It is a world, at least the US corner of it, in which any common understanding of drug value is confused by opposing incentives – to opacity and transparency, to looking at benefit broadly or narrowly, long-term or short-term: value, in short, to whom?

Menacing clouds on the horizon, or opportunity for medtechs large and small in the evolving health care delivery ecosystems? Probably both, and a significant amount of risk, too, for those medtechs who push through the pain barrier to, in some cases, redefine their own roles. Helping patients understand the value being created will also be a major success factor for medtechs. Whatever the outcomes, these are exciting times, says ZS' Brian Chapman, in this future-gazing podcast with In Vivo.  

The extra resources, time and expense that the EU Medical Device Regulation (MDR) will mean for companies in Europe has been a dominant theme since spring 2017, but the repercussions on non-European markets that rely on EU medtech legislation – in Asia, for example – are now coming to the fore, says regional medtech regulatory specialist Jack Wong. 

Payers cannot control the pricing of new products by biopharmaceutical companies, but their goal is to deliver quality health care in a cost-effective manner. Several payer medical directors representing over 100 million commercially insured members have shared their insights for managing the challenging US market – revealing their thoughts on drug pricing currently, and steps they plan to take in the next 3 to 5 years to better control rising costs.

In view of the political and regulatory threats and opportunities likely to emerge in 2019, for those in the medtech industry, it pays to be vigilant, advises ZS' Brian Chapman. And while some new tech entrants appear to represent a threat to established medtech players, their emergence in general promises significant opportunities for savings and innovation in health care. At the same time, there will likely be a short-term return to both old medtech industry values, and to major M&A.  

Scott Gottlieb's FDA continues to push out policy reforms and experiments at a rapid pace, with special focus on digital and AI technologies. In parallel, US Medicare officials are more publicly signaling plans to roll out policies for a quicker path to reimbursement for new devices. However, public scrutiny of whether device regulations properly protect patient safety is growing, and it could have an impact.