In the 12^th edition of EY’s medtech report, The Pulse of the Industry, we examine the annual performance of the medical device industry in the context of the technological advances and rising customer expectations associated with the Fourth Industrial Revolution. To thrive in this transformative age, medtechs must adapt their business models to meet the increased expectations of consumers and other health care stakeholders.

An increasingly data-rich healthcare sector presents both opportunities and challenges for the MedTech industry, just as it does for the health systems and patients served by MedTech products.

Used intelligently and appropriately, the vast quantities of real-world data emanating from multiple healthcare sources, such as electronic medical records (EMRs), claims databases, products and disease registries, provide the raw material for real-world evidence (RWE) that can inform strategy and decision-making throughout the MedTech-product lifecycle.

Mike Ward, head of pharma content, sat down with Srinivasa Karri, a strategist with Oracle Health Sciences, to discuss the survey findings and highlight how companies can best manage the torrent of clinical data from multiple sources that will underpin their regulatory submissions.

US FDA is an ever-evolving organization, from recent changes to facility inspections under its so-called "Program Alignment" initiative, to plans to harmonize the agency's Quality System Regulation with international quality systems standard ISO 13485 – just to name two big-ticket reforms.

Adoptive Cellular Transfer (ACT): Novel Cancer Trials Demand That Participating Sites Act Differently

As more pharma and biotech companies bring their ACT platforms to the clinic, there is a need for the assistance of clinical research organisations (CROs) to support the conduct of clinical trials. Valued for their relationships with trial centres, CROs have been thrust into the forefront of operationalising ACT studies. So what can sites expect and commit to when participating in ACT trials?

Iron deficiency is a global public-health challenge in need of urgent attention. It affects more people than any other nutritional disorder, particularly in the developing world, but also with significant prevalence in industrialized countries

The history of stem cell research has been marked by a combination of great promise, disappointment and controversy. But progress is being made, with a number of stem cell therapies approved and many more in the late-stage pipeline. While the US has lagged behind other regions in stem cell therapy approvals, recent developments on the regulatory front are intended to provide a clearer path forward and accelerate development.

For more than 20 years – from the passage of the US Food and Drug Administration Modernization Act (FDAMA) in 1997 until just this year – the life sciences industry has had little to go on when deciding what health economic information about products could be shared with payers. This was especially true with regard to products or indications that had not yet been granted marketing approval; the boundaries of what was permissible were blurry at best.