Medical Device Design & Development

INDUSTRY PERSPECTIVES

Reimagining HACCP And Other Process Flow Risk Analysis Methods Using Relational Risk Analysis

Combining relational risk analysis (ReRA) modeling strategies with hazard analysis and critical control point (HACCP) and other process flow risk analysis methods makes them more efficient.

Maximizing The Value Of An Internal Audit Program In Pharmaceutical Quality Operations

A shrinking FDA and rising supply pressures demand stronger risk management and smarter internal audits. Here’s how pharma can truly “see things as they really are.”

Building World-Class Global Quality Teams That Break Down Silos

Over 25 years leading global quality and regulatory organizations, I've learned that the most difficult challenges aren't regulatory or technical; they're organizational and cultural. 

Mastering Cultural Intelligence In Global Quality And Regulatory Leadership

The medical device industry has gone global, but most quality and regulatory leaders still operate with regional mindsets. Leaders who master cultural intelligence build quality systems that leverage diversity as competitive advantage.

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WHITE PAPERS & CASE STUDIES

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.

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.

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DESIGN COMPONENTS & SERVICES

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.

PAX-10M 10-Watt Precision-Aligned, Modular, Xenon Light Source Product Note
Excelitas Technologies’ latest precision-aligned and pre-calibrated xenon module, PAX-10M, offers a full 10 Watts of power in a compact, modular design with a remote flash head allowing for easier integration in space-limited applications. The PAX-10M is the ideal pulsed Xenon light source with “Plug-and-Play” functionality for clinical diagnostics, invitro diagnostics, life sciences, drug discovery, proteomics, and analytical instrumentation applications.
Low Volume Molding

PTI's expertise and experience are ideal for complex, low-volume injection molding. They are committed to delivering the same precision and price advantages of high-volume production molds. The Low-Volume Production (LVP) molding program utilizes the latest injection molding equipment, including electric injection molding machines with closed-loop processing, and automated material handling systems. PTI also is capable of customized, higher volume production runs.

Medical Ventilator Integration

Parker's broad portfolio of high performance products – in conjunction with their ability to design and manufacture complex integrated assemblies – makes them a strong, reliable partner for respiratory care and anesthesia delivery device manufacturers. From concept to launch and long-term sustainability, Parker delivers innovative solutions for:

  • Inventive system solutions utilizing a broad range of products and sub-assemblies
  • Advanced technologies that are smaller, lighter, more energy efficient, and highly reliable
  • Acute care ventilators
  • Home care ventilators
  • Transport ventilators
  • CPAP and BiPAP
  • Anesthesia ventilators
  • Airway management
Miniature, Cost-Effective Linear Positioners: XE Series

The XE series of miniature, mono-carrier style linear positioners feature integrated precision screw and linear guidance, a precision ballscrew drive train, a rigid steel U-Channel body, packaged adjustable limit sensors, and flexible motor mounting options.

Silicone Wire Wound Heaters

Heatflex silicone wire wound heaters by Heatron are an excellent choice for high flex applications. They can be used for blood/fluid and instrument warming, sterilization, temperature therapy, and in instrumentation for dialysis, CPAP, DNA analysis, blood diagnostics, and surgical irrigation.

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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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