From May 2nd to May 4th 2017, Polaris joined the annual MedTech conference held in Amsterdam, the Netherlands. Senior peers including CEOs of several multinational medical device companies, government officials, and compliance experts from MedTech Europe and GMTA (incl. Member Associations) discussed the regulatory environment of compliance for global medical devices. Two of the key topics discussed during the conference are highlighted in this article: value based healthcare and the new MedTech code.
The shift to value based healthcare
Value based healthcare is nothing new; life sciences companies are well-aware of the necessity to adapt their business models to changing environments. Traditionally, healthcare eco systems have been valued by volume of total care delivered. The perceived value of healthcare is then directly linked to costs, even though the cost of care continues to increase worldwide and quality varies greatly. Nowadays, patients and government authorities are placing more demand on companies to justify the impact of price changes on quality changes. Thus, healthcare systems worldwide are being restructured to focus on value provided to patients – not costs, customer service, or any other business-oriented KPI.
But it’s not easy – there are many challenges companies face when making a business model shift. For example, there is no clear definition of value. Patient outcomes vary greatly, and some may become visible only after several decades. Pilots by medical device companies to place a business model on value based healthcare are not flawless and create new compliance issues, including regulation and data integrity risks. Smart medical products for instance provide a huge competitive advantage as large data collection give better results to physicians. But the question is, who will keep, maintain and secure the data?
Under a value based model, customer satisfaction metrics will need to be re-defined and incorporated into products profiles, while at the same time medical device companies will need to become more service rather than product oriented. Advanced procurement structures need to be established that can be used to purchase value from manufacturers, rather than volume. But most importantly, the health-economic value of the business model shift needs to be proven. The industry needs to create value beyond the device.
Harmonizing global Medical Device codes
The MedTech conference once again opened the debate on how to structure regulations. Now that the focus has shifted towards value based healthcare, the need to have rules that support that approach becomes more evident. Companies are increasingly adhering to the MedTech code and shifting away from direct sponsorship to better educate the business and involve more stakeholders. But how can we better talk to regulators so that we may come to a more widely accepted and workable code? There is a need for cross-functional collaboration with Subject Matter Experts in the Medical Device field, where knowledge is shared among legislators, lawyers, compliance officers, purchasers, etc. On a global scale, governments are far from aligned on codes and regulation, as this is a long and tedious process.
There is a shared sentiment that compliance is addicted to rules. It seems we are continuously feeding the ‘compliance monster’ with more rules and regulations. Even if this is true, the majority of the speakers and attendees of the conference were in favor of a detailed global MedTech code, and if possible within the next 5 years. It should however be stipulated that rules are only there to serve a purpose.
The Global Medical Technology Alliance (GMTA) in collaboration with some of its international counterparts (particularly US association member AdvaMed) is already working towards such a global code. Work on the Chinese code is progressing and a Latin American code is on its way as well. MedTech Europe is focusing on further implementing their code, which will come to effect in January 2018. The main changes, which were important topics discussed at the conference, are the phasing out of direct sponsorship, educational grants and the collection of data for disclosure in 2018. Member Companies can no longer provide financial or in-kind support to HCPs to participate in Third Party Organized Events. Members are still allowed to provide educational grants, for which the intended purpose should be clearly specified in the Grant agreement. They must be publicly disclosed and aligned with grant allocation requirements, ensuring increased transparency of the funds allocated to medical education. MedTech members will also need to comply with the Conference Vetting System. The Independent MedTech Europe Compliance Panel will be fully occupied with analyzing and answering the CVS submissions next January.
Polaris – Your Trusted Partner
Polaris has worked in the last 15 years to help Life Sciences companies to address new compliance challenges. If you would like to discuss the impact of any of these trends or any of our specific healthcare compliance solutions and services, please reach out to our team here.
Uniquely focused solely on the life science industry, Polaris delivers best-in-class solutions for today’s toughest compliance challenges. The firm’s services range from comprehensive technology and software solutions to expert consulting, strategy and planning, as well as end-to-end managed services. Since 2001, the world’s most recognized pharmaceutical, biotech and medical device companies have relied on Polaris at their trusted life science compliance partner.