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. 

More Industry Perspectives

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

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).

Miniature Diaphragm Isolation Valve: R9 Series

The R9 is a 9mm miniature diaphragm isolation valve designed to deliver the liquid flow capabilities of a 16mm valve. These valves feature a 44% reduction in width, pressures up to 100 psi, low carryover performance, and particulate and crystallization resistance.

Digital Mass Flow Sensors For Medical Devices

First Sensor WBI series of digital mass flow sensors feature flow ranges from 200 sccm and 1 slpm or 2 to 50 slpm, high accuracy in both of its flow ranges, thermal mass flow sensing, a fast response time, and low power consumption. They are available in the WBI, WBA, or WTA series.

Process Validation Capabilities

PTI is experienced in advanced precision inspection and testing abilities that tackle a number of dimensional and functional product requirements and specifications. These validation processes support a wide range of comprehensive inspection actions including receiving final audits, first article layouts, and full AIAG PPAP and IQ, OQ, PQ Process Validation Submissions.

Thick Film Aluminum Heaters

Heatron’s line of thick-film aluminum heaters are ideal for a wide variety of medical devices. This includes machines for dialysis, DNA analysis and blood testing, surgical devices, MRI equipment, and CPAP.

Capture4
Adhesive Films Coatings And Sealants Technology

DSM Biomedical delivers a versatile and tunable hydrophilic polymer technology designed for adhesive applications. This technology mimics the proteins of marine mussels when they bond to underwater surfaces.

More Components & Services

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.

LATEST HEADLINES

More News