Medical Device Design & Development

INDUSTRY PERSPECTIVES

  • Attribute Vs. Variable Testing For Device Functionality: What They Are & When To Use Which

    Testing performed during medical device development serves to (1) demonstrate that the developed manufacturing process can produce good products that meet the established specification reliably and (2) demonstrate with confidence that the device design will consistently meet the established specification. This article discusses the difference between variable and attribute testing, when to use which, and strategic approaches to selecting one over the other.

Risk-Benefit of Personally Identifiable Information in Extended Reality Medical Applications

The expanding use of extended reality (XR) in medical applications presents a number of unique opportunities and challenges. Due to the extensive reliance on software and networked data, cybersecurity risks must be addressed during the design, development, and use of XR devices. And, of course, compliance with all regulations concerning privacy and control of PII is essential. 

Collaborative Communities: An Opportunity To Contribute To Medical Device Industry Improvements

Collaborative communities are a global grassroots effort convened by interested public and private stakeholders who work to solve shared challenges and achieve common goals related to medical devices. These communities do not replace established regulatory mechanisms, are not federal advisory committees, and are not chaired or convened by the FDA, but FDA may participate. Here are the descriptions, goals, and contact information for each of the 12 collaborative communities that have FDA CDRH participation.

How To Create A Pathway For Diversity In Medtech

When different perspectives and backgrounds come together, it sparks innovation that can drive significant technological advancement. The most diverse companies are now more likely to outperform their less diverse peers. Beyond company performance, ensuring adequate representation throughout the product development pipeline leads to better outcomes for patients in underserved and underrepresented communities.

The Role Of Trust And Communication In Successful Medical Device Teams

Why do we experience teams that seem to start out well, then stumble throughout the project, resulting in delayed launches, product defects, and poor sales? How do they differ from teams that start out similarly yet appear to breeze through the project development stages to launch a successful product? This article also examines each team member's role in improving trust and communication.

WHITE PAPERS & CASE STUDIES

  • Quality System Metrics That Matter

    Product quality is a top priority in any business because nothing else matters without it. Measuring the impact of quality instantly becomes the No. 1 business imperative when those process inefficiencies begin to negatively affect the bottom line. See how these companies digitized and connected their document management processes to help accelerate the time it takes to get a product to market without jeopardizing regulatory compliance.

Metrics That Matter For Contract Manufacturing

For Contract Development, Manufacturing and Packaging organizations (CDMOs, CMOs and CPOs) improving operational flexibility, increasing capacity, shortening lead times and improving product quality is more important than ever as demand and competition for contract services increases. In these examples we show how moving from a paper to a digital solution these customers were able to eliminate data entry errors, reduce deviations, and improve overall efficiency and productivity.

Getting Executive Backing For A Digital QMS

As someone working in quality, you understand how vital your role is for improving efficiency, achieving quality, and meeting compliance. Your work is critical, and it’s essential to have the right tools do your job well – which means having a digital quality management system (QMS). Most executives cite the high cost of adopting technology as the main reason they reject plans to invest in digital systems. This article offers guidance that will help you quantify and communicate the importance of quality, and how a digital QMS delivers considerable savings.

6 Must-Haves For A Quality Management System (QMS)

The best way to build quality into a product is with an effective, connected quality management system (QMS), which serves as the foundation for long-term regulatory compliance and market success. However, not every QMS has the same capabilities and connectivity. A QMS that isn’t connected to other areas of the enterprise still slows down quality processes and introduces the possibility of more human error. In this article we highlight six features of a QMS system that will help companies realize maximum value for years to come.

Automating Document Control Processes To Comply With FDA And ISO Requirements

Careful handling of the large amounts of documentation required for regulated products is critical for achieving compliance. Furthermore, document control guidelines enforced by the U.S. Food and Drug Administration (FDA) and the standards set by the International Organization for Standardization (ISO) continue to evolve. This means your document control system should be agile and scalable to keep up with the changing regulatory landscape. This article details the FDA guidelines and ISO standards that apply to document control, and it illustrates how digitizing document control processes is essential for ensuring ongoing compliance and future relevance.

DESIGN COMPONENTS & SERVICES

The AvaSpec-2048x14 Fiber Optic Spectrometer is a back-thinned type CCD spectrometer with high quantum efficiency and high UV sensitivity. The optical design is based on the AvaBench-75 symmetrical Czerny-Turner design with a 2048x14 pixels high UV sensitive CCD image sensor.

These circular connectors are ideal for medical devices that transfer data or involve data communications due to their 360o electromagnetic shielding. This is a key feature for patient monitoring systems, home health monitors, and EEG/ECG systems.

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

The OV’R Driver is a miniature electronic device placed between a voltage source and a solenoid valve. This circuit has a self-contained 'spike & hold' voltage controller that allows the valve to run at various voltages to compensate for fluctuations in power sources. One key advantage of the OV’R Driver circuit is its ability to self-adjust the pulse width of the output spike voltage based on the input voltage level.

Spanner bushing filters solve those tight center-to-center hole spacing requirements. The spanner bushings are designed without the hex used on the standard bolt-in series. The spanner feedthrus are easily installed using the CMI spanner tool. Spanner bushings can be installed with center-to-center spacing down to .110” or 2.8mm when using the 2*56 threaded size. Spanners are available with capacitance up to 10,000 pF and sizes from 2*56 to 8*32.

Brimrose hyperspectral imagers utilize a NIR camera with an acousto-optic tunable filter as a monochromator to produce hyperspectral imaging of any target area, or to measure visible or NIR hyperspectral imaging information remotely on a variety of materials.

LATEST HEADLINES