Medical Device Design & Development

INDUSTRY PERSPECTIVES

How To Stop (Most) Medical Device Recalls Before They Happen

Supplier quality failures are a leading cause of medical device recalls. This article distills a practical framework for managing supplier quality, from standard off-the-shelf items to custom contract-manufactured components.

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.

More Industry Perspectives

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.

More White Papers & Case Studies

DESIGN COMPONENTS & SERVICES

Silicone Etch Foil Heaters

Heatron’s silicone etch foil heaters offer up to twice the wattage of wire wound heaters and feature complex heat distribution, excellent circuit repeatability, and the elimination of edge loss due to compensation using distributed wattage.

Silicon Photodiodes for Blood Analysis and Point-Of-Care Devices

Hamamatsu’s silicon photodiodes feature high-speed response, high sensitivity, and low noise, and are available in metal, ceramic, and plastic packages with a wide variety of surface-mount types available. This page provides an overview of their use in medical applications.

Product Development And Product Design
Product Development And Product Design

Donatelle offers product development and product design services that are integral to product success – spanning functionality, repeatability and cost effectiveness. Their highly qualified team of engineers, designers, machinists and toolmakers consult with customers from the start to help ensure critical medical devices and components are delivered on spec to market as quickly and cost-effectively as possible.

ADMP801 Hearing Aid Omnidirectional MEMS Microphone

The ADMP801 is a high quality, ultralow power, analog output, bottom-ported, omnidirectional MEMS microphone, designed specifically for hearing aid applications.

Restrictor Check Valves (For Plastics)
Restrictor Check Valves (For Plastics)

The IMH Restrictor Check Valve functions as an orifice in series with a check valve that is made for installation into plastic. The 5.5 mm valve is made with an easy press-in installation design, having the possibility for installation in either direction, and providing forward or reverse flow capabilities.

canon image
Motion Control Products: DC Motors

Canon offers a variety of brushless, coreless, and ironcore DC motors that are custom manufactured to achieve the exact speed, power, and currents required for OEM applications. These motors are supplied with attached gears, pinions, pulleys, lead wires, and conductors in order to reduce OEM labor and material costs.

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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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