(Karl) Martin Becker

Medical Device Design & Development – Challenges When Transitioning Legacy Products | Educo Life Sciences recently caught up with Richard Young to discuss legacy products and some of the most challenging aspects when transitioning them to comply with the new medical device regulations. Watch or read the full interview here - https://buff.ly/3xYwC7z #educolifesciences #MDD #MDR #design #development #medicaldevices

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🚀 Exciting News from the Medical Device Manufacturers Association (MDMA) Annual Meeting 🌐 At the recent 2024 Medical Device Manufacturers Association (MDMA) Annual Meeting, Richard Phillips, Executive Director of the Association of British HealthTech Industries (ABHI), shared insights that shed light on the UK's Medicines and Healthcare products Regulatory Agency's (MHRA) forthcoming plans. According to Phillips, MHRA is gearing up to introduce an international recognition framework for medical devices, aiming to streamline the process for bringing these crucial products into the UK market. This move comes on the heels of MHRA's earlier adoption of the International Recognition Procedure (IRP) for pharmaceuticals, enabling the agency to leverage decisions made by esteemed international regulators such as the US FDA, EMA, Health Canada, Swissmedic, and Japan’s PMDA. Phillips highlighted Chancellor of the Exchequer Jeremy Hunt's previous announcement regarding MHRA's intention to implement a swift and efficient system for approving medical products already authorized in select jurisdictions, signaling a significant step forward for device manufacturers. As MHRA prepares to publish a proposal for international recognition for medical devices this spring, Phillips emphasized the importance of readiness among stakeholders. "In the next year or so, prepare to bring your FDA approvals to the UK," he advised, underscoring the shift towards a model of international recognition in the post-Brexit regulatory landscape. See the full RAPs article here: https://lnkd.in/edBwf9GV

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🚀 Exciting News from the Medical Device Manufacturers Association (MDMA) Annual Meeting 🌐 At the recent 2024 Medical Device Manufacturers Association (MDMA) Annual Meeting, Richard Phillips, Executive Director of the Association of British HealthTech Industries (ABHI), shared insights that shed light on the UK's Medicines and Healthcare products Regulatory Agency's (MHRA) forthcoming plans. According to Phillips, MHRA is gearing up to introduce an international recognition framework for medical devices, aiming to streamline the process for bringing these crucial products into the UK market. This move comes on the heels of MHRA's earlier adoption of the International Recognition Procedure (IRP) for pharmaceuticals, enabling the agency to leverage decisions made by esteemed international regulators such as the US FDA, EMA, Health Canada, Swissmedic, and Japan’s PMDA. Phillips highlighted Chancellor of the Exchequer Jeremy Hunt's previous announcement regarding MHRA's intention to implement a swift and efficient system for approving medical products already authorized in select jurisdictions, signaling a significant step forward for device manufacturers. As MHRA prepares to publish a proposal for international recognition for medical devices this spring, Phillips emphasized the importance of readiness among stakeholders. "In the next year or so, prepare to bring your FDA approvals to the UK," he advised, underscoring the shift towards a model of international recognition in the post-Brexit regulatory landscape. See the full RAPs article here: https://lnkd.in/edBwf9GV

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https://lnkd.in/d4nWf3QP MHRA has this week released a policy statement setting out a framework to allow devices with comparable regulator country (CRC) approvals access to the UK market depending on device type, class, and prior approval. This welcome statement is an important step towards a smarter form of regulatory oversight for medical devices in Great Britain which reduces the duplication of assessments by comparable regulators. The statement proposes an international recognition pathway for access to the UK market to be  in place alongside the implementation of future core UK medical device regulations which are aiming to be in force in 2025. The proposed framework is yet to be finalised, but manufacturers should take account of the statement to start considering whether their devices will be eligible for the proposed alternative routes to market. Under the framework, manufacturers with eligible devices will be able to apply for a certificate of international recognition that will grant devices approved in Canada, the US, Europe and Australia access to the Great Britain market but would not provide a UKCA marking or UKCA certification. Manufacturers of medical devices would still have the option to use the UKCA marking to place devices on the Great Britain market. Software as a Medical Device (SaMD) (including Artificial Intelligence as a Medical Device (AIaMD) approved via a route which relies on equivalence to a predicate (US 510(k)) will not be eligible for this international recognition, but de novo or pre-market US-approved software as a medical device could take advantage of the proposed framework for UK market access. Market access for eligible devices would likely be in accordance with the validity of the supplied certificate from the CRC and must be re-certified when their original certificate, if applicable, expires, or if indefinite market access is granted by a comparable regulating country, the validity for the certificate of international recognition would be in accordance with the quality management system certificate Manufacturers will need to submit a dossier to the MHRA in the IMDRF ‘table of contents’ format, or equivalent format used in the CRC prior to and for AIaMD there will be a review of premarket (training and test) data, implementation verification and validation and use of predetermined change control plans. At Deviceology, we think this is a completely positive step in the right direction. This approach will remove unnecessary regulatory hurdles, reduce costs for manufacturers operating across multiple markets, and will hopefully encourage better patient outcomes by enabling faster market access for proven and safe innovations. We’ll continue to track these developments as they emerge, but well done MHRA.

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It is a very naive report and inadequately researched peice in The Guardian that says “Medical device companies pay millions to NHS while pushing products, says study” published in The Guardian on April 21, 20241. Here’s a summary with a focus on the impact of medical device companies in the UK healthcare system: Medical device companies are providing substantial financial support to hospitals in the UK. They contribute to staff training, awareness campaigns, and other initiatives while simultaneously promoting their products, which include implants, heart valves, and diagnostic equipment. This is nonsense! An analysis of disclosures by these companies revealed that between 2017 and 2019, they reported €425 million (approximately £367 million) in payments to healthcare organisations across Europe. Within the UK, they paid over €37 million to hospitals and other healthcare bodies during the same three-year period. This is an incomplete picture as it’s important to note that these figures likely represent only part of the actual payments. Many consultancy fees for medical staff and other payments remain undisclosed. There are concerns in this article that such payments can influence clinical decisions regarding the use of specific drugs and medical products. While the Association of the British Pharmaceutical Industry (ABPI) maintains a database called Disclosure UK for drug companies’ payments to healthcare organizations and individuals, it does not currently include payments by medical device companies. Despite the potential influence concerns, the financial contributions from medical device companies play a crucial role in supporting the NHS. These funds help train staff, raise awareness, and improve patient care. The NHS has also taken steps to accelerate the adoption of innovative medical devices. The MedTech Funding Mandate (#MTFM) policy, launched in April 2021, aims to facilitate quicker access to selected medical technologies. In summary, while there is reason for monitoring and measuring influence the collaboration between medical device companies and the NHS remains essential for advancing healthcare and patient outcomes. 🏥💡 Without the collaboration, the NHS would be in a far worse position than it is now. https://lnkd.in/ezn3kHY7 NEMERA. Novartis. Philips Fresenius Medical Care (Schweiz) AG. Siemens Healthcare FZ LLC B. Braun SE. Smith+Nephew. Getinge Drägerwerk AG & Co. KGaA Stryker CMR Surgical @

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Positive news in MedTech Dive that Venture Capital investment in medtech companies is continuing to recover. The recent UK election has gone some way to reducing the unknown for our market and we would hope the same effect will be seen in the US once the new President is in office early next year. Coupled with the potential of interest rates reducing, investors will be looking for better growth rates and could further open up the VC market. https://loom.ly/IMu0yO0 #MedTech #MedTechInvestment

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Join our session 'HWS: Using Quality Benchmarking Data to Create Value Based Healthcare Models', which starts at 13:00 BST today. Follow the link below to register... https://lnkd.in/ehVaacVM

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📣 The MHRA in the UK released a statement of policy intent. The goal is for the MHRA to recognize the approval of medical devices from regulators in Australia, Canada, the EU, and the USA. This proposed policy runs in parallel with the UKCA mark authorization, which is still an attractive option for those wanting to launch their medical devices in the UK. The MHRA continues to review the list of comparable regulator countries and is actively discussing with the Pharmaceuticals and Medical Devices Agency (PMDA) to explore the recognition of medical device approvals from Japan. The proposed frameworks are still in draft form, but the final version would be integral with the future core regulations. Make sure to stay updated on future medical device legislation and learn how PLG can continue to support your MDR and global registrations: https://lnkd.in/dW6cyy8A #mhra #medtech #medicaldevices #healthcare #lifescience #pharma #regulatory #pmda #ukca

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Discover our detailed three-stage process of onboarding new projects/partnerships by following the link: https://lnkd.in/epbGi6w6. From the initial no obligation consultation, the signing of non-disclosure agreements all the way to your very first device that we work on, our truly dedicated teams are always on hand to ensure that all projects commence on time, without a hiccup. #partnership #oemsupplier #oem #returntobase #fieldservicemanagement #engineer #biomedicalengineer #laboratorydevicemaintenance #medicaldevicemaintenance #preventativemaintenance #correctivemaintenance #FSN #Fieldsafetynotices

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Human factors engineers are often brought into projects too late. But what if they were integrated from the start? By fully leveraging HF expertise throughout medtech development, companies can reduce risk and speed products to market in at least seven different ways. One key benefit: HF helps create the right stimuli for user studies—just enough fidelity to get valid insights, without overcomplicating things. Take our work on the Dexcom G6. Our first foam models had no internals, yet they achieved exactly what was needed—thanks to an integrated HF team that kept the focus where it mattered. The result? More efficient iteration. Less cost. Less time. Ready to see how HF can transform your next medtech project? Get our white paper, “An Underutilized Role in Medtech” and explore our design for the Dexcom G6 - links in the comments. #medicaldevices #medtech #humanfactors

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Why is Design for Manufacturing (DFM) often an afterthought in medical device development? It comes down to early-stage priorities. In the rush to innovate and meet strict regulatory demands, teams are focused on one thing: creating a clinically effective, compliant product. Manufacturing? It’s left for “later.” Here’s why DFM should be a priority from the start - → 𝐂𝐨𝐬𝐭 𝐂𝐨𝐧𝐭𝐫𝐨𝐥 By factoring in manufacturing feasibility early, teams avoid expensive reworks, material waste, and blown-out budgets. → 𝐒𝐜𝐚𝐥𝐚𝐛𝐢𝐥𝐢𝐭𝐲 If a design isn’t built for mass production, demand spikes can quickly turn into manufacturing headaches. → 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐒𝐭𝐫𝐞𝐚𝐦𝐥𝐢𝐧𝐢𝐧𝐠 Adjustments to accommodate manufacturing at the eleventh hour often trigger additional regulatory reviews, delaying product launch. → 𝐑𝐞𝐥𝐢𝐚𝐛𝐢𝐥𝐢𝐭𝐲 Inconsistent manufacturing impacts product quality and patient safety. DFM mitigates risks, setting up for reliable, high-quality production. Follow for more.

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Evolving... but Not Immediately: The UK's Regulatory Landscape for Medical Devices. The UK's regulatory landscape for medical devices is undergoing significant change, with new regulations expected to take full effect by July 2025. This shift from the EU's CE marking to the UK's own UKCA marking will still profoundly influence procurement and maintenance strategies across healthcare facilities. However, it's important to note that the transition period allows continued use of CE marking for some devices. The UK government intends to recognise CE marking for medical devices for an extended period, possibly until 2028-2030 depending on the specific device type. Despite the delay, these upcoming regulations aim to enhance patient safety and ensure that devices meet rigorous standards through thorough conformity assessments and robust after-market monitoring. The changes will also increase the responsibilities of importers and distributors, particularly in ensuring traceability and compliance when UKCA marking becomes mandatory. For healthcare providers, this means it's still crucial to begin rethinking procurement strategies to favor suppliers who are prepared to comply with UKCA marking. Similarly, maintenance strategies must evolve to stay aligned with this dynamic regulatory framework. We understand the challenges these changes might pose, and we're here to help. Our deep expertise in supplying and repairing medical equipment positions us perfectly to guide you through compliant equipment procurement and ensure your maintenance protocols meet the new regulatory standards. By tapping into our comprehensive knowledge of these changes, we aim to keep your operations both efficient and compliant. We'll help you stay informed and prepared as you navigate these regulatory waters, ensuring seamless compliance and continued excellence in healthcare delivery. Stay Updated: For the latest information on UKCA marking for medical devices, please refer to the UK government website: https://lnkd.in/ervSGv4. #UKHealthcare #MedicalDevices #HealthTech #RegulatoryCompliance #Medtech #MedicalEquipment #MedicalSales

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"In the complex world of medical and pharmaceutical device manufacturing, where precision and efficiency are everything, the integration of truly interoperable software is not merely a ‘nice to have’, but a ‘licence to operate’." Stuart Powell, Global Head of Product at Kallik, discusses the potential challenges associated with integrating software into a business’ pre-existing digital ecosystem, and the importance of interoperability. Read more: https://lnkd.in/ghcf9EFn #MedTech #Insights #Regulation #Software

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Self-employment in the UK continues to rise! There is a lot of top senior medtech talent going down the independent / consultancy route right now. Typically people struggling to find work in current conditions... Restructures, mergers, acquisitions and liquidations! Leading to lay-offs, redundancies and in worst cases terminations. A lot of firms are downsizing leadership and reinvesting into individual contributors. Which means: Less opportunities = Leaders making it happen solo And a lot of people making a good success of it too Which will probably never look back into corp leadership. As the pendulum of the market swings, it's critical that firms have succession planning in place and continue to develop the born leaders of the future.

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✨Join us for a live webinar exploring the many opportunities within Quality Assurance for MedTech Professionals, hosted by industry experts from Key2Compliance✨ Whether you are just starting out or looking for mid-career progression, this webinar will equip you with practical strategies and actionable steps to support a successful career in MedTech Quality Assurance. You’ll have a chance to hear and discuss with a panel of experts actively working in the field as they share best practices for gaining valuable experience to support advancement in MedTech QA. ◾ What’s hot in the industry right now: We’ll discuss the areas and skills that are most in demand by employers and explore how technology is changing the game. ◾ Expert Insights: Hear from seasoned professionals as they share their unique career journeys and real-world experiences working as consultants and trainers in the Nordic region ◾ Develop Your Career Plan: Empower yourself with the tools and knowledge needed to craft your own career plan within the realm of QA. Discover the courses and certifications that can help you stand out. ◾ Interactive Q&A Session: Don’t miss the chance to engage directly with our panelists during the session! Ask questions, seek advice and make connections. Register now and take your next step to unlock your full potential in this exciting field 🚀👇🏻 https://lnkd.in/gX2fvnQ7 📅 Date: 28th of May 🕒 Time: 13:00-13:30

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Sustainable Medicines Manufacturing Innovation Programme 5 February 2025 Innovate UK, in partnership with the Department of Health and Social Care (DHSC), is investing in Expression of Interest (EoI) projects as part of the Sustainable Medicines Manufacturing Innovation Programme (SMMIP). SMMIP is funded as part of the wider VPAG Investment Programme agreed as part of the 2024 Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG). EoI seed funding will support the formation of consortia and the preparation of proposals for future large-scale Grand Challenges - large-scale collaborative research and development (CR&D) awards of up to £10 million per project. https://lnkd.in/ek-bN5hP

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