Speaker: John B. Pracyk, MD, PhD, MBA, FAANS, FACS
Integrated Leader, Medical Affairs, Pre-Clinical & Clinical Research, DePuy Synthes – Spine, Johnson & Johnson Medical Devices Companies
The medical device industry is facing challenging times ahead. A broader set of influencers (regulators, hospital administrators and other value-orientated customers) will see a shift from individual outcomes to a focus on population-led effectiveness and will require the development of comprehensive value propositions for any device or drug.
In addition, sweeping reform of the rules that govern the medical device industry in Eu-rope represents one of the most disruptive changes to affect the global medical technology sector in recent times. Under the European Medical Device Regulation, companies will have three years to comply with a broad swathe of new rules for almost every kind of product in the medical device spectrum. How do medical device manufacturers deal with a decidedly more frugal and selective customer base? This webinar looks at serving the needs of all stakeholders by helping to ensure that the company gets safe, reliable products to market efficiently and cost-effectively—without any barriers to clearance.
After participating in this Webinar, participants will be better able to:
- Understand the development of Value Analysis in integrated delivery networks
- Understand Design to Value for OEM Medical Device Manufacturer
- Develop comprehensive value propositions for any device or drug
- Understand how the new Medical Device Regulation (MDR) will drive global value, specifically:
- State of the Art
- Device Classifications
- Evidence Generation
- Equivalent Comparator
- Post Market Surveillance & Follow Up
- Data Mining and Requirements