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. 

The health care world once viewed barriers to access in terms of reimbursement and legislation. While these are still prevalent in the conversation, there is a greater focus on nuanced barriers – such as how treatments impact quality of life, convenience for patients, route of administration and side effects.

Medtech continues to outperform biotech from a sustainable investment growth point of view, and meanwhile medtech CEOs are on message about advancing value- and outcomes-based models with their provider partners. It all points to medtech being in a good place for 2019, and there is no reason for M&A and industry consolidation to stop anytime soon, says Jefferies equity analyst Raj Denhoy.