FEATURED EDITORIAL

Cybersecurity For Not-Yet And Never-To-Be Connected Medical Devices
Cybersecurity For Not-Yet And Never-To-Be Connected Medical Devices

Any device that uses any kind of code — in other words, practically all modern medical devices more complicated than a basic scalpel — can potentially be hacked or otherwise compromised, even if they are not directly connected to the internet.

  • Optimizing FDA Submissions For Companion Diagnostics
    Optimizing FDA Submissions For Companion Diagnostics

    In this article — part one of a two-part series — we will examine the history of companion diagnostic approvals by FDA. Through this process, trends can be identified to suggest better approaches to optimize review times.

  • Value-Based Tech And Changing Patient Demographics: The Dental Device Market’s Future
    Value-Based Tech And Changing Patient Demographics: The Dental Device Market’s Future

    The dental medical device industry is shifting due to changes in regulatory factors, demographics, and economics. These shifts ripple outward to affect the patients, the dentists, and ultimately the manufacturers of dental medical devices, in a way that is causing major changes in the competitive landscape.

  • Cancer Care’s Evolving Recovery And Remission Phase Demands Evolved Medical Devices
    Cancer Care’s Evolving Recovery And Remission Phase Demands Evolved Medical Devices

    Cancer research receives a huge share of global R&D spending, driving lots of innovation in therapies and changing the landscape of the remission and recovery phases, in particular. However, the availability of drugs on self-administration device platforms is one element of cancer care that is not aligned with a non-clinical, long-term care model. Herein lies a great opportunity for medical device manufacturers. 

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INDUSTRY INSIGHTS

Auto Injectors, From Planning To Launch: Preparing For The Overall Development Process

Looking at the rising trend towards self-administration therapies, injectable drug delivery devices such as pen injectors, autoinjectors and needle free injectors show a significant growth potential in the near future.

Tribology And Testing Of Orthopedic Implants

The orthopedic implant industry is in a continual state of development, witnessing an explosion of novel materials, designs, and applications. This process is, however, often laced with challenges and articulating joints can present the greatest number of these. By Aia Malik, Lucideon, and Chris Pickles, Ph.D.

Sterilization Of 3D Printed Medical Devices

Fused Deposition Modeling™ (FDM® ) can be used to produce an array of medical devices; however, for such devices to be practical, they must be manufactured using sterilizable materials. By David Espalin, Francisco Medina, Mireya Perez, and Ryan Wicker, The University of Texas at El Paso; and Terry Hoppe and Rob Winker, Stratasys

An Introduction To Manufacturing Execution Systems For The Medical Device Industry

Manufacturing Execution System (MES) solutions have the potential to generate efficiencies, improve productivity, and simplify compliance within the medical device manufacturing industry. Used to manage production activities, this class of software typically provides the ability to schedule activity, deliver instructions to operators, synchronize manual activities with automated processes, and integrate with manufacturing computer systems to enable quality control, deviation management and effective enterprise resource planning (ERP), equipment management, and the documenting of floor activities for monitoring and reporting purposes.

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SOLUTIONS

Lab Testing and Sterilization Validation Services Lab Testing and Sterilization Validation Services

REVOX has put together a team comprised of 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. With such a team, REVOX can work to enable their 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.

As with any sterilization method, the REVOX room temperature PAA sterilization process must prove sterility using one of two testing methods—the overkill method or the bioburden method.  

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.

Pressure Relief Valves (For Plastic) Pressure Relief Valves (For Plastic)

The IMH Pressure Relief Valves for plastic incorporate a simple, press-in design for easy installation. With features including metal to metal seating, the valves provide low leakage, highly repeatable cracking pressure, and compatibility with a wide range of fluids and gases.

Drug Delivery Device Prototyping Solutions Drug Delivery Device Prototyping Solutions

Being able to create prototype injection molded components and assemblies quickly gives product developers a critical competitive edge. 

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.

Quality And Regulatory Services Quality And Regulatory Services

The Tech Group recognizes the quality and regulatory framework required for successful scale-up or transfer of their customer’s medical, drug delivery, and diagnostic devices.

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FEATURED SUPPLIERS

Battelle Battelle

Medical Product Development|Commercialization|Market Research|Industrial Design

REVOX Sterilization Solutions REVOX Sterilization Solutions

REVOX Sterilization Solutions is part of the Cantel Medical Corp.; a company dedicated to infection prevention and control.  Our in house experts include mechanical engineers, chemists, microbiologists, quality assurance and regulatory affairs professionals. The REVOX team will work to understand your challenges, concerns, and opportunities and provide expert insight to help you decide if REVOX Sterilization is the right sterilization solution for your product or product concept, and/or operational efficiency improvement goals.

DOUG'S LATEST COLUMNS

Doug's Latest Columns

LATEST HEADLINES

  • Nokia Expands Digital Health Business Through Partnership With Finnish Hospital
    Nokia Expands Digital Health Business Through Partnership With Finnish Hospital

    Nokia has announced a partnership with the Helsinki University Hospital (HUS) in Finland, and the collaboration’s first project will focus on remote monitoring solutions for patients suffering from neurological conditions. This move reflects Nokia’s desire to expand past consumer fitness wearables and into clinical solutions, according to senior leadership.  

  • Microsoft, Median Technologies Ink Big Data Initiative For Early Cancer Detection
    Microsoft, Median Technologies Ink Big Data Initiative For Early Cancer Detection

    Microsoft and France-based Median Technologies are teaming up to extract biomarkers from medical images using advanced algorithms, with the aim to help oncologists diagnose and treat cancer patients in the United States, Europe, and Asia.

  • Centric Medical's Subtalar Arthroereisis Implant System For Foot And Ankle Earns FDA Approval

    Centric Medical, a division of Life Spine, Inc. has announced that the U.S. Food and Drug Administration (FDA) has given 510(k) marketing clearance to the Subtalar Arthroereisis Implant System for treating hyperpronation of the foot and stabilization of the subtalar joint.

  • FDA Releases Final Guidance On Extrapolating Clinical Data For Pediatric Indications
    FDA Releases Final Guidance On Extrapolating Clinical Data For Pediatric Indications

    The FDA has released a final guidance outlining the agency’s thoughts on leveraging data obtained during clinical trials with adults to secure device labeling for pediatric indications. The agency hopes that this new approach will “streamline” the approval process for pediatric devices and improve children’s access to important life-saving technology.

  • IBM Forms “Medical Imaging Collaborative” To Fight Cancer, Heart Disease
    IBM Forms “Medical Imaging Collaborative” To Fight Cancer, Heart Disease

    IBM is forming a “Watson Health medical imaging collaborative” with sixteen leading health systems, academic medical centers, ambulatory radiology providers, and imaging technology companies to help clinicians utilize IBM Watson cognitive imaging analysis in diagnosing increasingly prevalent disorders, such as cancer, diabetes, and heart disease.

  • St. Jude Earns CE Mark For CRT Portfolio Software

    St. Jude Medical, Inc., a global medical device company, announced CE Mark approval and launch of SyncAV CRT software, designed to build upon the company’s first-to-market MultiPoint Pacing technology and further optimize St. Jude Medical’s comprehensive cardiac resynchronization therapy (CRT) portfolio. MultiPoint Pacing technology with the SyncAV CRT software algorithm is designed to address and effectively treat heart failure patients who are not responsive to other pacing options.

  • Philips Buys Digital Pathology Firm Path XL, Inks Software Partnership
    Philips Buys Digital Pathology Firm Path XL, Inks Software Partnership

    Philips is expanding its foothold in digital pathology with the acquisition of Path XL, a digital imaging analysis (DIA) and software firm based in Ireland, as well as a licensing agreement with Visiopharm, a software company developing algorithms for breast cancer. Philips CEO Frans van Houten commented that he expects Philips digital pathology business to double year over year.

  • FDA Authorizes Emergency Use Of Two IVDs For Zika Virus Detection, Clinical Trial For Experimental Vaccine
    FDA Authorizes Emergency Use Of Two IVDs For Zika Virus Detection, Clinical Trial For Experimental Vaccine

    The U.S. Food and Drug Administration (FDA) has announced the issuance of Emergency Use Authorizations (EUAs) for two in vitro diagnostic (IVD) devices for detection of Zika virus. The EUAs were based on prior determination by the Secretary of Health and Human Services (HHS) that the present Zika outbreaks in the Americas constitute a public health emergency, and pose a threat to U.S. national security or the health and security of U.S. citizens.

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