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Market Access

Featured Articles

March 21, 2025
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?

October 31, 2024

Japan Medical Device Reimbursement Update 2024

By Ames Gross

Medical Device reimbursement levels in Japan are now more in line with the reimbursement levels in the EU. The Japanese government has pledged not to allow Japanese device reimbursement to be as high as the US prices.

June 30, 2024
FDA

FDA publishes long-awaited clinical trial diversity guidance

By Hogan Lovells Engage

An analysis from the Life Sciences legal team at Hogan Lovells.

March 6, 2024
Sanobar Syed

Overcoming Forecasting Challenges in Cell and Gene Therapies

By Sanobar Syed

Predicting the potential of cell and gene therapy pipelines presents unique challenges. Following are considerations for forecasters working with novel technologies.

November 29, 2023
Naomi Schwartz

Medcrypt Appoints Former FDA Officer to Vice President of Services

“We’re excited to have Naomi in this role. With her FDA experience, her visionary approach will pave the way for success, ensuring that businesses not only meet the FDA's stringent requirements but also thrive in an environment where cybersecurity is a fundamental business value.”

November 1, 2023
Puzzle piece

Drivers and Implications of Multi-Billion Dollar Acquisitions in Medtech

By Laurie Halloran, Maria Shepherd

While billion-dollar deals are common in the medtech industry, multi-billion-dollar megadeal acquisitions were still notable in 2022. Often, these deals result in a ripple effect on the industry when two large companies merge. Here we look at some recent examples, the growth drivers behind them and what they mean for the medtech industry.

September 20, 2023
FDA Logo

FDA Updates Breakthrough Devices Program Guidance

By MedTech Intelligence Staff

The updated guidance clarifies how the program applies to medical devices that may address health inequities, as well as those that may increase access to care or provide a non-addictive treatment option to treat pain or addiction. It also clarifies the FDA’s current interpretation of the Breakthrough Device designation criteria.

September 6, 2023
FDA Logo

FDA Issues Three New Draft Guidances on the 510(k) Program

By MedTech Intelligence Staff

The FDA has issued three new draft guidances related to the 510(k) submissions program, including Best Practices for Selecting a Predicate Device, Use of Clinical Data in Premarket Notification and Evidentiary Expectations for Implant Devices. The agency is accepting comments and will host a webinar for stakeholders on October 26, 2023, to provide more information on the guidances.

September 1, 2023
Christian Götz and Dr. Jara Brenke

EU MDR Annex XVI Introduces New Burdens for Products Without an Intended Medical Purpose

By Christian Götz, Dr. Jara Brenke

Previous EU regulatory acts did not cover products without an intended medical purpose—typically devices with aesthetic indications. This now changes with Annex XVI of the EU Medical Device Regulation (MDR). Notified Bodies can assess these products for their conformity with the regulation. However, responsibility for proactively pursuing the EU certificate of conformity for the products rests with the manufacturers.

August 30, 2023
GetWell Logo

Get Well Achieves FedRAMP Authorized Designation

By MedTech Intelligence Staff

The Get Well platform is used at more than 70 Veteran Affairs Medical Centers (VAMCs). Now that it is listed on the FedRAMP Marketplace, the Get Well digital patient engagement platform can be contracted by any government agency without additional security vetting required. 

View More Market Access Articles »

Columns

November 15, 2023
Soapbox

Unlocking Success in SaMD Product Launches Through AI

By Caroline Shleifer
Caroline Shleifer

AI-driven regulatory platforms support SaMD organizations by proactively monitoring and adapting to the dynamic global regulatory landscape. The technology alerts users to anticipated regulatory updates worldwide, facilitating improved foresight and trend detection. It also provides guidance on addressing potential lapses in product compliance, integrates with existing workflows and streamlines regulatory tasks from classification to registration and market entry.

September 20, 2023
Soapbox

The Power of AI to Enhance Clinical Trials

By John Schwope
John Schwope

AI not only improves data collection and analysis, it impacts which products are engaged in clinical trials, determines necessary medical criteria, helps design the trials and can even choose the best participating facilities. The result is, organizations that leverage AI will be more successful and will go to market faster than those that don’t.

August 15, 2023
Soapbox

MedTech Marketing Pearls for FDA Clearance and Beyond

By Amanda Bloom
Amanda Bloom

As VP of Product Marketing for a MedTech startup, my role is to champion pioneering medical technology, strategically spark interest and drive it out of the design lab and into the field where it will ultimately change, or even save lives. Over the last two decades, I’ve seen the industry evolve in interesting ways, and I’ve learned some enduring lessons about market introduction and launch of market-making technologies post-FDA clearance.

August 2, 2023
From The Editor's Desk

Join J&J, Pfizer and FDA at the Supply Chain Summit and Advanced Manufacturing Conference

By MedTech Intelligence Staff
Supply Chain and Adv Mfg 2023

Supply chain challenges and the move to advanced manufacturing are two key issues affecting the Medtech industry. On November 7-9, MedTech Intelligence will be hosting the MedTech Advanced Manufacturing Conference and Supply Chain Summit, in partnership with Axendia, Inc. The two events will run back-to-back with registration options available for each program as well as a discounted rate for professionals who would like to attend both programs.

July 6, 2023
Soapbox

Managing the Post-Pandemic Pricing Squeeze

By Farida Ali
Farida Ali

As technology component pricing continues to rise, MedTech manufacturers are applying proven methods and exploring new approaches to maintain profitability and extend product lifecycles.

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






Market Access Archive
  • Digital Health
  • MedTech Economics
  • Manufacturing Execution
  • Product Design & Development
  • Quality/Regulatory

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

Combination Products

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