Medical Device Design & Development

INDUSTRY PERSPECTIVES

Conducting A Medical Device Stability Study: A Practical Guide

Stability studies measure how medical devices respond to environmental stresses such as temperature, humidity, light, and time. Let's take a closer look at designing and conducting a stability study.

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. 

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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

Actuators for Pumping and Dosing
Actuators for Medical Dosing & Micropump Design

PICMA® Stack Ceramic-Insulated Piezo Actuators for Pumping and Dosing

  • Sub-Nanometer sensitivity
  • Superior lifetime (>100 billion cycles)
  • Non Magnetic and High Vacuum compatible
  • Microsecond response and high stiffness
  • Very large operating temperature range
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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.

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Contract Manufacturing for Single Use Finished Medical Devices

Passion for technology has driven SMC Ltd. to be a leading manufacturing partner to the top medical device OEMs. With operations spanning the United States, Costa Rica, and India, SMC is positioned to assist you on your next finished medical device.

 

Optical Design and Engineering

Producing precision optical systems demands a comprehensive opto-mechanical design. II-VI Optical Systems’ team of experienced engineers work collaboratively with your team to design intricate, highly producible systems. We specialize in designing complex systems that are precisely matched with our manufacturing and assembly capabilities to deliver high yields and predictable, optimized results.

Drive Electronics
MicroMo's drive electronics are specifically designed to work with MicroMo's line of DC Motors, Brushless DC Motors, Miniature Stepper Motors, and Micro Drive product lines. MicroMo offers linear controllers, 2/4 Quadrant motion controllers, Synchronous drive motion controllers, and voltage and current mode drives.
Flash Lamps

Flash Lamps - high performance flash and arc lamp applications such as medical and industrial laser pumping, digital and studio photography, warning beacons and strobes, stroboscopic and effect lighting

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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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