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.

More Industry Perspectives

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.

More White Papers & Case Studies

DESIGN COMPONENTS & SERVICES

Xenon Flash Lamps for Medical Devices

Hamamatsu’s Xenon flash lamps feature a long lifetime, low heat output, a high intensity output, and high stability. They’re ideal for use in blood analyzers and in instruments for in vitro diagnostics.

Thermoplastic Molding

ProMed works with and molds a variety of thermoplastics for medical devices. This includes EVA, PSU, PLA, PLGA, PEEK, filled PEEK, and Ultem. Their main area of expertise involves both long and short-term implantable components as small as .002g, and shot sizes of .05g up to 3g.

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.

Dovetail Connectors

Smith’s line of dovetail connectors have been designed to overcome interconnection complications encountered when connecting one element to another. Because of their configurable nature, design engineers can position the spring contact probes in whichever pattern will suit their medical device’s needs.

Miniature Inert Systems of Tubing and Components (MINSTAC)
Miniature Inert Systems of Tubing and Components (MINSTAC)

The Lee MINSTAC System is made up of a variety of small, inert tubing and connection components that are designed to precisely control flow, rate, pressure, filtration and other performance factors of aggressive fluids.

Medical Device Manufacturing

With over 35 years of experience in the medical industry, PTI Engineered Plastics is poised to take on your medical device’s manufacturing process. They specialize in handling multi-part programs and medical device molding for a variety of different types of medical devices, no matter how complex.

More Components & Services

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.

LATEST HEADLINES

More News