FEATURED EDITORIAL

Concept of a healthy female reproductive system-iStock-1202348409 An Analysis Of The Pelvic Organ Prolapse Repair Medical Device Market

Pelvic organ prolapse is common and may affect 50% of women, though the severity of the condition varies and, in some cases, may be resolved with non-surgical treatments. As of 2019, however, approximately 15% of American women needed surgical repair for POP at some point in their lifetime. This article analyzes the current device market and describes the opportunity for innovation.

  • A retro-validation is a re-execution of the method validation with the method parameters, setup, and everything kept the same as before to retrospectively cover all prior generated data. It is not the same as past validation because you would shore up the validation deficiencies or gaps. This article discusses the 6 important considerations.

     

  • It’s always best to prevent the need to investigate a non-compliance, but if you experience a non-compliance, it’s necessary to quickly and effectively perform an investigation. The investigation report needs to be clearly understandable to anyone reviewing the report, and hopefully you'll also learn enough to make sure the non-compliance doesn't recur.

  • While medtech firms have had proven success with scaling and short bursts of innovation from special projects and acquisitions, many firms have struggled to achieve a steady stream of disruptive innovation. This article provides three strategies for leveraging agile methodologies for better innovation.

INDUSTRY INSIGHTS

  • How Reengineered Components Optimize Medtech

    Reengineering is useful in replicating discontinued components or parts whose original designs no longer exist. The process also empowers designers to improve part performance, fit, and/or production speed.

Providing Superior And Secure Care With RFID Technology

Hospitals and healthcare providers are going well beyond the basics of patient care these days. Years ago, hospitals took good care of patients by providing the best quality medical care they could. Today, they’re tasked with that and so much more.

The Future Of Virtual Healthcare

The shift to virtual care is transforming healthcare. Thanks to ever-improving technologies and digital tools, virtual care was gaining traction before the COVID-19 pandemic, but accelerated dramatically last year, as providers and patients sought ways to minimize the virus’ spread.

Molding Bioresorbable Materials For Medical Devices And Components

Taking full advantage of bioresorbable materials in medtech requires an understanding of each material’s strengths, production challenges, and ideal applications.

More Than Tracking: How RFID Protects Patients And Medtech Users

RFID technology provides life sciences applications with product and component traceability while safeguarding against human error, unsterilized tools, outdated materials, and more.

SOLUTIONS

PTI has developed a new standard for protecting, storing and presenting data generated from its line of non-destructive leak testers in the form of a software package called PTI Ethos.

Whether you need a few pieces or a few thousand, Donatelle's highly specialized team can produce parts with near-production tolerances in as little as a few days. As part of their integrated services, they work closely with your design team to select the best polymers and metals to bring accuracy and consistency to your molded components. You can also rely on their expertise with hundreds of exotic materials, including high-temperature, implantable-grade and silicone.

Caplugs has been a global leader in plastic molding with six different molding processes and thousands of material options. The in-house team of engineers works with customers throughout their comprehensive process to design a unique solution process from creating concepts and rapid prototyping to packaging and inventory management.

Cardinal Health’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.

Quick Time To Market, Significantly Lower Risk

Daikyo Crystal Zenith® Luer Lock syringes are designed to fit a variety of standard drug delivery devices, and compared to glass they offer unprecedented strength, durability, and protection.

MTD Micromolding is solely committed to providing the highest quality micromolding services of advanced medical products. MTD offers their innovative skills in exploring and producing very small, delicate, and intricate components required for advanced medical applications and products such as specialized surgeries, bioabsorbable devices, and implant devices. With a constant demand for newer, smaller, never-before-seen micro medical devices, MTD is also prepared to assist their strategic partners in the development of new solutions.

FEATURED SUPPLIERS

With more than 60 years of experience in formulation of quality aqueous cleaners, Alconox Inc. understands the cleaning needs of the medical device manufacturing industry including stringent FDA regulations and GMP compliance.

Proto Labs, Inc., through its Firstcut and Protomold services, utilizes proprietary computing technologies and automated manufacturing systems to provide prototype parts and short-run production services. All parts are made by standard production methods, delivered at affordable prices, and can be delivered in as fast as one day.

MED DEVICE ONLINE CONTENT COLLECTIONS

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The EU’s Medical Device Regulation (MDR, effective May 26, 2021) and the In Vitro Diagnostics Regulation (IVDR, effective in May 2022) are certainly hurdles for medical device manufacturers to tackle. However, those aren’t the only new regulations in Europe to prepare for.

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