Medical Device Design & Development

INDUSTRY PERSPECTIVES

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.

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.

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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

Thin Profile DC Micromotors
DC Motors - Thin Profile DC Micromotors from MicroMo Electronics feature ultra flat dimensions, with no cogging or preferred rotor position
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.

Linear Motor Positioners: mSR Series

The mSR (miniature square rail) series is made up of miniature, dual square rail guided, linear positioners designed to provide submicron level precision in two different form factors. These linear motor positioners utilize selectable levels of linear encoder technology configured to match the application need. Within the same form factor, OEMs have the option of either the precision grade mSR; the most accurate standard positioner able to achieve a repeatability of 5.0nm, or a cost competitive version; uses magnetic encoder technology for less precise applications.

Low Profile Miniature Positioner: MX80S Stage

This 35 mm high x 80 mm wide stage offers reliable positioning in space-restricted medical device applications. The multi-axis platform can be used in normal or cleanroom environments and has selectable travels of 25, 50, 100, and 150 mm.

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.

ECM
Extracellular Matrix (ECM) Technology

DSM Biomedical’s Extracellular Matrix (ECM) OPTRIX technology is used to create natural and biologically friendly soft tissue scaffolds.

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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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