WuXi AppTec’s Post

In some ways, devices for generic pharma have all the same needs as for innovators: rapid scalability, reliability, safety, efficacy, low cost of goods, etc. But they also have some distinctive challenges driven by the regulatory route and the IP environment of the ecosystem. Our drug delivery experts have put their years of experience in generics together and outlined TTP's take on rapid, low-risk generic device development. Read the full article here: https://lnkd.in/eGS-bnyE #scalabledesign #drugdeliverydevices #makemillions

#Medical_Device_Testing_Services Market is estimated to grow at a high CAGR >> https://lnkd.in/dxga2YDm #Medical device testing #services refer to a range of specialized services provided by testing #laboratories and organizations to #evaluate and assess the safety, #effectiveness, and #quality of medical devices. These services are #essential to ensure that medical #devices meet #regulatory #requirements and #perform as intended, providing #reliable and safe #healthcare solutions for #patients. SGS Holding a.s. Labcorp American Preclinical Services, Now Part of NAMSA Sterigenics Charles River Laboratories Element Materials Technology Eurofins Scientific Finland Oy Pace® Analytical Services Intertek Group-Panama #technologies #marketgrowth #medicaldevicemanufacturing #testingsolutions #biotechnology #quality

Download your free report summary here: https://lnkd.in/d5V_kRgz A growing emphasis on patient-centered care and the swift pace of innovation in the healthcare sector have led numerous biopharmaceutical and medical device companies to develop "connected healthcare applications," which improve current drug delivery or device systems and gather vital treatment data. According to Best Practices, LLC’s benchmarking research, among companies with direct access to connected device data, 75% receive device usage logs for all user interactions, with half of these companies also obtaining user input data. Our study, titled "Connected Health Excellence: Assessing the Development, Deployment, and Impact of Integrated Treatment Apps," delves into the benefits and business rationale for connected apps and delivery systems, standard data gathering procedures, excellence in product development, models of external partnerships, and current regulatory approaches. Grab your free report summary now: https://lnkd.in/d5V_kRgz #connectedhealth #connecteddevices #integratedtreatment #connectedapps #app #pharma #medicaldevices #biopharma

▶️ User unmet needs: Towards mitigating the incidence of incorrect differentiation of insulin long acting & rapid acting medicines in pen devices at the domestic setting Join Dr. William Denny, Sandoz Device Development Centre and the industry leaders in exploring the forefront of industry trends, connecting with professionals, and gaining insights that drive progress, sign up for the upcoming #VLDDCP 🔸6th Drug-Device Combination Products🔸 📆October 15-16, 2024 📍 Berlin, Germany 🔗Register 👇 https://buff.ly/4cH86Xd The summit aims to address the critical importance of ensuring harmony between drug products and their delivery mechanisms towards the successful advancement of sustainable and connected combined drug-device products #combinationproducts #design #engineering #drugdelivery #future #digital #connecteddevices #medicaldevices #compatibility #suspensions #sustainability #digitalhealth #autoinjector #injectors #medtech #contractmanufacturing #drugdevelopment #DDSs #innovation #conference #summit #ssr #humanfactors #pharmaceuticalmanufacturing #regulatory #externalinnovation #formulation #injectabledrugs #injectables #injectiondevices #digital #materialscienc

🔍✨ Integrating Medical Device & Drug Guidance ✨🔍 Ever wondered about the intricate dance between medical device and drug guidance in manufacturing processes? 🧪🏥 Dive into my latest blog post where I unravel the fusion of perspectives, offering insights that could transform your validation strategies! Click for a deeper exploration. https://lnkd.in/erbJ6hbg #ManufacturingRegulations #QualityAssurance #ProcessOptimization 💡🔬

BIG NEWS! A new day has come, and your recognized preclinical partner AccelLAB is back to serve your medical device evaluation needs. Your recognized entrepreneurial medical device preclinical research partners are back. After some time under the direction of Charles River Laboratories, key members of the management team acquired the group. Our AccelLAB medical device team of preclinical experts is proud to announce that we are returning with our entirely independent, turnkey contract research activities, managed by the same team you have grown to trust. Let’s rediscover together what has been the secret of our success since AccelLAB’s foundation.   More than ever, we’re ready to support your R&D programs with safety, efficacy and performance evaluations. More than ever, we’re ready to support your access to the medtech market with the same commitment to scientific excellence, client-centric appreciation, and an understanding of regulatory considerations. Expect the interaction and dynamism, scientific rigor, and cost-effectiveness that you have known us for in the past. Thank you to all the partners that made this possible, including the Charles River team and Fairmount Partners, a leading investment bank in the pharma industry, who not only served as the exclusive financial advisor to Charles River Laboratories, but were also excellent partners for AccelLAB throughout this project. Welcome back to AccelLAB ! #medicaldevices #meddevices #preclinical #preclinicalresearch #implants #biomaterials #regulatorytesting #safetytesting #performancetesting #regulatory #medtech

  ✍🏼The “sign-off” for market position options should be a process of how best to study them. 😐Typically, the sign-off happens in later phase, which results in a short review, wordsmithing, or a lack of trust in the team’s process.  ☝🏾There is only one solution to senior management sign off for positioning: they must sign-off on the process, not the solution.    What does this look like? Click the link below to read more on “The Sign-off” by IDEA Pharma | From R&D to RxD CEO, Mike Rea   https://lnkd.in/emSXJC83   #pharmaceuticalinnovation #asymmetriclearning

#RegUpdatesWithRegDesk This guidance is for sponsors who want to change a medical device or IVD medical device's entry in the Australian Register of Therapeutic Goods (@ARTG). It is critical that the information contained in the ARTG is kept up-to-date and correct in terms of public health, regulation, and transparency. When any of the information in the ARTG changes, the sponsor should assess whether they need to request that the @TGA modify the respective ARTG entry. Follow RegDesk and get daily regulatory alerts sent straight to your inbox. Get Started:   https://lnkd.in/eamX_xqP #regdesk #holisticrims #rims #software #entrepreneurship #medtech #lifescience #healthcare #health #diagnostics #meddevice #regulations #pharmaceutical #pharmaceuticalindustry #ai #technology #future #innovation #medicaldevices #regulation #australia

Empowering real-world evidence (RWE) generation with unified platforms.🔗 Discover how unified clinical trial management platforms are revolutionizing the generation of real-world evidence (RWE) in healthcare and life sciences. Explore the critical role of RWE in complementing traditional clinical trial data, providing valuable insights into the safety, effectiveness, and value of medical interventions in real-world settings. Learn how unified platforms enable seamless integration of diverse data sources, including electronic health records, claims databases, wearable devices, and patient-reported outcomes, to unlock the full potential of RWE. https://hubs.li/Q0219R1t0 #CTMS #eTMF #EDC #RTSM #SafetyPV #Pharmaceutical #Biotechnology #MedicalDevices #Diagnostics #Cloudbyz #ClinicalTrials #RealWorldEvidence