Medical Device Design & Development

INDUSTRY PERSPECTIVES

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.

A Better Interpretation Of POH In ISO 24971

Probability of harm (POH) is critical to appropriately scoring risks, so how should it be done? POH needs to show all probabilities, not suppress them.

Why Pharmaceutical And Medical Device Risks Must Be Analyzed By Their Risk Mechanisms

Current risk analysis methods focus on the possibility and severity of bad events instead of focusing directly on analyzing and improving the performance of systems and processes producing the bad events. 

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WHITE PAPERS & CASE STUDIES

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.

Laerdal Error-Proofs Medical Kit Assembly With AI-Powered Vision Verifications

Discover how Laerdal Medical implemented an automated kit assembly solution that enhances quality control and supports continuous improvement through real-time monitoring and visual documentation.

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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).

Overmolding Capabilities

PTI’s overmolding capabilities cover the entire process of molding thermoplastic materials into a second material in order to produce a single part. By employing two separate molds that will bond two separate materials, one part can be better formed with aesthetics and functional appeal.

Custom LED Light Solutions

In addition to a wide variety of high quality sensor components, Marktech Optoelectronics' capabilities include complete design and manufacturing of custom light rings for applications ranging from medical instrumentation to machine vision. Chip on board configurations can contain both emission and detection chips within a very small package design. Wavelengths include UV, Visible and IR ranges from 260nm through 2.6µm

Process Validation
Process Validation

Donatelle's team of specialists includes certified packaging professionals and quality engineers. Among other areas, they’re experienced in medical device process validation methodologies, Geometric Dimensioning and Tolerancing (GD&T) and scientific process development.

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Injectable, Settable, Drillable Putty For Remodeling Bones: ColOSSIS™

ColOSSIS™ from DSM Biomedical is an injectable, settable, drillable putty designed for remodeling bones. It offers improved handling in preparation and delivery and can be mixed with saline, blood, and bone marrow aspirate, allowing for an affordable, fast-remodeling, settable, and drillable biomimetic solution to fracture repair.

Optical Sensors
Intelligent Vision Sensor (IVS) machine vision systems are high-speed, noncontact optical sensors
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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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