Regulatory scrutiny of medical devices is increasing across developed economies to keep patients safe and maintain public confidence.

Regulators around the world are increasing their scrutiny of medical devices as these become more critical to patient outcomes. Referencing new research, Peter Muller and Mike Baird of Schlafender Hase consider how well Class 2 and 3 device manufacturers are adapting. Published in LifeSci Voice The global medical device industry is expected to be worth ... Read more

As medical devices become more critical to patient outcomes, regulators around the world are steadily increasing controls around the manufacturing, distribution and monitoring of devices.

Peter Muller & Mike Baird of Schlafender Hase how well they think suppliers are adapting to new regulatory demands for Class 2 and 3 Medical Device Manufacturers.

Reviewing new international research, Peter Muller and Mike Baird of Schlafender Hase explore how Class 2 and 3 device manufacturers in Europe and the US are coping with rising Agency controls. Published in PharmaPhorum As medical devices become more critical to patient outcomes (the global market could reach a value of $886.80 billion by 20321), ... Read more

In the light of new research, Peter Muller and Mike Baird of Schlafender Hase assess how well Class 2 and 3 device manufacturers in Europe and the US are adapting to a rise in regulatory controls. Published in MedTech Intelligence The global medical devices market is expected to grow from $542.21 billion in 2024 to ... Read more

E-labelling provides patients and healthcare professionals with up-to-date product and safety information. Schlafender Hase’s Dr. Jutta M. Hohenhörst discusses the benefits of e-labelling for the medical device sector and provides some practical tips for getting ahead with processes, procedures and solutions that deliver efficiencies across today’s labelling landscape, and add value for patients.

In the consumer world, it’s now common practice to access product information online. For detailed instructions or information about manufacturing practices, safety advice and so on, users can scan a QR code or go to a web address. This will take them to the latest details, in an easily digestible format - often including audio and video options now, for maximum accessibility.

As the medical device sector continues to rapidly evolve, it is becoming increasingly important to ensure that patients and healthcare professionals have access to up-to-date product and safety information. E-labelling provides a convenient way to share important information. Here, Schlafender Hase’s Peter Muller explores the advantages of e-labelling for the medical device sector, as well as providing some practical tips for getting ahead with the processes, procedures and solutions necessary for a successful transition to e-labelling.

E-labelling offers patients and healthcare professionals the convenience of always having up-to-date information on their products, such as the latest safety updates. It also provides regulators with greater oversight and assurance that manufacturers are providing accurate and timely information. Dr. Jutta M. Hohenhörst, from Schlafender Hase, explores the benefits of e-labelling for the medical device sector and provides some practical tips for getting ahead with processes, procedures and solutions that deliver efficiencies and add value for patients.

New directives and guidance aim to connect patients, physicians and other stakeholders across the healthcare ecosystem with a consistently up-to-date information source for product and safety information that isn’t dependent on paper. Schlafender Hase’s Peter Muller explores the promise of e-labeling and practical next steps required to deliver on these directives.

By allowing medical device suppliers to provide up-to-date, reliable product and safety information in a secure and accessible format, e-labelling has the potential to revolutionise how medical professionals and patients access and manage information. In this article, Peter Muller of Schlafender Hase examines the potential of e-labelling and recommends practical steps to secure the benefits of e-labelling.

As they try to plug the gaps, and hang on to the qualified and experienced experts they already have, life sciences companies need to be clever about how they support those people to make best use of the time, and how they alleviate the aspects of their job which add the least value professionally yet cannot be skimped on.

With the steely eyes of the regulators firmly trained on everything that life sciences organisations do, the last thing firms want is to incur fines, market delays or worse because of overlooked mistakes in labelling and product information. Yet incidences of labelling issues and associated product recalls are rising sharply, now accounting for over 50% of all recalls according to the FDA. The conditions are rife for the trend to continue, due to growing complexity in life sciences firms’ operations and external market requirements.

“Pharma labels are not just important for patients to learn about the specific formulations of a product, but also serve to identify, protect, and inform the patient on how to use them safely, and effectively,” says Regional Sales Director of Schlafender Hase, Marc Chaillou. At this juncture, one of the key challenges for pharma companies is aligning drug prescription instructions with regulatory requirements and additional language translations for a label.

In this age of automation, it seems astounding that some fundamental tasks such as packaging and labelling quality checks are still handled manually to at least some degree. Yet this is the case even among some of the biggest pharmaceutical brands. That’s despite the high regulatory standards designed to protect patients, and the reputational risks and steep costs if errors slip through the net.

No market is immune to change, and life sciences continues to face its fair share of upheaval as the industry accommodates emerging innovation in healthcare and a raft of other challenges to the status quo. Below are five of the most prominent trends and what they mean in practice.

One practical way to get ahead is to harness automation in the preparation of data by identifying and selecting the definitive source documents; checking for updates; and aligning languages, fonts and other intricacies. Sophisticated tools are available that reliably and precisely compare files in different formats for the possible information they contain. This ability to quickly contrast content of similar documents from multiple sources in large batches could help save firms vast amounts of time in this substantial preparatory stage of getting the company’s product data assets in order.

The global market is currently experiencing a turbulent period, as national elections continue, governments change and the UK edges closer to Brexit. One of the practical concerns for life sciences is how this might affect the regulatory landscape, and momentum behind specific regulatory developments such as the phasing in of ISO Identification of Medicinal Products (IDMP).

Life sciences technology vendors and consultancies are busy promoting Identification of Medicinal Products (IDMP) compliance solutions, which seems odd given that many details of the final requirements have yet to be published. With a further two years to go until the latest deadline comes around, organisations have every reason to be sceptical of the value of investing now, says Marc Chaillou of Schlafender Hase.

Harnessing automation is one way to minimise the burden on skilled personnel. When it comes to organising and verifying definitive source documents, checking for accuracy and currency, and comparing these across different languages, file and font types, there are now sophisticated tools that can help relieve the pressure on already time-starved teams – taking care of the heavy lifting so the overseeing professionals only need to proof content once, as a final check.

Change is the only constant in the new normal, something that applies as much to life sciences now as to other markets more readily associated with disruption, such as retail and banking. But the pharmaceutical industry is not known for its adaptability, so how will it weather the choppy conditions currently characterising the market - and can technology ease the strain?

Within all of this, the clinical trials process carries its own particular share of risks and associated costs. If drugs do not pass human testing – and most don’t – all of the work that precedes this will have been for nothing: certainly it will not deliver the expected return. So life sciences companies need robust processes in place to ensure that products are taken absolutely correctly, leaving no scope for error in dosage, for example.

The life sciences industry, keen to reduce its reliance on expensive blockbuster drugs, has recognised the opportunity and wants its share of the action. Many firms are now embracing health foods and nutraceuticals through acquisition or partnership, or the expansion of existing businesses to include new divisions.

It is no coincidence that the food and nutraceuticals industries are now beginning to look to these more experienced sectors – particularly pharma - for guidance on best practices – and as a source of regulatory professionals as they seek to bolster their teams.

Its new Nutrition Facts label guidance, which applies to packaged foods, will ensure that labelling reflects the latest scientific information, including the link between diet and chronic diseases, for example. New requirements also include updated serving sizes, and a refreshed design which highlights information such as calorie content, portion size, added sugar content. New nutrients must be declared too, including Vitamin D and potassium, to combat associated deficiencies.

In the fast-growing nutraceuticals market, rules are becoming stricter too. Authorities in Scandinavia are clear that if nutrition companies are going to start making medicinal claims about their products, they must categorise themselves as pharmaceutical businesses and be bound by similar requirements. And countries from Japan and India to Canada have already put the regulatory wheels in motion.

Pharma has come a long way in refining its processes and harnessing technology to streamline workflow and tighten up reliability, so as an industry it provides a valuable reference point. One of the techniques a lot of companies here have adopted is an automated approach to label checks, using sophisticated text verification – a process which can very quickly pick up even the tiniest discrepancies between regulatory text, artwork briefs and packaging artwork, irrespective of the font or language in use. Although humans should never be distanced entirely from critical checks, using reliable automation can save on several rounds of laborious proofreading and accelerate time to market, freeing up skilled resources for more specialist work.

Manual tasks are unrewarding, demotivating and a poor use of qualified professionals’ time. So it is far from ideal that the life sciences industry is using scientific writers with PhDs to check over content for regulatory/QA purposes, at great expense to the business. Avoiding a product recall or safety scare is clearly in everyone’s interests, but there must be a better way.

Even without the implications of Brexit, these are turbulent times for regulatory teams. Compliance has become a full-time job, and administrative demands are on a permanently upward trajectory.

Regulatory requirements are increasing all the time in life sciences, and recently it has seemed as though the rate of release of new guidelines and directives is accelerating.