May 17, 2020

Supply Chain Software Gives Medical Industry A Boost

3 min
Safety in the Medical Supply Chain in King
Written by Shukti Sarma Read this article in the August issue of Healthcare Global The importance of a robust supply chain cannot be exaggerated, espe...

Written by Shukti Sarma


Read this article in the August issue of Healthcare Global 

The importance of a robust supply chain cannot be exaggerated, especially in a field like healthcare. It will not be amiss to say that the supply chain is the backbone of the industry, and hence, it is important to maintain that in ship shape.

Modern technology has come a long way. Software today is a crucial component in proper management of all business and systems, and healthcare supply chain is no exception.

Software Accounting: Cutting Losses

One of the major concerns in this field is the rising cost of treatment and running businesses. But what many people fail to realize is that apart from labour, the healthcare supply chain accounts for the biggest expenditure for a hospital or caregiver institution.

Good software can help maintain a firm grip on a company’s management of resources and its supply change. Bruce Johnson, CEO of GHX- a leading healthcare supply chain management software/services company – recently stated that about “$5 billion is lost annually in the implantable device supply chain as a result of waste, inefficiency and lack of visibility”. A good software solution can help a business streamline and automate the supply chain and help cut costs, which may add up to a significant amount.

The GHX NuViasolution, for example, claims that hospitals can achieve significant savings from reduced errors, lower costs from better contract alignment and improved revenues through the use of more accurate, up-to-date data in the materials system.

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Better Integration

Efficient management of the supply chain is much more than keeping tabs on the prices of medical supplies. Software can enable better consolidation within the supply chain community too. A major component in management of supply chain is distribution, and inefficient distribution leads to wastage, leakage and even fraud. Many solutions provider are looking at innovative designs and strategies, which minimize such inefficiencies.

Some software solutions provider, like TECSYS healthcare solutions move away from the traditional distribution model to a self-distributionmodel where products are purchased directly from the manufacturer and received at the hospital centre where they are directly delivered to the patients.

There are other solutions providers too, like The Diver Solution, which enables users to track ordering and usage patterns, as well as historical trends, helping reduce unnecessary purchasing variation and drive down costs.

Regardless to say, better management and better integration also saves time and energy, which the hospitals and caregivers can dedicate towards providing care for the patients. Software makers like Infor, also stress that an efficient system eliminates the complexities of fragmented solutions, and moves data from department silos and make it accessible, in real time, across the enterprise.

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Looking Into The Mirror

Most importantly, good supply chain management software can be immensely helpful for small, regional caregiving institutions. They are most affected by inefficiencies, and a good software solution can help create connectivity and linkages that enable supply chain partners to share data with one another. This not only builds up mutual trust and helps visibility, but also establishes a strong network, which is better equipped to handle transfers and cater to more patients.

With increasing costs and pressing demand for better performance, healthcare providers and institutions cannot afford to lag behind and let inefficiencies get the better of them. Managing the supply chain is a crucial matter, and hence, it is imperative that they have a good look at their IT solutions. The key is to identify one’s needs, and then choose the solution that addresses those needs. Most software solutions providers offer customized packages, which have produced visible results.

With rising healthcare costs, shortage of labour and other complexities, hospitals need to be up-to-date with their systems. Good software not only helps in better integration; it saves costs, reduces wastage, saves time, helps track medical supply and keeps other information up-to-date. They also free up caregivers from getting involved in fruitless and cumbersome chores, which lets them provide better service to their patients. 

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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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