Building MedTech Compliance for Tomorrow
Building MedTech Compliance for Tomorrow
Each fall the two of us meet to discuss global healthcare legal and compliance developments and to assess implications on the medical technology industry, patient care and innovation. When we first began collaborating the iPhone was just invented (healthcare apps were unimaginable) and, since that time, quite a bit has changed!
When we annually meet, we reflect on member company input and surveys, leading health official statements and policies, medical professional societies and patient perspectives, business trends, and developments in other industries - a 360 degree review! From transparency to FCPA to the phase out of direct sponsorship we've analysed most developments shaping this field and tried to position our industry ahead of the curve when we could.
The Global MedTech Compliance Conference, GMTCC in short, is our annual forum for global medtech compliance and ethics exchange on the trends and topics we see as most pressing to patients, industry and users. This is our industry’s opportunity to learn from each other, from thought leaders, and to continuously advance our work, just as our industry continuously drives ahead new patient care innovations.
As an industry and legal/compliance experts we've achieved remarkable success - new guidance, distributor trainings, outreach to important stakeholders, including also international organisations such as OECD, small company boot camp, etc. - and our annual GMTCC dialogue among global leadership has been instrumental to this success.
In past years we've focused on new law enforcement theories and assessed how we can lead industry to safety, preserve industry innovation and establish credible self-regulatory approaches through ethics and compliance guidance. When possible, we've tried to align our policy work to avoid regional fragmentation for a global industry dependent on global lines of scientific exchange.
But, when we met last fall, and we again reflected on developments, trends, thought leader guidance, member priorities and experience and more, there was something different. It seemed like everything had suddenly changed.
What struck us most was the extent of fundamental business transformation across the industry. Consumerization of sophisticated medical technologies through advances in digital technology; new procurement and business models premised not on volume but on value; compliance data analytics capacities fuelling sophisticated company compliance structures and approaches; convergence of medtech codes globally; and more. In short, the profession and medtech compliance itself will tomorrow look as different as the iPhone looked to us when we first began our GMTCC collaborations. This is why we thought that this year, GMTCC - taking place in Amsterdam at the beginning of May - should be focusing discussions on the “compliance of tomorrow”.
We have organised the conference as follows: the first more philosophical debate is labelled “Less rules, more trust” and will discuss today’s compliance model, as some call it 'Godzilla Compliance' which is mostly based on a concept that places rules in the centre and are then translated into business processes. If this model does not work, could it be turned around and have business processes take the lead and then have rules translated into them? Could the key function of compliance be that employees are enabled to do their job without 'complicated rules and processes' but make sure that they don't make any problems?
The second plenary debate tackles the new reality of medtech companies, the shift to value-based healthcare, where companies play a broader role in more effectively integrating technology and related services into all aspects of patient care, and what this means for compliance and how to take an intelligent risk approach, where accountability and responsibility, respect and consideration of all stakeholders are taken into account.
The last plenary session will be an interactive session on the topic of Code Convergence. The session will be set up to provide a workshop style interaction amongst the participants and the panellists. The panellists will provide an introduction to the three topics, i.e. a common framework among stakeholders, one Code for the healthcare industry and a global MedTech Code, while the participants will be encouraged to give their opinion on the session’s discussion.
The three breakouts will tackle some of the more practical aspects: (1) distributors and how the topics described above impact the relationship between companies and distributors; (2) privacy and compliance, i.e. how in the evolving digital world in which we live, what these evolutions mean for the medtech industry and how industry can protect and use (health) data protection in a world that presents more and more challenges to medtech manufacturers; and finally (3) in a world that is phasing out direct sponsorship, how to optimise Educational Grants to ensure industry support to medical education.
Finally, there will be the opportunity to ask specialists on many different topics, any question that you may have during the session “Ask the Expert”.
Over the last few years, the conference became the event to attend if you are interested in medtech compliance, with more than 300 delegates attending last year. We hope that it is for the agenda that is carefully crafted to respond to the concerns of our members, but it is also the one opportunity to get to know each other, with many networking opportunities. This year, we have changed a number of aspects, starting from the length of the conference, which is now only 1,5 days long, to new more interactive sessions. Judge for yourself if you like the new concept. Register today!
This blog is part of the GMTCC 2017 blog series. You can follow the conversation under #GMTCC and find more details and at gmtcc.com.