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

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

Vascular Access Imaging Device: VeinViewer Flex®

The VeinViewer flex is an imaging device designed to locate a patient’s optimal venipuncture site during the pre-, during-, and post-vascular access procedure. It does this by projecting near-infrared (NIR) light which is then absorbed by blood and reflected by the surrounding tissue. What this gives the operator is an accurate image of a patient’s blood pattern.

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.

Assembly And Packaging
Assembly And Packaging

To help you bring your medical products to market accurately and on schedule, Donatelle provides 24/7 assembly and packaging as part of their suite of integrated services. They have an impeccable track record of meeting project deadlines and maintain a 99%+ on-time delivery rate.

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.
Hydraulic Safety Screens (For Plastic)
Hydraulic Safety Screens (For Plastic)

IMH Hydraulic Safety Screens are designed as “last chance” safety screens to protect critical fluid control components against rogue contamination. They are meant to be companion parts to other IMH products, or can be used as standalone components for installation into plastics. (These are not intended to serve as system filters.)

Thermal Medical Imaging By Xenics

Thermal medical imaging is a new and exciting application for infrared imaging. Promising research is being done in the fields of vascular, muscle and cancer detection. Xenics is the leading developer of innovative infrared detection solutions for a wide range of applications including medical imaging.

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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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