Mike is the Director of Product Management for Schlafender Hase. He is committed to continuously improving the existing software portfolio and at the same time also delivering new and innovative solutions to exceed customer needs. He has more than 25 years of experience working with global packaging, labelling, pre-media and artwork management leaders in the pharmaceutical and medical device sectors.
RAPS Webinar Highlights: Learning the New Language of the EMA & The FDA – FHIR
As the healthcare industry undergoes rapid transformation, it is shifting away from product information (PI) based on physical and unstructured digital formats to electronic data formats offering greater accessibility, interoperability, and potential for global alignment. A key factor in this transformation is the data standard Fast Healthcare Interoperability Resources (FHIR).
Introducing TVT 12: A New Era in Compliance and Efficiency
With growing demands on regulatory professionals to ensure accuracy and efficiency, the newest version of the industry-trusted proofreading software, TVT 12 delivers enhancements that allow users to navigate complex document requirements with greater ease and confidence.
The Game-Changing Features of TVT 12: A New Era in Compliance and Efficiency
TVT 12 is here!
This annual update is packed exclusively with new features and improvements from customer requests that support key industry initiatives, boost efficiency, and add even more speed and detail to your document reviews.
The medical device sector’s surging regulatory burden: how are suppliers coping?
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 $886.80 billion by 2032[1]. It is no coincidence that company representatives now make up a growing proportion of attendees at Regulatory Affairs Professionals Society meetings. As devices become more critical to patient outcomes, regulators around the world are steadily increasing their associated safety controls. A new international benchmark report[2] considers how well manufacturers and their international partners are adapting to the rising regulatory demands. The 2024 study was conducted with 202 regulatory professionals at Class 2 and 3 device companies in the EU (Germany) and North America (the US). Emerging & intensifying regulatory requirements The research first tested medical device companies’ awareness of and current involvement with a number of increasingly prominent regulatory initiatives. E-labeling/eIFU E-labeling is high on the medical device regulation agenda on both sides of the Atlantic. Electronic information provision and management promotes standardization and consistency (e.g. of format and terminology), making it easier to manage and process the contents in any market. It also plays a key role in product traceability, a critical safety lever. Providing critical product information digitally (e.g. under expectations associated with electronic instructions for use, or eIFU) makes it easier to issue prompt updates, too. It also simplifies international content and translation management and, in the case of user advice or safety information, facilitates spontaneous online or mobile lookup by clinicians or patients. Crucially, e-labeling allows device manufacturers to provide more detail than can fit on a physical label. Currently, just under two-thirds (62%) of medical device companies are involved in e-labeling initiatives. EU companies are more likely to be actively involved in e-labeling than those in the US (71% vs 53%, respectively). 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 is a proposed new global standard, designed to streamline data exchange and facilitate real-time information access for healthcare providers. It will shift the emphasis of content creation and management to ‘publishing’ rather than ‘printing’, promoting the digitization of the production and management of regulated medical device information and content. In the survey, three in five respondents (60%) were 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) employs a unique numeric or alphanumeric code to identify individual devices across the healthcare supply chain. Although approached slightly differently, a UDI system is advocated by both EMA and the FDA. Benefits include expedited and more targeted
Learning the New Language of the EMA & The FDA: FHIR
Watch our interactive discussion session focusing on the evolution and outlook of Fast Healthcare Interoperability Resources (FHIR).
FHIR represents a significant step in how we manage and exchange information and is rapidly gaining acceptance. In this session, industry experts will provide an introduction to the FHIR initiative, explore some current applications as well as the impacts, benefits and prospective timelines.
The Rise of Regulatory Requirements for Medical 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.
The booming medical device sector: How well are suppliers adapting to new regulatory demands?
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), regulators around the world are increasing quality and safety controls, to bring device suppliers more in line with providers of pharmaceutical goods. Now, new research2 has assessed how well manufacturers and their regional or national partners are adapting. Medical devices: The rise of regulatory requirements The 2024 study, of 202 regulatory professionals at Class 2 and 3 medical device companies in the EU (Germany) and North America (the US), started by reviewing medical device suppliers’ involvement with a number of regulatory initiatives. E-labelling/eIFU Currently, just under two-thirds (62%) of medical device companies are involved in e-labelling initiatives, and up to a third of these (30%) are ‘very’ involved. EU companies are more likely to be actively involved in e-labelling 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 labelling as a service. FHIR/standardised data exchange Fast Healthcare Interoperability Resources (FHIR) is a proposed new 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 digitisation 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. Navigating the new 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); process digitisation and automation; greater use of outsourcing or third-party collaboration; and hiring of more regulatory people – all cited by more than a third of companies. The difficulty of finding and appointing qualified professionals to alleviate soaring regulatory workloads is a challenge on both sides of the Atlantic, while almost a quarter (23%) said that staff retention was their biggest issue. Supporting technology Over the next two to three years, respondents foresaw projects linked to existing devices (cited by 32%, rising to 35% among US respondents); emerging healthcare trends (28%, rising to 34% of German/EU respondents); and new
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.
E-labeling: The Road to Efficient Pharmaceutical Labeling and Packaging
Practical next steps for pharmaceutical manufacturers & distributors as regulators demand the digital delivery of customer-facing product information in place of paper inserts.
E-labeling: The Road to Efficient Pharmaceutical Labeling and Packaging
Practical next steps for pharmaceutical manufacturers & distributors as regulators demand the digital delivery of customer-facing product information in place of paper inserts.
Serialization in pharmaceutical packaging and drug labeling is crucial to product safety, regulatory compliance, supply chain efficiency and the fight against counterfeit drugs.
Serialization in pharmaceutical packaging and drug labeling is crucial to product safety, regulatory compliance, supply chain efficiency and the fight against counterfeit drugs.
RAPS Webinar Highlights: Learning the New Language of the EMA & The FDA – FHIR
As the healthcare industry undergoes rapid transformation, it is shifting away from product information (PI) based on physical and unstructured digital formats to electronic data formats offering greater accessibility, interoperability, and potential for global alignment. A key factor in this transformation is the data standard Fast Healthcare Interoperability Resources (FHIR).
RAPS Webinar Highlights: Learning the New Language of the EMA & The FDA – FHIR
As the healthcare industry undergoes rapid transformation, it is shifting away from product information (PI) based on physical and unstructured digital formats to electronic data formats offering greater accessibility, interoperability, and potential for global alignment. A key factor in this transformation is the data standard Fast Healthcare Interoperability Resources (FHIR).
