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September 15, 2023
4 Min Read
Image courtesy of Mayo Clinic
There’s a lot happening in the world of cardiac implantables that could impact how medtech companies design these technologies. Next month, Marie Reyes, a Senior Engineer/Project Manager at the Division of Engineering at Mayo Clinic, will address what’s happening with these devices and how to overcome design challenges, in a session at MD&M Minneapolis, titled Cardiac Implantables: Design for Meeting Cost, Performance & Regulatory Demands.
Recently, Reyes spoke with MD+DI about the upcoming session.
MD+DI: Before we discuss your session, could you talk a little bit about some of the trends you see in cardiac implantables? What’s happening in that space right now?
Reyes: Across industry we are seeing a consistent improvement in technology which demands a need for supportive technologies such as assemblies and sophisticated performance demands to meet the needs of patient specific issues and anatomy. Across medicine, there is a huge shift towards the use of AI paired with imaging and custom work. Surgery results are enhanced when surgeons can visualize and assess the size and placement of implants using patient-specific anatomical models.
This is something that we are working a lot with at Mayo Clinic. On the manufacturing side, top organizations are struggling to meet the high demand, high volume output, with delicate specifications on even the most basic of models. They are also bogged down in research and development under the constraint of new designs which don't use PTFE liners which have long lead times due to supply chain issues. There are also some potential regulatory changes across markets within the US and internationally which affect the direction of development and current production methods.
MD+DI: Let’s talk a bit about the session. Who is the target audience and who would have the most benefit from the session?
Reyes: The target audience is anyone (technical and nontechnical) in the cardiac medical device industry that wants to learn and explore the potential challenges and opportunities for innovation in this area.
MD+DI: Could you discuss why there is a need for creative design paired with existing approved materials?
Reyes: Regulatory compliance is a driver of this need for creative design but using only approved materials since approval takes a long time and is costly. The influx of new devices, and demand for less invasive devices/procedures is also another driver of the need for creative design.
MD+DI: What are some of the regulatory challenges or demands in the cardiac implantable space?
Reyes: Most large companies sell and market to not only the United States but also Europe and Asia, they often aim to be compliant in multiple markets which can create challenges for design and development. As the regulatory landscape changes, it directly impacts existing products. It requires multiple submissions to multiple governing bodies, and they all have their own requirements.
MD+DI: What changes in national and international regulation have affected manufacturing?
Reyes: Organizations that plan to sell in international and national markets must take on regulatory gap assessments and transition strategies for products. They must also ensure that their personnel are knowledgeable. MDR (Europe) has impacted medical device regulation and manufacturing, and some organizations are struggling to meet demands. Class III Medical devices (cardiovascular devices are typically class III), it is very important that they are safe and effective. We also need to understand the process to follow to get them approved. There are much more carefully defined requirements for the approvers. They must be extremely informed on what they do. This poses challenges due to the stringent scrutiny and evaluation of the proposed devices. The information from the panels, which evaluate the devices, will be public information in Europe. The lengthy process of evaluation could delay innovation and price out research and development.
There needs to be a balance of stringent scrutiny and progress for innovation to move forward. Unique Device Identification (UDI) System (USA and Europe): FDA and the European Medicines Agency (EMA) mandated the use of UDIs for medical devices, including cardiac implants. UDIs help track and trace devices throughout their lifecycle, improving patient safety and facilitating recalls if necessary.
Risk-Based Classification (USA and Europe): Both FDA and the EU have revised their regulatory frameworks to implement risk-based classification for medical devices, which impacts the regulatory requirements for cardiac implants based on their risk levels. ISO 13485 is revised every five years, and the new version has greater emphasis on risk management and risk based decision-making as well as changes related to the increased regulatory requirements for all organizations including vendors within supply chains and direct manufacturers.
MD+DI: The session will also talk about having an impact in the development of cardiac implantable devices. Could you touch on that briefly?
Reyes: Supply chain challenges have negatively affected many sectors of production and research including: lack of resin/polymer materials, shortages of liner producers (PTFE, FEP, heat shrink, polyolefin etc.), shortages of precious and nonprecious metals. labor - technicians, machinists, operators.
Reyes' session, Cardiac Implantables: Design for Meeting Cost, Performance & Regulatory Demands, will be held in the Medtech Theater 11:30 to 12:15 CT, Wednesday, Oct. 11 at MD&M Minneapolis.
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