Hope is not a strategy – Insights from the MedTech Summit
25 September 2019
Written by Angela Leek – Medical Devices Community
From 17 until 21 June 2019, the MedTech Summit took place in Brussels. Over 150 expert speakers came together at the Crowne Plaza Hotel to navigate professionals from the industry through current challenges by giving presentations, holding discussions and in-depth case studies. On behalf of the Medical Devices Community, I was present to get insights on the most recent developments.
To start with, one of the most important messages of the MedTech Summit was: ‘Hope is not a strategy.’ Currently, there are many changes in the medical technology market, such as the transition towards the MDR and IVDR, as a result of which many companies must redefine their strategy and implement significant changes. Hoping that everything will work out is certainly not enough.
Now, there are still many questions about the MDR and IVDR left unanswered. Many speakers at the MedTech Summit were trying to clarify and analyse the gaps. With that in mind, I followed different tracks to find out more about the required adjustments for medical devices and diagnostic companies. My focus especially was on the stricter rules for clinical evidence and the involvement of notified bodies.
Most significant changes due to the MDR and IVDR
First, we must clarify the most important changes due to the MDR and IVDR. According to Andreas Stange, Vice President MHS global IVD at TÜV SÜD, there are seven:
- Reclassification according to risk
- Product scope expansion
- Oversight and involvement of notified bodies
- Stricter requirements for economic operators
- Rigorous post-market control
- Implementation of a unique device identification
- Stricter rules on technical documentation and clinical evidence
Clinical evidence to verify safety and performance
As already stipulated in the MDD, all the appropriate technical and functional features of the devices, in particular, those involving safety and performance, have to be appropriately addressed. New in the MDR is the focus on expected clinical outcomes; this was put forward by Klaus Schichl, Director Clinical Affairs CRM/EP at Biotronik Germany, in his presentation about the MDR requirements on clinical investigations compared to the current legislation (MDD/AIMDD) and ISO 14155. Companies must ensure that they are prepared to comply with the new rules before the MDR will be officially introduced in May 2020.
According to the MDR, a clinical evaluation is defined as a systematic and planned process to continuously generate, collect, analyse and assess the clinical data about a device to verify the safety and performance, including the clinical benefits of the device when used as intended by the manufacturer. This kind of clinical evaluation should take place during the entire product life cycle.
Sandra Bugler, Managing Consultant for Clinical Affairs at PROSYSTEM, an NSF international company, elaborated on this in her presentation ‘Practical Experience in conduction of Clinical Evaluation Reports for Medical Devices’. According to Sandra Bugler, companies need to plan several actions to comply with the new requirements. “You have to think about the adaptation of procedures and templates, consider process interfaces, adapt or create clinical evaluations, check if you have sufficient clinical data, generate clinical data for CE-marked devices and plan post-market clinical follow-ups.”
Benjamin Rochette, Regulatory Affairs Director at Medtronic, France, shared some pragmatic examples for collecting clinical data for legacy products during his presentation. Manufacturers can typically face numerous practical barriers to ensure that a sufficient level of clinical evidence is available with legacy devices, although these products might have been clinically used for several years. Benjamin Rochette commented on the pivotal role that real word evidence could play to confirm the clinical safety and performance of these devices, such as post-market registry-embedded investigations and clinical data extraction from registries involving scientific societies.
Legacy products – using equivalence?
According to Alexandra Rieben, Global Lead Clinical Research & University Account Management at Nobel Biocare Services AG in Switzerland, there are some concerns to keep in mind with the re-confirmation under the MDR of legacy products while using equivalence. Common issues are:
- New requirements as defined by the MDR are not met
- More than one equivalent device is used, establishing only partial equivalence for each
- Missing justifications, missing measurements, an insufficient demonstration of equivalence
- A substantial equivalence table as required by the FDA for a Premarket Notification, 510(k), is used and not adapted to MDR
- An insufficient level of access to data of an equivalent device
- An equivalent device is used that does also not have clinical data
- An equivalent device is used that has no CE-mark
To prevent the above-mentioned issues, Alexandra Rieben recommends performing a gap analysis, to make a decision whether to focus on collecting clinical data for a legacy device or whether to focus on rectifying issues with the equivalent device. Defining the acceptable level of sufficient clinical data plays a crucial role in any approach. As soon as this is defined for your device also considering indications/patient populations, you check how much clinical data you have (quantity and quality) and identify the clinical gaps. This is then followed by an evaluation of feasibility/validity of all means of clinical data collection, as several options exist to gather clinical data. Also, when the decision is made to bring a legacy device to compliance with the MDR by demonstrating equivalence to another device, PMCF activities will need to be considered for the legacy device.
Transition to the IVDR
Besides the MDR, there also is a transition to the IVDR for organisations with in-vitro diagnostic devices. During the MedTech Summit, I was present at the presentation ‘Practically preparing for the transition to the IVDR’. Paul Kenny, Regulatory Affairs Head at Oxford Gene Technology, gave his perspective on this transition for small companies.
“Because hope is not a good strategy, it is good to keep some transition issues to the IVDR in mind”, according to Paul Kenny. “Small companies like Oxford Gene Technology, have limited resources to fight the many regulatory fronts. Moreover, the new regulation represents a seismic shift in regulation and is far more invasive than any other regulation. Much of the new regulation is unclear, such as classification, clinical evidence, the role of PMCF, harmonised standards et cetera. However, there is already a lot where small companies can start with.”
Notified body feedback on implementing the IVDR
Under the IVDR, the role of notified bodies increases significantly. I attended a presentation by Andreas Stange, Vice President MHS global IVD at TÜV SÜD, who shared his view on implementing the IVDR from a notified body perspective.
An interesting fact he shared, is that under the IVDD, only 15 per cent of the diagnostic products are under the supervision of a notified body. With the IVDR it will be approximately 90 per cent, amounting to an enormous increase of the workload for notified bodies. Andres Stange said: “It is important for a medical devices company to start or maintain a good partnership with a notified body and to discuss and fine-tune the approach.”
How to work with notified bodies
Andreas Stange’s colleague from TÜV SÜD, Dieter Schoenwald, TÜV SÜD Product service GMBH in Germany, shares his advice on how to work with notified bodies:
- Be aware of the role of a notified body as an independent third party
- Expect a critical evaluation of your processes and products
- Do not expect a consultancy
- Try to understand the requirements
- Develop your solutions and hold timelines
- Do not try to test out the minimum necessary to achieve approval
- Notified bodies must be able to justify their decisions
- Notified bodies are under the strict scrutiny of competent authorities
- A conformity assessment is a strictly regulated process which needs reliable information and proper planning on all sides
All in all, I would recommend taking part in meetings like the MedTech Summit that can help you further with the transition towards the MDR/IVDR. Many changes also include concerns and uncertainties. The speakers present together with the visitors created an atmosphere in which valuable knowledge was shared. With this knowledge, it should be easier to shift from the hope that it will all work to an excellent well-considered strategy.
MedTech Summit 2020 will be taking place on 22-26 June in Dublin, and research for the agenda is well underway. If you are interested in speaking at this year’s event, please contact: Rebecca.Brady@KNect365.com. For sponsorship and exhibiting opportunities, please contact LCole@knect365lifesciences.com.
