Medical Device Design & Development

INDUSTRY PERSPECTIVES

Reimagining HACCP And Other Process Flow Risk Analysis Methods Using Relational Risk Analysis

Combining relational risk analysis (ReRA) modeling strategies with hazard analysis and critical control point (HACCP) and other process flow risk analysis methods makes them more efficient.

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.

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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.

More White Papers & Case Studies

DESIGN COMPONENTS & SERVICES

Overmolding And Insert Molding Capabilities
Overmolding And Insert Molding Capabilities

Proto Labs offers rapid overmolding and insert molding capabilities to produce parts from a range of thermoplastic and liquid silicone rubber materials for on-demand production, bridge tooling, pilot rune, and rapid prototyping needs. With the utilization of aluminum molds that offer cost-effective tooling, prototypes and on-demand production parts may be produced in as fast as 15 days.

Rapid Medical Device Prototyping

ProMed sets themselves apart from other silicone molding contract manufacturers by eschewing popular 3D printing techniques that create prototypes made from similar materials to what the end result will actually be. Instead, they leverage their Rapid Prototype Development Department to offer their medical device manufacturing customers molded parts using the specified, final material in less than one business week.

Certified ISO Class 8 Clean Room
Certified ISO Class 8 Clean Room

Caplugs’ Class 8 certified Clean Room is designed to ensure a secure and safe product from production to packaging.  Equipped with full molding capabilities, an inspection table with ionization blowers, and a controlled packaging area, Caplugs’ Clean Room is also ISO13485 certified.

Miniature Liquid Control Valves

Parker Precision Fluidics offers a wide range of miniature liquid control valves used in medical device product development.  These liquid control valves offer a broad range of specs that span a variety of medical device applications like radioactive liquids used in MRI, analytical chemistry, and clinical diagnostic applications.  Parker’s liquid control valves are ideal for these applications offering chemical resistance, non-corroding, high pressure / high flow, and rugged features.

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Twin Tube Series: Multiple Line Couplings
The 3/32" flow Twin Tube™ coupling provides one easy-to-use quick disconnect for two separate fluid lines. The non-valved Twin Tube maintains two individual flow paths in one coupling. Featuring the Colder thumb latch, the Twin Tube can disconnect two lines with the push of a button. The panel mount design keeps a low profile on the front of the equipment panel.
DC Motor-Tachogenerators
In MicroMo's DC-Tachogenerators, the commutator and brushes are made of a high quality gold alloy. This results in a very low, constant transition-resistance, minimum starting friction and virtually insensitivity to environmental conditions
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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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