This space is devoted to the unprecedented challenges that the MedTech industry faces from fundamental changes to the environment in which it operates.  As the Association of British Healthcare Industries (ABHI) says, after 15 years of relative stability:

- way Companies operate commercially will be largely controlled by the new Code of Business Practice;

- development and introduction of new technology will change under the Commission’s latest proposals to recast the Medical Devices Directive;

- business risk is likely to increase dramatically if the Commission’s current proposals result in US-style Class Actions being introduced into Europe, and

- environmental considerations will affect the way in which companies do business and demonstrate their “green credentials”. 

These are not just technical changes: they go to the heart of companies’ business models.  They link together to create a new environment in which business operates.  They demand the attention of both senior commercial management and their key advisers.  Not only are these changes unavoidable, but they present a real opportunity for those Companies that are ready to use them to their advantage.