May 17, 2020

Q&A with Roberta Barker, Director of Human Resources at NHSBSA

industry-focus/management-best-practices/q-roberta-barker-di
Admin
5 min
Human Resources
Part of Britain's National Health Authority, the NHSBSA is a Special Health Authority providing a wide range of critical central services to suppor...

Part of Britain's National Health Authority, the NHSBSA is a Special Health Authority providing a wide range of critical central services to support NHS organisations, NHS contractors, patients and the public. Created by the merger of five, previously separate NHS organisations, including the NHS Pensions Agency, into a single, unique department, this re-alignment precipitated a transformation project of considerable scale. Roberta Barker, Director of Human Resources at NHSBSA explains the intense task the business faces with such a transition and how the recruitment and selection of appropriate leadership is critical to a successful outcome. She also tell us how Executive Online, the fast track headhunting company, took them on an unusually hi-tech route to deliver an unexpected, but highly effective, solution.

1. What led to the creation of the NHSBSA?

The creation of the NHSBSA followed a review of the Department of Health Arm’s Length Bodies. This review, which was published in July 2004, was driven by the goal of freeing up resources for the NHS frontline. The five NHS organisations which merged to form the NHSBSA were previously known as:

• NHS Prescription Pricing Authority

• NHS Pensions Agency

• Dental Practice Board

• NHS Logistics

• NHS Counter Fraud and Security Management Service Authority

NHS

2.What challenges did you face in becoming this single, unique department?

The task of integrating five companies into one would always be a complex one with multiple operational and cultural challenges. A specific project of this nature was best served by the deployment of an experienced interim manager who could help the organisation overcome the various change challenges it faced without delay. This strategy was successful and as a result the transition was completed. However with the interim project complete the requirement for a Managing Director, who could lead the NHS Pensions division of the new authority on a more permanent basis, became the priority.

3.What recruitment methods did you use to find the right person?

Traditionally, when looking to recruit new employees, the NHS advertises in the Times but in this instance we found that this delivered disappointing results. We recognised that in order for us to access a much wider and richer talent pool, the internet was likely to have a far broader reach. So, on the strength of its Global Talent Bank and impressed by its online acquisition model, we approached Executives Online to help us source exactly the right candidate for the Managing Director role.

We worked closely with Executives Online to convey our specific requirements and that relationship meant they were able to quickly deploy their resources to seek out exactly what we were looking for. This role needed someone with strong leadership skills who could demonstrate a proven track record of motivating employees and delivering improved performance within challenging environments. However, neither experience of working within the public sector nor having a vast amount of knowledge of pensions were prerequisites. Nevertheless, the NHS Pension Scheme is the largest of its kind in Europe (it has 1.4 million customers) so it was important for us to feel confident that the candidate could support employees through the proposed pension change agenda. They also needed to be able to provide effective management of our complex stakeholder framework that includes scheme members, pensioners, employers and the Department of Health.

4.What were the advantages of working with Executives Online?

Through its Fast Track Search methodology which is part of a unique, three stage process, Executives Online was able to proactively search its Global Talent Bank of over 60,000 pre-screened candidates in order to identify whether an existing optimum-match already existed. This process was further complemented by a comprehensive digital search of candidates using its online acquisition engine and web search tools. This bespoke process meant that a high-quality short-list could be rapidly assembled and the interview phase was quickly entered into. At this stage the Executives Online team provided vital support, often setting up meetings at extremely short notice.

Paul Barron, our director of Director of Executives Online North described it well. He said “The priority throughout this project was on getting the right candidate for this particular role. In response to this we made sure that we allocated resource to understand where the organisation wanted to be in the future and aligned our approach to complement their aspirations. As a result, 15 candidates were put forward following an extensive and additional screening process which we conducted on behalf of NHSBSA.”

Peter

5. Did it work? Did you successfully find exactly the right candidate?

Absolutely. Peter Robinson was offered the Managing Director role for NHS Pensions. His extensive experience of running large, customer-centric organisations and leading successful business transformation initiatives made him stand out from the crowd. Peter has also been certified as a Six Sigma Black Belt professional. Six Sigma is a quality management and process improvement methodology which was particularly interesting to the us due to the nature of the changes that needed to be made. We wanted to look closely at how NHSBSA could provide a better service for our customers and we knew that Peter’s knowledge and expertise of Six Sigma philosophies and principles, including supporting systems and tools would help us to deliver that.

Since joining the NHSBSA, Peter has also brought a real sense of empowerment to the leadership team and has swiftly grasped the level of operational work needed to ensure we continue delivering service excellence to all of our customers. He has surpassed our expectations and thanks to Executives Online we now have someone who can effectively lead the organisation and help us meet our future aspirations. Utilising the web is an extremely effective recruitment strategy and one which other organisations should look to adopt. Its responsive and supportive approach will no doubt see us turning to the Executives Online team again when looking to source exactly the right senior level candidate.

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Jun 20, 2021

Medical device companies: how to prepare for Brexit

medicaldevices
supplychain
Brexit
Compliance
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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