FEATURED EDITORIAL

Unintended Con$equences Of FDA Form 483s
Unintended Con$equences Of FDA Form 483s

I talked with Sandra Maddock, president and CEO of IMARC Research, about trends in clinical research for medical devices, and she opened my eyes to a few very sticky situations with the FDA.

  • Uterine Fibroids And Endoscopy: Lack Of Choice In Asia And Oceania
    Uterine Fibroids And Endoscopy: Lack Of Choice In Asia And Oceania

    iData's key finding in its 2017 Asia-Pacific Gynecology Reports was a lack of treatment options in gynecology. The problem is that procedures are more likely to be chosen based on procurement and a surgeon’s repertoire, rather than the optimal treatment for the patient’s condition, more so than in Europe or North America. 

  • 3 Design-Related Partners For Medtech Development
    3 Design-Related Partners For Medtech Development

    This article is the second in a series exploring some of the important relationships involved in each phase of medical device development. Here, we'll look at key relationships during the design phase.

  • Integrating Risk Management In The Quality Management System — A Primer
    Integrating Risk Management In The Quality Management System — A Primer

    This article will first present the definitions and requirements regarding risk and then introduce some tools that can be utilized to incorporate and integrate risk management techniques in and throughout the QMS.

More Featured Editorial

INDUSTRY INSIGHTS

  • How Many FDA Premarket Applications Are Necessary For Your Combination Product?
    How Many FDA Premarket Applications Are Necessary For Your Combination Product?

    Often, an already-approved drug can further benefit patients when applied with a medical device. In such cases, the pharmaceutical product sponsor may utilize the 505(b)(2) pathway for regulatory approval of the combination product. But even when the regulatory pathway is known, submission strategies for regulatory approval of combination products can be challenging and confusing. The development and review of combination products in the U.S. typically requires the involvement of multiple centers within the Food and Drug Administration (FDA), under the oversight of the FDA’s Office of Combination Products (OCP).

Validation: A Key Stage In Mobile Health Development

To enter the rapidly growing mobile health space, companies must overcome the Mobile Health Development-crucial hurdle of validation. This process demonstrates that the app – in combination with the underlying technology platform / device – performs comparably to traditional products on the market..

IoT-Enabled Medical Devices Are The Wave Of The Future

Winning in the medical devices market of the future requires mastering advanced technologies – or finding a partner with these capabilities. The global Internet of Things (IoT) in healthcare market is forecasted to reach $410 billion by 2022. To succeed in this arena, device companies need to stay out in front of manufacturing innovations so they can quickly integrate information technology (IT) functionality into their products, accelerate time to market and control costs.

Using A Component Management Process To Scale Up Manufacturing Of Drug Delivery Devices

The best practice for fitting multiple parts into a single assembly at tight tolerances is to choose a single component supplier with a sufficient array of core competencies in advanced device manufacturing methods. The chosen supplier should also utilize a well-designed component management process that includes close attention to important elements, proper planning, and high performance levels to provide an affordable, highly scalable drug delivery device.

Segmentation Of The Diagnostics Market

The in vitro diagnostics (IVD) market is commonly segmented by techniques, products, application, end users, and geography. To better navigate the IVD diagnostic market landscape, understanding and recognizing how each segment is distinct, yet related to one another is critical for the company that wants to optimize its opportunities within this market.

More Industry Insights

SOLUTIONS

In Vitro Diagnostics

Battelle brings together deep experience in bioinformatics, biologics, chemistry and related fields to deliver innovative in vitro technologies with unparalleled accuracy and detection limits — all at unprecedented speed and with significant cost savings.

Medical Device Contract Manufacturing Medical Device Contract Manufacturing

Contract manufacturing for single-use medical devices is how Phase 2 got their start. They provide ultrasonic cleaning, injection molding, solvent and UV bonding, soldering, annealing, and more manufacturing services to both startup single-use medical device companies and larger-sized OEMs.

Solutions For On-time, Deficient-Free Delivery Of Medical Supplies, Medicines And Other Products Solutions For On-time, Deficient-Free Delivery Of Medical Supplies, Medicines And Other Products

For the person with diabetes in need of insulin, the heart patient awaiting a monitor or the individual expecting critical lab results, a delay of even one day isn't acceptable. Timely delivery of medical supplies or medication could mean the difference between recovery and relapse.

Electro-Mechanical Assembly Electro-Mechanical Assembly
Corry Micronics offers a wide variety of electro-mechanical assembly services, including...
Avalanche Photodiodes (APDs) With Enhanced NIR sensitivity Up To 950nm: Series 9.5 Avalanche Photodiodes (APDs) With Enhanced NIR sensitivity Up To 950nm: Series 9.5

First Sensor’s new Series 9.5 of avalanche photodiodes (APDs) are designed with an increased sensitivity in the near infrared (NIR) wavelength range up to 950 nm. Due to their fast rise time and very low dark current, these ADPs are ideal for applications with low light intensities and high modulation frequencies such as laser range-finding and laser scanning. Other applications for the photodiodes include safety scanners, 3D-mapping, environmental monitoring, high resolution LIDAR systems for autonomous driving, as well as high speed photometry, and fiber optical communication.

Fischer Plastic Series Fischer Plastic Series

The Fischer Plastic Series is a family of high performance, fully insulated plastic connector bodies that are all compatible with Fischer’s metallic connectors. Key features include high reliable signal path, high signal and contact density, clear coding for easy operation, and resistance to large temperature variations.  

More Products & Services

FEATURED SUPPLIERS

Accumold Accumold

Accumold® is a high-tech manufacturer of precision micro, small and lead frame injection molded plastic components

FMI, Inc. FMI, Inc.

FMI is dedicated to producing medical-grade silicone components for Class II and Class III medical devices. In fact, custom silicone moldings are the only products we manufacture and health care is the only industry we serve. That singular focus allows us to provide the highly customized components that medical device manufacturers depend upon for patient safety, efficacy and reliability.

MDO-FTE-bmarshall

LATEST HEADLINES

More News