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

  • GettyImages-2243791302-syringe-production-line-glp-1
    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

SMCLtd_Automation
Automated Manufacturing Services for Medical Devices

Automated cells can improve quality, reduce labor, lower cycle times and increase production. At SMC, we take pride in offering industry-differentiating automation expertise. We are committed to meeting or exceeding our customers’ requirements by designing and building work cells that gain a competitive edge. Our in-house automation team will design cutting-edge automation customized to your specific program, ensuring that your requirements for quality and reliability are met time and time again.

Disposable Connectors

Smiths Connectors disposable connectors are designed to meet customer’s ergonomic requirements and reduce total system cost.  These disposable medical connectors are a great lower cost option that offers active mating contacts on reusable side that maintains reliability. 

Simulation Software
Software offers improvement in the design of artificial heart valves and pumps to help cut the death rate from cardiovascular disease.
Integrating Electrical/Mechanical Features on Medical Devices

Molex’s Molded Interconnect Device/Laser Direct Structuring (MID/LDS) capabilities combine the two-shot molding process for MID with the speed and precision associated with LDS to create medical-grade electronic devices for integration into blood glucose monitors, drug delivery systems, pulse oximeters, disposable catheter interfaces, CPAP devices, neurostimulation controllers, and more.

Short-Run Injection Molding for Medical Devices

PTI Engineered Plastics offers short-run injection molding for medical device design and molding, whether the need is for 15 pieces or thousands per year. Short-run molding reduces lead times and gets products to market much faster.

Precision Aspirate and Dispense Syringe Pump

The Parker Hannifin Smart Syringe Pump is ideal for precision flow control, sampling, reagent addition, and liquid handling applications in both the clinical diagnostics and analytical chemistry markets. It’s one-third the size of standard 30mm syringe pumps. It helps to optimize the performance of the systems it’s integrated into through improved resolution and by bringing the pump to the point of dispense.

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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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