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With new legislation imminent in Belgium on distribution rules for medical devices, how much more open is the market going to become, and what must companies be aware of? Two experts discuss.
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The clinical laboratory industry praised the US Centers for Medicare and Medicaid Services for making changes in its final Clinical Laboratory Fee Schedule rule to allow more data from hospital outreach labs to be considered in setting laboratory test pay rates. But lab advocates are still pursuing a lawsuit and pushing for legislative reforms.
Devices that collect and communicate patient data present opportunities for device-makers to have a closer relationship with end-users, but most device companies have little experience working directly with patients. Device firms need to close this gap by seeing the patients who use their devices as their primary customers, rather than just focusing on intermediaries like doctors, hospitals, and payers, industry experts tell Medtech Insight.
As digital health rapidly expands its footprint, Cognizant's Vyom Bhuta says medical device companies need to evolve with the changing health-care landscape by making better use of the vast troves of available device data to improve products and patient lives.
The Turkish Government postponed a $10bn medical device tender for at least the third time, to January 10. But it is the government's insistence that the giant tender will go on at all, rather than be canceled outright, that has attracted criticism from local companies, who object to some of the tender's conditions.
Medtech stakeholders were reminded recently at the UK's largest regulatory forum that even those willing to make the best of Brexit are still working in the dark. The lack of useful government outreach is frustrating most efforts to secure business continuity. And that is without factoring in the huge regulatory changes that the EU's twin medical device regulations – the MDR and IVDR – will bring.
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