Medical Device Design & Development

INDUSTRY PERSPECTIVES

  • CAPA effectiveness-GettyImages-2283083181
    You Can't CAPA What You Can't Classify

    An LLM or agentic error can occur with no component broken in any way the QMS recognizes. Classifying it takes two fields: the error type and the error origination point.

Who Exactly Owns Quality?

We’ve all heard the rhetorical question, “Who owns quality?” And we all reply with the answer they expect to hear: “We all do!” This mindset needs to be fully integrated into the minds and systems of a company.

The Career Path Through QA Produces Better Medtech Engineering Leaders

Engineers with direct exposure to failure outcomes are more likely to build risk mitigation in from the start, not bolt it on later. When they're tapped for leadership positions, this makes them better leaders.

Navigating The New Era Of Design Controls For SaMDs: A Strategic Guide

This article explores the current state of design controls for software as a medical devices (SaMDs), focusing on the FDA’s recent regulatory shifts, the integration of Agile methodologies, and the evolving landscape of AI/ML.

A Much-Improved Approach For Understanding And Managing Safety Risks

Learn how causal mechanism and effect analysis (CMEA) and its principles can be used to develop and maintain safer working environments in the pharma/biotech and medical device industries.

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WHITE PAPERS & CASE STUDIES

The Life Sciences Guide To AI In Quality & Compliance

Implement AI in quality workflows without regulatory risk. Learn how strong governance and clear validation keep you audit-ready for compliance.

Extraction And Chemical Characterization Pitfalls In Complex Medical Devices

Standard extraction protocols routinely fail tissue-derived products, hydrogels, absorbables, and silicone implants. Learn the material-specific study design strategies that prevent regulatory rejection and repeat work.

Accuracy, Safety And Ease Of Use

Safety, ease of use, and accuracy guide modern medical device design, advancing through improved materials, engineering innovation, standards adoption, and user‑centered development.

Color Consistency In UHMWPE Medical Textiles

Color consistency improves surgical visibility, differentiation, and workflow efficiency, requiring medical textiles that deliver strength, compliance, and reliable quality in every color.

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DESIGN COMPONENTS & SERVICES

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.

Flexible Heaters for Medical Devices

Heatron designs, and manufactures highly engineered flexible heaters and heating solutions for the medical device industry. These flexible heaters and heating elements are found in some of the world's most innovative and award-winning medical devices.  Heatron offers a range of flexible heaters designed to meet any challenge your engineering team is facing with product design.  If there is not a flexible heater solution, Heatron’s engineering team will work directly with you to develop a customized solution that fits your need.  The lines of flexible heaters for medical devices are:

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.

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.

NIR Light Source: Vivo

VIVO is a NIR light source that provides NIR drug analysis, food safety analysis, and more. The system contains four tungsten halogen bulbs that can be turned on or off individually. The risk of overheating the sample is mitigated through active cooling. This protects the sample and ensures accuracy every time. The four halogen tungsten light sources make the Vivo a high-powered VIS-NIR source, allowing users to integrate their spectrometers for a shorter time than conventional methods.

Avalanche Photodiodes

An Avalanche Photodiode (APD) provides higher sensitivity than a standard photodiode. It is ideal for extreme low-level light (LLL) detection and photon counting. Offered in Silicon or InGaAs materials, these devices provide detectivity from 400 nm - 1100 nm. Multiple configurations are available to provide a wide range of sensitivity and speed options.

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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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