Deven D. Parghi

Discover why integrating human factors engineering early in the design process is crucial for medical device success. This MD+DI article shares insights from Virginia A Lang’s session at our recent Medical Device Playbook event and sheds light on how prioritizing human factors testing can lead to regulatory approval, marketability, and profitability. #medtech #humanfactors #medicaldevices

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Medtech propels economic growth and innovation in Southern California: Many medtech companies are thriving in Southern California, and prospects are bright for continued development of the sector. Leaders who capitalize on the region’s advantages have much to gain.  http://dlvr.it/T65SB0 #InsightsonLifeSciences #Medicalproducts #UnitedStates #Innovation

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Risk is a critical consideration for #medicaldevice design and regulatory submissions. Check out FDA's great video here on Risk Basics for Medical Devices! #medtech #medicaldevices https://lnkd.in/ebCpckPc

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Turn MVP into CVP. CVP = Clinically Viable Prototype MVP = Minimum Viable Product If you're in #medtech, part of your mission is to improve clinical outcomes. Maybe your outcome will: - Improve morbidity post surgery - Improve accuracy of a diagnostic - Improve patient compliance - Or something else But in the thick of raising funds, building a team, and launching a product, many companies lose sight of this #clinicalbenefit. Instead, focus turns to 👇 "How do I get this product launched as quickly as possible?" This is when the clinical #valueprop evaporates and the 'me-too' device is born. Instead of racing to the market with a 'me too', think about your CVP: (Clinically Viable Prototype) - Define the right endpoint - Draft the clinical study design - Design the CVP for the study - Strip away unnecessary features - Demonstrate safety - Capture evidence on clinical benefit Often, this won't be your final product. And it won't be the one that sells to healthcare. There's still commercial risk ahead of you. But, if you succeed with the CVP, you'll have addressed clinical risk -- and that's one huge step closer to launching a medical device that makes a high impact on healthcare.

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Calling all #medicaldevice industry professionals! Help shape the future of Advanced Manufacturing adoption by participating in our research survey conducted in partnership with Axendia, Inc. Complete this brief, anonymous survey to receive a complimentary copy of the final report. Get started here: https://lnkd.in/esSbkgTW #advancedmanufacturing #qualityassurance #medtech #healthtech

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2024 comprehensive update on ISO18562 series change for gas pathway medical devices is out now on Cormica Global Medical Device Testing Medical Engineering Technologies Ltd - A Cormica Lab. Read our article below 👇 #medicaldevices #gaspathway #testing #cormica #medicalengineeringtechnologies

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Nice set of points for consideration to add to one's list of values. Specifically I remember the 2 day Team Trek Course I attended in Arkansas for team-building and learning about the '100% Responsibility' concept as a part of Leadership Germantown! #TeamTrek #LeadershipGermantown

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The FDA, #HealthCanada, and #MHRA have collaborated again to publish guiding principles for #transparency in ML-enabled #MedicalDevices. This is such an important topic that has been desperate for clarification from the #FDA. Fundamentally, the principles focus on the questions we learned to ask in elementary school when telling a story or describing anything clearly—who, what, where, when, why, and how? Don't forget that these principles should be integrated into your #QMS and your product development plans. Reach out if you need help understanding the expectations and how to operationalize these principles. Brooke & Associates #RegulatoryAffairs #QualityManagement #QualityAssurance #RAQA #AI #ML #GMLP

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🔹 How are other med device manufacturers enhancing risk management? 🔹 How are they maximizing design controls and requirements management processes? 🔹 How are they ensuring quality and data integrity? Learn answers to these questions (and have an opportunity to ask any others you have!) during our upcoming webinar, featuring a panel of medical device manufacturing leaders and engineers. 🔷 Register Now: https://lnkd.in/eb8t_tW3

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Getting products to market quickly is crucial. However, this speed must be balanced with strict compliance and thorough risk management. Without this balance, the rush to market can lead to serious issues—like regulatory warning letters, product recalls, and dissatisfied customers. Justin explores significant challenges the MedTech industry faces in 2024 with a look toward 2027. #medtech #innovation #medicaldevices #entrepreneurship #startups

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What is the first question you need to be asking yourself before you start on your #medtech project? There's a couple litmus test questions to determine a go/no-go. #innovation #testing #ideas

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For the "intent" of producing safe and effective medical products, a comprehensive and functionally aligned QMS has been shown to be a most effective pathway. We have to think beyond "compliance" to the regulations for the sake of passing audits. It is important that we understand and recognize the value and intent of the regulations. #medicalproducts #QMS #compliance #regulatory #meddevices

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#Neurotech startup Motif Neurotech receives industry validation for their miniature bioelectronic device 🧠 💪 Rice University Professor Jacob Robinson and his team at Motif Neurotech have made significant strides in the fight against treatment-resistant depression. They've developed the Digitally programmable Over-brain Therapeutic (DOT), a wireless device designed to provide neuromodulation for psychiatric conditions like depression, OCD, and PTSD. What sets DOT apart is its size – just 9 millimetres wide – making it easily implantable while still delivering powerful electrical stimulation to the brain through the dura (the membrane that protects the brain and spinal cord). The innovation could offer an alternative to traditional treatments like transcranial magnetic stimulation (TMS). A recent publication showcases successful implantation and stable performance in both human and animal subjects. CEO of Motif Jacob Robinson said: “It overcomes challenges by using a battery-free and wireless approach to create an implant that can deliver precise and programmable stimulation to the brain, without brain surgery,” #DBS #medicaldevice

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What is FDA registration and the review process for 510(k) submissions? Uncover the essentials of navigating FDA regulations and ensure your medical device meets all requirements. Learn more in our comprehensive blog! https://lnkd.in/eM6UJgK8    Get connected:  Mail ID: enquiry@operonstrategist.com                             Phone no: +91 9370283428   .   .   .  #FDARegistration #510kSubmission #MedicalDevices #RegulatoryCompliance #FDAApproval #HealthcareInnovation #MedicalDeviceConsulting #medicaldevicemanufacturing #medicaldeviceindustry #healthcare #healthcareinnovations #government #medicalequipment #operonstrategist #consultation #consulting

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"So, while I agree...on the importance of function over form in medical device design, I think today's #medicaldevices need to be designed with the intended use environment in mind. If you're developing a surgical device, function will matter much more than form. At-home medical devices, on the other hand, must take the aesthetics into consideration upfront." h/t MD+DI #innovation #medtech #medicaldevicedesign

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Discover how VivoSense uses BioRadio's RIP technology to advance Rett Syndrome research. Their precise respiratory measurements in a multi-center clinical trial provide crucial insights for better patient outcomes. Learn more about their groundbreaking work here: https://hubs.la/Q02DMKSS0 #clinicalresearch #clinicaltrials #digitalendpoints #digitalbiomarkers

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Inadequate sterilization of medical devices can lead to life-threatening infections. Don't miss the next Town Hall on Medical Device Sterilization, April 29th at 1:00 p.m. EDT. See event details on FDA's website: https://lnkd.in/gfPsicMr #FDA #MedicalDevices #PatientSafety #Healthcare #IVDWise #OneMDC

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