Medical Device Design & Development

INDUSTRY PERSPECTIVES

Improving Drug-Device Combination Product Co-Development

Early recognition and mitigation of drug and device integration difficulties are critical to the success of combination products. The collaborative effort in development cannot be overstated. 

Minimizing The Impact Of Human Errors Using Relational Risk Analysis

This article describes how a mechanism-based risk analysis approach can provide two complementary opportunities for minimizing the likelihood of a human error impacting pharmaceutical and medical device risks.

Process Validation: Optimizing Operational Excellence In Pharma And Medical Devices

Process validation is often viewed as a costly regulatory formality. However, it is actually a strategic investment that, when integrated into business planning, delivers measurable outcomes in productivity, compliance, speed-to-market, and profitability.

Expanding A Bow Tie Risk Analysis Model Using Relational Risk Analysis

Relational risk analysis can be used to enhance and expand a bow tie analysis in the pharma and medical device industries to more effectively analyze risks as relationships between mechanisms and events.

WHITE PAPERS & CASE STUDIES

Implementing A Next-Gen MES At A Fraction Of The Cost

Discover how a top medical device manufacturer accelerated product launch by digitizing assembly processes, streamlining training, and ensuring compliance.

Custom Orthodontic Aligner Manufacturer Ensures Compliance With Tulip

A pioneering orthodontic startup is transforming custom aligner production using 3D printing and software to cut time and costs in half while scaling rapidly to ensure quality and compliance.

Laerdal Error-Proofs Medical Kit Assembly With AI-Powered Vision Verifications

Discover how Laerdal Medical implemented an automated kit assembly solution that enhances quality control and supports continuous improvement through real-time monitoring and visual documentation.

Leverage Apps To Reduce Line Changeover Time From 14 Days To 3

A global biopharma leader modernized its complex equipment changeover process using an innovative platform to achieve faster execution, fewer errors, and greater visibility through digitized, validatable SOPs.

DESIGN COMPONENTS & SERVICES

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.

LED Fiber Optic Illuminators and Modules from Excelitas Technologies are based on state-of-the-art solid state lighting technology. These LED light sources are designed to couple high-intensity white light into fiber optic bundles for applications such as endoscopy, headlamps, microscopy, industrial borescopes, inspection systems, and machine vision. These LED-based products offer an energy-efficient, maintenance-free alternative to halogen and metal-halide lamp-based fiber optic illuminators.

II-VI Optical Systems has increased its presence in the medical technology arena by applying their vast experience in precision space and defense technology to medical applications where that precision can lead to better diagnostic and therapeutic outcomes.

With their sole focus on being a contract manufacturer of medical devices, Phase 2’s Quality Management System (QMS) has helped to establish the company as a provider of quality medical devices manufactured in a lean production environment.

An Avalanche Photodiode (APD) provides higher sensitivity than a standard photodiode. It is ideal for extreme low-level light (LLL) detection and photon counting. Offered in Silicon or InGaAs materials, these devices provide detectivity from 400 nm - 1100 nm. Multiple configurations are available to provide a wide range of sensitivity and speed options.

Dyconex, an MST company, offers an array of biocompatible flexible substrates that are ideal for short term and long term direct implant applications such as diagnostics, neurostimulation, implantable electrodes, catheters, sensors, and actors. These substrates combine biocompatible structures and conventional PCB technology, and are composed of dielectric base materials such as LCP, PI, or glass.

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