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

Optical Design On Steroids
This is the second in a four-part series on "design for manufacturing and assembly" or DFMA for short — an innovative way to bring prototypes, or even cocktail-napkin concepts, into profitable production.
pti2
Medical Device Package Inspection

The quality testing of medical device packaging is highly significant in ensuring the safe delivery of medical devices from their place of origin to the market. Guidance documents such as ISO 11607 provide a list of methods that have the capability to improve the package quality testing of today’s capability. PTI offers inspection methods that provide more reliable, sensitive, and traceable data. They offer in-depth feasibility studies, test method development, and test equipment to bring the supreme level of quality to high-value medical device applications. PTI’s inspection solutions are unique in their performance, reliability, and use of sensory technology.

Direct Metal Laser Sintering Capabilities
Direct Metal Laser Sintering Capabilities

Proto Labs’ Direct metal laser sintering (DMLS) process is an industrial 3D printing process that is ideally used for prototyping in production-grade materials, functional, end-use parts, and for reducing metal components in an assembly. These fully functional metal prototypes and production parts can be created in 7 days or less.

Tethered Silicone Caps For Tube Protection: MCN-TCS Series
Tethered Silicone Caps For Tube Protection: MCN-TCS Series

Caplugs offers the MSN-TCS Series of tethered silicone caps for protecting tubes and ports from contamination. The caps are constructed from USP class VI silicone, and are designed for easy removal and reapplication for a variety of medical procedures such as fluid draining.

Hexapod Multi-Axis Motion Systems
6-Axis Micro Robotic Positioner

Hexapod motion systems are based on six high-resolution actuators acting on one platform through a parallel kinematic arrangement. The advantage is a smaller design, with higher dynamics and precision compared to classical multi-axis motion.  A sophisticated controller allows the user to change the pivot point at will.   The bottom line is an extremely versatile motion,  very similar to a human hand, which is why in medical engineering hexapod positioners are often used for handling systems and for surgery and endoscopy. In therapeutics, they allow the patient to be placed in exactly the right position, e.g. for the treatment of a tumor.

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