Archetype MedTech

⚠️This is worth a read - the World Economic Forum highlights AI’s transformative impact on healthcare, including enhanced diagnostic accuracy, optimised ambulance dispatch, and early disease detection. 🏥It emphasises the importance of responsible AI implementation to bridge global healthcare gaps, offering a compelling vision for AI-driven medical advancements. Take a look ➡️ https://loom.ly/irmm3ps

Thank you to Orthopaedic Product News for featuring our thoughts on the use of ISO 14971 in driving innovation. You can read it here 📖 https://loom.ly/rzjSmTY #medicaldevices #drivinginnovation #orthopaedic

The MedTech industry is just beginning to recover from the impact of the Medical Device Regulation (MDR), which required significant resources to address compliance, but with questionable improvements in patient safety. With that in mind, is now really the right time for the EU to introduce another broad regulation that could further limit EU patients' access to beneficial new devices? This article by @osborneclarke provides a good overview of the new ‘green deal’ for MedTech. See what you think. https://loom.ly/0jwyy8Y

Archetype’s principal consultant Dr Stuart Grant recently shared his review of Biodesign: The Process of Innovating Medical Technologies by Yock et al – one of the two books he recommends as the perfect starting point for understanding the medical technology product innovation process. Here are his thoughts on the second ‘essential read’ - Medical Device Design: Innovation From Concept To Market, by Ogrodnik. With his extensive experience as a biomedical engineer, Ogrodnik crafts a detailed guide that walks the reader through the entire lifecycle of medical device innovation, from initial concept to market entry. The book is structured to provide a clear understanding of each phase of the medical device design process. Ogrodnik begins with an insightful overview of the medical device industry, highlighting the unique challenges and regulatory requirements that innovators must navigate. This sets the stage for a comprehensive exploration of the design and development process. My three standout takeaways: • A practical approach - Ogrodnik does not merely present theoretical concepts; he integrates real-world examples, case studies, and practical exercises, ensuring readers can apply the concepts to their projects, making the book a valuable tool for both students and professionals. • Demystifying the complex regulatory landscape - Ogrodnik provides clear guidance on compliance with standards such as ISO 13485 and FDA regulations. His step-by-step approach to design verification and validation provides an especially useful compliance roadmap. • Focus on user-centred design – Ogrodnik underscores the importance of understanding the end-users’ needs and incorporating their feedback throughout the design process. This user-focused approach not only enhances the usability and effectiveness of medical devices but also aligns with current industry best practices. Conclusion: Ogrodnik’s expert insights and practical guidance provide a comprehensive framework for navigating the complex journey from concept to market, making this book a cornerstone in the field of biomedical engineering and an essential read for anyone involved in medical device innovation. #medtech #bookreview

IEEE has introduced a new standard (2933) addressing cybersecurity threats in medical devices. It emphasises the importance of the TIPPSS framework - Trust, Identity, Privacy, Protection, Safety, Security - in ensuring secure device interoperability, thereby enhancing patient safety and healthcare efficiency. @medicaldesign&outsourcing provides a good overview of it here: https://loom.ly/HV6oRI8

Great discussion with the Chair of NHS England - Richard meddling at the Giant health conference. #gianthealth #medtech #archetypemedtech

It takes a multitude of in-house teams and consultants to drive a MedTech product from seed of idea to market approval, with complex layers of overlap between product design and development, quality assurance, regulatory documentation, marketing and project management. So why add Archetype to this heady mix? Simple: We integrate seamlessly with all your in-house teams and external consultants to ensure the end goal of market approval remains front and centre at every stage of the journey. Which is easier said than done. Our unique combination of specialised market approval knowledge and front-end product innovation and development will give your product the best possible chance of making it onto the market and transforming the lives of patients. Why not take a closer look at how we do it: https://loom.ly/xkpOiGo #ArchetypeMedTech #MedTechinnovation #marketapproval

It takes a multitude of in-house teams and consultants to drive a MedTech product from seed of idea to market approval, with complex layers of overlap between product design and development, quality assurance, regulatory documentation, marketing and project management. So why add Archetype to this heady mix? Simple: We integrate seamlessly with all your in-house teams and external consultants to ensure the end goal of market approval remains front and centre at every stage of the journey. Which is easier said than done. Our unique combination of specialised market approval knowledge and front-end product innovation and development will give your product the best possible chance of making it onto the market and transforming the lives of patients. Why not take a closer look at how we do it: https://loom.ly/xkpOiGo #ArchetypeMedTech #MedTechinnovation #marketapproval

This ophthalmic technology is fascinating, and I’m keeping an eye on @siliton to see this company’s progression! 👀 https://loom.ly/iB7wGws #opthalmic #medtech

In the “Flying the Flag for Innovation” podcast John Bessant highlights the value of symbols in fostering innovation, tying this concept to ISO 56000, the international standard for innovation management. He emphasizes how ISO 56000 provides a structured framework for driving innovation and aligning organizational efforts. Bessant likens the ISO standard to an “innovation flag,” symbolizing commitment to creativity and systematic progress. By adopting ISO 56000, organizations can demonstrate their dedication to building a culture of innovation, uniting teams under a shared vision and ensuring consistent practices for sustainable growth and competitive advantage. #johnbessant #ISO56000 #MedTech  #MedTechInnovation  #Archetype https://lnkd.in/efqrN3rd