Quality In, Quality Out: Regulatory Drivers of Supplier Quality Management in the Medical Device Industry (Part 2 of 4)

Following on from the first webinar in this 4-part series, “Quality In, Quality Out: Exploring Pharmaceutical and Medical Device Supplier Quality Management,” this presentation will take a specific and deeper dive into the regulatory requirements for supplier management for the MedTech – medical devices and in-vitro diagnostics – industry. Next month’s webinar will focus on the regulatory requirements for supplier management for the pharmaceutical and biopharma industry.

The supplier pyramid is more complex in MedTech than in the pharmaceutical arena, often with a multi-level supply chain providing parts that feed up into the finished device. It is the organization at the end of this chain (who is considered the legal manufacturer, or specification developer) that registers the resulting device and places the device on the market. It is also this organization that the regulators hold responsible for safety issues in the field. Therefore, it is critical that this organization is aware of and abides by all the applicable regulations.

A large part of the regulator’s focus is identifying how legal manufacturers can effectively control their suppliers and sub-suppliers. This is particularly challenging as some sub-suppliers simultaneously produce other parts intended for general industrial use that are not intended to be part of a complex medical device and therefore do not adhere to the common medical device QMS requirements (i.e., ISO 13485:2016).  More so, those same sub-suppliers may not want to take on the challenges associated with making a finished medical device or a medical device component, and they may decline to provide their products/materials to a demanding customer.

In the past, it has been common practice for virtual manufacturers, private label manufacturers (PLM), or own brand labelers (OBL) to take finished medical devices from contract manufacturers and then label them as their own brand, making use of the contract manufacturers’ technical files/dossiers. Recent updates to the ISO13485:2016 standard and EU competent authorities (MHRA) have revised the responsibilities of the legal manufacturer to include not only quality assurance at the sub-contractor, but complete oversight of the regulatory technical files/dossier. Within the medical device arena, the terms ‘PLM’ and ‘OBL’ will be withdrawn and replaced with ‘virtual manufacturer,’ which is more in alignment with the pharmaceutical industry term.

During this presentation, our featured speaker will look further into the revisions to ISO13485:2016 which increase the requirements for supplier management, especially the monitoring of suppliers. This standard further documents the need for manufacturers to take a “risk-based approach” in the selection, qualification, monitoring, and re-evaluation of contract suppliers of both product and services. In addition, we will cover the specific needs, by country, of the Medical Devices Single Audit Program (MDSAP), and will discuss what to expect from an MDSAP audit in relation to supplier management.

An overview of 21 CFR Part 820 will be presented, providing guidance and industry views on how the FDA interprets purchasing controls for both legal manufacturers and their suppliers. We will also offer further analysis of the most common FDA enforcement actions (483, Warning Letters) and present the latest FDA statistics for 2018 YTD on the increasing number of product recalls for medical devices.

Speaker

Phil Johnson, Senior Director, Quality and Compliance Services, IQVIA

Phil is an experienced regulatory and quality based professional who has worked in the medical device, in-vitro diagnostic (IVD) and pharmaceutical industries for over twenty-five years. His core expertise is in the quality requirements for medical devices, diagnostics and pharmaceuticals. This has included the writing, implementation and maintenance of quality systems, auditing of external suppliers and manufacturing/distribution sites and due diligence auditing.

Phil has worked on FDA remediation programs in response to warning letters and import bans, providing strategic consulting to companies. He has had several long-term consulting placements within medical device, IVD manufacturing and distribution sites and corporate offices. He supports companies by providing complete business, regulatory and quality support for global market entry requirements, including the setting up of logistics and distribution networks and the license requirements for these operations.

In his industry roles prior to joining IQVIA he was very involved in supplier management, in both the manufacturer role of evaluating and qualifying suppliers, and also in the supplier role providing services and products to pharmaceutical clients. In his consulting role with IQVIA he has run many supplier management projects, providing support from corporate clients to virtual organizations and start-ups. This has covered the whole breadth of services from supplier selection, evaluation, qualification, monitoring and follow up auditing, covering both business and quality functions. This has given him a good oversight of good client processes and equally poor systems that have needed extensive remediation.

Prior to joining IQVIA in 2002, he was the founder and director of a UK central laboratory providing worldwide IVD services to the pharmaceutical industry.

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