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

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.

Solenoid Valves: IEP Series
Solenoid Valves: IEP Series

The IEP Series is made up of 2-way, extended performance, axial-flow solenoid operated valves. Each of these valves are supplied with a 1/16” inlet and outlet stainless steel tubing, allowing the valves to be connected through the use of standard high-pressure chromatography fittings, or welded directly in place.

Micro Molding Medical Grade Materials

ProMed offers micro molding services for both long-term and short-term implantable medical device components, making parts as small as .002g and shot sizes up to 3g. They have experience with a variety of medical-grade plastic materials (thermoplastics) such as EVA, PSU, PLA, PLGA, PEEK, Filled PEEK, and Ultem. They also work with Polycarbonate, ABS, and Pebax.

Image Sensors for Blood Analysis and Point-of-Care Devices

Hamamatsu’s line of image sensors includes CMOS, CCD, NMOS, and InGaAs image sensors available for integration into instruments for in vitro diagnostics (fluorescence assays), blood analyzers, and point-of-care devices.

LED Fiber Optic Illuminators and Modules
LED Fiber Optic Illuminators and Modules from Excelitas Technologies are based on state-of-the-art solid state lighting technology. These LED light sources are designed to couple high-intensity white light into fiber optic bundles for applications such as endoscopy, headlamps, microscopy, industrial borescopes, inspection systems, and machine vision. These LED-based products offer an energy-efficient, maintenance-free alternative to halogen and metal-halide lamp-based fiber optic illuminators.
Overmolding Capabilities

PTI’s overmolding capabilities cover the entire process of molding thermoplastic materials into a second material in order to produce a single part. By employing two separate molds that will bond two separate materials, one part can be better formed with aesthetics and functional appeal.

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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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