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

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.

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:

FluoroPEELZ™ Peelable Heat Shrink

Zeus offers the FluoroPEELZ™ peelable heat shrink designed with quick and easy peel away capabilities to improve product efficiency and safety, and to accelerate catheter production.

Low Profile Miniature Positioner: MX80S Stage

This 35 mm high x 80 mm wide stage offers reliable positioning in space-restricted medical device applications. The multi-axis platform can be used in normal or cleanroom environments and has selectable travels of 25, 50, 100, and 150 mm.

Tethered Plastic Caps For Tube Protection: MCN-TCP Series
Tethered Plastic Caps For Tube Protection: MCN-TCP Series

The MCN-TCP Series of tethered plastic caps are made from a low-density polyethylene to protect medical tubes and ports from contamination.  The caps are designed to be easily removed and reapplied when necessary for applications such as fluid drains.

Image Companion®
The company is a leading developer and supplier of comprehensive, easy-to-use and highly innovative software applications, capable of assisting and advancing productivity of image and data processing, computer-aided detection ("CAD"), diagnostic imaging support and image retrieval for a variety of customers and markets. The Company’s flagship product is Image Companion®, that enhances, filters, sharpens and profiles digital images or Regions of Interest (“ROI”) within digital images, as well as detects, counts, measures and searches objects for similar to selected template(s) object(s) or even template image. While equally successful in application to a variety of different types and modalities images, all processing and analysis is independent of the image sources. Enabled with non-scripting Macro Libraries capability and batch processing, this simple-to-use software facilitates computer-aided segmentation, and biomedical information retrieval automation at the same time reducing operating costs, improving analytical accuracy and easy user barrier to complete automation
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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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