Medical Device Design & Development

INDUSTRY PERSPECTIVES

Maximizing The Value Of An Internal Audit Program In Pharmaceutical Quality Operations

A shrinking FDA and rising supply pressures demand stronger risk management and smarter internal audits. Here’s how pharma can truly “see things as they really are.”

Building World-Class Global Quality Teams That Break Down Silos

Over 25 years leading global quality and regulatory organizations, I've learned that the most difficult challenges aren't regulatory or technical; they're organizational and cultural. 

Mastering Cultural Intelligence In Global Quality And Regulatory Leadership

The medical device industry has gone global, but most quality and regulatory leaders still operate with regional mindsets. Leaders who master cultural intelligence build quality systems that leverage diversity as competitive advantage.

A Better Interpretation Of POH In ISO 24971

Probability of harm (POH) is critical to appropriately scoring risks, so how should it be done? POH needs to show all probabilities, not suppress them.

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WHITE PAPERS & CASE STUDIES

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.

Custom Orthodontic Aligner Manufacturer Ensures Compliance With Tulip

A pioneering orthodontic startup is transforming custom aligner production using 3D printing and software to cut time and costs in half while scaling rapidly to ensure quality and compliance.

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DESIGN COMPONENTS & SERVICES

Engineering: Design For Manufacturing (DFM)

PTI offers over thirty years of industrial Design For Manufacturing (DFM) experience in determining product requirements and establishing initial design visions. Their expert design and advanced product development teams assist customers in bringing innovative concepts to efficiently manufactured plastic products.

2 W Xenon Flash Lamp Modules (L12336 Series)

These new xenon flash lamp modules integrate a 2 W xenon flash lamp, power supply, and trigger socket into a compact cube package, the smallest in its class. Other features include high stability, long lifetime, and broad emission range from UV to NIR. The L12336 series lamp modules are suitable for integration into portable instruments used in spectroscopy, blood analysis, and environmental monitoring.

Vascular Access Imaging Device: VeinViewer Flex®

The VeinViewer flex is an imaging device designed to locate a patient’s optimal venipuncture site during the pre-, during-, and post-vascular access procedure. It does this by projecting near-infrared (NIR) light which is then absorbed by blood and reflected by the surrounding tissue. What this gives the operator is an accurate image of a patient’s blood pattern.

CNC Milling Capabilities
CNC Milling Capabilities

The Proto Labs CNC milling process is a subtractive manufacturing process that utilizes multiple toolsets based on efficient cutters for a specific plastic or metal material. A machine will then rapidly mill parts out of the block with either 3- or 5-axis milling. Custom prototypes and end-use production parts can be created in as fast as one day.

Medical Device Product Development

ProMed has been a contract manufacturer of custom implantable medical device components for over twenty years now. They offer materials selection analysis, cost analysis, prototypes in their specified material in five business days or less, reduced tooling costs, reduced qualification times, IQ, OQ, and PQ validations, and process failure mode and effects analysis (PFMEA).

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ComfortCoat® Hydrophilic Lubricious Coatings

DSM Biomedical offers ComfortCoat® hydrophilic lubricious coatings to help improve device performance in a wide range of applications and procedures, including cardiovascular and urology. Hydrophilic coatings are designed to enhance the handling of medical devices such as catheters by clinicians during insertion by maintaining lubricity throughout the procedure.

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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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