Medical Device Design & Development

INDUSTRY PERSPECTIVES

Reimagining HACCP And Other Process Flow Risk Analysis Methods Using Relational Risk Analysis

Combining relational risk analysis (ReRA) modeling strategies with hazard analysis and critical control point (HACCP) and other process flow risk analysis methods makes them more efficient.

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.

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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

QUICKSHAFT

The innovative design with a 3-phase self-supporting coil and non-magnetic steel housing offers outstanding high-resolution performance. The absence of residual static force and the excellent relationship between the linear force and current make these motors ideal for use in micro-positioning applications. 

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Medical-Grade Polyethylene Fibers: Ulteeva Purity®

DSM Biomedical offers a variety of different medical-grade Ulteeva Purity® fibers for numerous medical applications, including medical devices in orthopedic trauma, medical implants, and other uses in the human body. These medical-grade fibers are 15 times stronger than steel at a similar weight, while maintaining increased flexibility and high pliability.

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NS1 Series Couplings

NS1 Series couplings compact, closed-system design is packed full of features including non-spill shutoff valves that ensure dripfree disconnects, and eliminate the need to purge air from the system.

Engineering: Design For Manufacturing (DFM)

PTI offers over thirty years of industrial Design For Manufacturing (DFM) experience in determining product requirements and establishing initial design visions. Their expert design and advanced product development teams assist customers in bringing innovative concepts to efficiently manufactured plastic products.

Custom Prisms

Precision Optics Corporation can custom manufacture prisms with tolerances to .01mm, <10/5 scratch/dig, λ/20 flatness, <5 arc second parallelism, +/- 0.1mm; 0.2mm to 150 mm diameter, and +/- 0.02mm (and as thin as 0.2mm) thickness.

XLM Series Of LED Fiber Optic Light Modules For Medical Applications
Excelitas’ XLM Series of LED Fiber Optic Light Modules are designed to be integrated by OEMS into endoscopy, surgical microscopy, and medical headlamps and other medical applications that require bright uniform illumination. These high performance fiber optic light modules feature many advantages for medical applications including remarkable uniformity, virtually no ultraviolet or infrared emissions, maintenance-free, long-life operation, and a variable speed fan. The XLM Series offers an excellent alternative to users of xenon, metal-halide and halogen lamps.
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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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