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.

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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.

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SOLUTIONS

Wearable Solutions For Continuous Health Monitoring Wearable Solutions For Continuous Health Monitoring

Wearable medical technologies allow for continuous health monitoring in the home so that patients can conveniently chart their wellness or progress electronically. Designers and engineers of high-tech medical devices have to consider the human skin interface during product development, not just as the last step before market. 3M has the expertise available to assist wearable medical technology manufacturers with selecting the right materials that work well with the human skin interface.

  PolyJet 3D Printing Services PolyJet 3D Printing Services

Proto Labs is proud to introduce PolyJet technology to their 3D printing capabilities. PolyJet technology is used to provide designers and engineers with the ability to manufacture elastomeric and overmolded prototypes without investing in tooling. This technology can create 3D-printed parts comprising both elastomeric and rigid materials, as well as multiple colors.

Hydrogels For Medical Devices Hydrogels For Medical Devices

Medtronic’s OEM division offers a large selection of latex-free hydrogels in bulk rolls or in slit widths. These medical device hydrogels are used in a variety of applications including ECG signaling, defibrillation, electrosurgical and iontophoretic return electrodes, T.E.N.S., wound care, cosmetics, and non-skin adhesives.

Rapid Tooling And Medical Device Prototyping Rapid Tooling And Medical Device Prototyping

Donatelle’s rapid tooling and prototyping services help accelerate the design process and bring critical medical device products to market – faster. With an experienced team of engineers, mold designers, machinists, and toolmakers, they are able to produce near-net shape parts with near production tolerances, machined or molded, in as little as a few days.

Medical Device Prototyping & Design Services Medical Device Prototyping & Design Services

Carclo's product engineers have multiple years of experience with medical device prototyping and design. They address your medical device design needs by getting involved as early in the product prototype and design cycle as possible.

Lab Testing And Sterilization Validation Services Lab Testing And Sterilization Validation Services

REVOX has put together a team comprising engineers, chemists, microbiologists, project managers, business consultants, and quality and regulatory professionals that are subject matter experts with strong expertise and experience in their fields. REVOX can work to enable sterilization technology to work to its fullest potential for medical devices. The company offers rapid 30-day sterilization development, materials and microbiological laboratory testing, supply chain optimization services, and regulatory development expertise.

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FEATURED SUPPLIERS

First Sensor AG First Sensor AG

First Sensor AG (Formerly Silicon Sensor) has over 20 years of experience in the development and manufacture of individual sensor solutions offering highest levels of precision and reliability.

Ophir Photonics Ophir Photonics

Ophir Photonics, a Newport Corporation, began making laser power meters, energy meters, and beam profilers in 1979, and we’ve never looked back. We have headquarters in the United States, Israel, Japan, and Germany, as well as distributors in over 50 countries worldwide.

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