Ben Fear, CEO of a medical devices supplier, reflects on the life-and-death challenge of keeping standards high during the past two challenging years.
The emergence of Covid-19 presented one of the biggest challenges of Ben Fear’s career – and it changed the focus of his business almost overnight.
Fear is Chief Executive Officer of medical devices company Platform-14. For the past decade it had been sourcing and supplying the UK’s National Health Service (NHS) and the private medical sector with the equipment needed to treat and care for patients.
As well as products including specialist pain-management devices, radiation protection and an implantable device for peripheral nerve pain, Platform-14 also supplies three types of personal protective equipment (PPE) to the NHS: radiation protective gowns and accessories such as thyroid collars and glasses, infection prevention gowns, and face shields.
As a medical supplier to the NHS, the company complies with ISO9001, which provides the necessary assurance that it has the management processes in place to deliver ongoing consistent quality, including clearly stated quality objectives, record keeping procedures and performance monitoring. It employs a regulatory and quality specialist who oversees these requirements and ensures the firm stays abreast of any updates.
“Our suppliers do this too and when needed we have used external auditors to give us a triple quality check,” says Fear.
He adds that the business is now also working towards ISO 13485:2016to strengthen its position in the market further. “The more rigorous ISO 13485 is not a requirement, but we have made the decision to adopt these standards to give ourselves parity with our manufacturing competitors,” he says.
In the past, NHS procurement lead times had been up to 18 months. As Covid-19 emerged in the UK in March 2020, and hospitals shut their doors to all but frontline medical staff, those lead times were slashed as it became imperative to get PPE to the front line as quickly as possible.
With Covid-related cases, hospitalisations and deaths rising rapidly – and customers redeploying resources and prioritising the sourcing of certain medical supplies to tackle the pandemic – Platform-14 quickly changed its focus.
“We concentrated on sourcing and delivering PPE to the NHS,” says Fear. This came with some “extreme challenges”, including in sourcing raw materials and shipping delays. But he argues that the company’s established supplier relationships enabled it to work quickly to develop faster supply chains for these vital items.
“Our ten-year history [of working] with the NHS and our suppliers meant we could pivot the business and scale up to meet urgent demand at a time when there was a huge shortage in the NHS system.”
Despite the demand for more rapid procurement, Fear points that the quality requirements – set in the UK by the Department of Health & Social Care and the Health & Safety Executive – remained the same as ever.
“There was no change in criteria,” he says. “We had to maintain quality, regardless of the pandemic. We continued to focus on using and applying the same rigorous processes and procedures as we do to the supply and distribution of other products in our portfolio.”
Of course, it was well documented that some PPE suppliers to the UK and other governments failed to achieve such high standards during those first few months of 2020.
However, Fear argues that his company were determined not to let standards slip, despite the tight timescales.
He points out that products supplied into the healthcare sector impact directly on the standard of care the company’s customers provide to their patients – so they must always be of the highest quality. The level of service expected from suppliers like Platform-14 is similarly high and applies across the whole supply chain.
Matter of life and death
“Quality in the med-tech sector is absolutely critical,” he says. “Sometimes it is literally the difference between life and death.”
According to Fear, regulatory standards provide the business with only the minimum quality measures required. He looks to set the bar higher by working with “only the best manufacturers” that run rigorous product and quality testing.
“In addition, we have commissioned additional standards testing of our products by assessment, auditing and certification company TÜV Rheinland,” he says. “This wasn’t legally required; we did it to achieve alternative confirmation of the quality of our our products.”
Working in international markets – including the UK, EU and Middle East – means the company must understand and implement the standards required in a range of different countries. However, while nuances apply to certain geographical regions, Fear looks to maintain a consistent focus on quality. As he points out, “regulation is a global language”.
Attribute to original publisher/ publishing organization: Ben Fear, CEO of a medical devices supplier, https://www.quality.org/knowledge/maintaining-ppe-quality-when-lead-times-are-slashed