Medical Device Design & Development

INDUSTRY PERSPECTIVES

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.

How To Stop (Most) Medical Device Recalls Before They Happen

Supplier quality failures are a leading cause of medical device recalls. This article distills a practical framework for managing supplier quality, from standard off-the-shelf items to custom contract-manufactured components.

A Case Study: Control Strategies For A Multi-Dose Pen Injector

A case study highlighting the importance of drug and device team alignment on control strategy, defining what to control and which controls can and should be implemented.

Control Strategies For Injectable Drug Delivery Combination Products

Defining combination product CQAs across drug and device enables an end-to-end control strategy that improves product quality from the start of development.

More Industry Perspectives

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.

More White Papers & Case Studies

DESIGN COMPONENTS & SERVICES

XLM Series Of LED Fiber Optic Light Modules For Medical Applications
Excelitas’ XLM Series of LED Fiber Optic Light Modules are designed to be integrated by OEMS into endoscopy, surgical microscopy, and medical headlamps and other medical applications that require bright uniform illumination. These high performance fiber optic light modules feature many advantages for medical applications including remarkable uniformity, virtually no ultraviolet or infrared emissions, maintenance-free, long-life operation, and a variable speed fan. The XLM Series offers an excellent alternative to users of xenon, metal-halide and halogen lamps.
Precision-Aligned Xenon Light Sources: PAX Family
Excelitas Technologies’ PAX Family of Precision-Aligned Xenon Light Sources offers OEM customers "plug-and-play," pre-aligned and calibrated pulsed Xenon Light Engine Modules. These compact, precision-aligned Xenon light engine modules generate light over a continuous spectrum from ultraviolet to infrared and are ideally suited to a wide range of clinical diagnostics, invitro diagnostics, life sciences, drug discovery, proteomics, and analytical instrumentation applications.
Miniature Pneumatic Solenoid Valve: Series 11/25/26

Parker Hannifin’s miniature pneumatic solenoid valves provide an ideal solution for OEMs manufacturing devices for oxygen conservation, compression therapy, gas chromatography, and other medical and analytical gas control applications.

Micro-PMT

Hamamatsu’s micro PMT is an ultracompact photodetector about the size of a fingertip, with the same characteristics as a conventional photomultiplier tube (PMT). Its small size, robust structure, high sensitivity, low noise, and fast time response make the micro PMT a suitable detector for high-performance portable devices and instruments. In addition, micro PMTs are easily mass produced and customized.

Actuators for Pumping and Dosing
Actuators for Medical Dosing & Micropump Design

PICMA® Stack Ceramic-Insulated Piezo Actuators for Pumping and Dosing

  • Sub-Nanometer sensitivity
  • Superior lifetime (>100 billion cycles)
  • Non Magnetic and High Vacuum compatible
  • Microsecond response and high stiffness
  • Very large operating temperature range
Low Profile Miniature Positioner: MX80S Stage

This 35 mm high x 80 mm wide stage offers reliable positioning in space-restricted medical device applications. The multi-axis platform can be used in normal or cleanroom environments and has selectable travels of 25, 50, 100, and 150 mm.

More Components & Services

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.

LATEST HEADLINES

More News