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FEATURE ARTICLE

Advancing Medtech

Advancing Medtech in 2025:
AI, Field Actions, and Regulatory Intelligence

By Seth Goldenberg, PhD

Evolving regulations and market requirements have kept medtech companies on their toes for years. EU MDR, for example, has been a top priority and now, more companies are moving toward EU MDR sustainability. As we look ahead to an unpredictable year in medtech, three areas stand out as opportunities for medtech to drive meaningful progress. AI, recall management, and regulatory intelligence could be key differentiators for medtechs — if approached strategically.  

FEATURE ARTICLES

lab

5 Lab IoT Breakthroughs Slashing Equipment Downtime

By Emily Newton

Lab IoT adoption is growing, and recent innovations make it more promising than ever. See how IoT advances can unlock new standards of equipment uptime.

The Agile MedTech Lifecycle:
Rethinking Regulatory Adoption in a Time of Global Disruption

By Arjunvasan Ambigapathy

The industry’s heavy reliance on waterfall project management has resulted in long, siloed, and high-risk product development cycles. This model does not accommodate evolving regulations, shifting geopolitical realities, or fast-changing healthcare needs.

HHS Announces Transformation to Make America Healthy Again

By MedTech Intelligence Staff

FDA will decrease its workforce by approximately 3,500 full-time employees, with a focus on streamlining operations and centralizing administrative functions. This reduction will not affect drug, medical device, or food reviewers, nor will it impact inspectors.

titanium

Titanium:
biocompatibility, durability and cost-efficiency continue to improve

By Kim Crabtree

Titanium has become a vital material in modern medicine due to its strength, light weight, corrosion resistance, and exceptional biocompatibility with high long-term success rates and minimal risk of rejection. Its non-ferromagnetic nature makes it MRI-safe, and its durability supports better healing outcomes compared to materials like stainless steel. Though more expensive, titanium’s costs are becoming more manageable, and demand is expected to surge with the aging population. Innovations like beta-titanium alloys, surface treatments, and 3D-printed implants continue to expand its medical potential.

Interoperability

What’s Missing in MedTech Innovation? The Journey Toward Plug-and-Play Device Interoperability

By Dr. Charles Jaffe, Todd Cooper

For over four decades, the medical device industry has wrestled with fragmented data exchange and proprietary integrations. HL7’s Device Interoperability FHIR Accelerator initiative offers a vendor-neutral framework to finally achieve plug-and-play interoperability—unlocking scalable, AI-powered MedTech innovation and improving patient outcomes.

Advancing Medtech

Advancing Medtech in 2025:
AI, Field Actions, and Regulatory Intelligence

By Seth Goldenberg, PhD

Evolving regulations and market requirements have kept medtech companies on their toes for years. EU MDR, for example, has been a top priority and now, more companies are moving toward EU MDR sustainability. As we look ahead to an unpredictable year in medtech, three areas stand out as opportunities for medtech to drive meaningful progress. AI, recall management, and regulatory intelligence could be key differentiators for medtechs — if approached strategically.

IVDR

IVD Intended Purpose:
Why it matters more than ever under IVDR

By Dr. Oliver Eikenberg

Under IVDR, clear and specific IVD intended use criteria are required and introduce significant challenges for manufacturers seeking CE Marking and global market access. With updated compliance deadlines approaching, how can manufacturers manage risk and avoid regulatory delays and disruptions in their market strategies?

Why Quality Culture is the Key for Tech Entrants in Healthcare

By Attrayee (Atty) Chakraborty, MS, MSc., Dinesh Puppala, MS, RAC

In the healthcare industry where patient lives are at stake, quality culture is a cornerstone principle extending beyond operational efficiency. It has profound effects on patient outcomes. As tech continues to disrupt healthcare, how do technology companies build a robust quality culture to succeed in healthcare?

VIEWPOINT

Fork in the road:
Conavi Medical’s route less traveled hopes to create a new standard in the fast-moving imaging market:

Angioplasty and stenting procedures (or percutaneous coronary interventions/PCIs) are performed more than four million times around the world every year to open up blockages in coronary arteries to allow the heart to receive proper blood flow. Most of these procedures -- 80-85 percent -- are only guided by traditional angiography, an x-ray of the blood vessels that requires a contrast agent to be flushed into the heart to identify where the blockages are.

Leveraging AI for Transforming Patient Care and Enhancing Clinician Experience in EMRs

By Josh Sol

As healthcare pushes forward in digital transformation, AI has emerged as a critical tool in optimizing electronic medical records. EMRs remain both vital and frustrating. Clinicians wrestle with usability, while patients struggle with engagement and access. By integrating AI thoughtfully and securely, we can create a more intuitive, efficient and user-centric experience for both groups.

Increased productivity through AI?

By Dr Christian Johner

MTI Viewpoint: I expect fundamental changes to our medical device ecosystem; not all companies will survive them. The ability to consistently use AI will also determine who will be among the survivors and even the winners. AI will not only be part of the devices but also an internal tool.

Regulations

Regulation vs. Deregulation:
Finding the Right Balance for AI-Driven Healthcare

By Mika Newton

AI’s reach depends on the environments in which it operates as well as how it is developed and deployed, highlighting a fundamental debate on whether we should push for regulation or opt for free-market-driven deregulation.

Ask the Expert

Captis Ask the Expert

AI and Automation Tools:
Medical Writers’ Point of View

EU MDR and IVDR have created many new challenges for medical writing and regulatory affairs professionals. An increased workload, combined with the scarcity of expert resources, makes it essential to find innovative solutions that maintain...

busting myths

Ask the Expert: Is Your MedTech Company Considering a Regulatory RIM Platform?

Misconceptions about using Regulatory Information Management (RIM) platforms to manage MedTech regulatory workflows. Here, we Bust 3 Naysayer Myths.

Smridula Hariharan

Ask the Expert: PMCF implementation under EU MDR

Smridula Hariharan leads a team of medical writers who work on CEPs, CERs, PMS Plan, Post-Market Surveillance Reports, Periodic Safety Update Reports, Post-Market Clinical Follow-up Plan and Reports, for devices spanning a wide range of therapeutic areas. Here, she shares secrets to cost-effective PMCF strategies in the dynamic landscape of the European Medical Device Regulation (MDR).

NEWS & VIEWS

  • FDA Announces Completion of First AI-Assisted Scientific Review Pilot and Aggressive Agency-Wide AI Rollout Timeline

  • FDA Announces Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities

  • Tariff Tsunami Hits U.S. Healthcare: Double-Digit Penalties Spark Cost Surge and Supply Chain Crisis, Black Book Warns

  • MedTech Industry Groups Coalesce on Tariff Exemption

  • FDA RECALL UPDATE: Regard Newborn Kit Recall – ROi CPS Neo-Tee T-Piece Resuscitator

  • FDA RECAL UPDATE: Power Assist Device – Max Mobility/Permobil Removes SpeedControl Dial Component Used with SmartDrive MX2+

  • FDA RECALL UPDATE: Biosense Webster Varipulse Use Instructions

  • Thermo Fisher Scientific to Acquire Purification and Filtration Business

  • Teleflex announces plan to separate its businesses

  • FDA’s Revolving Door? The Agency moves to rehire CDRH staffers fired days earlier

  • Elizabeth Holmes’s Appeal to Overturn Conviction Is Denied

  • Sweeping FDA Cuts Hit CDRH Staffer’s Inboxes

  • Medtronic Acquires Nano Surface Technology Assets from Nanovis

  • Philips to sell its Emergency Care business to Bridgefield Capital

  • Stryker to sell U.S. spinal implants business


Upcoming Events & Webinars

No posts found.



On Demand Events & Webinars

February 26, 2025 – 2:00 pm – 3:00 pm
Are you talking to me? Communicating effectively with your Notified Body for an Accountable and Sustainable Working Relationship
January 21, 2025 – 11:00 am – 12:00 pm
Medical Device Labeling Best Practice for 2025: The Global Design Master
December 17, 2024 – 2:00 pm – 3:00 pm
Adapt, Thrive, and Lead: Insights for Global Medical Device Executives
October 29, 2024 – 10:00 am – 11:00 am
The Art of Benefit-Risk Calculation: Essential Tools for EU MDR Mastery
September 26, 2024 – 1:00 pm – 2:00 pm
Adopting a RIM Platform in MedTech: Myths vs. Reality
August 27, 2024 – 10:00 am – 11:00 am
Decoding global regulatory pathways: How to classify your Medical Device
July 31, 2024 – 12:00 pm – July 31, 2024 – 1:00 pm
Managing global regulatory strategy and compliance: assessing status, gaps, and needs.
July 18, 2024 – 2:00 pm – 3:00 pm
Now that the EU MDR deadline is passed, how do you sell your device abroad?
May 16, 2024 – 12:00 pm – 1:00 pm
2024 State of the US MedTech Regulation: Innovation, Regulatory Transformation, and Artificial Intelligence
April 24, 2024 – 10:00 am – 11:00 am
Mastering Compliance: Essential Insights into PMS Documentation









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Upcoming Events & Webinars

No posts found.



On Demand Events & Webinars

February 26, 2025 – 2:00 pm – 3:00 pm
Are you talking to me? Communicating effectively with your Notified Body for an Accountable and Sustainable Working Relationship
January 21, 2025 – 11:00 am – 12:00 pm
Medical Device Labeling Best Practice for 2025: The Global Design Master
December 17, 2024 – 2:00 pm – 3:00 pm
Adapt, Thrive, and Lead: Insights for Global Medical Device Executives
October 29, 2024 – 10:00 am – 11:00 am
The Art of Benefit-Risk Calculation: Essential Tools for EU MDR Mastery

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