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On Friday, March 26, 2021, over 180 attendees worldwide attended McKinsey & Company’s first Global HealthTech CEO Connect of 2021. The discussion focused on regulatory and legal considerations for software as a medical device (SaMD) in both the United States and Europe and specific use cases for digital therapeutics and other digital health products. Speakers included Morrison & Foerster partners Bethany Hills and Wolfgang Schönig as well as special guest Corey McCann, president and CEO of Pear Therapeutics, in a fireside chat at the end of the program.
Globally, the convergence of software technology and life sciences creates a massive opportunity for growth, and the market for these products is growing exponentially. Both the U.S. Food and Drug Administration (FDA) and European regulators have focused on establishing a regulatory framework for oversight of SaMD.
Introduction
The research and development (R&D) of medicinal products is important both from an individual perspective, considering its objective to identify and treat pathologies (with the consequent improvement in patients quality of life), and from a collective perspective, considering its role in controlling the spread of diseases or eradicating them altogether. R&D activities can be defined as activities carried out in humans (who may be healthy or ill) to:
improve knowledge of pathologies;
identify forms of treatment.
R&D activities are subject to legal and regulatory frameworks and practitioners must comply with various requirements, including:
respecting the human dignity principle and trial subjects fundamental rights;
Fertility Treatment: Are Cryogenics the Key?
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Developments and research are ongoing, but there have already been considerable advancements in reproductive medicine over recent years. More options are available than ever before in terms of the management and potential treatment of infertility, while new and innovative alternatives are increasingly available for people unable to conceive or at risk of becoming sterile.
Cryogenics offers a potential advantage to this work. As well as advancements in health and fertility treatments, a range of contemporary developments in the use of cryogenics have led to countless benefits.
One popular use of cryogenics lies in vitro fertilization (IVF). This process sees sperm, embryos, and oocytes frozen and preserved for use in later fertility treatments. Cryogenics plays a central role in this process, facilitating the safe storage of these important samples.
Stem Cells: How Long can They be Stored?
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The science of regenerative medicine and stem cell applications is continually advancing. These techniques are employed in the treatment of illnesses and immune disorders, ultimately saving lives.
Blood and cell samples can be stored using cryogenics, but it is important to be aware of the applications of these materials and how long they can they survive in cold storage.
Stem cell applications
The majority of the body’s cells are differentiated and designed to serve a certain function. Stem cells are undifferentiated, however, meaning they have the potential to develop into a diverse range of cell types able to serve various purposes.
Software As A Medical Device In Europe – New Regulatory Regime About To Enter Into Force – (Part 4 Of 6) - Food, Drugs, Healthcare, Life Sciences mondaq.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from mondaq.com Daily Mail and Mail on Sunday newspapers.