Industry Insights

  1. New PTC Heater Option Brings Greater Control For Hand-Held Medical Devices And Disposables
    1/17/2017

    Typical heating solutions for devices used on location, by patients, or field staff, such as etched foil flexible polyimide and silicone heaters or Thick Film heaters, deliver performance and reliability but require costly sensors and controls. This paper introduces a new heating element solution that is designed specifically for tightly controlled single-use or disposable medical device applications.

  2. Are You Gambling With Medical Device Compliance?
    1/5/2017

    OEMs can ease their burden of ensuring CMO regulatory compliance by selecting a CMO with a fully integrated system for DHR creation. Not only can such a system eliminate the inaccuracies of paper records, but it also enforces documentation and automates error prevention, giving OEMs peace of mind.

  3. Collecting A Body Of Data
    12/28/2016

    As the popularity of wearable technologies and diet-tracking apps increase, the digital health industry is looking to find a way for these devices to help track not only what is eaten, but the actual effect that it has on the body. The future of wearable devices could include analyzing the changes in sweat and how it relates to the body’s chemistry, measuring diabetics’ blood sugar, and measuring different levels of vitamins, hormones, and other blood components.

  4. Evaluation Of Wear Time For Various Tapes On Human Volunteers: 8-Day Study
    12/21/2016

    There are many types of adhesive tapes for securing wearable sensors, health monitors, and other medical devices that need to meet a variety of requirements. Depending on the application, some adhesives must be gentle, able to adhere in high moisture conditions, flexible, stretchable, and/or conformable. This white paper covers a study that was to determine the approximate adhesion time of ten commercialized and two experimental tapes on non-compromised skin of healthy volunteers.

  5. Skin vs. Stainless Steel Adhesion Testing For Medical Design
    12/21/2016

    Choosing the correct adhesion tape for a patient with the best adhesion to skin may be difficult due to the many changing factors that human skin has, including cell renewal cycles, elastic surfaces, rough textures, and breathing surfaces. As a solution, adhesion of tape made at different times following the same production standards to a standardized substrate like stainless steel will provide a reproducible value under controlled conditions, and therefore is a desirable choice as part of a quality control specification. This white paper discusses the differences between skin and stainless steel adhesion testing for medical applications, as well as considerations for choosing the optimal adhesion for your patient.

  6. Evaluation Of Wear Time For Various Tapes On Human Volunteers: 21-Day Study
    12/21/2016

    There are many types of adhesive tapes for securing wearable sensors, health monitors, and other medical devices with a variety of requirements. Depending on the application, some adhesives must be gentle, able to adhere in high moisture conditions, flexible, stretchable, and/or conformable. This white paper covers a study that was intended to determine the approximate wear time of five commercially available and seven investigational tapes on non-compromised skin of healthy volunteers.

  7. Use Of Adhesives In The Medical Device Industry
    12/21/2016

    Adhesives have been replacing many other types of fastening systems in the assembly of medical devices over the past few decades. With many types of adhesive forms, including structural, non-structural, and pressure sensitive adhesives, they are able to meet many different needs and offer significant benefits over other mechanical fastening systems. This white paper presents the general benefits of using various adhesives over mechanical bonding techniques, and discusses the different types of adhesives that may be used.

  8. Rapid PCR Instrument Development
    12/21/2016

    Next-generation PCR-based diagnostics are growing in demand to use for the rapid analysis of patient samples and simultaneous detection of multiple diverse markers. However, PCR imaging systems limit testing to one, slow PCR protocol at a time that may run over several hours or days. As a solution, a new, rapid, real-time PCR instrument is developed with multiple, randomly accessible thermal blocks and easy to use software. This white paper discusses the development of this next-generation system, and how it provides researchers and clinicians with flexibility in workflow with rapid results in twenty minutes.

  9. Three Strategies For Assessing IVD Instrument Feasibility Early In The Design Process
    12/21/2016

    Successful rapid product development relies on the quality and completeness of the information available early in the development process, and promises accelerated time to market and lower development cost. Understanding the user requirements, selecting and optimizing the hardware/software architecture, and leveraging off-the-shelf technologies are all essential elements of successful rapid development of IVD instruments. This white paper discusses three strategies for assessing the feasibility of a new IVD instrument early in the development process that can minimize design changes, speed the product to market, and meet user needs at a reasonable cost.

  10. How To Ramp Up High Volume Bioabsorbable Micro Component Production While Decreasing Part Price
    12/2/2016

    Many OEMs will utilize multi-cavitation tooling to reduce piece part prices while preparing to increase the production volume of a micromolded component. While this may be a cost effective approach for simple thermoplastic parts, it may not be the best technique for micromolded parts, especially those made of bioabsorbable or high dollar value materials. This article discusses overcoming expenses such as material waste, and mold and automation issues, and presents four key areas for cost savings in bioabsorbable products.