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FEATURE ARTICLE

Toddler Wearable Health Devices and Monitors

From Toddlers to Teens: The Hidden Complexities of Bringing Pediatric Wearables to Market

By Lavanya Ramnath, Srividya Narayanan

Many challenges of designing and validating pediatric digital health devices are over-looked across developmental stages. Regulatory strategy, human factors, software architecture, and algorithm performance are critical consideration in dynamic patient populations.  



FEATURED CONTENT

From Prototype to Production: Building a Validation Strategy That Scales with Manufacturing Volume

By Aniruddha Dhole

Validation documentation should define process parameters, monitoring strategies, and operating ranges that can support future production increases. How does a practical framework for validation, revalidation, and process control help during medical device scale-up?

Managing AI in Medical Technology: From Innovation to Compliance

By Ali Behbahani, Dr. Ibrahim Halfaoui

Companies developing or deploying AI systems now face increasing scrutiny around risk classification, transparency and lifecycle governance. An AI management system (AIMS) aligned with ISO/IEC 42001 provides a structured way to address these challenges while significantly improving efficiency, quality, and innovation outcomes — and ensuring AI system are  effective, safe, compliant, and trustworthy.

Artificial intelligence, medical devices

Seven Things Every Medical Device Manufacturer Must Know Before Integrating AI

By Jonathan Ripley, Ruaidhrí Primrose

No longer a horizon technology, Artificial Intelligence in healthcare has reached a level of real-world performance that makes clinical value demonstrable at a critical time in healthcare – a time of clinician shortages, backlogs, and rising costs that have made access to treatment a challenge.

Data protection, intelliectual property, medtech

Cybersecurity Tactics for Medical IoT Devices

By Alexander Podgornyy

Protect patient data with medical IoT security. Learn how AI, Zero Trust, and encryption can prevent cyber threats and secure healthcare IoT devices.

Toddler Wearable Health Devices and Monitors

From Toddlers to Teens: The Hidden Complexities of Bringing Pediatric Wearables to Market

By Lavanya Ramnath, Srividya Narayanan

Many challenges of designing and validating pediatric digital health devices are over-looked across developmental stages. Regulatory strategy, human factors, software architecture, and algorithm performance are critical consideration in dynamic patient populations.

navigating regulatory strategy

Beyond Reporting: Realizing Continuous Safety Surveillance for Medical Devices

By Jonathan Messer

Having already set expectations around the structured capture of medical device safety data, regulators are now ready to analyze related insights, and they expect device manufacturers to match this capability.

Safeguarding Scientific Publishing from AI Hallucinations and Fabricated Citations

By Ome Ogbru, PharmD

As generative AI becomes embedded in clinical research, concerns around hallucinated citations and unverified outputs are growing. These inaccuracies are already entering scientific literature, raising questions about reliability, compliance, and patient safety. Addressing this challenge requires more evidence-grounded AI and disciplined implementation.

The Healthccare Burnout Backlask (pt 4): Why Contract Negotiation Has Become a Core Strategic Skill for Healthcare Administrators

By Melissa Corneal

Traditionally, contract negotiation has been viewed as a financial or legal responsibility, typically led by finance teams, legal counsel, or executive leadership, with operations stepping in afterward to execute against decisions that have already been made, but that model is evolving as healthcare delivery becomes more interconnected and operationally complex, requiring administrators to engage earlier in the process, not only to understand what is being agreed to but to help define how those agreements will function in real-world environments.






MEDTECH VIEWPOINT

The Structural Tension at the Heart of MedTech

By Moshe Barel

MedTech leaders must find a balance between the slow, careful world of medicine and the fast-paced expectations of investors. Real success comes from choosing high-quality science over quick shortcuts, as being thorough is the only way to build lasting trust and reach the market.

Interoperability was Never the Finish Line in Healthcare

By Mika Newton

A long-overdue push to reduce administrative friction, improve access to patient data, and move the system away from workflows that continue to waste time for both patients and providers.

north star

Beyond Reimbursement: Why Market Access is MedTech’s Strategic North Star

By Joan Hinrichs

Companies that embed Market Access early in innovation are the ones best positioned to navigate the changing global landscape.

QMS Interoperability

Chicken or the Egg: Should Device Interoperability or QMS Interoperability Come First?

By Carl Washburn

To achieve medical Device Interoperability, system boundaries need to be defined, system architecture needs to be aligned, and interfaces and communication protocols need to be established across individual components of the medical device. In some cases, it is as important to design and implement QMS Interoperability as it is to design Device Interoperability.

ASK THE EXPERT

medtech development

Product Development Outsourcing Needs Speed, Safety & Certainty

Seek partners who can see your vision — the full picture, anticipate challenges, and help you navigate complexity with confidence.

medtech design standards

4 FAQs to Notified Bodies

Notified bodies receive numerous questions from legal manufacturers during technical assessments. We cannot always answer them for individual legal manufacturers because this would constitute consultation.

Product Lifecycle Management

Managing MedTech Cost Pressures With Data-Driven Lifecycle Intelligence

To navigate increasingly complex global regulations and rising market expectations, organizations are embracing the Intelligent MedTech Lifecycle: a unified, data-driven approach that breaks down silos and drives agility across the entire product journey.

NEWS

  • Medtronic’s Updated Mitral Valve, Mosaic Neo, Gets FDA approval

  • Sonire Therapeutics Initiates First U.S. Clinical Study of Ultrasound-Guided HIFU Therapy for Pancreatic Cancer

  • Edwards Lifesciences Shares Ten-Year Pivotal Data Supporting Long-Term Durability of Resilia Tissue

  • Johnson & Johnson Enters Agreement to Acquire Atraverse Medical

  • enVVeno Medical Receives FDA IDE Approval for Non-Surgical Replacement Venous Valve

  • Medtronic Gains CE Mark for Stealth AXiS surgical system

  • Medtronic Continues Cardiovascular Care Growth with Completion of CathWorks Acquisition

  • CMS, FDA Announce RAPID Coverage Pathway to Accelerate Device Reimbursement

  • Styker Adds IVL Technology to Peripheral Vascular Portfolio with Amplitude Acquisition

  • FDA Reminds More Than 2,200 Sponsors and Researchers to Disclose Trial Results

  • BD Announced Application of CE Mark for the Liverty TIPS Stent Graft

  • Blackstone and TPG Complete Acquisition of Hologic; Names New CEO

  • Endospan Receives FDA Approval for the NEXUS Aortic Arch Stent Graft System

  • InVera Medical Receives FDA Clearance for Non-Thermal Chronic Venous Disease Device

  • Allevion Medical Receives 510K Clearance for Vantage Spinal Decompression System


Upcoming Events & Webinars

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On Demand Events & Webinars

December 1, 2025
From Silos to Synergy: Building the Intelligent MedTech Lifecycle
September 17, 2025
Japan Medical Device Reimbursement Strategy
February 26, 2025
Are you talking to me? Communicating effectively with your Notified Body for an Accountable and Sustainable Working Relationship
January 21, 2025
Medical Device Labeling Best Practice for 2025: The Global Design Master
December 17, 2024
Adapt, Thrive, and Lead: Insights for Global Medical Device Executives
October 29, 2024
The Art of Benefit-Risk Calculation: Essential Tools for EU MDR Mastery
September 26, 2024
Adopting a RIM Platform in MedTech: Myths vs. Reality
August 27, 2024
Decoding global regulatory pathways: How to classify your Medical Device
July 31, 2024
Managing global regulatory strategy and compliance: assessing status, gaps, and needs.
July 18, 2024
Now that the EU MDR deadline is passed, how do you sell your device abroad?









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Boost Product Quality with Integrated ALM and PLM
Whether you’re managing complex product portfolios, navigating regulatory pressures, or striving to deliver higher customer satisfaction, this guide will help you understand the tangible benefits of integrating ALM and PLM.

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