Ryan Olmstead

Engineer Aid's first blog post - What are Medical Device User Needs? Follow the Engineer Aid page for more! #medicaldevice #productdevelopment #designcontrols

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At the heart of human factors engineering is understanding the challenges and constraints of users, whether they’re surgeons in an operating room, nurses in an ICU, or patients managing chronic conditions at home. By involving end-users early and throughout the development process, we can create devices that are not only effective but also truly life-changing. Here, Marcus Agunloye talks about the importance of human factors in device design. #MedicalDeviceDesign #MedicalDevices #HumanFactors #PatientSafety #MedTechInnovation #UsabilityEngineering https://lnkd.in/eiVJv-FE

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Revisit an enlightening interview featuring the late Sean Hägen, founder of BlackHägen Design, a trailblazer in product design and Human Factors Engineering. Explore pivotal discussions on the integration of Human Factors in medical device design. Key Points Covered: 🔹 UFMEA vs. URRA: Know when to employ each method effectively. 🔹 Early integration of human factors and usability engineering for enhanced user experience and risk mitigation. 🔹 Strategies for gathering patient insights and integrating them into product development. 🔹 Pitfalls to avoid in human factors studies for smoother project execution. 🔹 FDA's evolving approach to human factors and the pursuit of continuous improvement in device safety and effectiveness. This interview is an invaluable resource for designers, engineers, and usability specialists in the medical device industry. Don't miss out on these enduring perspectives! Full Interview: https://buff.ly/3QuIggn #HumanFactors #MedicalDeviceDesign #UXUI #ProductDevelopment #UsabilityEngineering #DesignThinking

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Why is Use-Related Risk Analysis (URRA) critical for medical device development? Learn how early URRA integration transforms device development in the second article of our five-part series: https://bit.ly/4aMW3qJ #humanfactors #medicaldevices #URRA #healthcareinnovation

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🔍 Understanding Human Factors Research in Medical Device Design In the complex world of medical device development, it's crucial not just to design, but to design with the user in mind. Human Factors Research (HFR) offers invaluable insights into how patients interact with devices, highlighting areas for enhancement and reducing risks associated with poor design. Early-stage HFR is not merely a regulatory checkbox but a proactive step towards safer, more effective medical treatments. From sensitivity in participant recruitment to the critical importance of meeting diverse user quotas, HFR tackles the intricate challenges of aligning medical device usability with the real-world needs of those it aims to serve. The process, while demanding, is essential for developing devices that are not only innovative but also inclusive and effective. Discover more about how Human Factors Research is shaping the future of medical device design and why it's indispensable in our pursuit of better health outcomes. https://lnkd.in/gbb4zAWh #HumanFactorsResearch #ProductDesign #Medtech

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How Design for X methodology could be applied to achieve cost-effectiveness when extending the life of an existing medical product design https://hubs.li/Q02VqjwJ0

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Season 7 of the Reliability Leader Podcast is here! In today’s episode, Arash Samimi, PhD and I talk about how to make safe medical devices and how do we make sure these devices work well and safely? Listen to the full episode here: https://lnkd.in/ed5CyesS #reliabilityleader #podcast #medicaldevices

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Usability engineering is where technology meets humanity and if they don’t meet to the likes of humanity, it renders the technology obsolete regardless of its innovation.

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From model to prototype in under two weeks. Giving a shout out to the Schivo team that quickly completed a new scissor prototype for one of our Medical Device clients. You truly embody our motto of making possible happen! 📅 Time from new cad model to quote = 1 Day 📅 Time from approval to 20 prototypes = 6 Days Whether you are an early-stage innovator or looking to improve an existing design, Schivo's skill, expertise, and use of technology enables us to readily prototype your design, develop a proof of concept, and create a repeatable manufacturing process to make your vision a reality. Schivo. We make possible happen. #Innovation #Medtech #MedicalDevices  #LifeSciences  #Manufacturing #prototypes

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Follow up more with Araya Amsalu, PhD, Director of Human Factors & Systems Engineering at SES Force-4 after his webinar with Korea Health Industry Dev on navigating the challenges of #medicaldevice usability testing for US FDA submission. Remember the 3 steps to success; Identify, Mitigate and Demonstrate. •Identify anticipated and unanticipated use errors and determine how hazardous the consequences are •Develop and apply measures to mitigate or control use-related risks that could result in harm •Demonstrate safe and effective device use through human factors validation testing #Engineering #Innovation #FDAApproval #LifeSciences #HumanFactors #MedTech #Korea

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Turning patient anxiety into confidence is a challenge that demands technical precision and empathy. A critical aspect of any design effort is using design research to dig into the roots of what makes medical devices intimidating for patients. We then apply this understanding to develop solutions that are straightforward and reassuring. By simplifying interfaces and enhancing usability, we make sure that even the most advanced therapies are approachable and manageable for everyone involved. #DesignForComfort #TechInHealthcare #SimplifyingInnovation

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The typical engineering framework involves identifying a problem and finding a cost-effective solution. Josh Divaker explores this traditional approach and emphasizes prioritizing user perspectives in medical device design. How do you prioritize user perspectives in your work? Share your insights below! #HumanFactors #UserCenteredDesign #BiomedicalEngineering #InterviewSeries

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In medical device development, human Factors should be like a movie director, not a movie critic. Instead of being brought in to consult at the end, HF should be involved throughout a project, “directing” development at every stage. Integrating HF fully into your design team could minimize project risk and speed your product to market. Ready to delve deeper?  In our new article, we explain:  ⚙️ How to fully leverage human factors expertise to reduce risk in medtech development ⚙️ What happens when HF is used to its fullest ⚙️ If you can’t use HF like we suggest, what you can do to still reap some of the benefits it provides. Read on: https://hubs.la/Q02yCgcs0 -- Hello. We're Delve, a product innovation firm. We help companies bring bold ideas to market through human-centered expertise—strategy, design, engineering. Learn more about medical device development services at Delve: https://hubs.la/Q02yCbq60 #medicaldevice #medtech #humanfactors

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Making your Design Easier to Build and Scale Designing hardware that’s not just functional but also easy and cost-effective to manufacture can really set your product apart. Check out these tips on collaborating with your Contract Manufacturer to cut costs, improve reliability, and get your product to market faster. Big shoutout to Yoku Sashida for all the valuable insights and support in putting this together! 👏 Ready to make your next product smoother and smarter to manufacture? Swipe through to see how. #DFM #Manufacturing #HardwareDesign #Engineering #ProductDevelopment

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In medical device development, Human Factors should be like a movie director, not a movie critic. Instead of being brought in to consult at the end, HF should be involved throughout a project, “directing” development at every stage. Integrating HF fully into your design team could minimize project risk and speed your product to market. Ready to delve deeper?    In his new article, Curt Irwin explains:  ⚙️ How to fully leverage human factors expertise to reduce risk in medtech development ⚙️ What happens when HF is used to its fullest ⚙️ If you can’t use HF like we suggest, what you can do to still reap some of the benefits it provides.   Read on: https://lnkd.in/dA36j26J -- Delve is a product innovation firm that helps companies bring bold ideas to market through human-centered expertise—strategy, design, engineering. Learn more about medical device development services at Delve: https://lnkd.in/ddPTE-fi   #medicaldevice #medtech #humanfactors

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🌟 The Importance of Human Factors and Human-Centered Design 🌟 🛠 “The Instructions For Use is much better than the instructions you receive from IKEA!" (feedback user simulated-use formative human factors study)   This is a post about an Instructions For Use that metamorphosed into a masterpiece.   🎤At the 3rd Annual European Medical Device Human Factors and Usability Engineering Conference 2024 in Berlin Tabea Daunus from uintent and I delivered a captivating presentation titled “Optimizing Instructions For Use - A human-centered approach”.   🩺Topic: Device Development of a Drug Device Combination Product for Clinical Trials intended for professional use and home use by lay users. 👥 Based on a case study, we demonstrated how involving users early and iteratively have helped to optimize the Instructions For Use based upon users’ needs. 🔑The core element: Craft designs actively with the user, for the user.   👓 The vision: Designing products with the users' needs at the forefront, to not only build the product right, but to build the right product for the intended users. 🤝 A huge THANK YOU to all contributors involved in the development of the Instructions For Use. It massively helped to create a safe, effective and enjoyable Instructions For Use that is both functional and considerate. 🙏 A special thank you also to TT Lifesciences for the outstanding organization.

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With medical devices, ensuring usability and safety is paramount. One significant challenge we often encounter is working with user interfaces (UIs) of unknown provenance—those whose design and development history are unclear or undocumented or were developed before the usability engineering standards were in existence. This doesn't always have to be a software interface, it can be as simple as opening a device and using it as per the instructions provided. EN 62366 has provisions built in to make assessment of these UOUP (User Interfaces of Unknown Provenance) using market data that's been collected using post-market surveillance, avoiding the requirements to perform formative and summative assessments.

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