Medical Device Design & Development

INDUSTRY PERSPECTIVES

A Case Study: Control Strategies For A Multi-Dose Pen Injector

A case study highlighting the importance of drug and device team alignment on control strategy, defining what to control and which controls can and should be implemented.

Control Strategies For Injectable Drug Delivery Combination Products

Defining combination product CQAs across drug and device enables an end-to-end control strategy that improves product quality from the start of development.

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.

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WHITE PAPERS & CASE STUDIES

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    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

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.
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NS4 ABS Series: Medical-Grade Couplings

Patented NS4 Series couplings feature non-spill valves in a compact size at a great price. These innovative couplings are lightweight, chemically resistant, and easy-to-use.

Miniature Connector with High Density, Signal, and Power: MiniMax™

Fischer’s MiniMaxTM series of connectors feature unmatched pin density in a miniature circular connector. Additionally, their ultra-compact size helps to solve device miniaturization challenges, and in some devices, they can reduce overall weight by more than 75%.

Fast And Efficient Heat Transfer: Cartridge Heating Elements

Heatron’s cartridge heating elements offer watt densities over 200 watts per square inch and a variety of lead configurations. They’re ideal for sterilization, blood analysis, drug delivery devices, or any other medical device that requires fast and efficient heat transfer.

Imaging Equipment
A line of imaging equipment for screen printing consists of lighting systems
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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