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Medical Device Design & Manufacturing Resource Center

Featured Content

March 12, 2024 | By MedTech Intelligence Staff

FDA Issues New Draft Guidance on Premarket Cybersecurity Considerations

The new draft guidance proposes select updates to the FDA guidance document “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” and focuses on information FDA considers necessary to support obligations under section 524B of the FD&C Act, “Ensuring Cybersecurity of Devices.”

February 28, 2024 | By MedTech Intelligence Staff

Closed-Loop Technologies Reduce the Burden of Chronic Pain

Ashwini Sharan, M.D., Chief Medical Officer of the Neuromodulation Division at Medtronic, discusses the development of the company’s recently CE Marked Inceptiv closed-loop spinal cord stimulator system for chronic pain and how the company plans to further incorporate closed loop technologies in its neuromodulation pipeline.

February 27, 2024 | By MedTech Intelligence Staff

NIST Releases Updated Cybersecurity Framework

The National Institute of Standards and Technology (NIST) has updated its Cybersecurity Framework (CSF) guidance document for reducing cybersecurity risk. The new 2.0 edition is designed for all audiences, industry sectors and organization types. This is the framework’s first major update since its creation in 2014.

February 21, 2024 | By James Darlucio

Navigating Sterilization Options for Silicone Medical Implants

How to choose the right sterilization method for silicone-based medical devices and a look at novel silicone technologies.

January 31, 2024 | By MedTech Intelligence Staff

DiMe Convenes Industry Leaders to Streamline Commercialization of Digital Health Products

The Digital Medicine Society (DiMe) is partnering with PHTI, ZS, and other leading organizations to develop and launch core components of integrated evidence plans for digital health products to support faster regulatory approval and commercialization.

See more News at the Medical Device Design & Manufacturing Resource Archive ››

Advanced manufacturing techniques that boost competitiveness
Avdanced manufacturing techniques that boost competitiveness

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Manufacturing & Supply Chain

  • Evolution of the blood glucose meter
  • Seven questions to ask a manufacturing partner
  • Using "Line Stop Assistants" to enhance production
  • How simulation and digital twins optimize medical manufacturing
  • Supply chain resilience

Medical Design

  • Smart syringe reference design platform
  • How MedTech companies can compete with wearable medical devices
  • Top 5 pitfalls in designing medical devices
  • Usability studies in simulated-use environments
  • Sustainable design in medical devices
  • Future proofing device components
  • Ecofriendly plastics in medical device design
  • Why human machine interface innovation is essential to transform healthcare

Technology

  • Sensor advancements improve medical devices
  • Smart test equipment

Featured Articles

November 27, 2024
sustainable design

From design to disposal:
Reducing the footprint of single-use drug delivery devices

By Alex Fong

How can drug delivery devices manage competing priorities - reducing overall carbon footprint without expense to patient and practitioner safety or treatment efficacy. Sustainability strategies must account for commercial and budgetary pressures.

July 8, 2024
LDT Development

The FDA’s final lab developed test rule places new burdens on manufacturers

By Laura Housman

Diagnostic manufacturers and pharmaceutical sponsors with therapeutics that rely on biomarker identification or companion diagnostics should adjust their commercialization and partnership strategies to fit the new regulatory environment.

January 22, 2023
Rama Chellappa

Instilling Trust in AI

Rama Chellappa, PhD, John Hopkins University Bloomberg Distinguished Professor in electrical, computer, and biomedical engineering, and co-author of "Can We Trust AI?" looks at the promise of AI in health care and how we can best utilize this extraordinary tool to save lives and improve health equity.

October 12, 2020
Arlen Ward, System Insight Engineering

Computer Modeling and Simulation Helps MedTech Developers Bring Innovation to Reality

By Maria Fontanazza

No longer just “the big company advantage,” Arlen Ward discusses how CM&S is an accepted and viable device industry path to market for large and small medical device makers alike.

September 2, 2020
Checkbox

Cybersecurity, COVID-19 and EU MDR Hot Topics of the 2020 MedTech Summer

By MedTech Intelligence Staff

Although the full impact of COVID-19 is uncertain, one sure thing is that industry continues to crave information to help them navigate EU MDR.

June 15, 2020
Abbott FreeStyle Libre 2

FDA Clears Abbott’s Continuous Glucose Monitoring System for Use in Children

By MedTech Intelligence Staff

The FreeStyle Libre 2 now has indications for children ages four and older.

May 25, 2020
FDA

In Face of COVID-19, FDA Updates Adverse Event Reporting Guidance Document

By MedTech Intelligence Staff

The goal of the guidance is to ensure that manufacturers are prepared to report adverse events during a pandemic.

March 17, 2020
N95 respiratory mask

Amidst COVID-19 Pandemic, Scams Involving Personal Protective Equipment Emerge

By MedTech Intelligence Staff

As the saying goes, if it looks too good to be true, it probably is.

View More Combination Products Articles »

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

Upcoming Events & Webinars

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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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