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

QUICKSHAFT

The innovative design with a 3-phase self-supporting coil and non-magnetic steel housing offers outstanding high-resolution performance. The absence of residual static force and the excellent relationship between the linear force and current make these motors ideal for use in micro-positioning applications. 

Medical Device Manufacturing

With over 35 years of experience in the medical industry, PTI Engineered Plastics is poised to take on your medical device’s manufacturing process. They specialize in handling multi-part programs and medical device molding for a variety of different types of medical devices, no matter how complex.

Ceramic Core Alumina Heater for Medical and Life Science Applications

Heatron’s ceramic core alumina heater is ideal for dialysis, CPAP, DNA analysis/testing, blood diagnostics, surgical devices, blood/fluid warming, MRI equipment, instrument sterilization, temperature therapy, and vessel sealers.  

Avalanche Photodiode (APD) C30659 Series

Excelitas Technologies’ C30659 Series includes a Si or InGaAs Avalanche Photodiode (APD) with a hybrid preamplifier, in the same hermetically-sealed TO-8 package, to allow for ultra-low noise operation.

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.

Light Capacity Rodless Miniature Linear Positioners: LCR Series

This series of linear positioners is ideal for medical device OEMs looking to automate light payloads. They’re ideal for applications involving sample preparation, liquid handling, microtiter automation, and elevators and storage/retrieval axis.  

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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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