OCTOBER 2021 Research Alert

This month we added four new studies to the Best Practice Database, the research repository for Best Practices, LLC. This month's new studies explore two topics: dealing with the new European Union Medical Device Regulation (EUMDR) and managing hostile stakeholders during a product launch. The first two studies revolve around how medical device organizations are dealing with the cost of implementing EUMDR with the first document addressing implementation and product class costs and the second study looking at the cost impact by company EU revenue level, the therapeutic area and implementation activities. The final two studies regarding hostile stakeholders examine how pharma organizations are relying on leadership and communication tactics (third document) and using science to defuse hostility as well as working with pricing groups to address concerns.

The new Best Practices, LLC studies listed below under Newly Added Research explore how leading companies have made their operations more effective across these different areas.

	Download: Navigating the Challenges and Costs of the New European Union Medical Device Regulation (EUMDR): Implementation and Product Class Costs (5698) This benchmark study probes the real-world costs and challenges that companies are experiencing during the transition from Medical Device Directive (MDD)/Active Implantable Medical Devices to new requirements in Medical Device Reporting (MDR). The study examines the costs associated with implementation of the new requirements and how those costs are reflected across medical device product classes.
	Download: Navigating the Challenges and Costs of the New European Union Medical Device Regulation (EUMDR): Cost Impact by Company EU Revenue Level, TA/Condition and Implementation Activities (5699) EUMDR creates new regulatory expectations with the device reporting regs four times longer than previously. These changes result in increased costs and complexity of doing business in the EU. This study analyzes the cost impact the new regs will have on companies with large vs. small EU revenues and on the product's therapeutic area/condition.
	Download: Managing Hostile Stakeholders during the Launch of a Breakthrough New Medicine: Leadership and Communication Best Practices (5700) Pharma launch leaders often walk a tight rope when launching a novel breakthrough medicine. The study identifies effective strategies for managing hostile stakeholders during the launch. It also probes about leadership involvement to ensure transparency and communication practices that help prevent issues and soften hostile reaction.
	Download: Managing Hostile Stakeholders during the Launch of a Breakthrough New Medicine: Using Science to Defuse Hostility and Working with Pricing Opposition Groups (5701) Many pharma companies are developing rapid response teams to map and engage the full range of hostile stakeholder groups. Best Practices, LLC engaged senior launch leadership from pharma companies and conducted extensive secondary research to understand mapping and engaging of hostile stakeholders, using science to defuse hostility and build the value story, and working with pricing opposition groups during product launch.