Medical Device Design & Development

INDUSTRY PERSPECTIVES

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.

A Better Interpretation Of POH In ISO 24971

Probability of harm (POH) is critical to appropriately scoring risks, so how should it be done? POH needs to show all probabilities, not suppress them.

Why Pharmaceutical And Medical Device Risks Must Be Analyzed By Their Risk Mechanisms

Current risk analysis methods focus on the possibility and severity of bad events instead of focusing directly on analyzing and improving the performance of systems and processes producing the bad events. 

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WHITE PAPERS & CASE STUDIES

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.

Laerdal Error-Proofs Medical Kit Assembly With AI-Powered Vision Verifications

Discover how Laerdal Medical implemented an automated kit assembly solution that enhances quality control and supports continuous improvement through real-time monitoring and visual documentation.

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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.

Medical Module
ELCAN Optical Technologies can boast of being on the leading edge of technology while enjoying an accomplished history that reaches back to the very beginnings of modern optics.
Pressure Sensors for Medical Analysis Instrumentation: HMI Series

First Sensor HMI pressure sensors are ideal for medical analysis instrumentation that calls for increased media compatibility and the ability to work with pressure ranges from 1 to 150 psi (100 mbar to 10 bar).  They have a Total Error Band (TEB) better than ±1.5 %FSS from -20 to +85 °C (-4 to 185 °F), and very small SIL and DIP housings with a selection of pressure ports.

Solenoid Valves: LFN Series
Solenoid Valves: LFN Series

The LFN Series Solenoid Valves are 2-way, normally closed, diaphragm valves. These valves feature an isolation diaphragm on an inert housing, making the valves suitable for controlling critical and aggressive fluids.

Horn Antenna for EMC/EMI/RFI Susceptibility Testing
Horn Antenna for EMC/EMI/RFI Susceptibility Testing

Electronic medical devices need to be tested for EMC/EMI/RFI susceptibility to ensure that they remain immune to interference from cell phones, other electronic medical equipment, or other sources of RF emission. The ATH800M6G is a high-gain horn antenna covering the 0.8 to 6 GHz frequency range and has been designed for such EMC testing applications.

Value Added Operations

While cleanroom manufacturing of silicone components for medical devices is at the core of what ProMed does, their Value Added Operations services are currently the fastest growing portion of their business. High-quality, value added components are delivered on time with the help of ProMed’s experienced production and engineering personnel, their New Product Development Processes, and their ISO-quality system.

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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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