Medical Device Design & Development

INDUSTRY PERSPECTIVES

Clinical Liquid Biopsy Explained: Applications, Techniques, And Players
Clinical Liquid Biopsy Explained: Applications, Techniques, And Players

A minimally-invasive diagnostic that can help clinicians detect, diagnose, and manage cancer patients has long been the dream of many healthcare practitioners. Now, we can dare to dream.

  • Grateful Patients Turn The Spotlight On You!
    Grateful Patients Turn The Spotlight On You!

    When was the last time someone expressed gratitude for the work you do? I don’t just mean a simple “thank you” for completing a task or deliverable. I’m not even talking about receiving a bonus because your company hit its performance targets this past year. Being told “thank you” is important and getting a bonus is very nice, but I am talking about something deeper and more meaningful.

  • Human Factors Align At The RAPS 2017 Regulatory Convergence
    Human Factors Align At The RAPS 2017 Regulatory Convergence

    Recently I had the privilege of co-presenting a session at the RAPS 2017 Regulatory Convergence with former colleagues from Regulatory & Quality Solutions (R&Q) and members of the FDA. Read more about the session here. 

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WHITE PAPERS & CASE STUDIES

  • Six Ways To Cut Machining Costs
    Six Ways To Cut Machining Costs

    Proto Labs has been in the machining business since 1999, and in that time, they’ve learned a thing or two about the intricacies of the CNC machining process. This document contains a compilation of their shared knowledge as it relates to reducing your overall costs by trimming machine expenses.

Giant Step Forward For Neural Bypass Technology

How recent accomplishments are taking science a step closer to realistically fixing paralysis.

Material Evidence: Examining Mysterious Medical Design Failures

Understanding the most common causes of material failures in medical devices can help manufacturers make better design decisions up front and avoid surprises after product launch.

Bioabsorbable Materials 101

There are a wide variety of materials to choose from when it comes to micro medical components. In this article, MTD Micro Molding answers some of the most commonly asked questions about bioabsorbables.

The Coming Wave Of Dual-Chamber Systems For Drug Delivery

Selecting and validating the best dual-chamber design option for the delivery of a given pharmaceutical.

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DESIGN COMPONENTS & SERVICES

Thin Profile DC Micromotors Thin Profile DC Micromotors
DC Motors - Thin Profile DC Micromotors from MicroMo Electronics feature ultra flat dimensions, with no cogging or preferred rotor position
PMC12 ¼-28 Series: Couplings PMC12 ¼-28 Series: Couplings
The popular PMC12 product line is available with a 1/4-28 flat bottom ports and threads to mate with small diameter and microbore tubing. With the use of commonly available nuts and ferrules, full featured connectors can be incorporated into fluid connections, eliminating the need to unthread and rethread nuts.
Intelligent Vision Sensor: VC μ Check System Intelligent Vision Sensor: VC μ Check System

This vision sensor system is ideal for print and surface inspection, identification, positioning and alignment, 2D and 3D measurements, and other applications where very small components need to be inspected. The system itself is comprised of an intelligent camera with a 700 MHz processor and a tele-centric lens enclosed in a 15.8 x 9.8 x 6.5 cm housing.

MPC Series: Medical-Grade Couplings MPC Series: Medical-Grade Couplings

MPC Series couplings add ease of use and security to your most critical fluid handling applications. Choose from a full line of connectors and configurations, including pressue sealing caps and plugs in sizes to fit 1/4" and 3/8" tubing.

OEM Spectrometers: AvaBench NIR Optical Benches OEM Spectrometers: AvaBench NIR Optical Benches

AvaSpec NIR spectrometer components can also be provided as separate products to be used in OEM applications. Avantes has developed different types of NIR optical benches, special for OEM customers. The optical bench AvaBench-50 is available in the 1000-1750nm range for uncooled detectors. The AvaBench-50TEC is developed for NIR range from 1000-2500nm.

Universal Polishing Fixture Universal Polishing Fixture
Krell Technologies’ Universal Workholder (UVG) is designed to polish any fiber optic component that incorporates a UPC-style ferrule with a diameter between 1.25mm and 3.2mm. This includes industry standard connectors such as SC, FC, ST, LC, MU, E2000 and SMA. M29504, TFOCA and ARINC 801 Mil-spec termini and contacts can also be loaded in the UVG. Even bare ferrules and fiber adapters are supported by this fixture. The UVG interfaces with all of Krell’s precision fiber optic polishing machines.
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MEDICAL DEVICE DESIGN & DEVELOPMENT

Medical device design and development is the cyclical process of creating a device for a specific task or set of tasks, and then continuously reevaluating its effectiveness and improving upon it until the device reaches obsolescence. Design and development begins with ideation and the creation of a concept that, if found to be both fiscally and clinically viable, is then designed, engineered, and prototyped. This preclinical period includes bench testing — accomplished through simulated use of the product — and animal testing, along with any necessary redesign work.

Throughout the process, the proposed medical device, and the process by which it will be manufactured, is examined for flaws that may negatively impact the device’s safety, market viability, regulatory acceptance, customer satisfaction, usability, or profitability. Any shortcomings are corrected, and the improvements applied to the final design. Due to the wireless connectivity capabilities of many modern medical devices, cybersecurity and interoperability also must be incorporated into the design. Clinical testing is conducted, using human subjects, to further expose flaws and confirm product strengths. Once both the product design and the manufacturing process have been validated and approved by the U.S. Food and Drug Administration (FDA), production and commercialization of a device may begin.

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