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From Compliance to Opportunity: How to Address the EU Device Regulation Changes

Posted by Matt Scheitlin on June 27, 2018



BlogPost_Image-636525-editedLikely, wherever you’re based in the world, you are aware of the General Data Protection Regulation (GDPR) that went into effect in Europe on May 25. These sweeping regulation changes affect every organization that controls or processes the personal data (whether customer or staff) of personnel based in the EU. If you’re reading this blog post, then your organization has been affected by the GDPR and, hopefully, built a capability over the past few years to ensure compliance. And if you’re best in class, your company is using the GDPR requirements as an opportunity to drive your business forward.

Less publicized but just as impactful for the medical technology industry are the EU medical device and in-vitro diagnostic (IVD) regulation changes that go into effect in 2020 and 2022, respectively. Since we’re now a year into the transition period, and with the GDPR fresh on people’s minds, I thought that it would be a useful time to revisit what these changes mean for the industry. I see three overarching themes:

1. EU alignment is increasing. In both the pre- and in-market product context, the EU is strengthening its ability to manage product and patient risk across member states in ways that are consistent (such as common specifications, notified bodies designation, etc.) and transparent (clinical study requirements, publicly available centralized databases, etc.). The establishment of the EU Medical Device Coordination Group (MDCG), with representatives from all member states, speaks to this focus on increased central alignment and oversight.

2. Manufacturer responsibility is intensifying. Whether we’re talking about product liability insurance, labeling and supply chain compliance, or even post-market surveillance and data collection, the responsibility and requirements for manufacturers to ensure that their products (and partners) meet all regulatory and safety requirements has been enhanced.

3. Market transparency is improving. With clear mandates to enhance clinical trial sophistication and proof burdens (planning, trial design, cross-country alignment, etc.), increase patient awareness (unique device identification), and publish safety and performance data, the EU is recognizing the need for consumers to have increased visibility regarding available therapies.

Fundamentally, the above themes speak to a more sophisticated and aligned EU regulatory environment that behaves much differently than the localized past. This change requires an equally transformative approach to how manufacturers support the EU market. Some changes, like unique device identification (UDIs) and supply chain compliance, are imports from the U.S. teams that have been dealing with similar regulations for years. Other changes, like what was required for GDPR, can’t be easily imported or built overnight. Thus, organizations must be effectively using the next two years of the transition period to ensure that they’re building the capabilities to excel in 2020 and beyond.

Here are a few capability areas that best-in-class organizations must improve:

  • Data management: Let’s be honest: In European medtech, we lag behind other industries in both data systems and management. However, considering the requirements to place product implants, and possibly clinical outcomes and trends, into a publicly available centralized database, we must adapt. This starts with not only identifying the right systems to ensure compliance, but also creating ways of working that allow for both internal and external data extraction and, of course, compliance with the GDPR.
  • Clinical affairs: Clinical trial outcome requirements will be moving beyond basic equivalence data, possibly lengthening the speed of CE (Conformité Européene) approval. The regulations outline an increase in clinical proof points and a focus on leveraging pan-EU trial coordination. All of this amounts to a dramatic evolution for the clinical affairs team and how they demonstrate a product's value to the market. Locally, capability improvement is required to drive customer selection and proof requirement alignment for new device clinical trials. Regional roles will also be important to ensure trial design consistency, execution coordination and management of the Medical Device Coordination Group. In addition, the ability to leverage this data to support local and regional clinical claims and proof points will be a critical enabler of a best-in-class capability.
  • Market access: That same explosion of real-world evidence data, on both pre- and in-market products, will be transformative to support market access activities, not only in market development with patient groups but also, perhaps even more importantly, to partner with payers and customers to effectively adapt local patient treatment pathways and reimbursement processes.
  • Patient (consumer) engagement: In the past few years, connected devices have opened up the patient engagement discussion in Europe like never before, and the transparency being driven by the new regulations will only accelerate and reinforce the need for a patient-focused capability. Fundamentally, for both clinical and commercial, this requires a complete shift in how we’ve typically thought of patient engagement.
  • Research and development: All of the above create a world of new information that must be leveraged by R&D in the product (and solutions) development pipeline. Understanding market needs beyond our clinical stakeholders allows best-in-class organizations to identify transformative and differentiated technologies that are not incremental life cycle extensions.

Perhaps not surprisingly, many of the capability improvements come in areas where disinvestment was rampant over the past 10 years due to short-term margin pressures. Rebuilding the capabilities will require investment in people (regionally and locally), systems and processes. Making this investment isn’t simple, but companies must develop a more sophisticated and future-looking commercial model in these key areas. It could be by transforming the sales force or the marketing organization, or perhaps even by growing the business through data and analytics. Whatever the method, the EU has graciously given us the deadline. Now, just like the GDPR, it’s up to us to build the capability that turns this compliance requirement into an opportunity for growth.


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Topics: medical devices, medtech, MedTech Europe, regulations, EU, compliance, GDPR, general data protection regulation, medical device regulation

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AUTHORS
Brian_Chapman_thumbnail
Brian Chapman
Principal,
ZS Associates
Tobi_Laczkowski_thumbnail
Tobi Laczkowski
Principal,
ZS Associates
Will_Randall_thumbnail
Will Randall
Manager,
ZS Associates
Matt-Scheitlin-London_thumbnail
Matt Scheitlin
Associate Principal,
ZS Associates
Andy-kach_thumbnail
Andy Kach
Associate Principal,
ZS Associates
Bhargav_Mantha_thumbnail
Bhargav Mantha
Associate Principal,
ZS Associates
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