Medical Device Design & Development

INDUSTRY PERSPECTIVES

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.

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.

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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

High-Speed, Long Life Solenoid Valves: INK Series
High-Speed, Long Life Solenoid Valves: INK Series

Because of their high-speed, repeatability, and long life cycles, INK solenoid valves by the Lee Company are ideal for replacing valves in existing printers, or in new drop-on-demand and dispensing applications involving in-vitro diagnostics, drug discovery, and therapeutic care.

Quality Management Systems for Medical Devices

With their sole focus on being a contract manufacturer of medical devices, Phase 2’s Quality Management System (QMS) has helped to establish the company as a provider of quality medical devices manufactured in a lean production environment.

Optical Sensors
Intelligent Vision Sensor (IVS) machine vision systems are high-speed, noncontact optical sensors
Precision Orifices (For Plastics)
Precision Orifices (For Plastics)

The IMH Precision Orifices for plastic installation are miniature flow restrictors with a simple, press-in design for easy installation. With forward and reverse flow directions for both liquids and gases, these orifices are economical, reliable, and highly accurate.

High Definition Cameras for Microscopy
Toshiba Imaging Systems has partnered with Dage-MTI to develop two new high definition cameras ideal for microscopy applications. Dage-MTI's RealView HD Microscope Cameras combine Toshiba Imaging's proprietary imaging technology with specially-formatted, preset values for use in critical microscopy applications.
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PMC12 Series: Couplings
The 1/8" flow polypropylene PMC12 offers many of the same configuration options as the PMC. The polypropylene material adds greater chemical resistance for more demanding applications. PMC12 couplings are also gamma sterilizable.
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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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