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.

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DESIGN COMPONENTS & SERVICES

drug delivery
TheraPEA™ Biodegradable Polyester Amide Platform

DSM Biomedical is a global leader in biomedical materials science with experience in creating advanced drug delivery technologies. Their proprietary bioresorbable polymers provide the foundation that enables biopharmaceutical companies to formulate implantable drug delivery systems for specific applications. This technology assists in the creation of platforms for medication delivery to precise target areas in the body, with controlled release from several days to multiple months.

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
ARforBioMedicalLifeSciences
AR Optical Coatings For Biomedical & Life Sciences

Precision Glass & Optics (PG&O) offers anti-reflective (AR) optical coatings for biomedical and life sciences applications. Ideal for coating on quartz, BK-7, glass, and a variety of other optical materials, AR coatings improve performance in optical systems, increasing transmission and enhancing contrast.

World Class Optical Thin Films

DELTA has been providing world class optical thin films for applications involving optical coherence tomography (OCT), image transferring systems, Point of Care (PoC) instruments, flow cytometry, raman spectroscopy, high performance monochromators, biomedical laser systems, and more.

Biocompatibility Testing for Medical Devices

The complexity involved in choosing the right biocompatibility testing for medical devices has substantially increased over recent years. In order to successfully move medical devices to market, it is crucial to have experts available to help develop complete submission packages, and to offer the right advice for biocompatibility testing. Industry-recognized scientists at WuXi AppTec are experienced in providing expert guidance to medical device and combination product manufacturers in designing specific biocompatibility programs for their submissions to regulatory agencies worldwide.

Optics - Perfect To Within λ/30!
Thanks to the development of innovative new surface finishing technologies, ELCAN Optical Technologies can now offer reflective optical surfaces with <30 nm PV accuracies & micro-roughness <0.5nm rms, perfect to within λ/30.
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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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