Stratus Design

???????????????? ???? ???????? ?????????? ?????????????? ???????????? ???? ?????? ?????????? ???????????????????? ?????????????? ?????????? ?????????????? ????????????????! We are very happy to be participating tomorrow, Thursday 11/14, in #NEMIC's 2024 HealthTech Pitch Night & Showcase!?Come visit us and stop by our table to network over complimentary refreshments. REGISTER TO ATTEND: https://lnkd.in/dgQnSrrJ Date: Thursday, November 14th Time: 4:00 - 7:00 PM Location: Venture Cafe Providence, 225 Dyer Street Providence RSVP via link above #StratusDesign #NEMIC #HealthTech #MedTech #Innovation #PitchNight

Announcing the pitch lineup for the November 14th NEMIC HealthTech Pitch Night & Showcase! Come hear pitches from: - Reach Neuro, Inc. - KT Cath (Katelyn Holt RN BSN-CMSRN, BS) - EMBioSys - Docs for Health - Native Orthopaedics - CranioSense - Just Breathe (Greg Calderiso) - Lectra Tech - FreezeNit Inc. We'll need your vote for the "Popular Choice" prizes?and make sure to enjoy pizza courtesy of Plant City and beer and wine courtesy of The Guild! Date: Thursday, November 14th, 4-8 PM Location: Venture Café Providence, 225 Dyer St Providence Join us in hearing some amazing pitches and learning about companies making a true impact. We hope to see you there! Register to attend in the link below: https://lnkd.in/eJ7ska6k #HealthTech #MedTech #LifeScience #Innovation #StartupShowcase #PitchNight #NEMIC Venture Café Providence RI Bio RI Life Science Hub

???????????????? ?????????????????? ?????? ????????'?? ???? ?????????????????????? ??????????????????! It was great to reconnect and collaborate with colleagues at the AAMI HF Committee Meeting earlier this week. I’m happy to share that after countless hours of refining and updating, the HE75 Standard is moving toward its final vote before public comment—a major achievement for the AAMI Human Factors Engineering Working Group! Special recognition goes to our dedicated co-chairs, Mary Beth Privitera and Molly Story, and to all those who’ve contributed over the years, including the late Daryle Gardner-Bonneau, Ella Cozmi, and Sean H?gen. But that’s not all—we’re also kicking off new initiatives to look into and potentially draft Technical Information Reports (TIR's) to provide additional guidance for the topics of Use-Related Risk Analysis (URRA), usability of at-home IVD test kits, conducting usability evaluations/testing, the design of augmented/mixed reality (AR/MR) systems, and for Artificial Intelligence and Machine Learning (AI/ML)-enabled devices. These steps will help support usability and drive innovation in healthcare! What do you think? I’d love to hear your thoughts and answer any questions. Share your comments and/or questions below! #AAMI #HumanFactors #MedicalDevices #Innovation #Usability

?????????????? ?????????????? ?????????????? ???????? ??: ???????????????? ?????? ?????? ?????????????????? ?????????????????????? ?????????????? ???? ?????????? Much like users and the use environment, a focus on risk is something regulatory processes in China, the EU and the USA have in common. Way back in August, we looked at classification of devices in China (3 classes) and the importance of risk and use-risk in human factors. Criticality isn't the only way to slice up tasks, the Guidelines for Review of Medical Device Usability Engineering Registrations also consider urgency and frequency. Though only the seriousness of a harm associated with potential use errors is used to define critical tasks, the other dimensions can be useful to keep in mind. Risk management should be strictly traceable and incorporate all parts of a device – that includes training, the instructions for use, cleaning, transport and storage! Look at the image below. What risk mitigation measures can you spot? There's a warning on the steps, there are belts to keep patients on the cot, paper covers on the cot – and probably many more! #instructionsForUse #RegulatoryInChina #MedicalDevices #Regulation #China #Healthcare #usabilityEngineering #usability

?????????????? ?????????????? ?????????????? ???????? ??: ???????????????? ?????? ?????? ?????????????????? ?????????????????????? ?????????????? ???? ?????????? We've looked at who is using medical devices, but what about where? The "Guidelines for Review of Medical Device Usability Engineering Registrations" call for the use environment to be defined for the Chinese market. The use environment can range from outpatient rooms, emergency rooms, operating rooms, wards, ambulances, homes or public places. The environmental conditions include but are not limited to space, lighting, temperature, humidity, air pressure, cleanliness, noise, vibration and radiation. ?? Keep in mind, that as with the users, the use environment must fit China. For example, while minimum room sizes for a CT scanner are often defined by the manufacturer, what the surrounding rooms look like can vary from country to country. Where in Europe a dedicated viewing room may be available just for the CT scanner, in China the viewing area may serve multiple radiology devices, have desks for multiple techs, and might even have an axolotl for luck – like one clinic we visited in China! #instructionsForUse #RegulatoryInChina #MedicalDevices #Regulation #China #Healthcare #usabilityEngineering #usability

We had a great time this year at MEDevice Boston! I can hardly believe a week has passed. It was great to connect with our peers as well as make new friends and learn of new opportunities to collaborate on new innovations. One of our greatest joys is smoothing the path for our clients. And we at Stratus Design will be working on fostering these new friendships in the coming weeks and months! The addition of Start-Up Stadium was one of my personal favorites this year. Such a great way to see and interact with cool, thoughtful innovations and meet the people that drive the startups. Many thanks to all the people that made this conference a success. I'm looking forward to see what next year brings! Connect with Stratus Design, and together we'll turn complexity into clarity — and solutions! #StratusDesign #MEDeviceBoston #MedicalDevices

It’s not often we are filing and receiving approval for the same medicine, by three major regulatory authorities, in less than a year! Today, I’m pleased to share that our treatment – the first-ever biologic for?certain adults with uncontrolled Chronic Obstructive Pulmonary Disease?– was approved by the US FDA and the China NMPA. This on the heels of approval in the European Union less than 3 months ago. ? These consecutive approvals speak volumes of the urgent need for more treatment options, and the potential impact for thousands of patients living with COPD.?? ? I would like to thank?all the?Sanofi?and?Regeneron?teams whose collective efforts led up to these approvals and who will continue working with other regulatory authorities around the world. ? Bringing forward breakthrough medicines with the potential to shift treatment paradigms is the driving force behind our ambition to be the leading immunology company and, importantly, our steadfast commitment to patients. Learn more about the US approval: https://lnkd.in/ddEwfhZS ...and China approval: https://lnkd.in/d3hjXM7G