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

Life Sciences Corporation Implements eLogbooks Across 15 Sites

New regulations challenged how surgical kits were tracked and processed across 15 U.S. sites. Discover how one team balanced compliance and efficiency to keep life-saving procedures on schedule.

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.

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DESIGN COMPONENTS & SERVICES

Miniature Linear Positioner/Stage: MX80M

The MX80M miniature linear stage is a manually driven positioner with precision cross roller bearings, optional clean room preparation, an optional low ESD coating, dowel holes in the top and base, and positive position lock.

Solenoid Valves: LFY Series
Solenoid Valves: LFY Series

The LFY Series consists of 7 styles of 2-way or 3-way, chemically inert solenoid valves. The LFY Series valves feature a unique internal configuration designed to minimize damage to sensitive materials.

Product Development And Product Design
Product Development And Product Design

Donatelle offers product development and product design services that are integral to product success – spanning functionality, repeatability and cost effectiveness. Their highly qualified team of engineers, designers, machinists and toolmakers consult with customers from the start to help ensure critical medical devices and components are delivered on spec to market as quickly and cost-effectively as possible.

Miniature Liquid Control Valves

Parker Precision Fluidics offers a wide range of miniature liquid control valves used in medical device product development.  These liquid control valves offer a broad range of specs that span a variety of medical device applications like radioactive liquids used in MRI, analytical chemistry, and clinical diagnostic applications.  Parker’s liquid control valves are ideal for these applications offering chemical resistance, non-corroding, high pressure / high flow, and rugged features.

Cleanroom Molding

Molding and manufacturing a product that requires a cleanroom environment is no easy task. At PTI Engineered Plastics, tooling material, gating and runner systems, automation, ejection, and mold maintenance processes are all subjected to product risk analysis to prevent contamination.

oem
OEM Genius 3 Tethered Tympanic Thermometer

Cardinal Health offers the Genius™ 3 OEM tethered OEM tympanic thermometer designed specifically for OEM integration. A developer’s kit contains all of the vital information needed to facilitate integration of the Genius™ 3 Tethered OEM Tympanic Thermometer into a multi-parameter device.

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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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