in2being, LLC’s Post

There is one question that all your buyers have in common. 👇💰 How much will it cost me? This question will keep on coming so you best answer it quick! But how do you do that in Medical Device??? Learn the best way to answer this question with our guide to writing pricing and cost articles with our complete guide here on our learning hub: https://bit.ly/49PJSbs #contentmarketing #inboundmarketing #TheyAskYou Answer #medicaldevices

Goal-setting... it's a crucial aspect to ponder when developing your medical device. It's important to think about your end goals from the very beginning, so you can determine the best path to take. What are your goals when it comes to device capability, medical use, and the desired scenarios in which you would like your device to be effective? Consider these goals as you are planning your project.

Maybe you are involved with #medicaldevices. Maybe you are just interested in this increasingly connected industry. (We certainly are!) Either way, if you haven't had an opportunity to see our latest #FieldServiceMedical eBook with Cumulocity, be sure to check it out: https://lnkd.in/e_HfyaeR In ""Navigating the Intersection of Innovation and Regulation for Connected Medical Devices," you will find actionable insights about: - Challenges in bringing connected medical devices to market - The relationship between regulatory frameworks and innovation - What to expect from the future of this space Enjoy!

So let’s talk about Day 1: What Are Medical Devices? | Quick Intro to Healthcare Tools In this quick intro, we’ll explain what medical devices are, from simple bandages to complex heart pacemakers. Discover why these tools are essential in healthcare and get a glimpse of what’s coming up in our series. Question of the Day: What’s a medical device you’ve used? Drop your answer in the comments! #medical #devices #day1 #educational

Important key points to remember in any software as a medical device: -Software errors may impact the quality/or the life of patients. -Non-secure software may leak patient information. -Non-validated algorithms may produce wrong results, affecting decisions/treatments and finally the patients' quality/or life. Like many medical devices, the quality starts since conception hence it is essential to follow good design practices i.e design controls: https://lnkd.in/eRBFM74s

Excellent listen from Monir El Azzouzi of Easy Medical Device and Cesare Magri of 4BetterDevices. 🌟 One key highlight for me was the discussion on various sources of data, particularly the comparison between databases and search engines. It raised an intriguing question: how does the importance of search reproducibility differ between PMCF (Post-Market Clinical Follow-up) and SOTA (State-of-the-Art) literature searches? 🌟 Cesare made a thought-provoking point in the context of evaluating device safety and performance, stating, "The fact that you find something … is much more important than how you found it." This insight underscores the need for medical writers to adopt a creative and flexible approach in their searches. ❓ It left me reflecting: what are some of the less conventional databases, registries, or sources of data where you have discovered unexpected yet valuable information for evaluations? I’d love to hear about experiences with uncovering those hidden gems! https://lnkd.in/dw6S3EbA

Are you an innovator, engineer or entrepreneur committed to improving healthcare? We've got a guide for you! In this e-book, we look at one of the most well-known yet controversial stories in the medical startup world: Theranos. By understanding what went wrong, we can gain profound insights into the essential pillars of successful medical device development. This e-book explores the five key factors that are crucial at every stage of development, from concept to final implementation with the patient. Let’s embark on the journey together towards a deeper understanding of what it takes to develop medical devices that not only meet the highest standards of quality and safety but also truly make a difference in the lives of patients worldwide. Get your guide here: https://lnkd.in/enDYJJCQ

Software as a Medical Device

For a #SaMD beginner the biggest difficulty is to grasp the multitude of regulations that your software has to meet. It depends on the intended use and the purpose of discussed software, but it’s never just one standard you have to follow - there are many of them. They revolve around: - risk cathegory and management, - quality management, - software development cycle (design, development, validation, maintenance), - usability studies, - providing security, - product’s lifecycle And many more aspects you need to have in mind when working on software for health purposes. The graphic by Christian Kaestner and Medical Device HQ outlines it pretty well 👏🏻

Hands up if you find the many regulatory standards surrounding medical device development confusing...if your hand is raised, you're not alone. However, it's important not to bury your head in the sand, as developing within a regulatory framework is critical in ensuring the safety and usability of your medical device. Our latest #blog - Navigating Medical Device Standards - will help! Our Head of Software, John Connah, has created a 'beginner's guide' that looks at the regulations and development standards that should be considered when developing a medical device. https://lnkd.in/eeHsbray