certificates and the issuance of new certificates. The position paper provides guidance on how competent authorities should apply Article 97 MDR to devices that do not comply with the MDR due to expiration of their CE certificates of conformity issued in accordance with the MDD and the AIMDD before being certified under the MDR.
In addition to the proposed legislative amendments, the European Commission intends to undertake a comprehensive evaluation of the MDR by May 2027. The purpose of the evaluation is to identify structural problems with the MDR, as well as potential medium- and long-term solutions to these concerns. Moreover, the European Commission intends to fund actions to support the implementation of the MDR under the EU4Health programme starting in early 2023.
If you have any questions about the effect of the extension of the MDR transition period, please reach out to a member of your Cooley life sciences regulatory team.
