Successful medtech leaders have ongoing regulatory strategies for their respective businesses. Successful medtech leaders have ongoing regulatory strategies for their respective businesses. Mention the words “regulatory impacts” and most industry professionals immediately think of requirements for getting new products to market. But the most effective regulatory strategies involve evaluating the impacts of regulatory bodies on both existing and future products (regardless of whether the innovation is incremental or disruptive). As 2019 winds down and medtech firms begin their strategic planning for 2020, it’s important for companies to determine whether their current regulatory strategy will be a “winning” one next year. It remains to be seen whether 2020’s regulatory issues will be headwinds or tailwinds. While it certainly can be argued that regulatory issues are beyond a company’s control (due to the changing nature of governmental policies), we contend that strategizing against the competition is usually “graded on the curve.” Creating (and maintaining) international market access for products allows organizations to commercially execute their game plans. Without market access, there is no chance to compete and, therefore, no opportunity to win.

Click Here For Complete Article Text

• Globalization

• Regulation / Standard

• Medical Product Outsourcing

• 9/1/2019

• Article