Custom Medical

It’s about to start!   Today marks the beginning of #4CUnplugged 2025 in Tübingen – where the MedTech community comes together to share ideas, build connections, and spark collaborations.   We’re thrilled to be there as a sponsor, with our Head of Operations, Dr. Jonas Walter, on site to take part in an exciting afternoon of innovation and networking.   Hosted by Medical Innovations Incubator GmbH, 4C Unplugged brings together startups, established manufacturers, investors, and healthcare partners from across Germany – all united by a shared goal: advancing medical innovation through collaboration.   For us at Custom Medical, it’s the perfect opportunity to connect with like-minded experts, exchange perspectives on usability and human factors, and see how the next generation of MedTech solutions is taking shape.   Here's to a great afternoon full of inspiring people, new ideas and interesting conversations! 🚀   #4CUnplugged #HumanFactors #MedicalDevices #UsabilityEngineering #CustomMedical

Hello from HFES ASPIRE 2025 International Annual Meeting!   This week, our colleague Stephanie Mello is in Chicago, immersing herself in the conversations and sessions that bring together some of the brightest minds in human factors, UX, and ergonomics.   ASPIRE is all about advancing how research and design improve the systems we rely on every day – from everyday tools to life-saving medical devices.   For us at Custom Medical, it’s an opportunity to connect with others who are just as passionate about designing for people – and to explore how emerging topics like AI in usability, systems thinking, and cross-disciplinary collaboration are shaping the future of medical device development.   Stephanie is soaking up fresh insights and inspiration throughout the week – and we can’t wait to hear what she brings back to our team.   If you’re at HFES - Human Factors and Ergonomics Society ASPIRE 2025, say hi to Stephanie or reach out to connect!   #ASPIRE2025 #ASPIREHFES #HumanFactors #MedicalDevices #UsabilityEngineering #CustomMedical

⚖️ When it comes to human factors validation, one question with which teams often struggle is: should the study be carried out internally, with freelancers, or through an agency?   Each option has its strengths. Internal teams can bring cost savings and deep product knowledge, but often face bias or limited capacity. Freelancers are flexible and can be brought in quickly, though scalability and process certifications are concerns. Specialized agencies offer broad expertise, certified processes, and international reach, but require higher budgets and time to onboard.   So which way to go? There’s no universal answer. The best choice depends on your device, your team, and your resources. In fact, for some projects, a combination of approaches works best.   👉 In our latest blog, we compare the pros and cons of all three approaches to help you make the right decision for your next usability validation: https://lnkd.in/eYmw-ht7   #HumanFactors #MedicalDevices #UsabilityEngineering #CustomMedical

When you’re keeping a human liver alive outside the body, every detail matters.   That’s why we chose a dashboard approach for Apersys AG Apvia: to give clinicians one clear overview instead of forcing them to search across screens.   At the center: the liver itself. Around it: all critical values – from perfusion pressure to oxygen levels – arranged to mirror the clinical workflow. This design helps clinicians instantly see what’s stable, what’s changing, and where action is needed.   It also can be adapted to the user’s needs using customizable views. Clinicians can highlight the parameters most relevant to their role or situation, while still keeping the whole picture.   By combining clarity with flexibility, the dashboard reduces information overload without hiding critical details. The result: a user interface that supports both fast orientation and in-depth analysis – exactly what’s needed in high-stakes clinical workflows.   👉 In our new case study, we take you behind the scenes of how Apersys Apvia was designed – and how it became a Red Dot Award: Interface & User Experience Design 2025 winner.   Link in the comments!   #Apersys #Apvia #UIDesign #HumanFactors #MedicalDevices #UsabilityEngineering #CustomMedical

How can UX help AI-driven health products meet MDR, GDPR & FDA requirements? – Hear our perspective at UIG-Tagung 2025   We’re excited to share that our Chief Growth and Innovation Officer, Dr. Benjamin Franz, will be speaking at this year’s UIG e.V. conference in Karlsruhe.   His talk will explore how UX acts as a key enabler for innovation in AI-driven medical and health products – even under the strict regulatory frameworks of MDR, GDPR, and FDA.   📅 24 September 2025 📍 Karlsruhe   If you’re working on AI in MedTech, this is a chance to learn how usability can turn compliance challenges into opportunities for better, safer, and more user-centered products.   👉 Event info: https://lnkd.in/eZ9jajpk     #UIG2025 #AI #UX #HumanFactors #MedicalDevices #UsabilityEngineering #CustomMedical

🔍 Is your medical device ready for human factors validation? A successful usability validation study depends on more than regulatory checkboxes. These five factors consistently make the difference between smooth approval and costly setbacks: 1️⃣ Risk-driven approach — Define potential use errors and critical tasks clearly, guided by your URRA. Use those scenarios in the human factors validation. 2️⃣ Equipment readiness — Every tool, disposable, and device must be available and ready. 3️⃣ Real-world conditions — Simulate actual use: lighting, noise, workflow, and ergonomics. 4️⃣ User recruitment — Participants must reflect your intended user groups, in both demographics and skills. 5️⃣ Expert oversight — Independent specialists can identify gaps and ensure regulatory alignment. Do you want to learn more about how to prepare for a human factors validation? Read our full blogpost / checklist here: https://lnkd.in/eV4Phh2V   #HumanFactors #MedicalDevices #UsabilityEngineering #CustomMedical

🏆 We did it – together with Apersys AG, we’re proud to announce that Apersys Apvia has won the Red Dot Award: Interface & User Experience Design 2025!   Apersys Apvia is a groundbreaking platform that keeps donor livers viable for up to seven days outside the human body. This opens up entirely new possibilities in transplantation, giving physicians more time and patients more hope.   Our contribution at Custom Medical: designing a user interface that turns this highly complex technology into something clear, safe, and intuitive for clinical teams to use. A huge thank you to Apersys for the collaboration and trust.   This award also marks our sixth Red Dot – and each one reminds us of why we do what we do: making medical innovation accessible through outstanding usability and design.   ✨ We’ll be sharing the full case study soon – follow us and stay tuned!   #RedDotAward #Apersys #Apvia #HumanFactors #MedicalDevices #UsabilityEngineering #CustomMedical

Do you know the preconditions for a successful summative evaluation? 🔍   Many usability validation studies stumble before they even begin — not because of the product itself, but because the groundwork wasn’t solid. The most common gaps?   1️⃣ Risk-driven design — A robust Use-Related Risk Analysis (URRA) should be used to guide scenarios and task selection for usability studies (formative and summative) 2️⃣ Formative foundations — Use formative usability studies to uncover and fix usability risks before usability validation. 3️⃣ Clear instructions — IFU, labels, and training should be tested with real users as well, to ensure nothing is left ambiguous.   Getting these preconditions right isn’t optional. They’re the difference between a smooth approval process and costly, time-consuming setbacks.   Do you want to know more about other preconditions and the preparation of a summative evaluation? Check out the full checklist to make sure your team is prepared: https://lnkd.in/eV4Phh2V   #HumanFactors #MedicalDevices #UsabilityEngineering #CustomMedical

Internal, freelancer, or agency? How to choose the right setup for your human factors validation? Each option offers distinct advantages – and potential drawbacks: Internal teams ✔️ Availability, cost-effective, deep product knowledge ❗️ Risk of bias, low scalability, have to been built   Freelancers ✔️ Flexible, cost-efficient for specific tasks ❗️ Limited scope, reliability risks, challenges with international studies and quality assurance   Specialized Agencies ✔️ Scalable resources, certified processes, usability labs, international reach ❗️ Higher costs, onboarding time   The best choice depends on your device, your team, and your long-term needs. In some cases, a combination is the most effective solution. In our blog post we give you a more detailed breakdown: https://lnkd.in/eYmw-ht7   #HumanFactors #MedicalDevices #UsabilityEngineering #CustomMedical

🔍 Preparing for summative evaluation?   Success depends on more than checking regulatory checkboxes. A robust usability validation study requires careful planning to avoid delays, costly repeat studies, or regulatory pushback.   Here are five essentials every validation study should cover:   1️⃣ Guideline Alignment — Understand your target market's regulations to avoid surprises. 2️⃣ Risk Definition — Identify critical tasks and potential use errors early and use them in development. 3️⃣ Participant Matching — Recruit users who reflect your intended user groups exactly. 4️⃣ Adequate Planning — Plan for the right sample size and account for potential dropouts. 5️⃣ Realistic Environment — Test under conditions that mirror real-world use.   We've written a full checklist on preparing for summative evaluations. If you want to dig deeper, here it is: https://lnkd.in/eV4Phh2V   #HumanFactors #MedicalDevices #UsabilityEngineering #CustomMedical