FEATURED EDITORIAL

A Simplified, Five-Step Approach To Applying FDA’s Human Factors Guidance
A Simplified, Five-Step Approach To Applying FDA’s Human Factors Guidance

FDA’s most recent guidance on human factors, Applying Human Factors and Usability Engineering to Medical Devices, highlights the importance of enhancing patient safety by adopting human factors engineering processes in the design and manufacturing of medical devices. 

  • Will Stemless Implants Dominate The Shoulder Arthroplasty Market?
    Will Stemless Implants Dominate The Shoulder Arthroplasty Market?

    Reflecting a growing trend of minimally invasive surgeries, stemless arthroplasty is driven by the desire to facilitate smoother revision procedures, and to prevent stem-related complications.

  • MDTX Was A Cure For The “Regulatory Blues”
    MDTX Was A Cure For The “Regulatory Blues”

    Last week’s MDTX event was a thought leaders' forum for medical device innovators who design, develop, or commercialize devices. There were interesting conversations with speakers and leading-edge knowledge from experts about everything from concept to commercialization, and regulations to reimbursement. My own presentation was on recently-released FDA guidance documents and how these new expectations might influence your next product development effort.

  • Express And Implied Preemption For Premarket-Approved Medical Devices:  A Dual Shield Against Tort Claims
    Express And Implied Preemption For Premarket-Approved Medical Devices: A Dual Shield Against Tort Claims

    In the past 10 years, manufacturers have used express and implied preemption to shield themselves from personal injury tort lawsuits involving PMA medical devices, but plaintiffs’ attorneys have sought to poke holes in these shields, occasionally establishing certain limited exceptions to these preemption defenses.

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INDUSTRY INSIGHTS

  • Improving Health Outcomes With Personalized Apps
    Improving Health Outcomes With Personalized Apps

    Advances in sensors, smartphones, communications, and analytics give developers new tools to build creative and powerful applications that promise to improve health outcomes and reduce healthcare costs.

Micro-MIM Succeeds At Making Precise Micro Metal Parts

As component sizes for medical devices shrink to micron size, conventional machining may not be the most efficient or consistent method for manufacturing. Learn why Micro-MIM is preferred for components with tight tolerances at high volumes.

Plan For Success With Sustaining Engineering In Medical Device Development And Manufacturing

Sustaining engineering enables the developer to plan ahead, getting the development and design of the device done right the first time, and smoothing the transition to manufacturing. KMC's executive director of engineering, Scott Leon, weighs in on the subject.

How To Uncover The Hidden Value Of Culture In Supplier Selection

The business pain of switching suppliers, both in terms of costs and revalidation time, heightens the importance of making the right decision the first time.

Taking Micromolding To the Next Level

Micromolding requires a high level of intimacy and attention to detail to be successful over the long run, so it’s important to work with micromolder with the capability, scalability, and sustainability to get a product from the design stage all the way to high-quality mass production. 

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SOLUTIONS

Compact Modular Cameras For Robust Applications Compact Modular Cameras For Robust Applications

First Sensor offers a family of rugged, compact cameras designed to withstand the toughest conditions, such as extreme heat, cold, or permanent vibrations. Each camera features a modular design with different interfaces and data formats for simple integration. All cameras can be adapted quickly and flexibly to customer-specific requirements.

Autoclavable SCHOTT Solidur® LEDs For Medical And Dental Devices Autoclavable SCHOTT Solidur® LEDs For Medical And Dental Devices

SCHOTT Electronic Packaging offers an array of sterilizable LED modules for the fulfillment of lighting needs in harsh environment applications, including and especially devices used in the medical field that must undergo repeated sterilization processes. 

Engineering And Design Services Engineering And Design Services

KMC Systems offers decades of experience in solving complex medical engineering and design challenges, and in considering innovative, highly-automated solutions for the development of full-system instrumentation. KMC Systems engineers work collaboratively with customers to achieve optimal interdisciplinary solutions to laboratory automation challenges, Design for Manufacturability and Serviceability (DFM and DFS) challenges, and medical device verification and validation.

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.

Hydrogels For Medical Devices Hydrogels For Medical Devices

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.

Low Volume Molding Low Volume Molding

PTI's expertise and experience are ideal for complex, low-volume injection molding. They are committed to delivering the same precision and price advantages of high-volume production molds. The Low-Volume Production (LVP) molding program utilizes the latest injection molding equipment, including electric injection molding machines with closed-loop processing, and automated material handling systems. PTI also is capable of customized, higher volume production runs.

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FEATURED SUPPLIERS

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.

Donatelle Donatelle

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

MDO-FTE-bmarshall

 EVENTS

Instructional Design for GMP Training – Improve Effectiveness and Measurability April 24, 2018
1pm-2:30pm EDT, Online Training)
Price:  $299 - Includes Bonus Handouts!
Measuring CAPA Effectiveness: Critical Tips in Getting the Right CAPA and Showing It Works April 25 - 25, 2018
2pm-3:30pm EDT, Online Training)
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
Executing Proper Event Investigations: Critical Steps In Ensuring Compliant Corrective Actions May 2 - 2, 2018
1pm-2:30pm EDT, Online Training)
Duration:  90-Minutes
Price:  $199 - Includes Bonus Handouts!
Effective Batch Record Review - Getting It Right The First Time May 7 - 7, 2018
RECORDING, Online Training)
Duration:  90 minutes
Price:  $299 - Includes Bonus Handouts!
Biocontainment For Manufacturing: Understanding The Risks, Guidance, and Design Requirements May 8 - 8, 2018
1pm-2:30pm EDT, Online Training)
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
FDA Guidance for Industry “Process Validation: General Principles & Practices” – Whatever Happened to IQ, OQ, PQ? May 16 - 16, 2018
1pm-2:30pm EDT, Online Training)
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
The Core Competencies of a World-Class Medical Affairs Team May 17 - 17, 2018
1pm-2:00pm EDT, Online Training)
Price:  $199 - Includes Bonus Handouts!
The EU General Data Protection Regulation (GDPR): What US Companies Need To Know To Comply May 22 - 22, 2018
1pm-2:30pm EDT, Online Training)
Price:  $299 - Includes Bonus Handouts!
Understanding Aseptic Technique and Cleanroom Behavior – Avoiding Human Error May 29 - 29, 2018
1pm-2:30pm EDT, Online Training)
Price:  $299 - Includes Bonus Handouts!
Pediatric Clinical Trials: Special Considerations and Requirements June 4 - 4, 2018
1pm-2:30pm EDT, Online Training)
Price:  $299 - Includes Bonus Handouts!
Understanding Cleanroom Microbiology – Building A Foundation For Compliance June 14 - 14, 2018
1pm-2:30pm EDT, Online Training)
Price:  $299 - Includes Bonus Handouts!
Electronic Data Integrity in a GxP Environment: Managing the Data Lifecycle for Compliance June 27 - 27, 2018
1pm-2:30pm EDT, Online Training)
Price:  $299 - Includes Bonus Handouts!
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