Nov 24, 2020

How a materials sourcing firm helped a state Covid response

Supply Chain
face masks
Leila Hawkins
3 min
How a materials sourcing firm helped a state Covid response
Matthew Boyd, Chief Commercial Officer at Boyd Technologies, tells us how they adapted their business to help with Massachusetts' Covid-19 response...

At the beginning of March, Massachusetts was becoming one of America's Covid-19 hotspots. Cases climbed rapidly - from just 26 on March 15 to more than a thousand two weeks later. By the end of April, the state was averaging 150 deaths per day.

"It left everyone here shocked and afraid" Matthew Boyd explains. "It is emotional and scary to go back to those early days for nearly everyone in Massachusetts." 

The US overall was "ill-prepared" for the crisis, Boyd says, but once its severity was understood there was an overwhelming response. "Actors from every sector of the Massachusetts ecosystem including the state government, healthcare systems, academia, to name a few – stepped forward to help. We were also fortunate to have a robust public health policy response which was, and continues to be, followed by the vast majority of people in the state."

Boyd Technologies, a company operating in the medical device and life sciences market, pivoted their services to produce personal protective equipment (PPE) like medical masks to help health care agencies battling Covid-19. 

The Governor of Massachusets Charlie Baker created a Covid-19 Response Command Center, out of which a group called the Massachusetts Emergency Response Team (M-ERT) formed, specifically to address PPE shortages. "We met three times per week to diagnose the demand requirements for PPE and connect those requirements to manufacturing solutions" Boyd says. "There were a significant amount of design and regulatory challenges that were addressed by this group."

"Initially we provided visibility and guidance on the supply chain for PPE, in particular the raw materials necessary to produce these products. We also worked with some of our partners overseas to import PPE products which we were able to supply to the state’s healthcare systems for a period of time."

In May, Boyd Technologies received a grant from via M-ERT that funded the production of 60 million medical surgical face masks and N95 respirators, produced from domestic raw material sources. 

Boyd explains that because of these efforts, the state is set to produce all of its own PPE in the near future. "As a result of the work done by the M-ERT, the manufacturing industry in Massachusetts is ramping up commercial production of almost every form of PPE. Many products are in the market now and by mid-2021 it will be possible to source most forms of PPE and a significant amount, if not all of, the necessary volume of PPE for the state in Massachusetts."

This summer Boyd Technologies helped produce a docuseries called Project Frontline that captures the evolving pandemic and the prompt response the state of Massachusetts had in taking action. Boyd describes it as "an in-depth look at the ecosystem here in Massachusetts to show the public the many good deeds from businesses and organisations that answered the call, and pivoted their operations for the greater good of the Commonwealth.” 

As infection rates climb across the US, Boyd says it will be a difficult winter. "Unfortunately this is the exact opposite of where we should be heading into the cold and flu season. A number of states have begun to address shortages in similar ways but ultimately it will take more time for domestic production to come up to full capacity which is likely not going to occur until mid-2021. 

"We’ve lost over 10,000 people in Massachusetts, which is the sixth highest death toll in the country" Boyd says. "This is one of the harshest realities of being one of the first virus hotspots in the country. However we’ve learned a lot as a medical community about how to treat patients, and we have more therapies available to us now."

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Jun 20, 2021

Medical device companies: how to prepare for Brexit

Ed Ball
6 min
Ed Ball, Senior Associate at RQM+ , explains how medical device companies can prepare for post-Brexit compliance

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. 

Rigorous Planning
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.

Authorised Representatives
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.

Clinical Investigations
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.

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