May 17, 2020

How To Deliver World Class Patient Care

customer service
Patient Care
patient / doctor communicati
4 min
Fresh Customer Service Starts With Your Employees
Healthcare Global speaks to Michael D. Brown, Founder of Fresh Customer Service about how to manage your employees to deliver world class customer serv...

Healthcare Global speaks to Michael D. Brown, Founder of Fresh Customer Service about how to manage your employees to deliver world class customer service >>>

With all the conversation, debate and noise around Obamacare and what it means or doesn’t mean for the healthcare industry – many in the industry are making the grave mistaking of cutting back or making anemic investment in their level of customer service.   This is the wrong direction – you are cutting pennies while dollars are flying over your head. Delivering a world-class customer service experience will have patients running to you (providing they are not coming to get a broken leg fixed). On the other hand being known for a poor customer experience will have patients running from your business with the dollars in hand.

The number one reason most companies fail, and that includes those in the healthcare industry, is that they provide a poor and anemic customer service experience. My advice runs counter to the adage that you should always put the customer first.  You should put the frontline employee first and the customer/patient second and, in return, the employees will treat your customers better. You end up getting customers for life and great employee retention. They are the people on the frontline who must translate all your good work to the customer/patient, so it behooves us not to put them second. Make sure they understand the level of service and experience you are trying to give and convey to the customer.

So I realize things are tight as a bandage applied with duct tape, so I am proposing a winning solution to world-class customer service that cost less than an apple a day. No an apple a day won’t keep the doctors away it will keep the frontline motivated, empowered, and equipped to keep customers knocking the door down for preventative, emergency and post services. This is what we want right, more patients who leave us less sick than when they came and taking preventative measures to not end up in the emergency room. This is ideally what we want, but many in the health care industry are making customer sicker with their ill fated, band aid “customer service” that has patients rushing to the competition for a true healing customer experience. One of sure-fire ways to ensure a negative experience is broadcasted is to agitate someone who is already sick or has something potentially wrong with their health – for anyone who has ever been ill you know what I am talking about. An increasingly number of patients are selecting healthcare facilities based on their level of customer service and feedback from other patients. Have you checked your social feedback lately?

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Customers are becoming more demanding in this economic tsunami, because they want the most for their money and they want an experience that doesn’t make them “sicker.” That means more pressure on the frontline, who will determine whether the customer feels welcomed and cared for. 

Fresh Customer Service demystifies the process of attracting loyal, happy customers who return again and again and recommend your business to their friends and families. This type of customer reaction, what some may consider as a minor detail, can actually tip the scales and prove the difference between a prosperous organization and a bankrupt organization. So what’s the secret? The Frontline Employee aka your First “Patient”

Throughout your organization’s entire process of selling, serving, marketing, cleaning, you name it, the only way you can hope to deliver a world-class customer service experience is by listening to, equipping, empowering, involving, and valuing the feedback and expertise your frontline employees can offer.  

How exactly do you implement and execute Fresh Customer Service?

The First Steps: Fresh Treatment & Understanding

Fresh Treatment

Getting your staff members to treat patients better may require that you first treat your frontline better. Customer service is one of the most important issues for the healthcare industry because it creates the repeat business that drives the brand and your bottom line. Many in the industry forget that the frontline staff are the vessels that takes care of the customer service and experience aspects of the business. Without incorporating their specialized knowledge and experience into the company’s business plan, they fail to meet the expectations and needs of the customer/patient and helping attract and retain current and future customers. You can start improving your service and team cohesiveness with a basic principle I call “gratitude to growth.” Recognition is the building block for motivating employees and business. Doctors receive feedback from grateful patients, so why shouldn’t surgeons give positive feedback to the frontline staff, which is a vital asset of the organization? Gratitude, a simple, but overlooked act, inspires employees to work to their full potential that will reach the customer/patient. The staff members are in daily contact with customers/patients and understand how company policy affects their experience.

Read more Fresh Steps about how your organization can improve employee and customer service >>>

Fresh Steps That Will Deliver World Class Patient Care

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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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