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

Silicone Molding

ProMed’s state-of-the-art silicone molding for medical devices takes place in one of several class 10,000 cleanrooms with equipment which features integrated automation, multi-drop, cold deck technology, computerized control, and precise injection units operating off of proprietary technologies.

Secondary Operations Saving Time And Money

PTI has exceptional plastic joining experience, technical expertise, and responsive services in place to meet secondary assembly challenges. This experience alongside their designs for manufacturability enables PTI to provide the best methods for matching important assembly requirements and other add value 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.

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Component Realization (Thermoplastic, Silicone, Micro)

Since our inception, complex thermoplastic injection molding has been a core competency at SMC. We specialize in programs that rely upon complex geometry and challenging quality requirements. Using “scientific molding” practices we assure premium components with each press cycle. With our vast array of molding options, we are confident we can align a process that best fits your medical device.

Miniature Diaphragm Pumps: BTC IIS and TTC IIS Series

Both the BTC IIS and TTC IIS Series by Parker Hannifin comprise brush and brushless DC motor driven pumps ideal for medical applications such as anesthesia monitors, CO2 monitors, wound therapy, urinalysis, and trace detection.

Thick Film Stainless Steel Heaters

Heatron’s thick film stainless steel heaters are ideal for applications that call for heating solutions up to 650oC. They can be machined into complex shapes and forms and are well suited for DNA analysis, dialysis, blood diagnostics, surgical devices, sterilization, MRI equipment, and other medical applications.  

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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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