Medical Design & Outsourcing

Medical Design & Outsourcing

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

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...

By Medical Design & Outsourcing
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...

By Medical Design & Outsourcing
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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How CathWorks Leaned on Its Partner Medtronic to Succeed
NewsFeb 17, 2026

How CathWorks Leaned on Its Partner Medtronic to Succeed

CathWorks, an AI‑driven startup that creates non‑invasive FFR assessments from routine angiograms, survived the pandemic by leaning on Medtronic’s early minority investment and strategic guidance. After automating its 3‑D coronary modeling to cut analysis time from 22 minutes to two,...

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This Startup Developed a First-of-Its-Kind Brain Function Assessment Device
NewsFeb 17, 2026

This Startup Developed a First-of-Its-Kind Brain Function Assessment Device

QuantalX secured FDA de novo clearance for Delphi‑MD, a first‑of‑its‑kind device that fuses transcranial magnetic stimulation (TMS) with electroencephalography (EEG) to deliver real‑time brain network function assessments. The system leverages proprietary algorithms and an age‑correlated normative database to generate actionable...

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Lubrizol Launches Tolerathane TPU for Implantable Medical Devices
NewsFeb 11, 2026

Lubrizol Launches Tolerathane TPU for Implantable Medical Devices

Lubrizol has launched Tolerathane™ TPU, a medical‑grade thermoplastic polyurethane designed for implantable devices. The material offers superior resistance to oxidative and hydrolytic degradation while maintaining exceptional softness and mechanical resilience. It integrates with standard thermal processing, enabling thinner‑wall, miniaturized designs...

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AdvaMed Names New EVP of Technology and Regulatory Affairs
NewsFeb 10, 2026

AdvaMed Names New EVP of Technology and Regulatory Affairs

AdvaMed announced Melissa Torres as its new executive vice president of technology and regulatory affairs, succeeding long‑time leader Janet Trunzo. Torres arrives with more than two decades of FDA leadership, most recently as associate director for international affairs at CDRH....

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Respiratory Care, Stroke Care, and Women’s Health: Philips CMO on the Exciting Possibilities in Digital Health
NewsFeb 10, 2026

Respiratory Care, Stroke Care, and Women’s Health: Philips CMO on the Exciting Possibilities in Digital Health

Philips Chief Medical Officer Dr. Carla Goulart Peron outlined the company’s push into digital health, emphasizing expanded CPAP and respiratory solutions integrated with consumer wearables. She highlighted AI’s role in early detection, especially for stroke and women’s heart disease, while...

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FDA’s New Guidance on Consumer Wearables Makes the Medtech Market More Complex
NewsFeb 9, 2026

FDA’s New Guidance on Consumer Wearables Makes the Medtech Market More Complex

The FDA’s new guidance clarifies, rather than rewrites, the line between general‑wellness wearables and regulated medical devices, emphasizing intended use as the decisive factor. By allowing sensor‑rich products to remain unregulated if they avoid medical claims, the agency reduces regulatory...

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