INDUSTRY PERSPECTIVES

Medtech Material Selection For Performance And Feel
Medtech Material Selection For Performance And Feel

When designing a medical device, material selection can be difficult, especially with thousands of plastic material options available. While material properties, environmental effects, regulatory requirements, and cost almost always are considered, "feel" is often overlooked – despite its importance to user and patient satisfaction, as well as market success.

 

  • Quality Focus In Outsourcing And Offshoring — What To Retain And What To Relinquish
    Quality Focus In Outsourcing And Offshoring — What To Retain And What To Relinquish

    When outsourcing and offshoring your operations, it may seem daunting to “let things go,” but redundancy wastes time and effort. Here, we will delve into the business areas to retain and those to relinquish control of, while still maintaining the high quality expected of your products.   

  • Insiders’ Guide To Winning In the Drug Delivery Device Market — Part 2: Regulatory Compliance
    Insiders’ Guide To Winning In the Drug Delivery Device Market — Part 2: Regulatory Compliance

    I recently sat down with David Amor, managing partner at MEDgineering, Inc., to discuss the challenges associated with bringing drug delivery devices to market, as well as emerging therapeutic areas and technologies. David’s background is in mechanical and biomedical engineering, with expertise in regulatory systems and compliance. 

  • Learning From FDA Warning Letter Trends
    Learning From FDA Warning Letter Trends

    An examination of warning letters issued by FDA to industry reveals trends that can help manufacturers avoid the agency’s wrath. In this column, we’ll review important sources of information on FDA enforcement activities, trends in FDA Form 483 observations, and tips to implement an effective quality management system.

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WHITE PAPERS & CASE STUDIES

Metallographic Examination Of Medical Implants

Metallographic examination has become an indispensable tool in the testing, quality control, failure studies, and post-mortem analyses of implantable devices. This paper presents techniques and results for examination of titanium-based acetabular cups and Co-Cr-Mo femoral hip stems and knees.

4 Avenues To Leveraging A Smartphone In Your Connected Health Product

Connectivity has evolved alongside the proliferation of the smartphone and the two are coming together to redefine how we manage our health. Considerations such as durability, battery life, security, user experience, and much more must be considered as you develop a connected medical solution, but the principal consideration for any smartphone is its principal purpose: Connectivity and communication.

Laser Marking Metal For Medical Applications

Medical product marking and decoration is used for inventory control, process management and internal tracking, branding, and functionality. In many cases, lasers provide the preferred means of marking and identifying those products.

A Crash Course In Choosing Biocompatible Wearable Tech Materials

What is the best part about wear­able tech­nol­ogy prod­ucts? You can wear them while they work! This also indi­cates, how­ever, that your wear­able device must be made of an appro­pri­ate mate­r­ial to be worn safely. 

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PRODUCT & SERVICE SHOWCASE

Medical Device Engineering Services Medical Device Engineering Services

Phase 2 Medical employs an engineering team with vast experience in the complexities of assembling, testing, and packaging single-use, disposable medical devices. Their engineers specialize in the LEAN manufacturing of medical devices.

Avalanche Photodiodes (APDs) Avalanche Photodiodes (APDs)

First Sensor has a large selection of high sensitivity, high speed and low dark current photodetectors optimized for ultraviolet, visible and infrared light as well as ionizing radiation. Package solutions include surface mount (SMD), through hole (THD) devices

Custom Prisms Custom Prisms

Precision Optics Corporation can custom manufacture prisms with tolerances to .01mm, <10/5 scratch/dig, λ/20 flatness, <5 arc second parallelism, +/- 0.1mm; 0.2mm to 150 mm diameter, and +/- 0.02mm (and as thin as 0.2mm) thickness.

Lead Frame / Insert Micromolding Lead Frame / Insert Micromolding

Accumold's tooling and automation systems for lead frame molded parts and insert applications are second to none. Components can be singulated and shipped bulk, or tape-and-reel to our customers.

Contract Manufacturing for Single Use Finished Medical Devices Contract Manufacturing for Single Use Finished Medical Devices

Passion for technology has driven SMC Ltd. to be a leading manufacturing partner to the top medical device OEMs. With operations spanning the United States, Costa Rica, and India, SMC is positioned to assist you on your next finished medical device.

 

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.  

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FEATURED SUPPLIERS

STERIS Isomedix Services STERIS Isomedix Services

STERIS Isomedix Services has been committed to providing contract sterilization services to the medical device, pharmaceutical, consumer, and industrial communities for over 40 years. Blending industry-advanced technology with a team approach to Customer service, STERIS Isomedix Services offers the industry’s most comprehensive advantage, encompassing radiation and ethylene oxide sterilization.

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.

LATEST HEADLINES

  • NIH Backs Artificial Pancreas Trial By Partners Cellnovo, TypeZero

    Cellnovo Group is partnering with technology company TypeZero to utilise Cellnovo’s e-connected insulin patch pump alongside its inControl AP software in an artificial pancreas program. This joint system will be in consideration for use in the International Diabetes Closed Loop Trial, which is funded by the National Institute of Health.

  • BD CEO: Medtronic Collaboration On Novel Infusion Set “On Track”
    BD CEO: Medtronic Collaboration On Novel Infusion Set “On Track”

    Becton, Dickinson and Company (BD) CEO Vincent A. Forlenza told investors recently that an ongoing partnership with Medtronic on a new insulin infusion set is on track, and unveiled the company's pipeline of new products in 2016, including a couple of new cell analyzers with faster simultaneous measurement capabilities. He also confirmed that savings from the medical device tax suspension will be re-invested into R&D.

  • FDA Offers Extension For Some UDI Implementation Deadlines
    FDA Offers Extension For Some UDI Implementation Deadlines

    The U.S. Food and Drug Administration (FDA) is giving original equipment manufacturers (OEMs) some additional time to remove legacy FDA labels from medical devices, citing concerns from payers and pharmacies that removing the labels prematurely would interfere with patient access. Certain medical devices manufactured before September 2018 will have until September 2021 to remove the legacy labels.

  • Nikon Invests $10M In Hand-Held X-Ray Analyzer Maker Tribogenics

    Tribogenics, the inventor of triboluminescence based X-ray technology for industrial, security and scientific applications, announced today that Nikon Americas Inc. has made a strategic investment in Tribogenics. Nikon Group’s investment will help speed the commercialization of Tribogenics’ Watson, hand-held XRF analyzer products.

  • Abbott's Needle-Free Glucose Monitor Receives CE Mark For Children Aged 4 To 17 Years

    Abbott has obtained CE Mark (Conformité Européenne) for the FreeStyle Libre flash glucose monitoring system indicated for children and teens with diabetes aged 4-17 years old. This means that children and young people with diabetes living in Europe are able to experience the liberation from the pain and hassle of routine finger pricks.

  • Edwards CEO Touts Increased Adoption of TAVR Program
    Edwards CEO Touts Increased Adoption of TAVR Program

    Edwards Lifesciences reported a strong fourth quarter performance built on increased adoption of transcatheter-based heart valve therapies, and company CEO Michael A. Mussallem believes momentum will likely continue this year as the company receives more indications for its Sapien 3 implant.

  • FDA Clarifies Human Factor Studies For Medical Device And Combination Product Design
    FDA Clarifies Human Factor Studies For Medical Device And Combination Product Design

    The U.S. Food and Drug Administration (FDA) has released two new draft guidances and one final guidance related to human factors in product design. One draft guidance describes the agency’s recommendations regarding human factor studies in the design of combination products; the other lists which device types should include human factors (HF) data in their premarket submissions. The final guidance focuses on applying human factors and usability engineering to medical devices.

  • Philips' Partnership With Validic Enhances HealthSuite Capabilities

    Royal Philips is further enabling connected health by signing an agreement with Validic, a U.S.-based fast-growing company that pioneers a technology platform for connectivity and access to digital health data from clinical and remote-monitoring devices, sensors, fitness equipment, wearables and patient wellness applications.

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UPCOMING TRAINING COURSES

Good Manufacturing Practices (GMP) – An Introduction February 9, 2016
1pm-2:30pm EST, Online Training
Analyzing and Understanding ISO 13485 Proposed Changes February 10, 2016
1pm-2:30pm EST, Online Training
Medical Devices - Effective Complaint Handling and Management February 16, 2016
1pm-2:30pm EST, Online Training
Answering Your Top 5 GCP Questions From 2015! February 17, 2016
1pm-2:30pm EST, Online Training
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