May 17, 2020

Top 10 Women's Healthcare Providers

4 min
Top 10 Women’s Healthcare Providers.jpg
In the last few years, womens healthcare has undergone a profound change. In todays world, women not only bear their share of ailments, stress, injurie...

In the last few years, women’s healthcare has undergone a profound change. In today’s world, women not only bear their share of ailments, stress, injuries and diseases, but also suffer from some unique conditions which require special care. Here are some of the most famous hospitals in the world which have taken upon themselves to take care of the fair sex.

1.       Brigham and Women’s Hospital:For the 21st consecutive year, Brigham and Women's Hospital (BWH) secured its place on the U.S. News & World Report’s Honor Roll of America’s Best Hospitals, ranking ninth, and appears on the second position in Gynecology. BWH Department of Obstetrics and Gynecology is widely regarded as the best in women’s healthcare, and are well known for always pushing for better technology and advances in medicine: like the use of high intensity focused ultrasound to treat uterine fibroids and the creation of a Division of Minimally Invasive Gynecologic Surgery. The Dana Farber/Brigham and Women’s Cancer Center is committed to conquering cancer also enjoys a solid reputation. The newly formed  Boston Center for Endometriosis, a joint undertaking with Boston Children’s Hospital, and the first in the world of its kind that will serve as the premier diagnostic, treatment, research, and educational resource for the disease throughout a woman's lifespan, from adolescence through adulthood is the latest feather on its cap; and the hospital draws talent from all over the world for educational opportunities.

2.       Mayo Clinic:Beating BWH in the Honor Roll of America’s Best Hospitals this year, the Mayo Clinic performs a record number of surgeries and delivers thousands of babies every year. Each year, more than 500,000 people from all walks of life come to Mayo Clinic locations in Arizona, Florida and Minnesota. As a not-for-profit organization, Mayo Clinic has been putting the needs of patients first for more than 100 years.

3.       Cleveland Clinic: It follows the aforementioned two closely, and is regarded as one of the best centres for gynecology in the world. It has enjoyed a stellar reputation, and is also a teaching hospital which attracts many students from all over the world.

4.       Liverpool Women’s Hospital:Or "the Women's" as locals call it, delivers more babies than anywhere else in Europe; about 8,500 a year. It is one of the only two hospitals in England that specialize in women and babies’ healthcare, and its reputation is legendary. It is also well known for its brilliant research programmes. Bliss, the special care baby charity are currently funding research at Liverpool Women's Hospital into parenteral nutrition for premature and sick babies.

5.       Magee-Womens Hospital of UPMC:Magee-Womens Hospital of UPMC is a 318-bed obstetrics and gynecology facility with 20,513 admissions in the most recent year reported. It performed 6,095 annual inpatient and 11,505 outpatient surgeries. Its emergency room had 21,285 visits. Magee-Womens Hospital of UPMC is a teaching hospital.

6.       Royal Women's Hospital, Melbourne:Australia’s first specialist women;s hospital provides a full range of services in maternity, gynaecology, neonatal care, women's cancers and women's health. It also offers complementary services such as social work, physiotherapy, dietetics and pastoral care. Specialist clinics in endometriosis, chronic pelvic pain, menopause symptoms after cancer, infertility are also available. It is a major teaching hospital of over 200 beds with links to the University of Melbourne and La Trobe University. The hospital also has specialties and departments that deal with more delicate issues like mental health, sex and sexuality, violence and sexual assault and fertility treatment.

7.       Women’s College Hospital, Toronto: Probably the most famous women’s healthcare provider in Canada, it is a pioneer on many fronts; and openedthe first cancer detection clinic in Ontario. Women’s College was the first hospital in Ontario to use mammography and the first in Canada to have a perinatal intensive care unit.  Its Women Recovering from Abuse Program (WRAP) at Women’s College Hospital is the only childhood abuse program for adult victims of child abuse in Canada.

8.       Prentice Women’s Hospital: Under the Northwestern Memorial Hospital Chicago, this hospital  provides a wide variety of services and specialized care just for women, through all stages of their lives- from gynecologic and pregnancy care to menopause and bone health

9.       UCSF Women’s Health Centre: Under the University of California, San Fransico, this centre is the only nationally designated Center of Excellence in Women's Health in Northern California. It is also recognized as one of the top hospitals in the nation for gynecological care.  Under the direction of Dr. Michael Harrison, UCSF was the first in the world to successfully perform open fetal surgery in 1981- and since has gone on to have more experience with fetal surgery and endoscopic fetal intervention than any other institution in the world. It also provides complete family planning and preconception counseling

10.   KK Women's and Children's Hospital: It is the largest hospital specialising in healthcare for women and children in Singapore. From 1966 to 1976, the hospital remained in the Guinness Book of Records for delivering the highest number of newborns within a single maternity facility- having birthed over 1.2 million Singaporeans since its inception. Over the recent years, the scope of care has expanded even more to provide holistic care to women and children patients. It strives to become the "Healthcare Leader for Women and Children", which has become its slogan. New departments were added to the hospital. Paediatric surgery was first added, followed by others such as colorectal surgery, psychiatry and orthopaedics for women with illnesses requiring expertise in those areas.

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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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