FEATURED EDITORIAL

Plastics Selection For Medical Wearables: Key Material Families
Plastics Selection For Medical Wearables: Key Material Families

The process of material selection often begins by evaluating the characteristics of a given polymer family, and comparing and contrasting them with the characteristics of other polymer families. This evaluation is done in concert with a thorough review of the performance requirements of the device. 

  • Understanding The Changes To Clinical Evaluation Guideline: MEDDEV 2.7.1 Rev 4
    Understanding The Changes To Clinical Evaluation Guideline: MEDDEV 2.7.1 Rev 4

    The MEDDEV guidance 2.71, revised by the European Commission this year, instructs manufacturers how to properly conduct a clinical evaluation, including demonstration of the scientific validity of data and conclusions. The document also covers requirements specifically for postmarket surveillance and postmarket clinical follow-up.  

  • Trump And The FDA: What to Expect (And What’s At Stake)
    Trump And The FDA: What to Expect (And What’s At Stake)

    Donald Trump’s advance team will soon be headed to FDA’s White Oak campus to observe and learn about the agency, to help facilitate the transition from the Obama administration to the Trump administration. In this article, I describe what I expect the nascent 2017 agenda will be as Trump’s team walks in the door, and I offer a few thoughts as to why the Trump team would do well to consider the unique nature of FDA as transition planning takes shape.

  • Clear And Present Danger: Act Now On Medical Device Cybersecurity
    Clear And Present Danger: Act Now On Medical Device Cybersecurity

    Medical device interconnectivity has obvious benefits, but it also introduces new cyber-attack vectors for hackers to insert malware, compromise connected technologies, steal patient data, or even jeopardize patient health. The current state of medical device cyber readiness and compliance requires an immediate, industrywide call to action

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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, ensuring that patients and providers can rely on the output to make appropriate medical decisions.

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.

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.

Solenoid Valves Solenoid Valves

Bürkert systematically follows the principle of maximum customer benefit when developing efficient solenoid valve technology. Regardless of whether you require a single component or a complex system solution, we always focus on optimum process reliability, efficiency, and economy.

mHealth Solution For Clinical Trials mHealth Solution For Clinical Trials

Mobile health momentum is building as new technologies emerge. The first steps in your journey — including regulatory strategy and device/data validation —can be challenging.

Medical Device Supply Chain Management (Metals, Electronics) Medical Device Supply Chain Management (Metals, Electronics)

At SMC Ltd. we understand your desire to have a single point of contact for your full medical device. With SMC’s demonstrated strength in IQ/OQ/PQ validation, our network of established and qualified suppliers, and our experience in custom manufacturing, we have the comprehensive resources in place to manage your program from conceptual design to final distribution.

Detergent 8: Low-Foaming Ion-Free Detergent Detergent 8: Low-Foaming Ion-Free Detergent

Detergent 8 is concentrated to save you money, biodegradable, and readily disposable. Its penetrating wetting power saves you time. It’s free rinsing to give you reliable results and no interfering residues.

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FEATURED SUPPLIERS

Donatelle Donatelle

Donatelle has been in business over 45 years providing medical device contract manufacturing services helping companies develop innovative and life-saving products. 

LATEST HEADLINES

  • Boston Scientific Builds Structural Heart Biz With Neovasc Deal
    Boston Scientific Builds Structural Heart Biz With Neovasc Deal

    Boston Scientific continues to diversify its foothold in the cardiovascular space, signing a definitive agreement to acquire select technologies and manufacturing capabilities from Neovasc, a Canadian biological tissue business specializing in elements used to build transcatheter heart valves. 

  • European Dx, Device Trade Groups Consolidate Into MedTech Europe
    European Dx, Device Trade Groups Consolidate Into MedTech Europe

    The European Diagnostic Manufacturers Association (EDMA) and the European Medical Device Manufacturers Association (Eucomed) have formally integrated into a single entity called MedTech Europe effective immediately. It's the culmination of four years of close collaboration between the two associations, which are now dissolved.

  • Flexan Medical Holdings, LLC Acquires MEDRON Inc. To Expand Contract Manufacturing Capabilities

    Flexan Medical Holdings, LLC, a leading global custom rubber molding company, announced today the acquisition of Medron Inc, a medical device contract manufacturing services company. This acquisition supports the current trend of the medical device industry’s strategic efforts to outsource with total solution providers who can consolidate critical offerings to address the needs of the global device market.

  • 21st Century Cures Bill Passes U.S. House, Expected To Clear Senate
    21st Century Cures Bill Passes U.S. House, Expected To Clear Senate

    The U.S. House of Representatives overwhelmingly passed a compromise version of the 21st Century Cures Act to streamline drug and medical device approval, and to boost research and medical innovation. The landmark legislation is headed next week to the Senate, where approval is seen likely.

  • Device Industry Reacts To Trump’s Nominations For HHS and CMS
    Device Industry Reacts To Trump’s Nominations For HHS and CMS

    President-elect Donald Trump has nominated U.S. Rep. Tom Price (R-GA.) as secretary of the Department of Health and Human Services (HHS), and tabbed Seema Verma, a healthcare consultant, to head the Centers for Medicare and Medicaid Services (CMS). 

  • Medtronic Signs Its First Integrated Health Solutions Agreement In U.S.
    Medtronic Signs Its First Integrated Health Solutions Agreement In U.S.

    Medtronic has inked an Integrated Health Solutions agreement with University Hospitals Cleveland Medical Center (UH), the first agreement of its kind signed by Medtronic in the U.S. Together, the organizations will implement Medtronic’s operational models to streamline workflow and efficiency in select catherization (cath) and electrophysiology (EP) laboratories.

  • FDA Issues Guidance On Mitigating Cross-Contamination Risk During Colonoscopies, EGDs
    FDA Issues Guidance On Mitigating Cross-Contamination Risk During Colonoscopies, EGDs

    The U.S. Food and Drug Administration (FDA) has released guidance recommending mitigation strategies to reduce the risk of cross-contamination from irrigation tubing and accessories that are part of a flexible gastrointestinal endoscope system.

  • Scientists Create First "Water-Wave" Laser
    Scientists Create First "Water-Wave" Laser

    For the first time, scientists have generated lasers from the interaction of light and water waves. This "water-wave" laser can find future application in optofluidic devices and "lab-on-a-chip” devices for studying cell biology and delivering drugs at the nanoscale.

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UPCOMING TRAINING COURSES

Update to ICH GCP E6 (R2) – Changes and Implementation December 12, 2016
1pm-2:30pm EST, Online Training
Reacting to “Human Error” – Moving Beyond “Retraining” As A Response December 13, 2016
10:30am-12pm EST, Online Training
Laboratory Data Integrity: Current Expectations for OOS Result Investigations December 14, 2016
10:30am-12pm EST, Online Training
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