medical devices Archives - HEALTH & LIFE SCIENCES NEWS

Investing in Global Healthcare

by Dale Van Demark, Michael Ryan, Stephen W. Bernstein, Kristian A. Werling, Hamid Yunis, Sharon Lamb, Emmanuelle Trombe and Dr. Stephan Rau | Jun 10, 2021 | Digital Health, Health M&A, Health Private Equity, Life Sciences

Today’s global healthcare marketplace is marked by unprecedented transformation. This presents both challenges and opportunity to today’s market participants. We know how important it is to structure cross-border investments and transactions to account for complex and ever-shifting regulations.

Within this dynamic environment, our health lawyers wield a deep knowledge of how healthcare services, medical technology and pharmaceuticals are delivered around the world, and how the laws that affect those entities and that help drive action are creating the market of tomorrow.

Bringing this experience and commercial focus together we are proud to present the Global Guide to Investing in Healthcare. Our one-stop resource is here to guide you through the healthcare systems of key jurisdictions, helping you to explore the regulation and provision of healthcare services, merger and foreign investment control, anticipated changes in healthcare and life sciences law, and much more.

Click here to visit our interactive report, and start exploring the opportunities and challenges for your business today.

After the Curve Podcast: Focus on Life Sciences

by McDermott Will & Emery | Oct 8, 2020 | Life Sciences

In this time of crisis, the life science industry has demonstrated remarkable speed, innovation and resilience. In this episode of the After the Curve podcast, our life sciences partners join us to discuss the most promising areas of drug discovery and device development that are emerging from the pandemic and the outlook for the industry in a post-COVID-19 world. McDermott’s Chief Marketing Officer, Leslie Tullio, is joined by Stephen Bernstein and Kristian Werling to discuss key topics impacting the life sciences industry today, including:

The reasons behind the immunity of life sciences to slowed investments
Why more investors are focusing their equity in healthcare and life sciences
Promising areas of drug discovery and device development emerging from the pandemic
Critical considerations for life science companies regarding rapid regulatory changes
Tactics for moving developments forward at an increased speed
The importance of Collaborative Transformation to the life sciences industry

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Regulating Medical Devices Post Brexit

by Sharon Lamb and Bella North | Sep 18, 2020 | Digital Health, Hospitals & Health Systems, International Health, Life Sciences

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published guidance on the new rules that will govern the regulation of medical devices and in vitro diagnostic medical devices placed on the market in England, Wales and Scotland after the BREXIT transition period (different rules will apply to Northern Ireland). This On the Subject outlines key dates for implementation of the new rules and certain practical implications of changed regime.

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published guidance (the Guidance) on new rules that will govern the regulation of medical devices after the end of the transition period. Whilst some of this guidance is similar to guidance issued as part of the “No deal BREXIT” publications in 2019, the MHRA has also set out proposals to engage and consult on a new medicines and medical devices regulatory framework for the UK.

The UK left the European Union (EU) in January 2020 but is currently in a transition period. The Guidance was released as part of a collection of updates covering various MHRA-regulated sectors (including medicines, clinical trials and licencing procedures) which will also be subject to new rules from 1 January 2021.

This update focuses on the new regulatory framework for medical devices and in vitro diagnostic medical devices (IVDs) placed on the market in England, Wales and Scotland (Great Britain) only. Different rules will apply to Northern Ireland.

Existing law to continue
The rules that currently regulate medical [...]

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Top Takeaways: Critical Business Considerations for Life Sciences and Medical Device Companies During COVID-19

by McDermott Will & Emery | May 5, 2020 | FDA, Life Sciences

Life sciences and medical device companies are dealing with an unprecedented crisis. The industry is not only managing the impact of Coronavirus (COVID-19), they are also a solution provider. Companies are rapidly adapting products, services, facilities and distribution channels to aid in the pandemic response. Simultaneously, they must maintain shareholder value, navigate highly complex regulatory hurdles and compliance obligations while rethinking strategies for growth in a post-COVID-19 world. McDermott Will & Emery and EY co-hosted a webinar to discuss critical COVID-19-related operational, regulatory and legal developments. Below are top takeaways from the program. For a deeper dive into these issues, listen to our webinar recording.

FDA enforcement discretion is a flexible, risk-based approach, not a free pass. Companies operating under FDA’s enforcement policies to provide COVID-19 countermeasures should have a strategy to ensure that products comply with the standard applicable requirements if the products will still be in distribution after the public health emergency ends. FDA will prioritize areas for follow-up and review after this crisis; clear documentation and protocols describing deviations from standard FDA procedures or requirements will be important in a post-COVID-19 environment.
Clinical trials remain an important FDA priority, and COVID-19 presents an opportunity to transform the clinical development model. The agency has been very flexible in terms of the approaches it is taking to allow trials to continue, including through the use of technology, such as remote patient monitoring, video consent and telemedicine, as well as the use of home health. [...]

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