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

Digital Mass Flow Sensors For Medical Devices

First Sensor WBI series of digital mass flow sensors feature flow ranges from 200 sccm and 1 slpm or 2 to 50 slpm, high accuracy in both of its flow ranges, thermal mass flow sensing, a fast response time, and low power consumption. They are available in the WBI, WBA, or WTA series.

Selective Laser Sintering (SLS) for Additive Manufacturing
Selective Laser Sintering (SLS) for Additive Manufacturing

Selective laser sintering is an additive process that draws on a bed of thermoplastic powder to create a fully sintered, Nylon-based part. This technique is ideal for parts with highly complex geometries.

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.

AD9675 Octal Ultrasound AFE With JESD204B

The AD9675 is designed for low cost, low power, small size, and ease of use for medical ultrasound. 

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PMC Series: Couplings
The 1/8" flow PMC coupling covers a wide variety of general-purpose applications. Featuring the Colder thumb latch, the PMC is easier to use than ball-and-sleeve designs. One-hand connection and disconnection and integral terminations make the PMC the choice for ease of use and manufacture.
DC Motors
MicroMo Electronics' DC motors differ from conventional, iron rotor DC motors in that they are equipped with an ironless, self-supporting, skew-wound copper coil. Because of this construction, the rotor is very light yielding a low moment of inertia. The rotor also rotates smoothly without cogging
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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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