The British Healthcare Trades Association (BHTA) has welcomed ProSys International as a new member. ProSys International designs, develops, and manufactures a range of clinical supplies and medical devices for acute and secondary care environments.
The BHTA recently caught up with Gill Sims, Clinical & Commercial Director at ProSys International, to discover more about the firm, the value of being a BHTA member, and difficulties keeping up with the latest regulations.
Gill enjoyed a successful career in medical device sales for over 30 years. She has previously worked in the stoma, urology, wound, and obstetrics and gynaecology markets.
Gill recently joined ProSys International to support the firm’s vision and business development strategy in expanding its bowel management, pressure area care, and infection control portfolio in both primary and secondary care environments.
“As a registered nurse I am passionate in supporting healthcare professionals with best practice solutions to support and overcome the challenges faced in today’s clinical and home care settings,” Gill enthused. “Providing products and educational services to enable care of the highest standard is our goal and we are building a respected team to spread our reach and support at grass roots.”
Gill says that contributing to the development of exciting new products in the pipeline in a dynamic environment is incredibly rewarding. ProSys International’s overall goal is to deliver high-quality and cost-effective solutions, which involves multidisciplinary professionals supporting the firm’s projects from the outset.
The company anticipates launching its latest development in early 2025. This will mark the start of a programme that sees the true development of the ProSys International brand over the next three years.
Prosys International is a micro SME founded in the late 1990s by Graham Steer. As a mechanical and bioengineer, Graham grew the business with a focus on the design, development, and manufacturing of medical devices.
The company developed a range of products to assist in the management of highly infectious bodily fluids based upon super absorbent systems, and this subsequently led to the development of the Secco Faecal Management system. The Secco Faecal Management System Secco Protect™ is an easy-to-use system that reduces skin breakdown and pressure ulcer development, while preventing cross contamination. With its unique super absorbency technology, it contains spillages and odours as well as maintains patient dignity.
“Most recently a range of pressure relieving devices were added to the product portfolio, and this addition will be a focus for the business as we move in a new strategic direction,” Gill adds.
The ProSys International range of products are sold via a range of distribution channels including the NHS Supply Chain.
Gill explains that, for a small team, it is difficult to keep up to date with the latest regulations, as resources are stretched.
She says: “For any size organisation the trials and tribulations of endeavouring to comply with both regulatory and voluntary requirements in the 21st Century is like ‘pushing water uphill’, but with the added issue of reduced resources in a company the size of ProSys our small team can be stretched, regulatory compliance is without a doubt our biggest challenge ahead.
“Barry Holland, Regulatory Affairs Manager for the company, explains that the two main adverse events in recent history that caused most disruption within the compliance field have been the PIP Breast Implant Scandal of 2010 and Brexit in 2020.
“Regulations have been strengthened (and lengthened), Notified Bodies are now relying on State-of-the-Art obligations with typical guidelines such as MEDDEVs (although most don’t have any legal status), and now, if we’re lucky enough to sell our medical devices into Europe, our costs to comply with both the EU Medical Devices Regulations 2017/745 and the UK Medical Devices Regulations 2002 have doubled.
“Politicians continually say that “red tape” will be reduced, but unfortunately this never happens! Government Quangos continue to publish commitments that micro businesses and SMEs be given a “light touch” approach, but again we are yet to see this happen.
“The challenges for medical device compliance have never been tougher.”
Gill says that joining the BHTA as a member will help give ProSys International a collective voice. The BHTA can also provide valuable support and guidance in overcoming some of these challenges.
There are many benefits to becoming BHTA member. For Gill, the most value comes from regulatory support, networking opportunities, educational sessions, being part of a collective voice, and aligning with the BHTA Code of Practice.
Gill comments: “Joining the BHTA was a no-brainer for me, having worked for several member companies in the past, I have enjoyed the networking opportunities, educational events, and the collaborative approach to our industry challenges.
“The BHTA Code of Practice aligns so well with the ProSys mission and values and reflects a philosophy of care and support, which is very much at the forefront of all our activities.
“I am so looking forward to meeting with the Section members in the coming months and engaging in discussions that enhance quality of life for our customers whilst developing and growing our respective businesses.”
To find out more about how the BHTA can support your business and how to become a BHTA member, visit this page.