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.

More Industry Perspectives

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.

More White Papers & Case Studies

DESIGN COMPONENTS & SERVICES

ENFit Connection System
ENFit Connection System: Monoject And Kangaroo Pharmacy Solutions For Enteral Feeding

ISO CD 80369-3 was created to define a safe design for an enteral feeding connector. Cardinal Health has helped to develop the ENFit Connection System. This includes a full line of bulk, non-sterile Monoject Purple Oral Syringes featuring the new ENFit connector and a transition connector that allows users to connect to feeding tubes and extension sets with the older design until all components have converted to the new ENFit design.

image1
PLC Series: Couplings
The 1/4" flow PLC Series is the most popular group of couplings from Colder. Proven worldwide in thousands of applications, the PLC line offers the widest selection of sizes and configurations. PLC couplings are injection molded from acetal thermoplastic and are durable and resistant to most mild chemical solutions.
Avalanche Photodiodes High Energy Radiation Detection Applications and Molecular Imaging
Large Area Si-APDs – UV-Enhanced APDs
The Large Area Silicon Avalanche Photodiode (Si-APD), C30739ECERH, is intended for use in a wide variety of broadband low light level applications covering the spectral range from below 400 nm to over 700 nm. It has low noise, low capacitance and high gain and is designed to have enhanced short wavelength sensitivity, with quantum efficiency of 60% at 430nm. This Si-APD is well suited for applications including molecular imaging, fluorescence detection and nuclear research.
Medical Device Product Development

ProMed has been a contract manufacturer of custom implantable medical device components for over twenty years now. They offer materials selection analysis, cost analysis, prototypes in their specified material in five business days or less, reduced tooling costs, reduced qualification times, IQ, OQ, and PQ validations, and process failure mode and effects analysis (PFMEA).

Silicone Wire Wound Heaters

Heatflex silicone wire wound heaters by Heatron are an excellent choice for high flex applications. They can be used for blood/fluid and instrument warming, sterilization, temperature therapy, and in instrumentation for dialysis, CPAP, DNA analysis, blood diagnostics, and surgical irrigation.

High-Temperature Injection Molding

High temperature plastic resins such as PEEK (Victrex), PPA (Amodel), PAI (Torlon), PPS (Ryton, Fortron), and PEI (Ultem) provide physical and dimensional stability and excellent elasticity. They’re resistant to harsh chemicals and hydrolysis and feature exceptional electrical properties and low flame and smoke toxicity. PTI works with a wide range of high-heat materials to obtain these types of resins in a variety of colors.

More Components & Services

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.

LATEST HEADLINES

More News