MD&DI

07/23/2025

📢 Webinar Alert: Revolutionizing Medtech Manufacturing Through Leak Testing Automation

In today's competitive landscape, reliable leak testing isn't just a quality control measure; it's essential for product integrity and patient safety. As automation reshapes our industry, understanding these technologies becomes critical for staying ahead.

Join us to explore:
• Market forces driving the automation revolution in medtech
• How automation directly impacts production goals and throughput
• Smart solutions to common leak testing challenges through domain expertise
• Must-have features in next-generation testing systems for performance and scalability

📅 Tuesday, July 29, 2025
⏰ 11:00 AM EDT
🔗 https://bit.ly/4f4GCNz

If you're looking to enhance quality control while boosting efficiency, this session is for you. Drop a comment if you're joining! 👇

07/22/2025

FDA's LDT Regulation Reversal Opens New Chapter for Diagnostic Innovation

Nearly two months after the agency's window to appeal closed, LDTs remain classified as professional services rather than medical devices - freeing laboratories from what would have been significant regulatory changes.

The ruling has breathed new life into the diagnostic space, with industry experts noting a "renewed excitement around creativity and expansion." As one lab executive put it: "All of the regulations that seemed like a black cloud over us are gone. We can now focus on our clients and patients who need diagnostic treatment."

While CLIA regulations continue to provide necessary oversight, the removal of potential FDA regulation allows labs to respond more quickly to emerging health threats like avian influenza and measles outbreaks.

What's your take? Has this decision struck the right balance between innovation and patient safety in laboratory medicine?
https://bit.ly/3IZm78M

Now that FDA’s final ruling on the oversight of laboratory-developed tests (LDTs) has been vacated, there’s a renewed sense of creativity for patient diagnosis and treatment.

07/21/2025

The Partner Companies (TPC) has just announced its acquisition of Precision Eforming, significantly enhancing its micro-component manufacturing capabilities and deepening its presence in the medical device sector.

"This addition is an ideal fit with TPC's long-term growth strategy to expand our complementary manufacturing capabilities to best serve our customers' needs, while also shaping the future of manufacturing," said Christian Streu, CFO of The Partner Companies.

Read more: https://www.utm.io/uiGng

The Partner Companies acquired Precision Eforming, expanding its medical device manufacturing capabilities with specialized mesh and sieve products.

07/21/2025

A concerning new report shows that 13% of medical devices in the U.S. come from China, putting a significant portion of the healthcare supply chain in jeopardy as lawmakers continue to increase tariffs.

The impact is already being felt across the medical technology sector, with companies scrambling to revise supply chains and procurement strategies.

As someone working in the healthcare/medical device industry, how is your organization preparing for these supply chain challenges? Are you seeing impacts already?

Despite data showing 13% of medical devices come from China, lawmakers continue increasing tariffs, forcing medtech companies to revise forecasts and mobilize against proposed Section 301 duties.

07/21/2025

Is your medical device company ready for the regulatory shift ahead? MD+DI's Claire Wallace spoke with Kim Trautman, Managing Director at Trautman International Services, about the upcoming FDA Quality Management System Regulations that will reshape compliance standards.

While companies already aligned with existing FDA quality systems and ISO 13485:2016 should navigate the transition smoothly, those who haven't updated their practices since the 1996 regulations may face significant challenges.

As Trautman notes, "It is imperative that the medical device industry improve practices and tools... to integrate QMS and RMS processes for improved device designs, more reliable supply chains, and ultimately benefit all our global patients."

Read the full article to ensure your company is prepared for February 2026! https://bit.ly/3TPHH1S

The Medical Device Single Audit Program provides a comprehensive framework for medical device manufacturers to assess compliance gaps ahead of the February 2026 FDA Quality Management System Regulations, offering a streamlined approach that satisfies requirements across multiple regulatory jurisdict...

07/18/2025

This piece by Lisette Hilton on MD+DI about the changing landscape of research funding language under the new administration is eye-opening.

The article details specific terms researchers are being advised to avoid in government grant applications, including words related to diversity, equity, inclusion, and many demographic descriptors that might trigger additional scrutiny.

While federal agencies may flag certain terminology, many private institutions continue with business as usual.

For those in the medical device industry seeking funding, this is essential reading.

The piece even includes practical alternatives suggested by grant writing experts to help navigate these new waters.

As our industry continues to innovate, understanding how to effectively communicate the value of research becomes increasingly critical.


https://bit.ly/451cIoP

Trump Administration changes to government research funding have changed the way grant applications should be written.

07/15/2025

The ongoing 50% tariffs on steel and aluminum imports are creating significant challenges for medical device manufacturers.

These tariffs are driving up costs for critical components like implants, stents, and product casings while disrupting supply chains.

In a recent MD+DI interview with veteran journalist Joe Darrah, Thomas Smolko from ORO Labs highlights how fragmented procurement systems are struggling to track supplier risk and reroute materials sourcing in real time.

The solution? Procurement orchestration that connects workflows across departments and provides real-time visibility into alternatives when tariffs force changes.

Read the full article to learn how medical device manufacturers are adapting their procurement strategies to navigate these challenges: https://www.mddionline.com/manufacturing/maintaining-medical-device-procurement-amidst-fluctuating-tariffs

As levies that impact the medical device industry continue to see-saw, manufacturers might need to recalibrate their business orchestration.

07/11/2025

Industry Insiders Discuss: Is Another Medtronic-Covidien Scale Merger on the Horizon?

Will the medical device industry see another transformative mega-merger like Medtronic and Covidien? MD+DI's Amanda Pedersen and Omar Ford assess the likelihood of similar large-scale acquisitions in today's healthcare environment.

07/10/2025

Mattel, Inc.'s latest initiative is partnering with Breakthrough T1D to launch a groundbreaking Barbie doll featuring an insulin pump and continuous glucose monitor!

This isn't just a toy—it's a powerful statement about inclusion and representation. The doll even comes with a phone displaying a CGM app to track blood sugar levels, mirroring the real-life experience of millions living with T1D.

As Krista Berger, SVP of Barbie, perfectly stated: "Barbie helps shape children's early perceptions of the world, and by reflecting medical conditions like T1D, we ensure more kids can see themselves in the stories they imagine."

What makes this collaboration special is the attention to detail—Mattel worked closely with Breakthrough T1D to ensure medical equipment accuracy down to the dress pattern.

For Breakthrough T1D's CEO, Aaron Kowalski, who has lived with T1D since age 13, this partnership is deeply personal: "It means the world to be part of bringing greater visibility to a condition that affects so many families."


https://bit.ly/4lrQdAu

In a collaboration with Breakthrough T1D, Mattel has unveiled an innovative Barbie doll designed to champion type 1 diabetes awareness and representation.

07/09/2025

The latest episode of Let's Talk Medtech features an insightful conversation with Chris Toth, Vantive's CEO.

In this compelling discussion with Omar Ford, MD+DI's Editor-in-Chief, Chris shares his expert perspective on the evolving digital health landscape
and how artificial intelligence is becoming a true game-changer for healthcare.

Don't miss this opportunity to hear directly from one of healthcare technology's visionary leaders as he unpacks the future of medtech and AI's role in revolutionizing patient care as well as Vantive's role in redefining renal care.

🔗 Listen to the full episode now! https://bit.ly/45XrFdH

What insights are you most interested in hearing about the intersection of AI and healthcare? Share your thoughts below!

07/09/2025

The Future of Medical Robotics: Innovation vs. Profitability

Fascinating insights from three pioneering CEOs disrupting the $8.1B medical robotics market (projected to reach $26.8B by 2032)!

In our latest article, leaders from Distalmotion, Neocis, and Noah Medical reveal:

• How they're challenging industry giants that control 85% of the market
• Their unique approaches to commercialization in specialized niches
• The critical balance between innovation and profitability
• Why the "grow at all costs" era is over for medtech startups

Greg Roche (Distalmotion) shares how they're revolutionizing outpatient surgery centers, while Alon Mozes (Neocis) explains making dental robotics affordable for private practices. Jian Zhang, PhD (Noah Medical) offers a candid look at the funding challenges ahead.

As BTIG analyst Ryan Zimmerman notes: "Investors are not willing to underwrite a company losing money in perpetuity."

What do you think is the biggest challenge for medical robotics companies today? Innovation, funding, or market pe*******on?

Three companies share their experiences and lessons learned in the global robotic surgery space.

07/02/2025

We're excited to share this insightful moment from Vantive CEO Chris Toth's recent appearance on the Let's Talk Medtech podcast.

In this clip, Chris discusses how empathy serves as a fundamental driver for quality and innovation in healthcare and highlights Vantive's strategic investments to expand supply and capacity for critical therapies.

Want to hear more? The full episode offers even deeper insights into Vantive's vision for healthcare transformation.

Check out the complete conversation here ----> https://bit.ly/3I3nBPd