A sneak peak behind the QbD screens: what does a Medical Devices expert do?
What do hip prostheses, orthotics and pacemakers have in common? All three are medical devices, or aids with a medical effect. These aids include medical instruments, devices and equipment but also software for diagnostic and/or therapeutic purposes, or any combination of the above. The production, validation and quality assurance of this type of medical devices brings a variety of challenges. Steven Vinkx, QA Project Manager and Medical Devices expert at Quality by Design, knows all about this.
Different fields and sectors
Steven was hired by QbD in March 2012 and not too long after he went to work for two major clients. Steven: “For the first client I focused on quality assurance during the manufacturing process of pharmaceutical products. After four years I started working as a quality engineer for another big client, where my job description included the optimisation of the quality management system (QMS), supplier management and the batch releases of in-vitro diagnostics.”
Since January 2019 Steven has been working on several individual projects for QbD clients. “QbD is active in different fields, including quality assurance, validation and regulatory affairs. We help companies in different industries, ranging from classic pharma to Advanced Therapy Medicinal Products (ATMPs). I myself also have several specialities, one of which is medical devices. As soon as the ideation phase and the market research for a new product are completed the Medical Devices expert gets to work on the regulatory go-to-market strategy for the product. This means you’re involved in the development from a relatively early stage. QbD and its partners always aim to support the entire lifecycle of a medical device. This includes the design and development phase, validation, commercial production and post-market surveillance. This last term means that you actively collect data after the product has gone to market so you can monitor and adjust the performance and safety of a device.”
Steven himself mainly focuses on quality assurance and quality management in medical devices projects. “For instance, I organise quickscans at companies. These scans last approximately five days and they often identify new priorities, such as the implementation of a QMS in accordance with the ISO 13485:2016 standard. Another example are the projects concerning the Medical Devices Regulation (MDR), the legal framework for medical devices within the EU, which enters into force on 26 May 2021. I am also the lead auditor for the ISO 13485:2016 standard. This means I visit suppliers, customers and service providers of our clients to carry out a so-called supplier qualification audit to determine whether they meet the applicable standards. And finally I also give trainings on a variety of subjects, such as QMS implementations or teaching customers how to perform an internal audit.”
Variety and innovation
His job is definitely varied. Steven comes into contact with a great many new medical devices and is often at the forefront of new technologies. “The term medical devices encompasses a very wide range of products, from algorithms and software to internal prostheses and basic products like plasters or contraceptives. The fun part about my job is that I get to contribute to the thought process on innovations in an early stage. I get an insight into how medical aids work and I am involved in answering the question: will this product be successful or not? To do this I consult with a variety of people from a number of sectors. From R&D and technology to supply chain and manufacturing: I am in regular touch with a variety of stakeholders in the process.”
The constant developments in the field of medical devices require Steven to keep abreast of the latest evolutions in his area of expertise. “I frequently attend conferences, such as an MDR conference last year in London. Together with a number of colleagues who do a lot of project-based work I am also a member of a PMO organisation (Project Management Office) within QbD. It’s the ideal way to acquire new knowledge, exchange experiences and call on each other’s expertise. I am also a member of QbD’s core team Medical Devices. With six colleagues we are currently working on new initiatives, think tanks and white papers to continue to expand our customer service portfolio.”