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

Absorv® Bioabsorbable Polymers

Bioabsorbables are capable of safely existing in the body for controlled lengths of time before absorbing without causing any harm or adverse reactions. The Absorv® biomaterial platform is optimized for the development of a wide variety of medical products for preventative care and disease treatments. The ever expanding list of applications includes orthopedic, dental, surgical, stents, and tissue engineering.

CMOS Image Sensors
The company has released two additions to its line of Digital Science image sensors, the KAC-0310 VGA sensor and the KAC-1310 Megapixel sensor
Solenoid Pumps: LPL Series
Solenoid Pumps: LPL Series

The LPL series of solenoid pumps are ideal for integration into medical devices that require precise, fixed volume dispensing. They’re available in MINSTAC port, straight port, flat bottom boss, standard manifold mount, and combination manifold/soft tube port styles. These self-priming pumps have a 10 million cycle life, low power consumption (2 and 2.5 W models), a 2 Hz response time and standard 50 µL dispensing (special sizes also available).

Brushless DC Servomotor: 1218...B Series

With MICROMO’s brushless DC electric motor, the ironless, self-supporting, skew-wound copper coil is a component of the stator.

SRC Connector Series
SRC Connector Series

Colder's new SRC connector is a unique small bore connector that eliminates the potential for misconnections with luer fittings. The intuitive design is simple to operate and provides a secure, leak-free connection.

355-400 UV LEDs

Marktech Optoelectronics offers a UV LEDS in a variety of standard and custom packaging to match application requirements. UV LEDs with wavelengths ranging from 355nm to 400nm offer advantages in UV sensing applications, standard detection and UV curing processes. UV LEDs are widely used in general sensing applications, which include airport identification and inspection equipment, coin and bill validation and medical sensing and purification.

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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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