Medical Device Design & Development

INDUSTRY PERSPECTIVES

Analyzing And Managing CDMO Project Risks Using Causal Mechanism & Effect Analysis

Since every sponsor–CDMO relationship can have widely different scopes, requirements, and procedures, this article focuses on the basic principles for analyzing and managing the risks of not achieving the relationship’s objectives.

Improving Execution Of Biological Evaluation Of Drug Delivery Devices

This article provides a framework to streamline the biological safety assessment process, reduce testing burdens, and improve patient safety for combination products.

Risk Is the Spine: What The First 100 QMSR Inspections Reveal

The FDA has now completed just over 100 inspections under its new Quality Management System Regulation, and the agency has begun sharing preliminary observations from those inspections.

Rethinking CQV In A Digital, Agile Manufacturing Landscape

While commissioning, qualification, and validation (CQV) remains foundational, the way it is planned and executed must evolve to keep pace with modern manufacturing realities.

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WHITE PAPERS & CASE STUDIES

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    Accuracy, Safety And Ease Of Use

    Safety, ease of use, and accuracy guide modern medical device design, advancing through improved materials, engineering innovation, standards adoption, and user‑centered development.

Color Consistency In UHMWPE Medical Textiles

Color consistency improves surgical visibility, differentiation, and workflow efficiency, requiring medical textiles that deliver strength, compliance, and reliable quality in every color.

Deterministic Nondestructive Seal Integrity Testing

Deterministic, non-destructive seal integrity testing delivers validated, quantitative results. Learn why this method outperforms traditional approaches in ensuring patient safety and product quality.

Accelerating Antibody-Drug Conjugate (ADC) Development

Explore how automated immunoassays help overcome ADC bioanalysis challenges, reducing hands-on time, improving throughput, and enabling multi-analyte workflows for more efficient assessments.

Choosing The Right PCD Configuration For Reliable Sterility Assurance

Accurate PCD configuration ensures sterility assurance. Learn how to align validation strategies with ISO standards, optimize cycle efficiency, and select the right BI format for EO sterilization success.

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DESIGN COMPONENTS & SERVICES

PTI Tooling And Mold Design

Having a good mold design is critical for delivering a capable, high quality product. Each part design is unique and has its own list of requirements, so one-size-fits-all mold build concepts will not make the cut. With over thirty years of experience in tooling and mold design, PTI’s team of skilled designers have helped pave the way in delivering mold designs and parts that continuously meet and exceed their requirements.

LIBS Broadband Spectrometer System: LIBS2500plus

Ocean Optic’s Laser-induced Breakdown Spectrometer Measurement Systems are detection systems that permit real-time qualitative measurements of elements in solids, solutions and gases. These broadband, high-resolution systems provide spectral analysis across a wide 200-980 nm range (depending on the system) at a resolution of ~0.1 nm (FWHM). The LIBS2500plus is a much-improved system from our previous LIBS offerings. Advantages of the new system include a smaller footprint,  Increased system sensitivity due to the elimination of internal fiber and more functionality for use with external triggering options, such as delay generators.

Hyperspectral Imaging Fundus Camera
Hyperspectral data is a set of contiguous bands, collected and processed from across the electromagnetic spectrum usually by a single sensor. Certain objects leave unique ‘fingerprints’ across the spectrum known as spectral signatures. Traditionally, hyperspectral imaging enables the identification of the molecular components that make up a scanned object.
R22i Optical Transmissive Encoder
MicroMo Electronics, Inc. is pleased to announce the new R22i optical transmissive encoder. The R22i has rugged PET 530 housing material with an IP-40 rating, making it a perfect match for light automation and office automation applications.
Scientific Molding

PTI’s scientific injection molding services are ideal for the manufacture of medical devices because of the four process parameters monitored during production. This controlled process is data driven and highly repeatable which yields Six-Sigma quality products.

Miniature Proportional Valve for Medical Devices: VSO®

This valve has been specifically designed for medical device manufacturers developing ventilators, oxygen concentrators, oxygen conservers, anesthesia delivery monitors, pressure flow control devices, blood pressure monitoring devices, or other devices that require precise control and flow up to 56 sipm.

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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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