May 17, 2020

Businessfriend Gives Social Media A Boost In Healthcare

4 min
Businessfriend Boosts Social Media In Healthcare
Written by Jamie Robinson Read This Article In the April Edition Of Healthcare Global The advent of social media has been compared to the popularizatio...

Written by Jamie Robinson

Read This Article In the April Edition Of Healthcare Global

The advent of social media has been compared to the popularization of the printing press, invented by Johannes Gutenberg more than 500 years ago. Both have forever changed the way we communicate, learn, educate, inform and interact with one another on a global scale, paradigm-shifting the processing of knowledge. Both revolutionary in their impact at the time, the printing press could only disperse information while social media supports and relies upon human interaction. Personally and professionally, social media allows humans to affect the database of knowledge: to challenge it, contribute to it, question it, popularize it and connect with it, building relationships through it.

The just-launched social and professional site Businessfriend is focused on our role as communicators – striving to enhance how we work and live today. Businessfriend is a fluid, all-inclusive channel that provides individuals with the tools to interact with people across the full spectrum of relationships – personal, professional and in between.

Healthcare & Businessfriend

Businessfriend connects professionals to their contacts via tools that centralize information. A side drawer on the website stores each tool, including the Bf Inbox (which can link to personal and professional e-mail accounts), Bf Cloud (a doc manager supporting more than 100 file types), Bf Calendar (to correlate business and personal appointments), a Digidex of contacts, note-taking application and video-conference ability.

For healthcare professionals, Businessfriend is an important tool that helps connect and centralize the often-blended personal and professional moving pieces in their lives. Utilizing inner and outer “circles,” the site allows sharing in a controlled environment. Users can share more personal posts with an inner circle of friends, or share more professional information with a larger group of contacts.

“Those in the healthcare industry can connect with vendors, patients and peers to utilize the tools, save information for both patient and doctor, and keep communication open with partners and suppliers in a one-stop shop,” says Businessfriend Marketing Manager Philip Diehl.

In a patient-professional relationship, of course, privacy is paramount in the healthcare sector. Businessfriend doesn’t strive to replace confidential Electronic Medical Records or release private information, but the site can help with scheduling, reminders, questions and general information.

Additionally, the spirit of Businessfriend focuses on connecting the work and social life of each individual – to the extent that they choose. Through Businessfriend, a healthcare facility’s employees can connect with colleagues, people within their fields and even clients in a controlled environment. This personalization and humanization of the professional online presence leads to the overall humanization of an employee’s workplace.

For healthcare facility executives, Businessfriend organizes events, meetings, shared information and articles, and encourages collaboration between intra- and inter-office colleagues. Additionally, healthcare supply chain executives are able to utilize the website’s calendar, doc sharing and more to set up vendor relationships, explore new products through company profiles and keep up with trends at similar facilities globally.

Taking Care Of BUSI

“Businessfriend allows you to engage with other platforms at the same time you engage with ours,” says Businessfriend Communications Director Rhonda Marable. “We aren’t asking users to ‘switch’ to Businessfriend and abandon other networks, but to acknowledge its value. It’s unique in its functionality, with its unique utility drawers and multitasking in a way that no other site does.”

Marable says, “productivity is the focus.” The site has adopted the term BUSI to describe its functionality as Business Utility/Social Identity. Users and companies who want to expand their presence and connectivity on Businessfriend can purchase customized tools that facilitate marketing, hiring and more.

Currently, Businessfriend is working on building its reach through professional events and partnering with foreign businesses to expand its global presence. For the healthcare field, a global business utility means professionals can network with their suppliers, vendors, customers, partners and more through one site, anywhere in the world, all from one location.

The Network Of Social Networks

Businessfriend is building a correlative and complementary relationship with social media behemoths LinkedIn, Facebook and Twitter, says Marable.

“Every platform and certainly a business’ own website can provide value,” she says. “We are looking to enhance each social and professional opportunity for individuals to engage them and encourage them to engage with one another.”

The diversity and infinite idea of the Internet as a tool is a mind-boggling concept, and this new site is looking to help each person create a unique, personalized presence with the ability to connect, to change, to inspire and create with others in Businessfriend’s space. As described by Mashable Founder Pete Cashmore, connecting on our increasingly global, fast-paced world as a professional is a must.

“Those who insert themselves into as many channels as possible look set to capture the most value,” Cashmore says. “They’ll be the richest, the most successful, the most connected, capable and influential among us. We’re all publishers now, and the more we publish, the more valuable connections we’ll make.”

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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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