Manufacturers pivot to support COVID-19 response
Not long after COVID-19 became recognised as a major global health crisis, governments from around the world have turned to various industries to shore up the vital supplies of medical equipment and consumables that are so desperately needed to save lives and protect public health.
Not since World War Two have we seen such a demand on these industries to provide vital supplies to support the “war effort”. But as many countries have declared states of national emergency, as they fight the war against Coronavirus, the analogy is apt. During World War Two, however, industries were asked to switch to making items that were not too dissimilar to their traditional manufactured products.
For example, silk garment manufacturers switched to manufacturing parachutes, steel makers produced ammunition cases, engineering firms switched to guns and automakers to tanks, and arguably, they had more time to do it. Today, however, we need those ventilators, hand sanitisers, face masks and other personal protective equipment in great quantities now. Indeed, President Trumps recent invoking of the Defence Production Act to compel manufacturers to switch to producing medical supplies is an example as to how seriously these measures are being taken.
While some manufacturers are switching to making more familiar products, such as Zara, the fashion apparel manufacturer, who is switching production to medical scrubs, and several skin-care manufacturers (and also Brewers and Distillers!) to hand sanitisers, others are pivoting to completely new types of products. In the UK, for example, Dyson the domestic appliance manufacturer is switching to manufacturing thousands of medical ventilators.
Even the Mercedes Formula One team is ramping up to produce thousands of Continuous Positive Airway Pressure creating devices (CPAP) subject to regulatory approval. Further afield, Foxconn the Chinese makers of iPhone started manufacturing surgical masks, and in the US General Motors is also turning to medical ventilators. The list continues to grow on a daily basis.
What these manufacturers have is not just the manufacturing expertise in related disciplines such as precision engineering, but also specialist equipment and facilities such as clean rooms. But such pivots, especially when performed virtually overnight is no mean feat. It is simply not a case of just switching from making one component to another by adjusting some machine settings. There is a much wider set of implications.
Production and quality personnel are moving to completely unfamiliar territory. Take the Mercedes F1 team as an example. There is a whole world of difference between making engine gearbox components to making medical CPAP devices. Failure of the former loses them a race or two, failure in the latter cost’s lives.
For medical device manufacturers, the environment they operate in is strictly regulated and new devices can take months, if not years, to achieve the regulatory approvals and validations needed to start shipping those products on to the market. And during the production process, the need for quality assurance and auditing is paramount. While government agencies are indeed fast-tracking these approvals, that does not mean that quality standards can be relaxed - otherwise lives are also at risk.
Another factor is the exponential change in production volume. Again, using the Mercedes F1 team example, they have stated that they could produce up to 1,000 CPAP devices per day. The consequential scalp-up in monitoring manufacturing process, quality inspection, testing and recording of quality data is equally challenging.
Added to that is the unfamiliarity of working with new materials and components from new suppliers. Not only will these require new certification and qualification processes to be performed, but monitoring the characteristics of these new raw materials, their performance throughout the conversion process, and their impact on the quality and safety of finished goods will also be new territory, where the hand of experience is absent.
What these manufacturers do have to help to address these challenges are the availability of advanced technologies such as data analytics, manufacturing and quality intelligence solutions that can be rapidly adopted to support these new products and manufacturing processes. The importance of such solutions should not be overlooked. Pivoting to wholly new, and often alien products is one thing, but pivoting to wholly new quality and manufacturing processes is another. But these challenges can be overcome if manufacturers, government, regulatory agencies and technology companies all come together with a common goal. Across the industry, we have the technology, capability, skill and expertise to make this work. We just need to have the collective resolve to make it happen now.
By Jason Chester, Director of Global Channel Programs, InfinityQS
Medical device companies: how to prepare for Brexit
Over the last decade, medical device businesses have been no strangers to regulatory changes and new compliance requirements. Companies with devices in the EU market have been working hard to achieve conformity with the requirements of the EU Medical Device Regulation 2017/745 (MDR) and In Vitro Diagnostic Regulation 2017/746 (IVDR), but the UK’s exit from the EU, effective as of 1st January 2021, demands yet another change: to comply with the new UK regulatory regime.
The Medicines and Medical Devices Act passed into law on 11 February 2021 does just that; it enables the UK to build its own regulatory system, although when this new framework will be fully in place is not yet known.
The transition to the UK’s new regulatory regime officially began on the 1st of January 2021, and with it a series of deadlines and phases that medical device manufacturers exporting to GB and Northern Ireland would do well to take close notice of. During the transition period, the UK Medical Devices Regulations (UK MDR) 2002, not to be confused with the EU MDR, will continue to apply in England, Scotland and Wales, whilst CE marked medical devices will still be accepted up to 30th June 2023.
The conformity assessment processes defined in the UK MDR 2002 (as amended) will require that medical devices carry the UKCA mark for entry in the GB market or the UKNI mark for entry in Northern Ireland (where the devices are not CE marked for the EU). In Northern Ireland, where the rules for placing a device on the market differ, the EU MDR and IVDR will apply in 2021 and 2022 respectively, in line with the EU’s implementation timeline.
This easing-in period of transition is valuable time that should be used productively by manufacturers to ensure that they get up to speed, keep up with relevant updates and prepare strategies and product portfolio for the next phase. To do this, businesses should make sure they consider the following areas as they assess their strategy for UK market access:
Potential Overlap with EU MDR and IVDR
Medical device manufacturers have been working to implement measures to ensure they comply with EU MDR and IVDR for quite some time. The experience, processes and objective evidence that they have gathered in these efforts are certain to be of use when applying for UKCA marking.
Product portfolios and new product pipelines should be evaluated against both overall compliance risk and commercial and strategic value. By identifying the regulatory compliance status for each product for the UK market and the efforts required to maintain that compliance, manufacturers can plan to use the grace period up to June 2023 to complete their activities. These plans should also be evaluated in consideration of the commercial importance of the individual products to help prioritise the workload. This may well result in the decision to discontinue certain products in the UK or to introduce new products on the UK market ahead of other markets.
Engage with Approved Bodies
This activity cannot take place too soon; as of the 1st of January 2021, UK organisations that were acting as EU Notified Bodies have become Approved Bodies in the UK, while EU Notified Bodies are no longer able to provide conformity assessments under the UK regulations. As there are currently only three UK Approved Bodies offering this service, there is a very real risk that latecomers will struggle to find a UK Approved Body to carry out the conformity assessment required to attain their UKCA mark in time.
Just as EU Notified Bodies are no longer relevant to pursuing UK certifications, UK-based Authorised Representatives are no longer valid when CE marking against the MDR or IVDR. Manufacturers using UK-based EU Authorised Representatives must switch to an EU-based Authorised Representative.
For the UK market, the role of the EU Authorised Representative is also no longer applicable. Non-UK manufacturers must have a UK-based Responsible Person (UKRP), which is equivalent to the EU Authorised Representative in terms of roles and responsibilities. Only one UKRP may be appointed, unlike EU Authorised Representatives, and they must have a registered place of business in the UK in order to register with the MHRA. Approved Bodies may be able to provide details of organisations acting as UKRPs and once this role has been assigned it will be critical for manufacturers to determine exact procedures for managing documentation and that clear communication channels are established.
Labelling and Import/Export
New UK regulations require that medical devices bear a UKCA mark in addition to the name and address of the UKRP for non-UK based manufacturers. Manufacturers who use the same products/packs for the EU and UK markets will need to consider the impact of adding more content to their labels in terms of usability for the supply chain and end-users.
While CE marking and certificates will continue to be recognised by the UK until June 2023, import/export administration is likely to change and become more burdensome. Manufacturers using separate products for GB (UKCA) and the EU and Northern Ireland (CE marked) will need to plan for how to ensure that the CE marked product is not shipped to GB post June 2023. Ensuring that processes and resources are in place to deal with developing situations will help manufacturers hit the ground running.
Many businesses will find that clinical investigations are carried out across multiple sites, some of which are outside the UK. In these instances, manufacturers will do well to have a plan for implementation and management of investigations, in compliance with local requirements. It is likely that the MHRA will also continue to update their requirements for clinical trials in the UK.
Data Protection and Standards
New tensions are emerging between the EU and the UK concerning UK data protection rules and the EU’s General Data Protection Regulation (GDPR), suggesting that maintaining ‘equivalency’ may involve a number of different phases.
Compliance with applicable standards also requires close attention; the list of designated standards for medical devices issued by the UK’s Department for Health and Social Care is based on the list of harmonised standards published in the Official Journal of the EU, which in turn are harmonised to the MDD, AIMDD and IVDD. More recently published standards, however, have not been harmonised to the latter European directives and are thus not in the UK’s designated list, despite being considered state of the art. It would be prudent for manufacturers to monitor the state-of-the-art standards and apply where applicable, rather than rely on superseded and outdated standards.
As the UK moves into a new regulatory regime, medical device manufacturers who have already invested time and resources to comply with EU MDR and IVDR can use this to attain their UKCA mark. However, a dynamic compliance environment combined with the new onus relating to export policies means that close attention needs to be paid on numerous fronts. Keeping pace with this changing environment will ensure that manufacturers face the future with confidence and do not lose important space on their markets.