Medical Device Design & Development

INDUSTRY PERSPECTIVES

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.

Causal Mechanism And Effect Analysis (CMEA): FMEA's Simpler, Effective Alternative

This article describes causal mechanism and effect analysis (CMEA) as an alternative to failure mode and effect analysis (FMEA) for analyzing and managing the industry’s risks.

Selecting The Right eQMS To Maximize Quality Maturity

Let's take a closer look at the current electronic quality management system (eQMS) landscape in pharma/biotech and what a future-ready eQMS must enable to support continuous improvement.

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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

Insert Molding For Medical Devices

Insert molding techniques can streamline the production of your next medical device and eliminate the need for additional secondary operations. This type of molding can result in consistency, stability, the potential for reduced size and weight, and design flexibility.

High-Speed, Long Life Solenoid Valves: INK Series
High-Speed, Long Life Solenoid Valves: INK Series

Because of their high-speed, repeatability, and long life cycles, INK solenoid valves by the Lee Company are ideal for replacing valves in existing printers, or in new drop-on-demand and dispensing applications involving in-vitro diagnostics, drug discovery, and therapeutic care.

CMOS Image Sensor
The company offers a 0.35 micron CMOS Image Sensors (CIS) process technology.
Custom Prisms

Precision Optics Corporation can custom manufacture prisms with tolerances to .01mm, <10/5 scratch/dig, λ/20 flatness, <5 arc second parallelism, +/- 0.1mm; 0.2mm to 150 mm diameter, and +/- 0.02mm (and as thin as 0.2mm) thickness.

High Performance TE Cooled Fiber Optic Spectrometer: SILVER-Nova

The SILVER-Nova high performance, TE cooled fiber optic spectrometer provides research grade high resolution and optical sensitivity for spectroscopic applications in the 190-1110nm wavelength range. The system is portable, packaged in a rugged metal enclosure for use with a single strand fiber optic cable.

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.

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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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