The world's leading automated proofreading software
Peter Muller
Peter Muller
Director – Americas at Schlafender Hase
For over 25 years, Peter Muller has worked on software and process improvement projects relating to proofreading with Fortune 500 companies from various industries: Pharmaceutical, Medical Device & Consumer Goods. He has a wealth of experience working with international clients to define their organization’s goals and help them leverage new technologies to achieve productivity gains, process improvements and cost savings.
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Peter Muller
September 2, 2024
4 minutes read
Soaring Medical Device Scrutiny: How is the Market Adapting?
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 $886.80 billion by 2032[1]. As devices become more critical to patient outcomes, regulators around the world are increasing their controls around their manufacturing, distribution, and monitoring – bringing suppliers of these products more closely into line with requirements around pharmaceutical goods. New research[2] has assessed how well manufacturers and their regional or national partners are adapting to the rising regulatory demands. The 2024 study, with 202 regulatory professionals at Class 2 and 3 medical device companies in the EU (Germany) and North America (the US), highlights the number of challenges currently vying for attention and investment and assesses device companies’ current state of regulatory readiness. Medical devices: the rise of regulatory requirements The study started by surveying medical device suppliers’ involvement with a number of regulatory initiatives. E-labeling/eIFU Currently, just under two-thirds (62%) of medical device companies are involved in e-labeling initiatives, and up to a third of these (30%) are ‘very’ involved. EU companies are more likely to be actively involved in e-labeling than those in the US (71% vs 53%). This makes sense as the EU is ahead of the US with the practice; companies here are also less likely to outsource labeling as a service. FHIR/standardized data exchange Fast Healthcare Interoperability Resources (FHIR) is a proposed global standard, designed to streamline data exchange and facilitate real-time information access for healthcare providers. It will make many regulatory professionals’ lives easier by shifting the emphasis of content creation and management to ‘publishing’ rather than ‘printing’, helping to drive process digitization in the production and management of regulated medical device information and content. In the survey, three in five respondents (60%) claimed to be involved with the standard, rising to 67% for EU (German) respondents; in the US, only just over half were occupied with FHIR (FHIR is not as high profile in the US, though the FDA is encouraging manufacturers to adopt interoperability standards). UDI/device identification Unique device identification (UDI) makes it possible to track individual devices across the healthcare supply chain internationally. In the survey, two-thirds (66%) of respondents (rising to 74% of EU survey participants, but accounting for a much lower proportion in the US at 57%) express involvement in UDI activity. Anti-counterfeiting Taking proactive measures to mitigate the threat to product quality and patient safety posed by counterfeit products is a further expectation and robust product identification and traceability are a cornerstone of this practice, along with vigilant supply chain monitoring. In the survey, over half (55%) of respondents indicate at least some involvement with anti-counterfeiting. Navigating regulatory demands Medical device companies are dealing with the impact of increasing regulations in a number of ways, including the implementation of key standards (e.g. ISO);
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June 11, 2024
5 minutes read
Regulatory Tools: Revolutionizing Promo Review
Regulatory authorities are approaching AI with understandable caution, recognizing its obvious opportunities as well as its inherent challenges. Workshops, workplans, input and industry collaboration are high on the agenda.
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June 5, 2024
3 minutes read
How TVT helps the Top 5 Functions of Regulatory Professionals
The challenges faced by regulatory professionals are substantial. New products must be brought to market quickly and the pressure is on to turn projects around faster. Furthermore, regulations are constantly evolving, which means labeling and packaging must be updated.
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May 17, 2024
4 minutes read
Off Label Marketing: How to Avoid False Claims in Pharma
The risk is high, whichever side of the coin you look at. Off-label marketing and other off-label promotion have led to some of the largest legal settlements in the pharmaceutical industry – up to $3 billion in one case
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April 30, 2024
3 minutes read
Tank Worldwide Case Study – Fast, focused quality control in advertising
The creative content from Tank WW includes text copy, videos, websites or micro-sites, email promotional material, PowerPoint presentations, and more. A proofreading team provides the quality control for advertising material to ensure accuracy, consistency and compliance across content and different media.
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March 22, 2024
5 minutes read
Best Practices for your Promotional Review Process
The aim of a pharmaceutical promotional review process is to ensure the accuracy and compliance of promotional material with the relevant medical, legal, and regulatory aspects of a specific market.
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February 12, 2024
4 minutes read
A Guide to Proofreading Medical Writing
Medical writing describes a wide range of writing in the fields of medicine and healthcare. Discover more about medical writing and “a day in the life.”
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December 8, 2023
5 minutes read
Preparing for MoCRA – FDA’s Updated Cosmetics Framework
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant change to cosmetics regulation since 1938. Are you prepared?
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November 30, 2023
4 minutes read
Comparison Software to Verify Drug Promotional Material
Ten years and $1 billion later, close your eyes and imagine; your product has been approved in the US by the Food and Drug Administration (FDA).
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September 18, 2023
2 minutes read
5 Must-Do Activities in Montreal During RAPS Convergence 2023
Welcome, esteemed professionals attending RAPS Convergence in Montreal! To help you experience the best of what Montreal has to offer, we've compiled a list of five must-do activities during your visit. Get ready to explore the charm and excitement of this captivating Canadian metropolis!
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August 22, 2024
Schlafender Hase Team
FHIR: Transforming Product Labeling
The shift from paper-based to digital processes has opened enormous opportunities in the healthcare sector in terms of data sharing and content management. But data can only be shared efficiently and add value if systems can "talk" to each other. The term we use for how compatibly systems work together is "interoperability." Traditionally, the healthcare sector has suffered from a high lack of interoperability.
- August 22, 2024
- By: Mike Baird
6 minutes read
FHIR: Transforming Product Labeling
The shift from paper-based to digital processes has opened enormous opportunities in the healthcare sector in terms of data sharing and content management. But data can only be shared efficiently and add value if systems can "talk" to each other. The term we use for how compatibly systems work together is "interoperability." Traditionally, the healthcare sector has suffered from a high lack of interoperability.
