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“Many product regulatory compliance frameworks are now not only directly driving innovation in products and product development processes  but helping reduce product cost, reduce development cost, and improve time-to-market." CHRIS MORGAN, EXPERT IN REGULATORY-DRIVEN PRODUCT INNOVATION , PA CONSULTING GROUP

Medical device risk management and usability engineering - do your drug-device combination products meet the new EU requirements?

Amendments to the EU medical device directive formally took hold on 21st March 2010 with changes to the "Annex I essential requirements and harmonised standard" impacting both new medical device developments and existing medical devices. There was no period of transition. Importantly, under EU regulatory guidance, changes to the "Essential requirements and harmonised standard" also directly impact drug-delivery devices regulated as medicinal products (ref: MEDDEV 2.1/3).

Do your drug-device combination product designs meet the new regulatory requirements?

PA Consulting Group continues to lead in regulatory-driven innovation and we understand the true impact of legislative changes on product designs and development processes.

Evidence suggests that many in the pharmaceutical industry are still confused by these changes and, in some cases, unaware of the direct impact on their drug-device combination products including: inhalers, auto-injectors, transdermal patches and pre-filled syringes. In particular there is uncertainty amongst manufacturers as to the exact nature of the changes and the impact on their current products and on-going product developments.

For new drug-device combination products placed on the market or put into service, compliance with the new requirements is simply essential. In many cases achievement or continuity of compliance includes timely substitution of key harmonised standards such as the risk management standard EN ISO 14971. In most cases, compliance also requires adoption of the recently harmonised usability engineering standard EN IEC 62366.

Risk management is an essential part of any drug-delivery device product development but when the recognised state-of-the-art is amended, it is vital that manufacturers review the impact of changes on their designs both old and new. PA recently completed a risk management review of an innovative drug-device combination product on behalf of a leading pharmaceutical manufacturer. The product had been in development for over seven years and the risk management process was based on the superseded standard EN ISO 14971:2000. PA’s actions included reworking the device risk management bringing the process and product documentation to the state-of-art and compliant with the revised requirements of EN 14971:2009 and the essential requirements of the new medical device directive.

The complexities of this conversion exercise have led to PA developing a streamlined and proven approach. Beyond the achievement of essential compliance with the latest legislation, the further benefits of carrying out such reviews can be significant. In this example, undertaking PA’s rework identified and helped fix a significant percentage of new safety risks (hazardous situations) that had essentially been “missed” by the previous seven years of risk management activity to the superseded EN ISO 14971 standard.  PA’s actions have significantly improved the chances of market success of this drug-device product, as well as increasing patient safety and essential regulatory compliance.

Poor usability engineering of medical devices, or "Human Factors" as it used to be known, has proven to be the highest risk to patient safety. All too frequently “use-errors” lead to devices being rapidly withdrawn from the market and manufacturers facing penalties and patient litigation. 

There is currently a high-profile drive by medical device regulatory authorities to provide for innovation in medical devices including improvement in device safety. As a result, EU (and US) regulatory authorities have now adopted the IEC 62366 usability engineering standard into their regulatory frameworks, such that the usability engineering process is now separately accountable within the device design and development process. 

PA’s strengths in medical device usability engineering are well known, and recent alignment of our product design processes with IEC62366 has allowed us to develop a scalable approach to usability engineering. Our new approach provides effective human factor programmes for low, medium and high risk medical devices while creating products that are innovative in their safety designs and provide a lower level of patient incidents. Our process and experience ensures devices are intuitive, compelling and safe, making the products more successful and profitable for our clients.

PA understands the impact of medical device legislation in both the medical product and process contexts and we have proven streamlined drug-device development processes.

To find out more about how PA's medical device design and compliance- related services, please contact us now.

Mark Humphries
Product development and manufacturing
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