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04-Product Design & Development

Medcrypt Appoints Former FDA Officer to Vice President of Services

Leave a Comment / 04-Product Design & Development, cybersecurity, Market Access, Medical Device, medical devices, MedTech, regulatory, RTA / By

Medcrypt Appoints Former FDA Officer to Vice President of Services     Naomi Schwartz, former premarket reviewer and consumer safety officer for the FDA, has been promoted to serve as Vice President of Services at Medcrypt, a cybersecurity solution provider for medical device manufacturers. In this new role, Schwartz will provide regulatory guidance to medtech companies …

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Making the Most of Medical Wearables: Addressing Patient Adherence Challenges

Leave a Comment / 01-Digital Health, 04-Product Design & Development, Care Delivery, Home Health, MEDdesign, Medical Device, medical wearables, MedTech, patient compiance, remote patient monitoring / By

Making the Most of Medical Wearables: Addressing Patient Adherence Challenges     Patient adherence has historically been a challenge. Patients may deviate from treatment plans due to a variety of factors, including lifestyle choices, technological complexity or just plain forgetfulness. Studies have shown that 50-60% of patients with chronic illnesses miss medication doses, take the wrong …

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Ask the Expert:  Improving Sustainability in Medical Device Manufacturing

Leave a Comment / 04-Product Design & Development, manufacturing, Medical Device, medical devices, MedTech, product design, RC - Device Design & Manufacturing, Sponsored Content / By

Ask the Expert:  Improving Sustainability in Medical Device Manufacturing     With a growing focus on climate commitment, MedTech companies are examining how their products are repaired, refurbished and recycled. The Health Solutions team at Flex is partnering with them on their sustainability journey to develop and implement tailored circular solutions to prolong a product’s life …

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Cordance Medical’s NeuroAccess Receives FDA Breakthrough Device Designation

Leave a Comment / 04-Product Design & Development, 05-Quality/Regulatory, blood brain barrier, Breakthrough Device Designation, Care Delivery, Medical Device, medical devices, MedTech / By

Cordance Medical’s NeuroAccess Receives FDA Breakthrough Device Designation     The FDA has granted NeuroAccess from Cordance Medical, a medical device company focused on opening the Blood-Brain Barrier (BBB) to facilitate liquid biopsy, Breakthrough Device Designation. The NeuroAccess device is indicated for adult patients (aged 22 and above) who have received a known or highly suspected …

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FDA Recognizes AAMI SW96 Cybersecurity Guidance Document

Leave a Comment / 04-Product Design & Development, cybersecurity, Health Information Technology, Medical Device, MedTech, postmarket, software bill of materials / By

FDA Recognizes AAMI SW96 Cybersecurity Guidance Document     The FDA has officially extended complete recognition to the Association for the Advancement of Medical Instrumentation (AAMI) guidance document on medical device cybersecurity, ANSI/AAMI SW96. Per the FDA, ANSI/AAMI SW96:2023, Standard for medical device security – Security risk management for device manufacturers, is an important resource for medical device sponsors, and …

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The Drivers Boosting Medtech Investments in Cloud-based Digital Transformation

Leave a Comment / 04-Product Design & Development, cloud-based solutions, cybersecurity, digital transformation, Medical Device, medical devices, MedTech, Soapbox / By

The Drivers Boosting Medtech Investments in Cloud-based Digital Transformation     This year, revenue from the medtech market is expected to reach $571 billion, according to Statista. The largest segment—medical devices—will reach a projected market volume of $472 billion. As with most industries experiencing steady growth, the medtech market faces several challenges, including supply chain issues, …

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President Biden Issues Executive Order on Artificial Intelligence

Leave a Comment / 01-Digital Health, 04-Product Design & Development, 05-Quality/Regulatory, AI, AI/ML, cybersecurity, data bias, data privacy, Health Data, Healthcare Policy, Medical Device, MedTech / By

President Biden Issues Executive Order on Artificial Intelligence     On October 30, President Biden issued an Executive Order establishing new standards for artificial intelligence (AI). The order focuses on safety and security, privacy protections, advancement of equity and civil rights, promotion of innovation and competition and advancing American leadership in AI. The Executive Order directs the …

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Ask the Expert: Four Key Reasons Medical Device Manufacturers Should Be Looking at Mexico

Leave a Comment / 04-Product Design & Development, labor shortage, manufacturing, Medical Device, medical device manufacturing, medical devices, MedTech, Mexico, OEMs, Sponsored Content / By

Ask the Expert: Four Key Reasons Medical Device Manufacturers Should Be Looking at Mexico     With the increasing global need for medical care and greater pressure on the healthcare system as people live longer, the medical device manufacturing industry has significant opportunities for growth. But with this growth potential comes increased competition and a need …

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5 Ways to Maximize the Security of Edge Medical Devices

Leave a Comment / 04-Product Design & Development, cybersecurity, hardware vulnerabilities, Medical Device, MedTech, patches, Soapbox / By

5 Ways to Maximize the Security of Edge Medical Devices      Cybersecurity attacks have morphed in recent years, exponentially increasing the risk of patient data exposure through lab equipment and other edge medical devices. Threat actors who once exclusively targeted the application layer have turned their attention to the physical layer targeting hardware, firmware, BMC …

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The Role of Computational Simulation in Modeling Fluidic-based Cassettes for POC Devices

Leave a Comment / 04-Product Design & Development, computational simulation, diagnostics, manufacturing, Medical Device, MedTech, point of care devices, RC - Device Design & Manufacturing / By

The Role of Computational Simulation in Modeling Fluidic-based Cassettes for POC Devices     The rising incidence of infectious diseases has acted as a driving force for the accelerated development of precise, decentralized and cost-effective diagnostic technologies. Within this landscape, point-of-care (POC) devices stand out as game-changing instruments, capable of delivering quick and accurate diagnoses right …

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