Medical Design & Outsourcing

Medical Design & Outsourcing

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Design, development, and outsourcing in medical devices and medtech.

Kingstec Advances Real-Time Medical Asset Tracking
NewsApr 27, 2026

Kingstec Advances Real-Time Medical Asset Tracking

Kingstec Technologies announced the rollout of Technology Trace Inc.’s trevii real‑time medical asset tracking platform at St. Joseph’s Healthcare Hamilton. A year‑long pilot delivered a 100% reconciliation rate and 98% floor‑level location accuracy, demonstrating the system’s reliability. Kingstec acted as the...

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How Supplier Collaboration Drives Medical Device Innovation and Accelerates Time to Market
NewsApr 24, 2026

How Supplier Collaboration Drives Medical Device Innovation and Accelerates Time to Market

Velosity argues that early collaboration with contract manufacturers is essential for medical‑device OEMs to innovate and accelerate time‑to‑market. By involving manufacturers from design‑for‑manufacturability through scalable planning, companies avoid costly redesigns and gain expertise in quality, regulatory and supply‑chain risk. Velosity’s...

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6 High-Resolution Additive Manufacturing Tips for Faster Medtech Development
NewsApr 23, 2026

6 High-Resolution Additive Manufacturing Tips for Faster Medtech Development

The article presents six actionable tips for using high‑resolution additive manufacturing (AM) to speed up medical‑device development. It urges teams to adopt an iteration‑first mindset, exploit sub‑10 µm layer precision to answer targeted engineering questions, and revisit designs once deemed impractical....

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Trelleborg Costa Rica Site Earns ISO 13485 Certification
NewsApr 23, 2026

Trelleborg Costa Rica Site Earns ISO 13485 Certification

Trelleborg Medical Solutions' Costa Rica manufacturing site earned ISO 13485:2016 certification, confirming its quality management for medical devices. The 107,600‑sq‑ft facility, opened in December 2025 in the Evolution Free Zone, is the company’s first Central American plant and supports nearshoring and supply‑chain...

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FDA Warns Device Manufacturers of Nitrosamine Impurities that Could Cause Cancer
NewsApr 22, 2026

FDA Warns Device Manufacturers of Nitrosamine Impurities that Could Cause Cancer

The FDA’s Center for Devices and Radiological Health has issued a warning to manufacturers of drug‑device combination products about the presence of nitrosamine impurities, specifically 1‑methyl‑4‑nitrosopiperazine, detected in rifampin‑impregnated devices. The agency highlighted that catheters, cardiac‑implant envelopes, and other devices...

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Stryker Pay Drops for Top Executives and the Median Employee
NewsApr 22, 2026

Stryker Pay Drops for Top Executives and the Median Employee

Stryker disclosed that total compensation for its top executives fell in 2025, with CEO Kevin Lobo earning $21.4 million, a 3% drop, and other senior leaders seeing 7‑8% cuts. Median employee pay also slipped to $81,018, a 3% decline, nudging the...

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PSN Manufacturing Earns ISO 9001 and 13485 Certifications
NewsApr 22, 2026

PSN Manufacturing Earns ISO 9001 and 13485 Certifications

PSN Manufacturing announced it has earned ISO 9001:2015 and ISO 13485:2016 certifications, confirming a robust quality management system for both general manufacturing and regulated medical‑device components. The company’s 100% climate‑controlled plant features a Class 8 cleanroom, a flexible molding floor for 50‑500 ton machines,...

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NB Corp. Of America Plans Live Demos This Week
NewsApr 21, 2026

NB Corp. Of America Plans Live Demos This Week

NB Corp. of America will showcase live demonstrations of its NV Slide Way configuration and the 3‑axis BG Actuator at the MD&M South trade show, Booth #2311 Automation. The Slide Way delivers precise linear motion without the need for a...

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CPC Biotech Debuts Unified Bioprocess Fluid Portfolio
NewsApr 21, 2026

CPC Biotech Debuts Unified Bioprocess Fluid Portfolio

CPC Biotech, a new brand under Dover’s Pump Solutions Group, launched by merging CPC’s sterile connector expertise with PSG Biotech’s low‑shear pumps, flow meters and sensors. The unified portfolio offers biopharma manufacturers a single source for connectors, pumps, and measurement...

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Regulatory Tips From a Breakthrough Noninvasive Device Startup
NewsApr 20, 2026

Regulatory Tips From a Breakthrough Noninvasive Device Startup

Compremium’s Quantis CVP, a noninvasive central venous pressure monitor, received FDA Breakthrough Device designation in January 2026 and subsequently joined the agency’s Total Product Life Cycle Advisory Program (TAP). The CTO explained that TAP eligibility hinges on prior acceptance into the...

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Freudenberg Medical Launches ISO Class 5 Cleanroom for Biopharma
NewsApr 20, 2026

Freudenberg Medical Launches ISO Class 5 Cleanroom for Biopharma

Freudenberg Medical announced CleanAssure, an ISO 5 controlled cleanroom that delivers washed, dried and gamma‑sterilized single‑use assemblies for biopharma customers. The service expands the company’s portfolio beyond component manufacturing to include validated cleaning and sterilization under cGMP conditions. By integrating this...

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MiniMed Flexes with Next-Gen Insulin Pump After Spinning Off From Medtronic
NewsApr 15, 2026

MiniMed Flexes with Next-Gen Insulin Pump After Spinning Off From Medtronic

MiniMed, the newly independent diabetes business spun out of Medtronic, secured FDA clearance for its next‑generation MiniMed Flex insulin pump within two weeks of its March 2026 IPO. The Flex is a screenless, pocket‑sized device that retains the 300‑unit reservoir...

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The MDO Nitinol Knowledge Webinar Returns with a Medtronic Distinguished Engineer
NewsApr 14, 2026

The MDO Nitinol Knowledge Webinar Returns with a Medtronic Distinguished Engineer

Medtronic Distinguished Engineer Ramesh Marrey will headline Medical Design & Outsourcing’s 2026 Nitinol Knowledge webinar on May 14. Marrey, a veteran of structural heart, aortic and neurovascular R&D, brings over two decades of expertise in implant biomechanics, finite‑element analysis, and regulatory strategy....

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The 2026 MDO Medtech Startups Special Report
NewsApr 14, 2026

The 2026 MDO Medtech Startups Special Report

Medical Design & Outsourcing released its 2026 Medtech Startups Special Report, a free guide packed with technical tips and strategic advice for early‑stage medical device companies. The report highlights a tightening fundraising environment as venture capital pours into AI and...

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Switchback Medical Is Expanding Into Costa Rica
NewsApr 13, 2026

Switchback Medical Is Expanding Into Costa Rica

Switchback Medical, a Minnesota‑based CDMO, has signed a lease for an 18,000‑square‑foot facility in Costa Rica’s Coyol Free Trade Zone, featuring a 3,500‑square‑foot cleanroom. The site will begin development and product transfers immediately, with full manufacturing and ISO 13485 certification slated...

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CDMO Arterex Upgrades Manufacturing Facility Near Boston
NewsApr 10, 2026

CDMO Arterex Upgrades Manufacturing Facility Near Boston

Arterex, a contract development and manufacturing organization for medical devices, is expanding its Mansfield, Massachusetts plant by roughly 15,000 square feet and installing a new steam sterilizer. The addition is expected to raise the site’s operational capacity by about 50%...

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FUCHS Highlights NYEMED 7477 Grease for Medical Devices
NewsApr 9, 2026

FUCHS Highlights NYEMED 7477 Grease for Medical Devices

FUCHS Lubricants Co. is promoting its NYEMED 7477 high‑performance grease, engineered for the demanding conditions of medical devices. The lubricant maintains mechanical stability across a temperature span of –50 °C to 250 °C and endures repeated sterilization cycles without loss of performance. Its...

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Inside the Challenging Development of a Low-Friction Micropump
NewsApr 8, 2026

Inside the Challenging Development of a Low-Friction Micropump

Trelleborg Medical Solutions engineered a 15 mm, lubricant‑free micropump for wearable drug delivery, delivering 2‑10 µL per dose. The project required a novel LSR material that bonded to a PBT housing on one side while remaining ultra‑low friction on the other, and...

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WAFIOS Hosts 2nd Annual Medical Tech Day in Mokena
NewsApr 8, 2026

WAFIOS Hosts 2nd Annual Medical Tech Day in Mokena

WAFIOS Machinery Corporation will hold its second Annual Medical Tech Day on June 3, 2026 at its Midwest Technical Center in Mokena, Illinois. The one‑day event gathers medical device manufacturers, technology partners and industry experts to showcase precision manufacturing solutions...

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Medtech OEMs Face a Rare but Closing Window of Opportunity
NewsApr 7, 2026

Medtech OEMs Face a Rare but Closing Window of Opportunity

Medtech original equipment manufacturers (OEMs) face a narrow window in 2026 to reshape their manufacturing portfolios as the CDMO market expands from $73 billion in 2022 to $91 billion in 2024. A recent $1.5 billion sale of a medical OEM division highlighted premium...

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Sovato’s New CEO Explains the Plan to Scale Telesurgery and Take It Worldwide
NewsApr 7, 2026

Sovato’s New CEO Explains the Plan to Scale Telesurgery and Take It Worldwide

Sovato has appointed former Intuitive executive Brian Miller as CEO to accelerate its telesurgery platform worldwide. Miller argues that surgeon shortages, geographic variability in outcomes, and proven remote‑surgery technology create a ripe market. Sovato’s strategy focuses on integrating with large...

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Zeus Adds Catheter Components to Chamfr Marketplace
NewsApr 7, 2026

Zeus Adds Catheter Components to Chamfr Marketplace

Zeus, a global polymer and catheter manufacturer, has added over 100 liner and heat‑shrink components to Chamfr’s online marketplace. The catalog now includes PTFE liners, FEP heat‑shrink tubing and the FluoroPEELZ peelable shrink, giving engineers on‑demand access to critical materials....

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FDA Warns Resin Change May Have Caused Tubing Danger
NewsApr 6, 2026

FDA Warns Resin Change May Have Caused Tubing Danger

The FDA issued an urgent alert that B. Braun’s recent tubing‑resin change in its Streamline Airless System and B3 Low Volume hemodialysis bloodlines is causing small air bubbles to adhere inside the arterial line. These bubbles trigger machine alarms, halt treatment...

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Bodycote Plans to Open a New Heat Treatment Facility in Mexico
NewsApr 2, 2026

Bodycote Plans to Open a New Heat Treatment Facility in Mexico

Bodycote, the London‑based heat‑treatment specialist, will open a new facility in Apodaca near Monterrey, Mexico, slated to start operations in 2026. The plant expands capacity for case hardening, nitriding, carburizing, carbonitriding and nitrocarburizing, targeting medical, automotive and general industrial customers....

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Binder Adds Triangular Moulding to M16 and M12 Connectors
NewsApr 2, 2026

Binder Adds Triangular Moulding to M16 and M12 Connectors

Binder introduced a triangular moulding for its M16 series and M12 K‑ and L‑coded connectors, aiming to improve mechanical durability in demanding industrial settings. The new geometry optimises force distribution, enhances anti‑twist protection, and offers a modern visual identity. Connectors...

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What’s New in Thermoplastic Polyurethanes How ChronoFlex™ S Delivers Softness and Strength for Implantable Medical Devices
NewsApr 1, 2026

What’s New in Thermoplastic Polyurethanes How ChronoFlex™ S Delivers Softness and Strength for Implantable Medical Devices

Mitsubishi Chemical Group has launched ChronoFlex S, a 60A thermoplastic polyurethane that delivers silicone‑like softness while retaining the superior tensile strength and abrasion resistance of TPU. The material contains 36% USDA‑certified biobased content and can be processed by melt, extrusion, injection...

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MDO Editor’s Picks: Three Technical Talks at DeviceTalks Minnesota
NewsMar 31, 2026

MDO Editor’s Picks: Three Technical Talks at DeviceTalks Minnesota

Three Minneapolis‑area medtech startups—Person Health, Vail Scientific, and Peytant Solutions—will present technical talks at DeviceTalks Minnesota on May 4. Person Health is developing graphene‑based nanosensors for a non‑invasive breath test that detects early‑stage lung cancer. Vail Scientific offers a handheld breath...

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Recall for Devices that ‘Exploded’ Reminds Us Patients Aren’t the only Ones at Risk
NewsMar 30, 2026

Recall for Devices that ‘Exploded’ Reminds Us Patients Aren’t the only Ones at Risk

Erbe announced a Class 1 FDA recall of 40,952 single‑use flexible cryoprobes after reports of loud ruptures that injured healthcare staff. The failures were traced to insufficient adhesive application, causing gas‑inlet loosening and tubing bursts outside the patient’s body. At least...

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Microcare Names New Director of R&D
NewsMar 16, 2026

Microcare Names New Director of R&D

MicroCare announced Dr. Uwe Wanner as its new director of research and development. Wanner will steer the company’s global R&D strategy, overseeing innovation, regulatory evidence, and product development for precision cleaning and fluid‑technology solutions. He brings more than two decades of...

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How Synergy Spine Engineered Its New Cervical Disc for Mobility and Alignment
NewsMar 16, 2026

How Synergy Spine Engineered Its New Cervical Disc for Mobility and Alignment

Synergy Spine Solutions secured FDA pre‑market approval for its Synergy Disc, the first artificial cervical disc that simultaneously improves spinal alignment and preserves full range of motion. The device features a patented interrupted‑articulation geometry that creates a low‑energy, lordotic position...

By Medical Design & Outsourcing
RQM+ Launches SMART Solutions for MedTech Development
NewsMar 13, 2026

RQM+ Launches SMART Solutions for MedTech Development

RQM+ announced SMART Solutions, a life‑cycle partnership model that fuses regulatory, quality, clinical, reimbursement and laboratory expertise for medical device and diagnostics firms. The offering comes in two formats: an integrated solution for small‑to‑mid‑size companies and a functional, modular option...

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Medline Expands Distribution with New Texas Center
NewsMar 12, 2026

Medline Expands Distribution with New Texas Center

Medline announced a new 1.2‑million‑square‑foot distribution center in Midlothian, Texas, slated to become operational in the second quarter of 2027. The facility adds to the company’s network of 45 centers and marks its second hub in the Dallas‑Fort Worth market. Equipped...

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Coming Soon: Capstan Medical’s Next-Gen Structural Heart Robotics System
NewsMar 12, 2026

Coming Soon: Capstan Medical’s Next-Gen Structural Heart Robotics System

Capstan Medical announced that its second‑generation robotic catheter delivery system will debut in 2026, following successful first‑in‑human mitral valve implants in Chile, New Zealand and Brazil. The company has expanded its valve sizing portfolio to include 37 mm and 42 mm implants and...

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Forj Medical Names Leadership Team for Costa Rica Plant
NewsMar 11, 2026

Forj Medical Names Leadership Team for Costa Rica Plant

Forj Medical, a global medtech CDMO, announced the leadership team for its new advanced manufacturing plant in Tacares de Grecia, Costa Rica. The 53,000‑square‑foot facility, completed in December 2025, will assemble complex medical devices for surgical navigation, electrophysiology, diabetes, cardiovascular...

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Nelipak Opens Asia-Pacific Technical Development Center
NewsMar 11, 2026

Nelipak Opens Asia-Pacific Technical Development Center

Nelipak announced the opening of a new Asia‑Pacific Technical Development Center in Singapore, consolidating its flexible and rigid sterile‑barrier packaging capabilities. The facility offers real‑time collaboration with the company’s global manufacturing and innovation network, ensuring solutions are production‑ready and scalable...

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Grand Avenue Report Examines 2026 Life Sciences Readiness
NewsMar 11, 2026

Grand Avenue Report Examines 2026 Life Sciences Readiness

Grand Avenue Software has published its 2026 Life Sciences Quality, Compliance & Operations Benchmark Report, drawing on hundreds of responses from QA, regulatory affairs and manufacturing professionals. The study reveals wide variation in FDA QMSR readiness, persistent quality improvement hurdles,...

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Stryker Medical President Jessica Mathieson’s Advice for Moving up in Medtech
NewsMar 10, 2026

Stryker Medical President Jessica Mathieson’s Advice for Moving up in Medtech

Stryker Medical President Jessica Mathieson emphasized a simple career mantra: talk less, listen more, and seek mentors who can spark ideas. Drawing on 17 years at Stryker, she rose from account manager to president, highlighting the role of mentorship and...

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Cook Medical Launches Interventional MRI Research Initiative
NewsMar 10, 2026

Cook Medical Launches Interventional MRI Research Initiative

Cook Medical has designated Indiana University as one of its inaugural Interventional MRI (iMRI) Centers of Excellence, part of a five‑year collaboration with the IU Launch Accelerator for Biosciences. The initiative blends device engineering, imaging science, and clinical research to...

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Stryker Wins Supply Chain Resiliency Honors From HIRC
NewsMar 9, 2026

Stryker Wins Supply Chain Resiliency Honors From HIRC

Stryker, the world’s fifth‑largest medical‑device maker, has been awarded the first Healthcare Industry Resiliency Collaborative (HIRC) Enterprise Gold Resiliency Badge for its overall supply‑chain performance. The badge, based on a third‑party assessment of demand planning, inventory management, visibility, supplier and...

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Next-Gen Prosthetics Tech Developer Blue Arbor Hits More Milestones
NewsFeb 28, 2026

Next-Gen Prosthetics Tech Developer Blue Arbor Hits More Milestones

Blue Arbor Technologies reported the first‑in‑human implantation of its RESTORE External Sensing Unit (ESU) at the Medical University of Vienna in December 2025, demonstrating functional prosthetic control within days. The company also secured a $5 million Series A investment led by German...

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The Science of Controlling Drug Release in Implants with Ultrasonic Spray Coating
NewsFeb 27, 2026

The Science of Controlling Drug Release in Implants with Ultrasonic Spray Coating

Ultrasonic spray coating is emerging as a core engineering discipline for drug‑eluting implants, with parameters such as drug‑to‑polymer ratio, nitrogen carrier‑gas flow, nozzle height, and spray power dictating coating thickness, profile, and elution behavior. The article explains how variations in...

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Zimmer Biomet Says Its SynTuition Algorithm Enhances Diagnostic Certainty
NewsFeb 25, 2026

Zimmer Biomet Says Its SynTuition Algorithm Enhances Diagnostic Certainty

Zimmer Biomet announced that its machine‑learning tool SynTuition dramatically improves diagnostic certainty for periprosthetic joint infection (PJI). In a study of 274 real‑world cases, the algorithm matched expert diagnoses 96% of the time, outpacing a pooled physician group that achieved...

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3 Lessons Learned From Developing a Novel Neurotechnology Device
NewsFeb 24, 2026

3 Lessons Learned From Developing a Novel Neurotechnology Device

QuantalX Neuroscience’s Delphi‑MD, a hybrid TMS‑EEG platform powered by AI, received FDA de novo classification in November 2025 and entered commercial launch in February 2026. The device delivers real‑time, age‑adjusted brain‑function assessments by comparing patient data to a cleared normative database. CEO Dr....

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Croom Medical Breaks Ground on R&D Site in Ireland
NewsFeb 20, 2026

Croom Medical Breaks Ground on R&D Site in Ireland

Croom Medical has broken ground on ACOT, a 38,000‑square‑foot Advanced Centre of Orthopaedic Technologies in Croom, County Limerick. The project represents the company’s largest capital outlay in its 42‑year history and will serve as a combined R&D and industrialisation hub....

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Leica Launches CM1950 Cryostat with DualEcoTec Cooling System
NewsFeb 20, 2026

Leica Launches CM1950 Cryostat with DualEcoTec Cooling System

Leica Biosystems, a Danaher subsidiary, unveiled the Leica CM1950 cryostat equipped with DualEcoTec cooling. The device cools specimens up to three times faster and chambers up to twice as fast, slashing setup and case times. It employs a near‑zero global...

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MIT Researchers Develop Miniaturized Breast Ultrasound Wearable
NewsFeb 19, 2026

MIT Researchers Develop Miniaturized Breast Ultrasound Wearable

MIT researchers have created a miniature ultrasound system roughly the size of a smartphone and costing about $300, capable of capturing real‑time three‑dimensional breast images. The device uses a square‑array probe with CODA geometry, reducing transducer elements from 1,024 to...

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Master Bond Debuts UV26DCMed Dual-Cure Adhesive
NewsFeb 19, 2026

Master Bond Debuts UV26DCMed Dual-Cure Adhesive

Master Bond introduced UV26DCMed, a single‑component, dual‑cure adhesive for medical device assembly that combines UV light for rapid fixturing with a heat bake for full polymerization. The formulation tolerates repeated sterilization methods—including steam autoclave, ethylene oxide, glutaraldehyde, and hydrogen‑peroxide—while meeting...

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The Blueprint for Commercializing Breakthrough Healthtech
NewsFeb 18, 2026

The Blueprint for Commercializing Breakthrough Healthtech

AI‑driven medtech firms must prove tangible ROI for patients, providers and payers to move from lab to bedside. Brent Ness outlines three pillars—capital efficiency with payer alignment, rigorous evidence and reimbursement pathways, and operational scalability paired with strong IP—that determine...

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Enlil Launches Milestone View for Its Medtech Product Lifecycle Traceability Software
NewsFeb 17, 2026

Enlil Launches Milestone View for Its Medtech Product Lifecycle Traceability Software

Enlil unveiled Milestone View, the industry’s first evidence‑based milestone interface for medical device product development. The new capability embeds directly within Enlil’s unified traceability platform, linking each milestone to underlying requirements, design outputs, risk controls, change histories and regulatory evidence....

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