By Paul  van Geffen and Eleonora  Lena, Deloitte Risk Advisory

The COVID-19 pandemic has disrupted everyone’s daily lives and touched every industry across the world. While many countries had influenza and other pandemic preparedness plans in place prior to COVID-19, no one was fully prepared for the speed and indiscriminate spread of the disease. Indeed, in many countries the demand for appropriate medical devices and equipment quickly outstripped supply, leading to critical shortages, particularly of ventilators and personal protective equipment (PPE). Consequently, traditional and novel medical equipment manufacturers have pivoted many of their activities to meet this demand. At the same time, international and national regulators have had to adapt their approach to granting market approval. These changes have implications for the future of medical device regulation.

How have the regulatory authorities and the industry responded?

To address the shortages, global regulatory authorities, like the World Health Organization (WHO), and international regulators like the Food and Drug Administration (FDA) and the European Commission (EC), have provided relevant guidelines on regulatory requirements.^1,2,3 For example:

• The EC published guidelines on derogations for national authorities and governments to consider when authorising medical equipment, while the necessary conformity assessments are carried out.^4,5,6 In response, national authorities put in place exemptions and derogations to enable manufacturing to be ramped up and temporarily place non-CE marked medical devices for pandemic use on the market for a limited period of time while the necessary procedures are carried out.⁷
• The FDA issued Emergency Use Authorization (EUA) letters, which allow for the expedited commercialisation of ventilators, PPE and test kits through several mechanisms.⁸ These included the lifting of 510(k), Good Manufacturing Practice, and Establishment Registration and Device Listing requirements for new facilities and devices.

While there has been some relaxation of regulatory requirements, critical step in demonstrating that the minimum specifications have been met has still been a critical part of the regulatory assessments.⁹

Meanwhile, individual governments in collaboration with national regulatory authorities have issued their own guidance on conformity and surveillance, and implemented various measures to increase medical supplies:

• Buy from outside and increase local production - initially governments looked to import medical equipment to address their shortages.¹⁰ However, as the outbreak spread to more countries, several governments put in place export restrictions.^11,12 Many countries also established local initiatives to stimulate local production.^13,14
• Use alternative manufacturers - to meet growing demand, governments opened the industry up to novel manufacturers. Automotive brands such as General Motors, Ford and Tesla started producing ventilators, either by innovating new designs or by manufacturing existing models. Fashion icons like Armani, Burberry and Chanel are using their factories to produce face masks and gowns.^15,16
• Reuse and repurpose existing equipment - new possibilities have emerged for the reprocessing of single-use equipment (e.g. decontaminating gowns and face masks), and the marketing and retro-fitting of medical alternatives. For example, the FDA has released guidance to help manufacturers adapt existing devices to act as ventilators, as well as using available ventilators beyond their shelf life or sharing ventilators between two people.^17,18 We also see other initiatives such as the modification of full-face snorkelling masks for health workers¹⁹ and for non-invasive patient ventilation.²⁰
• Define minimally acceptable specifications - national authorities have specified criteria for minimally acceptable product performance and safety. For example, the MHRA issued a specification for rapidly manufactured ventilator systems to facilitate the production and assessment of ventilators with a minimal clinically acceptable benefit-risk profile.²¹ Similarly, the FDA referenced a list of recognised standards in the ventilator EUA guidance to help ensure minimum performance standards. Such specifications are intended to mitigate product risks and allow manufacturers to accelerate the development of acceptable medical products. This could also motivate alternative manufacturers to enter the medical space.²²

What regulatory challenges have arisen?

The increased volume of production and the need to accelerate market access for essential medical supplies are inevitably linked to higher risks and challenges. To reduce such risks and ensure device safety, traceability, and the possibility for recall, the EC has adopted a guideline with conditions under which governments may authorise non-CE medical devices on the market.²³

Some individuals are taking advantage of the current situation by placing counterfeit products on the market²⁴. In several countries, large quantities of poor-quality face masks were introduced on the market, and had to be recalled as regulators judged them to be unsuitable for use.²⁵

Another challenge is how to conform products or remove them from the marketplace, when they have been brought to market deviating from the standard regulatory guidelines, post the emergency period. Most manufacturers and industry bodies are taking steps to ensure distribution traceability. For example, the Australian regulator has set up expedited pathways to ensure recalls of defective or unauthorised products that were placed on the market through derogations during the pandemic.²⁶

How should regulators and industry prepare for the next wave of COVID-19 or a new pandemic?

The exceptional regulatory measures that authorities have adopted in response to the pandemic are intended as a temporary solution to counteract the shortage of emergency medical supplies. However, sustainable solutions are needed in order for countries to be adequately prepared for a resurgence of the current pandemic or the next pandemic to surface so that public safety and health is not compromised.

Regulators need to continue to collaborate and join forces to review the lessons learned in the different countries, and develop shared codified measures should similar situations arise in future. Already authorities are implementing legislation to support the availability of emergency supplies during any future pandemic, such as creating medical equipment stockpiles or making existing stockpiles more robust, aligned to what was adopted by the European Commission in March 2020.²⁷ An extension, or further legislation, may be required as lockdown measures are reduced and further wave of infections occur.

Conclusion

COVID-19, while unprecedented in its scale and pace of impact, has forced all entities in the medical product universe to reassess mechanisms for bringing critical products to market. Although many of the measures are short-term, lessons learned should be used to help establish a regulatory regime that would enable countries to prepare more effectively for future disruptive outbreaks.

In 2018, in our report ‘A bold future for life sciences regulation’ we made predictions as to what the relationship between the industry and regulators might look like in 2025.²⁸ While we identified that the regulatory environment was already changing rapidly, with evidence of a growing number of cross border national and international collaborations between regulators, we did not anticipate the speed of change that we have seen in response to the COVID-19 pandemic. Moreover, some of the predictions, such as regulators and industry (including non-traditional companies) working more closely together sharing real-time data and advanced analytics to detect risks and the fast-tracked deployment of ’new generation’ technologies, that we expected to take five years to materialise, have happened, or started to happen over a matter of weeks. We expect regulators and industry to continue to evolve, identifying and adopting what has worked well, leading to a more collaborative, consistent and transparent approach to regulation; and importantly, improving access to medical products.

Paul  van Geffen, Senior Manager, Deloitte Risk Advisory

Paul joined Deloitte Risk Advisory in March 2020. He is a senior manager in the Regulatory Risk team with an industry focus on Life Science & Health Care. Before Deloitte, he worked as a Q&R consultant for the MedTech industry for nearly 10 years. He has vast experience in delivering regulatory compliance projects covering a wide range of medical devices and technology including in-depth knowledge of many aspects of the Medical Device Regulation across the entire device lifecycle.

Email | LinkedIn

Eleonora  Lena, Senior Consultant, Deloitte

Eleonora is a Senior Consultant within the Life Sciences Advisory practice based in Basel, Switzerland. With years of experience in life sciences consulting, she is focusing on helping medical technology and pharmaceutical clients understand and navigate the impact of regulatory framework changes in their business models. Her areas of specialty are regulatory intelligence, regulatory analysis and positioning with decision-makers.

Email | LinkedIn

_____________________________________________________________________

¹ https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance-publications?healthtopics=b6bd35a3-cf4f-4851-8e80-85cb0068335b&publishingoffices=aeebab07-3d0c-4a24-b6ef-7c11b7139e43&healthtopics-hidden=true&publishingoffices-hidden=true
² https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19
³ https://ec.europa.eu/info/live-work-travel-eu/health/coronavirus-response/public-health_en
⁴ https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32020H0403
⁵ https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52020XC0519(01)&from=EN
⁶ https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/883334/Essential_Technical_Specifications__5_.pdf
⁷ Switzerland is an example: https://www.swissmedic.ch/swissmedic/en/home/news/coronavirus-covid-19/br-versorgungsengpaesse.html
⁸ https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
⁹ https://op.europa.eu/en/publication-detail/-/publication/a247dab0-6794-11ea-b735-01aa75ed71a1/language-en
¹⁰ https://www.wto.org/english/news_e/news20_e/rese_03apr20_e.pdf
¹¹ https://www.wto.org/english/tratop_e/covid19_e/export_prohibitions_report_e.pdf
¹² http://www.wcoomd.org/en/topics/facilitation/activities-and-programmes/natural-disaster/list-of-countries-coronavirus.aspx
¹³ https://www.politico.eu/article/macron-urges-massive-increase-in-local-production-of-medical-equipment/
¹⁴ https://unctad.org/en/pages/newsdetails.aspx?OriginalVersionID=2375
¹⁵ https://www.theverge.com/2020/4/15/21222219/general-motors-ventec-ventilators-ford-tesla-coronavirus-covid-19
¹⁶ https://www.businessinsider.com/luxury-fashion-moguls-donating-to-combat-coronavirus-giorgio-armani-2020-3?r=US&IR=T
¹⁷ https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-continues-facilitate-access-crucial-medical-products-including
¹⁸ https://www.fda.gov/media/136437/download
¹⁹ https://www.covidlifesavermask.com/
²⁰ https://www.scientificamerican.com/article/snorkeling-mask-apparatus-might-help-covid-19-patients-avoid-intubation/
²¹ https://www.gov.uk/government/publications/specification-for-ventilators-to-be-used-in-uk-hospitals-during-the-coronavirus-covid-19-outbreak
²² https://www.ventilatorchallengeuk.com/
²³ https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52020XC0519(01)&from=EN
²⁴ https://www.gov.uk/government/news/uk-medicines-and-medical-devices-regulator-investigating-14-cases-of-fake-or-unlicensed-covid-19-medical-products
²⁵ https://www.businessinsider.nl/coroanvirus-holland-recalls-over-half-a-million-masks-imported-from-china-2020-3/
²⁶ https://www.tga.gov.au/behind-news/expedited-recall-system-faulty-or-unauthorised-covid-19-devices
²⁷ https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32020D0414&from=EN
²⁸ https://www2.deloitte.com/content/dam/Deloitte/uk/Documents/life-sciences-health-care/deloitte-uk-life-sciences-regulation-predictions-2025.pdf