Life Sciences GBS organizations today have evolved into strategic partners for their enterprises, driving both operational and technological advancements. As part of the evolution, Life Sciences GBS organizations are increasingly supporting critical functions, including R&D operations, and scaling up these capabilities has been a top priority.
Join this virtual roundtable as our experts and your peers discuss and explore the vision, effort, and support required for scaling R&D capabilities from offshore/nearshore delivery centers.
What you will take away:
In this collaborative session, we’ll uncover the key aspects of building R&D capabilities in GBS, such as:
Who should attend?
Virtual Roundtable Guidelines
The only price of admission is participation. Attendees should be prepared to share their experiences and be willing to engage in discourse.
Participation is limited to enterprise leaders (no service providers). Everest Group will approve each attendance request to ensure an appropriate group size and mix of participants. The sessions are 90 minutes in duration and include introductions, a short presentation, and a facilitated discussion.
With the increased adoption of remote monitoring technologies, wearables, and smart implants, the medical devices industry is shifting toward building a connected care ecosystem that seamlessly integrates people, technology, and data across the care continuum. Enterprises are looking to augment their current device portfolios with digital technologies to support the patient journey across care settings. To support enterprises on their connected care journeys, providers are ramping up both their engineering and digital capabilities through industry-specific partnerships, IP, and innovation centers to benefit stakeholders across the healthcare and MedTech ecosystems.
In this research, we present an assessment of 19 medical device service providers featured on the Connected Medical Device Services PEAK Matrix®. This report examines:
Connected medical device services market trends
The service provider landscape for connected medical device services
Service providers on several capability- and market success-related dimensions
The PEAK Matrix® provides an objective, data-driven assessment of service and technology providers based on their overall capability and market impact across different global services markets, classifying them into three categories: Leaders, Major Contenders, and Aspirants.
Surgical Devices Market
VIEW THE FULL REPORT
The EU had planned to implement a new set of regulations – the European Union Medical Device Regulations (EU MDR) in May 2021 and In Vitro Diagnostic Regulations (IVDR) in May 2022 – to establish stringent device controls, improve transparency and product traceability, and strengthen clinical evaluation and post-market surveillance. But a series of overwhelming events has forced EU regulators to shift the MDR implementation from May 2020 to May 2021.
The global COVID-19 pandemic is the primary cause of this deferment. However, constant pushbacks from trade associations have also played a role, as has strong evidence of the industry’s under-preparedness to comply. For example:
To overcome these challenges, stakeholders across the medical device industry, including medical device manufacturers, contract research organizations (CROs), and service providers, should focus on specific areas.
The medical device industry is exploring multiple ways to continue to stay relevant in the European market. While some organizations are leveraging the EU MDR and IVDR transitional provisions (MDD and IVDR certificates issued before May 2017, which will remain valid until they expire or May 2024, whichever comes earlier) to extend their market presence, others are building their regulatory capabilities and deploying both internal and external workforces to do so. Cook Medical, for instance, is hiring 20 full-time EU MDR-specific roles and working with over 70 contract-based individuals. Likewise, service providers such as Capgemini and TCS are seeking to hire regulatory specialists.
The launch date’s extension by a year might just provide the much-needed relief and time all stakeholders need to build their capabilities to comply with the new regulations.
For more insights on the impact of EU MDR and IVDR on the medical device industry, please see our recently published viewpoint Regulatory Overhaul of the EU Medical Device Market or contact [email protected], [email protected], or [email protected].