Medical Device Design & Development

INDUSTRY PERSPECTIVES

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.

Why Pharmaceutical And Medical Device Risks Must Be Analyzed By Their Risk Mechanisms

Current risk analysis methods focus on the possibility and severity of bad events instead of focusing directly on analyzing and improving the performance of systems and processes producing the bad events. 

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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

Encoders
A range of different encoders is available for applications requiring an accurate control of motor velocity, direction of rotation and positioning. The performance of a drive or servo system depends on the precision and reliability of the servo components available
SMCLtd_SupplyChainMng
Medical Device Supply Chain Management (Metals, Electronics)

At SMC Ltd. we understand your desire to have a single point of contact for your full medical device. With SMC’s demonstrated strength in IQ/OQ/PQ validation, our network of established and qualified suppliers, and our experience in custom manufacturing, we have the comprehensive resources in place to manage your program from conceptual design to final distribution.

From Concept Through To Finished Product
Imagine an x-ray is taken and within 6 seconds the technician will know if the picture quality is accurate. IDC (Imaging Dynamics Company, Ltd.) had this vision and ELCAN brought this vision to life.
Plastic Injection Molding
Plastic Injection Molding

Our plastic injection molding process produces custom prototypes and end-use production parts in 15 days or less. We use aluminum molds that offer cost-efficient tooling and accelerated manufacturing cycles, and stock more than 100 different thermoplastic resins.

Medical Grade Silicone For Medical Device Components
Medical Grade Silicone For Medical Device Components

Flexan uses medical grade silicone for implantable and disposable medical devices that require high performance and safety characteristics whenever in contact with a human body. With no side effects and the ability to be sterilized, this material meets or exceeds all USP Class VI test requirements. It will also retain its shape under pressure and temperature extremes.

Pressure Sensors for Medical Analysis Instrumentation: HMI Series

First Sensor HMI pressure sensors are ideal for medical analysis instrumentation that calls for increased media compatibility and the ability to work with pressure ranges from 1 to 150 psi (100 mbar to 10 bar).  They have a Total Error Band (TEB) better than ±1.5 %FSS from -20 to +85 °C (-4 to 185 °F), and very small SIL and DIP housings with a selection of pressure ports.

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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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