The medical devices Quality Management System, commonly known as ISO 13485:2016, is the reference standard for the Medical Devices industry, developed and published as the third edition by International Organization for Standardization (ISO).
For us to understand the current quality trends in the medical devices industry, we first have to acknowledge the strides that have been made as part of history in the medical devices industry regulation.
ISO has described the need for this standard as follows:
“Safety and quality are non-negotiable in the medical devices industry, that is why we developed ISO 13485.” (ISO)
The organization further describes the medical devices industry regulation as:
“Regulatory requirements are increasingly stringent throughout every step of a product’s life cycle, including service and delivery. Increasingly, organizations in the industry are expected to demonstrate their quality management processes and ensure best practice in everything they do. This internationally agreed standard sets out the requirements for a quality management system specific to the medical devices industry.” (ISO)
For someone who is new to the medical devices industry, understanding the history and the need for this industry to have a global standard would be essential before embarking on reviewing the current quality trends in the medical devices industry.
History of quality in the Medical Devices industry
The first management system standard to be developed and published by ISO as an initial release was ISO 13485:1996, namely, Quality systems — Medical devices — Particular requirements for the application of ISO 9001, which covered specific requirements, among them: design and development, installation, and servicing of medical devices.
ISO maintains a frequency of reviewing already published standards after every 5 years, where the work is approved as a new project and the relevant Technical Committee handles the entire process including development of new ISO standards.
The ISO 13485:1996, was initiated for a review in between 2001-2003 after which it was revised to ISO 13485:2003 Medical devices —Quality management systems — Requirements for regulatory purposes and this time the standard of reference was ISO 9001:2000 Quality management systems — Requirements, which provided the framework for the standard and further designing to give organizations the opportunity to implement an international standard which helps them comply to medical devices industry regulations and customer requirements.
Since ISO 9001:2000 was being used as the parent framework for medical devices standard, it is good to also understand how the standard came to existence. The first initial release of the quality management system was in 1987, namely, ISO 9001:1987 Quality systems — Model for quality assurance in design/development, production, installation and servicing, which was later revised to ISO 9001:1994 Quality systems— Model for quality assurance in design, development, production, installation and servicing before being updated to the ISO 9001:2000 version.
Another standard covering risk management for the medical devices industry had also been developed and published with an initial release, ISO 14971-1:1998 Medical devices — Risk management — Part 1: Application of risk analysis which was also revised and replaced by ISO 14971:2000 Medical devices — Application of risk management to medical devices.
Therefore, the review here is about 3 standards: ISO 9001, ISO 13485 and ISO 14971 and how they have revolutionized the quality aspects of the medical devices industry. Fast forward, the three standards have undergone several reviews and updates through the relevant ISO Technical Committees as follows:
ISO 9001:2000 Quality management systems — Requirements was updated to ISO 9001:2008 Quality management systems — Requirements, which is the current standard of reference for the ISO 13485 standard. The standard would later on undergo major changes to include risk-based thinking to complete the Plan-Do-Check-Act (PDCA) model and the adoption of a High-Level Structure which has not been applied for the ISO 13485 standard, the ISO 9001:2015 Quality management systems — Requirements.
Furthermore, ISO 13485:2003 Medical devices — Quality management systems — Requirements for regulatory purposes, has been the longest medical devices standard version to remain unrevised until the current version was published in 2016, ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes.
ISO 14971:2000 Medical devices — Application of risk management to medical devices was updated to ISO 14971:2007 Medical devices —Application of risk management to medical devices and then to the current version ISO 14971:2019 Medical devices — Application of risk management to medical devices.
Medical Devices regulatory frameworks
The first globally recognized regulatory framework is ISO 13485:2016 standard which provides a voluntary medical devices standard that any organization involved in the lifecycle of a medical device, can implement and get certified against in any part of the world. It emphasizes on standardization of organization’s processes towards meeting customer and regulatory requirements.
Another framework is the Medical Devices Directive that provides a harmonized framework for medical devices being handled within the European Union (EU) territory. This regulatory framework is commonly abbreviated as MDD and it applies to both manufacturers within the EU and importers to the EU. It emphasizes on safety and performance of the medical devices.
The other framework is for WHO, namely, WHO Global Model Regulatory Framework for Medical Devices, which provides guiding principles on the international harmonization efforts for the medical devices industry. Current efforts by the WHO are on support for the Global Harmonization Task Force (GHTF) and its successor, the International Medical Device Regulators Forum (IMDRF). It emphasizes on a globally harmonized regulation of medical devices towards mutual recognition efforts.
The US FDA is another medical device regulatory framework which regulates the sale or manufacturer of medical devices in the USA through the Code of Federal Regulations (CFR) for both the current Good Manufacturing Practices and Medical Devices.
Moreover, the USA also happens to be in other agreements supporting its interest in global medical devices i.e., through the Medical Device Single Audit Program (MDSAP) which provides a harmonized medical devices auditing approach for several countries including the USA, Australia, Japan, Canada, Brazil as official members, observers (EU, UK & WHO) and new affiliate members including Argentina, Republic of Korea and Singapore. It emphasizes on safety and efficacy of the medical devices in the market. The other medical devices regulatory frameworks are country or regional based regulations. Most countries now through the International Medical Device Regulators Forum (IMDRF), have/are establishing their own medical devices regulatory frameworks with reference to existing frameworks so as to maintain a harmonized regulatory context making the medical devices regulation easier.
It is good to note that individual countries have their own legal frameworks through their National Medical Devices Regulatory bodies and the movement towards harmonization with global frameworks could be at different phases depending on the current regulatory frameworks for individual countries.
Quality in a Medical Device lifecycle
The medical devices quality context is currently being implemented through the ISO 13485:2016 standard which provides requirements that any organization involved in a medical device lifecycle can implement and get certified by an ISO/IEC 17021-1:2015 accredited certification body to ensure global recognition of using or applying international standards which in essence smoothen trade among countries or global markets.
The quality in medical devices can be segmented to quite a number of items, both as quality assurance and quality control including:
- Medical Devices Documentation
- Medical Devices Design and Development
- Medical Devices Components and Materials
- Medical Devices Traceability
- Medical Devices Customer Experience
- Medical Devices Organizational Processes
- Medical Devices Safety and Efficacy
- Medical Devices Performance
- Medical Devices Cleanliness
- Medical Devices Sterility
- Medical Devices Compliance
Recent quality trends in the Medical Devices industry
The medical devices industry as one of the highly regulated markets and that definitely calls for high quality standards that can guarantee for safe and quality medical devices to be adopted and maintained throughout the entire product lifecycle.
The growing interest in medical devices quality trends is being driven by the ever-ageing population, advancing medical research, advancing technology, and the increase in chronic diseases. It is estimated that the medical devices industry will reach a massive USD 612 billion by 2025 (Clare Naden, 2021).
The US FDA announced in 2018 the intention to adopt ISO 13485:2016 into its existing medical devices regulatory framework, which is going to be a huge development for the ISO standards which will increase their implementation by a wider number industry players in the medical devices lifecycle.
US FDA stated the following on its above intention:
“FDA intends to harmonize and modernize the Quality System regulation for medical devices. The revisions will supplant the existing requirements with the specifications of an international consensus standard for medical device manufacture, ISO 13485:2016. The revisions are intended to reduce compliance and recordkeeping burdens on device manufacturers by harmonizing domestic and international requirements. The revisions will also modernize the regulation.” (FDA, December 5, 2018).
Some of the current quality-driven trends in the medical devices include:
- Streamlining of medical devices manufacturing with an emphasis on their efficiency, adoption of globally recognized standards, and use of advanced technology to improve customer/patient experience i.e., there is now an increase in more wearable medical devices which have sensors or monitoring components to provide data on customer experience for the manufacturers to keep improving their products as the technology advances.
- Adoption of automatic cleaning processes in the medical devices industry including disinfection and sterilization processes. Most companies have moved away from manual cleaning methods to ensure the health and safety of the personnel operating the processes and to maintain a good manageable system that improves efficiency and can easily be upscaled.
- Product recalls or adverse effects experience from customers/patients has also led to medical device manufacturers increasing their budgets in research, innovation and development. Most manufacturers are now keen on maintaining strong post-market surveillance systems to ensure a great customer/patient experience and eliminate or minimize on adverse effects and product recalls.
- Increased trend in contract manufacturing controls for the medical devices industry has also led to most manufacturers requiring contractors to implement internationally recognized regulatory frameworks i.e., ISO 13485:2016 to ensure quality and safety of the component parts being manufactured on their behalf by externally contracted entities.
- Several countries have also made it mandatory for medical devices entities operating in their territories to be ISO 13485:2016 certified before operation i.e. South Africa.
- There is an increase in the expansion of diagnostic testing facilities that target to improve the point of care outreach more so with the current Covid-19 situation. We are now seeing a lot of rapid diagnostic kits being manufactured to provide instant services to customers without compromising their safety or product quality.
- An increase in remote healthcare service provision has also called for an increase in quality of both the products and the competence of those involved in the processes. There is an increased need for continual training for personnel involved in the entire lifecycle of medical devices to keep upgrading their knowledge in quality trends and safety measures so as to keep momentum with the ever-changing business/market environments.
Quality challenges in the Medical Devices industry
Finance, changes in technology, and weak regulatory systems in some countries are just some of the challenges that are currently posing threats to the achievement of a globally harmonized strong medical devices regulatory frameworks.
Since not all countries are able to invest in the medical devices regulatory frameworks, they depend on international development partners by bilateral or multi-lateral partnerships to fund those needs. In most cases, this delays the process as the phases of getting such support could be lengthy and come with strict measures on fund utilization.
Technology is now changing at a very fast rate and trends suggest that the future will be data driven in most decision-making processes of companies including medical devices which is currently utilizing that approach with the possibility of upscaling it globally to the entire lifecycle of medical devices. Moreover, the 5G technology is being adopted globally with some countries already ahead of the pack and others are now preparing with the setting up of infrastructure for the technology. We know that with every technological advancement comes challenges, and we look forward to see how the medical devices will change with the 5G technology and other Artificial Intelligence systems being supported by the research, innovation and development functions of medical devices manufacturers.
Most low-income countries (developing economies) have regulatory infrastructures for their internal territories but medical devices regulatory frameworks are either not strong or there is a gap in the enforcement and implementation of such frameworks. This challenge also comes with how long the industry is present in the country. The most advanced countries such as the USA and China have stronger regulatory frameworks while continents such as Africa, where most of the lower income countries (developing economies) are located, have weak regulatory frameworks for the medical devices or the enforcement function is lacking. Countries like Ghana, Kenya, South Africa, Egypt have great quality infrastructures for the medical devices industry.
Beyond 2021, we are going to see an increase in most of the countries, more so from the developing economies, which will adopt standardized quality infrastructure for medical device industry. There will also be an increase in the adoption of the International Medical
Device Regulators Forum (IMDRF) so as to be part of a global harmonization measure for the medical device industry to simplify the supply chain flow.
There will be a significant increase in the adoption of ISO 13485:2016 for organizations involved in the entire lifecycle of the medical devices, more so with the recent intention of US FDA to adopt and recognize the standard for its medical device regulatory framework.
Therefore, all organizations who are part of the medical device lifecycle should continue implementing and improving their quality systems through ISO 13485:2016. Meanwhile, those that have not adopted the standard, can seek the services from a consultant and aim to train their personnel on the standard requirements together with other quality systems that support the medical device industry to create a global industry with quality and safe medical devices.
Vincent Mokaya started his auditing expertise in 2014 as an ISO Internal Auditor before moving to third party audits in 2018 with MSECB. He is a Certified MSECB Auditor in ISO 9001, ISO 14001, ISO 45001, ISO 13485 & ISO 22000 and has conducted over 35 audits all over Africa, both as Supplier Quality Audits and ISO Management Systems third party certification audits. Some of the sectors that he has been able to provide such services include: Testing and Calibration laboratories, Oil and Gas entities, Manufacturing entities, Pharmaceutical, Consumables and Medical Devices manufacturers and suppliers, Engineering firms, Consulting firms, Food Catering providers, Hospitality entities, Telecom firms, Security firms among others. Moreover, Vincent is a fully competent auditor who has also offered internal and lead auditor training programs as per the ISO 19011:2018 Guideline for Auditing Management Systems.
MSECB is accredited by IAS to offer audit and certification services for a wide range of ISO Standards. If you are interested to certify your management systems start by getting a Free Quote.