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.

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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.

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DESIGN COMPONENTS & SERVICES

Liquid Silicone Molding
Liquid Silicone Molding

Each liquid silicone component will be molded in an ISO 7 (class 10,000) cleanroom, which has added capabilities for post-molding annealing, cleaning and insert molding. Donatelle's microprocessor-controlled, closed-loop systems provide fast cycle time and high output volume, along with optimal process control for tight tolerances and critical part features.

Quality Management Systems for Medical Devices

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.

Image Sensors for Blood Analysis and Point-of-Care Devices

Hamamatsu’s line of image sensors includes CMOS, CCD, NMOS, and InGaAs image sensors available for integration into instruments for in vitro diagnostics (fluorescence assays), blood analyzers, and point-of-care devices.

Thin Profile DC Micromotors
DC Motors - Thin Profile DC Micromotors from MicroMo Electronics feature ultra flat dimensions, with no cogging or preferred rotor position
Selective Laser Sintering (SLS) for Additive Manufacturing
Selective Laser Sintering (SLS) for Additive Manufacturing

Selective laser sintering is an additive process that draws on a bed of thermoplastic powder to create a fully sintered, Nylon-based part. This technique is ideal for parts with highly complex geometries.

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CarboSil® Thermoplastic Silicone Polycarbonate Polyurethane (TSPCU)

DSM’s CarboSil® Thermoplastic Silicone Polycarbonate Polyurethane (TSPCU) is a copolymer that combines the biocompatibility and biostability of conventional silicone elastomers with the processability and toughness of thermoplastic polycarbonate-urethanes. The silicone portion of CarboSil® TSPCU works synergistically with the polycarbonate component to improve stability. This medical-grade polymer is highly biocompatible and well suited to be used in many types of medical devices.

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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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