Edoardo Dell’Amico (EDA), Cardiovascular Implants Senior Product Specialist, Auditor, TÜV SÜD, Munich and Rob Fraser (RF) Interim ViVitro General Manager, recently participated in the September 2018 meeting of the ISO/TC 150/SC 2 – Cardiovascular implants and extracorporeal systems (ISO 5840) committee.
After discussing the Cardiovascular Pioneer interview with Luke Herbertson, Ph.D. of the Fluid Dynamics Laboratory at FDA’s Center for Devices and Radiological Health, Edoardo spoke with Rob about his work at TÜV SÜD, ISO standards, MDR, and the European market.
RF: How does a typical day at TÜV look like?
EDA: A normal day at TÜV SÜD is very busy as there are many things going on at the same time and normally no day is like the other one! In general, I spend 60 percent of my time in performing assessments of the documentation provided by manufacturers (class-III Design Dossiers) seeking approval of their products in the European market. This includes different data ranging from biocompatibility to performance assessment, also including analysis of the results from bench testing.
The remaining 40 percent of my time is split between auditing companies that are submitting their products for our assessment in order to have a complete quality management overview, and on keeping myself up to date by attending congresses and actively participating in the ISO committee that is working on the release and maintenance of ISO 5910 and the 5840 standard series.
RF: Do you specialize in heart valves? Or do other medical devices come across your desk as well?
EDA: Within TÜV SÜD we are required to have a solid background on the product we are assessing. Normally each product specialist is authorized to assess specific product scopes depending on the technical background. TÜV SÜD product specialists are selected to have the capabilities and skills to deeply and powerfully analyze these types of data. In fact one of the requirements for working with TÜV SÜD is to have extensive experience in R&D in order to deeply understand the data that manufacturers and factories are providing.
Based on my experience in the Heart Valve industry as R&D Product Qualification Engineer, I have been authorized as Product Specialist (PS) for Heart Valve Replacement and Repair Devices. Furthermore, I also gained the Senior Product Specialist (SPS) qualification. Within TÜV the SPS is responsible for training of new Product Specialists, maintenance and update trainings for already authorized colleagues and for generating product specific assessment procedures. Finally the SPS is involved in resolving technical or regulatory disputes related to the products in his scope. At TÜV there is one SPS per each product scope.
RF: Globally, where are companies coming from when they’re submitting data to you? Is it mainly European or US companies? Or is it companies from around the world submitting data to TÜV SÜD?
EDA: At the moment, most of my clients are located in the US. I’m very lucky because most of them are based in California (laughs). So, when I go to visit them I am always very happy to undertake these trips. Nevertheless, in Europe there is a lot of work which is still hidden. But it will come out soon. There are many very interesting projects and start-ups that are working on innovative products and we are very lucky to be already part of this.
RF: We’re just wrapping up an ISO meeting in San Diego California. Will you please comment on ISO standards and their importance in the European market?
EDA: In Europe the ISO standard is considered a very important document, but formally is not binding. It’s a good document that goes through all the activities and considerations that are necessary to ensure a device is safe and functional. In my daily business I rely on the ISO standard (but not only) for assessing the technical documentation submitted by the Manufacturers.
RF: In the US the FDA will publish draft guidances of their own. Sometimes those are more prescriptive than the ISO standards. A durability test in the US might be 600 million cycles for rigid valves whereas 400 million is appropriate in ISO’s eyes. Do you feel the FDA is being too cautious or is Europe is being too lax?
EDA: The 5840 ISO standards are based on a Risk approach. The 400 Million minimum required cycling is to be considered as the basic testing, but the Manufacturer shall calculate the number of required cycles based on a risk assessment approach. The outcome of this assessment can be 400, 600, or even more. The Manufacturer shall justify the choice. Based on this consideration I can respond that European (well, International) approach is adequate.
RF: The MDR is coming. Is there anything you want to say?
EDA: The MDR is a big thing, I think it is smart to get prepared as soon as possible. Manufacturers that have not started getting prepared for MDR might face the risk of not being ready for the certification, and therefore not being able to sell their products on the European market after the transition period.
RF: That’s great advice. Start early. Don’t leave this to the last minute. It’s really important. We were talking earlier about data submitted that comes from homemade (non-commercial) equipment and how it is maybe more challenging. Could you talk about that?
EDA: I’ve seen a big amount of data provided by the manufacturers and I can say that most of them have been obtained by using ViVitro’s system. The ViVitro system is a system that I know very well because I’ve worked with it many years. It is a very good system because it allows to replicate any sort of physiological and pathological condition and to characterise very well the device.
At the ISO committee, huge effort is being made to standardize the way that the devices shall be characterised and tested, and also the way the results must be provided to Regulatory Authorities. We are looking at many datasets coming from different companies and it’s immediate to recognise what data has been obtained with a testing apparatus like the ViVitro system and what are obtained with other methods. There is the need to go towards standardization of test methods.
RF: Do you have any advice for our readers? Or common mistakes that you see?
EDA: My advice is that the tests must be as close as possible to the conditions that are expected in the human body. So, my advice is to work extensively on the test conditions and the test chamber geometry and compliance.
RF: You mentioned with the MDR to come early. I always hear that regulators don’t want people to be afraid of them. I always get people asking “is this number of tests okay?” or “is this test condition okay?” I always tell them to go talk to their notified body or regulator before executing a big study. Would you say that’s the case?
EDA: Related to the MDR, currently European Notified Bodies (NB) are waiting for accreditation and therefore no NB is allowed to provide MDR-related services yet. However, in general it is wise to get in contact with the NB at an early stage.
Read about other Cardiovascular Pioneers here.