Faulty Devices: How Does Cardiology Compare to Aviation?

John Pepper OBE MA MChir FRCS FESC

Disclosures

Eur Heart J. 2019;40(25):2103-2106. 

In This Article

Conclusion

Innovation has played a significant role in the marked reduction in mortality due to cardiovascular disease (CVD). Forecasts suggest that by 2030, CVD could affect up to 40% of the population.[8] To respond to this, challenge efforts will have to be focused on pioneering new techniques which allow faster delivery of effective treatments to all patients in need, including reduced length of stay in hospital, fewer readmissions, improved quality of life, and overall value for money. But the cost of healthcare is rapidly accelerating. The Cardiovascular Round Table[9] believes that a major element of the innovation process is under threat from declining investment.

From the perspective of manufacturers, the need for complex submissions has made it harder to justify business cases for cardiovascular devices in recent years. It is, of course, crucial to demonstrate safety and clinical efficacy, and industry also accepts that it has to demonstrate value and prove cost-effectiveness in order to address concerns over rising health expenditure. But because there is currently a lack of transparency, consistency, and predictability across European healthcare systems, there is no certainty that such steps will lead to timely approval or adequate reimbursement.

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