What do you do when your regulatory team is at full stretch and you can’t hire more staff?
Compliance Navigator hasn’t just saved time at ELLA-CS – it’s helped its very survival. We spoke to CEO Oldrich Benes to find out how they’re managing all the changes that the EU MDR is bringing.
“It’s not just a tool to make the business better; for me this is a tool for how to survive.”
Background
ELLA-CS develops and manufactures a range of medical devices. The company is the sole manufacturer of several globally unique healthcare devices. They specialize mainly in gastro-intestinal stents, with a portfolio including oesophageal, pyloroduodenal, biliary and colorectal
stents. They have distribution arrangements in over 70 countries and they continue to expand. They currently employ around 120 people. Their CEO is Oldrich Benes. He is also acting as a Director of Regulatory Affairs and has a background in engineering and quality.
Customer need
One of the biggest challenges Oldrich faces is recruiting new people for the regulatory team. He has searched for someone to take over his role as Director of Regulatory Affairs without success. He says: “The number of people with relevant experience is limited. It’s not something you can learn in school; you need to work on it in practice. It’s a very specific topic - not like an engineer who can move from one industry to another. You need someone not just from compliance, not just from compliance in pharma, but very specifically with a background in compliance in medical devices.” It’s not just a question of paying more; there simply aren’t enough experienced people. “For us that means big trouble. So for me it’s very important that I can achieve compliance during this time of change with just the people I have already.”
When hiring more people is not an option, you need ways to help your existing team to become more productive. One of the most time-consuming activities for the regulatory team at ELLA-CS was gap analysis – their term for the impact assessments needed whenever standards are introduced or changed. Oldrich explains: “Before we introduced Compliance Navigator, we used our own regulatory department for this activity. Three people were employed to check out new releases and updates of standards and try to find the differences so that we could analyse the implications.”
"[I]t’s very important that I can achieve compliance during this time of change with just the people I have already.”
The solution
Given the time savings Compliance Navigator offered, the decision to invest in the tool was straightforward. So was the implementation. Oldrich set up 70 users (a majority of the company) to have access to the system. Any of them can use it to check that they’re ready for questions and audits. BSI trained eight key users and those key users trained the rest. Everyone felt well supported – all the questions raised during the training were answered promptly. Oldrich says, “We were done in six weeks. It compares brilliantly with our attempts to introduce a document control system, which has taken far longer with no end in sight.”
“Compliance is a never-ending story. This year we have EU MDR standards coming into force. This has taken us many hundreds of hours over the last few months, and without Compliance Navigator it would have been far, far more. We have saved a lot of time.”
Customer benefits
Compliance Navigator has transformed the regulatory team’s productivity. No longer do they have to spend time tracking down differences in updated standards. The company gets notice of any new or updated standards, normally well before the release date. “This is a very useful function, to have advance notice of standards updates.”
The expert commentaries in Compliance Navigator also help to save time. “Standards are written in a structured way, but it’s not always easy to translate the requirements into practical implications, particularly for unique products, products in which we are pioneers. Expert commentary is definitely helpful. We still have to put together a gap analysis – our own document setting out the differences arising from revised standards and the implications for our own work – whether we need to do more testing, validation or other evaluation of the product. But we take the expert commentary into account and so our meetings are much shorter – though of course the decision on whether to retest or revalidate is ours.” He also values the Compliance Navigator blog: “the blog on the website is great because it helps us to avoid the mistakes of others. It helps us to use the tool in the best way.”
Oldrich’s particular focus at the moment is the European Medical Device Regulation (MDR), which fully applies from 26 May 2020. That means a lot of work for Oldrich and his team. “Compliance is a never-ending story,” he confirms. “To fulfil the new MDR requirements, we have to update technical files and the design dossier for our product before their expiration – in our case, in June 2022. This has taken us many hundreds of hours over the last few months, and without Compliance Navigator it would have been far, far more. We have saved a lot of time.” Oldrich reflects that behind all the benefits – the savings in work, time and money – there’s something even more important. Over the coming months, significant changes to the European regulatory regime will mean that medical device manufacturers will need to change their systems and processes. “Compliance Navigator will help me do all that – and it will help us survive. It’s not just a tool to make the business better; for me this is a tool for how to survive.”
