Medical Device Design & Development

INDUSTRY PERSPECTIVES

From Principles To Practice: Building Quality Into Generative AI-Assisted Pharma Operations

Learn what regulators are already asking about AI, what quality must mean in this new context, and how organizations can begin building the governance infrastructure.

Why Medtech Should Retire The "One-Size-Fits-All" Mindset

A systemic bias in medtech design continues: a failure to account for female-specific data. Teams often resort to a dangerous shortcut: scaling down men's measurements. But we must design for the real-world diversity of human physiology for the future of care.

Generative AI Can Write The Code, But Who Builds In The Quality?

Code democratization demands a return to the fundamentals of quality in pharmaceutical and regulated environments.

The Cybersecurity Void In Mexico: Why Your FDA-Compliant Device Might Still Fail

While Mexico's health authority, COFEPRIS, has streamlined registration for medical devices, a dangerous shadow regulation has emerged with ad hoc stringent cybersecurity requirements.

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WHITE PAPERS & CASE STUDIES

  • GettyImages-614956020 textile factory
    Color Consistency In UHMWPE Medical Textiles

    Color consistency improves surgical visibility, differentiation, and workflow efficiency, requiring medical textiles that deliver strength, compliance, and reliable quality in every color.

Deterministic Nondestructive Seal Integrity Testing

Deterministic, non-destructive seal integrity testing delivers validated, quantitative results. Learn why this method outperforms traditional approaches in ensuring patient safety and product quality.

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.

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DESIGN COMPONENTS & SERVICES

Biocompatible Flexible Substrates For Directly Implantable Applications

Dyconex, an MST company, offers an array of biocompatible flexible substrates that are ideal for short term and long term direct implant applications such as diagnostics, neurostimulation, implantable electrodes, catheters, sensors, and actors. These substrates combine biocompatible structures and conventional PCB technology, and are composed of dielectric base materials such as LCP, PI, or glass.

Screw Driven Automation Table: XRS Cartesian Robot Module (Small)

This automation table combines a mix of linear servo motor and ballscrew drive technology  and comes in a small size for light loads and shorter travel distances. It has an X-Y work area to 600mm x 300mm and a max load capacity of 5 kg.

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.

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.

Liquid Silicone Rubber Injection Molding
Liquid Silicone Rubber Injection Molding

Liquid silicone rubber (LSR) molding is a thermoset process that mixes a two-component compound together, which is then heat cured in the mold with a platinum catalyst to produce a final part. Liquid Silicon Rubber parts are formed through an injection-molding process similar to that of conventional plastic injection molding with one major difference — the material delivery system is cooled and the mold is heated. Liquid silicone rubber possesses thermal, chemical and electrical resistance, plus biocompatibility. Also, Liquid Silicone Rubber parts can withstand sterilization while maintaining physical properties at extreme temperatures.

Thick Film Aluminum Heaters

Heatron’s line of thick-film aluminum heaters are ideal for a wide variety of medical devices. This includes machines for dialysis, DNA analysis and blood testing, surgical devices, MRI equipment, and CPAP.

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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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