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ISO13485: A licence to practise in the medical engineering sector

Kirkstall Precision Engineering is where surgical instruments come to life. Over the past 30 years, they have been operating at the forefront of global precision engineering for the medical sector and are highly regarded as specialists in this field. They provide a diverse range of global clients with bespoke turnkey solutions that meet their specific business requirements.

“Whether we’re dealing with a multinational conglomerate like Johnson & Johnson who have a budget of millions, or a new start-up orthopaedic surgery who rely on R & D grants, our approach remains the same. In principle, we work with the exact same stakeholders: designers, manufacturers, quality assurance teams to ensure compliance, then liaising with procurement and supply chain teams to meet stocking and delivery requirements.” states Operations Director, Iqbal Bahia.

So, how did a modest set-up in Kirkstall become a trusted global partner? Let’s explore this meteoric rise.

To drive a car, you need a licence. To supply instruments to the medical sector, you need to be approved to ISO13485, which Kirkstall Precision Engineering are. ISO13485 has become the worldwide accepted standard in the medical manufacturing industry and certifies that your practices conform to the necessary regulatory requirements. This certification guarantees that every medical device KPE produce conforms to international standards, from design right through to distribution.

However, obtaining this certification was not the end of the road, but rather the beginning of the journey. “For us, ISO13485 is not just a standard or system, it’s a working philosophy, it is a culture – a company-wide ethos. Because we are assessed on an annual basis, a lot of hard work goes on behind the scenes to maintain this gold standard, but the benefits to us as a business cannot be overstated.” says Iqbal.

As the internationally recognised standard within the medical industry, client and patient concerns are immediately alleviated when they know they’re dealing with experts. In the same way that a valid MOT guarantees a car is safe to drive, KPE’s conformity to these standards ensure the products they manufacture are safe, reliable and fully functioning. This in turn contributes to enhanced customer satisfaction, as patients are reassured that their medical needs will be met by the medical instruments designed for manufacture and manufactured by KPE.

In addition to enhancing their perception externally, being certified to ISO13485 standards also helps the business grow internally. The process approach outlined in ISO13485 has facilitated greater efficiency and cost savings –  identifying and eliminating waste, reducing errors and avoiding rework. This has empowered Kirkstall Precision to embrace an evidence-based decision-making system, decisions which they now say tend to be better aligned with their strategic goals as a business.

These benefits have also had a massive impact on the morale and output of the team at Kirkstall Precision Engineering. It has fostered a culture of continual improvement and enhanced engagement. Staff now spend less time on non-value-added tasks and more time searching for ways to improve their output. This means not only are they more invested in the strategic business goals, but they also better understand their roles and how they can be more productive.

To maintain these high standards, continual investment in people, building and infrastructure is essential. After all, the technology used is only as good as the people behind it. And this is what Iqbal believes differentiates Kirkstall Precision Engineering from their competitors.

“As all our major competitors will also be certified to ISO13485 standards, it’s critical that our people make the difference.” – Iqbal asserts. He continues: “Recruiting a new member of the team is only the first stage of that process. We make sure all of our team attend regular training courses to hone their current skillset and develop new skills. As well as fantastic people driving our success, we follow a strict set of processes and procedures which keep up on track and aligned with our targets; it’s something hasn’t escaped the attention of external auditors, who have ranked our Business Management System (BMS) ‘best in class’.”

Ultimately, KPE are adamant that it’s their people that will drive them forward and ensure that they are adequately prepared for future challenges that the medical sector will bring. In the past 30 years the world has changed drastically and so has the medical industry. From a client perspective, there’s been a gradual shift and increased demand for effective risk management and risk decision management in relation to product lifecycle. From a customer perspective, there has undoubtedly been a greater emphasis on documentation, traceability and software validation to minimise the risk of a device failing in a medical theatre. To meet these demands and reduce any customer concerns around safety, KPE have expanded their quality assurance team to meet further scrutiny and increased customer expectation.

In the world of medicine where advancements and breakthroughs can change the landscape in an instant, KPE must be vigilant to ensure their processes do not become obsolete. Today, a bespoke knee replacement can be done in just a 24 hour stay in hospital – something relatively unheard of even a few years ago. Some of their key clients are projecting 200% growth in the next three years in implant sales alone.

There will also be growing demand for the design and manufacture of new robotic surgical instruments as surgical procedures become more automated. So, the need to stay ahead of trends and ensure they’re compliant is more prevalent than ever – especially as the medical industry represents an area of considerable projected growth for Kirkstall Precision as a business.

The medical industry is always changing, and this brings about its own certain set of unique challenges that working in other sectors wouldn’t, as Iqbal admits. “We have to think about ethical considerations as we are dealing with patients’ health and their recovery. Naturally, it’s absolutely critical that any risk is managed and mitigated. However, the fact that we play such an integral role in getting people back to full health is fulfilling and incredibly satisfying, both from a personal and business perspective.”

Kirkstall Precision Engineering started as a relative unknown and have grown into a full-fledged specialist within the medical sector. Their immediate future will focus on consolidating the hard work they’ve achieved so far and building on the reputation they’ve established, looking toward areas for growth in the future.