News & Analysis as of

Manufacturers Research and Development Medical Devices

Gardner Law

The Importance of a Clinical Trial Strategy

Gardner Law on

Developing a medical product, such as a medical device, comes with important milestones that can cause a project to sink or swim. One major milestone is amassing the clinical data needed to support pre-market submissions....more

J.S. Held

Inside the Healthcare Industry: The Impact of Human Factors & User Experience in Healthcare

J.S. Held on

Human Factors and User Experience testing play an important role in healthcare settings and in the development of healthcare products. They can greatly impact the delivery of care, and the patient experience delivered by...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Woodruff Sawyer

How to Manage Exposures When Commercializing a Life Sciences Product

Woodruff Sawyer on

The road to commercializing a life sciences product is a long one, spanning years to perform research, develop the product, conduct clinical trials and testing, and receive approval from the Food and Drug Administration...more

Allen Matkins

Life Sciences Real Estate Update -1.06.23 #1

Allen Matkins on

California’s lab and biotech industries provide 435,693 jobs that generate $376 billion in total economic output, according to a new report from Biocom California, an association representing life sciences companies and...more

K&L Gates LLP

Impact of the Growing Marketing Authorization Holder Pilot Program in China's Medical Device Industry

K&L Gates LLP on

This article reveals the mechanics of a growing pilot program for registration of Class II and Class III medical devices to be contract manufactured in China that has gained significant recognition across China over the past...more

BakerHostetler

How to Protect and Clear Your Medical Device During Development

BakerHostetler on

Partner Hussein Akhavannik breaks down specific patent protection and clearance strategies for each stage of medical device development, from concept and design to the manufacturing and sale....more

McDermott Will & Schulte

[Webinar] Critical Business Considerations for Life Sciences and Medical Device Companies Amid the COVID-19 Pandemic - April 17th,...

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...more

McDermott Will & Schulte

21st Century Cures: A Closer Look

On December 7, 2016, the US Congress enacted the 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by encouraging biomedical research investment,...more

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