Medical Device Design & Development

INDUSTRY PERSPECTIVES

  • How To Drive Powerful CAPAs With Lean Six Sigma

    Corrective and preventive actions (CAPAs) are an important and integral part of any quality system for a life sciences company. And yet, strangely, CAPAs rank among the top reasons why companies get 483s and warning letters from the FDA. This article explains how Lean Six Sigma tools and techniques can be applied to improve the CAPA process.

What Happens To ISO 13485 When Annex L Is Adopted?

Although the structure of ISO 13485 will expand from the current eight main clauses to ten, most of the QMS requirements should essentially remain the same.

Understanding Costs And Risks For Human Factors Engineering (HFE) Usability Studies – Part 2: Outsourcing HFE Usability Testing

This article -- the second in a two-part series -- examines how to navigate the complex problem of optimizing data quality while controlling for study costs and time constraints when employing independent HFE testing agencies.

Cybersecurity Bill Of Materials For Medical Devices: What’s Next?

In October, the U.S. FDA published an updated draft of Premarket Cybersecurity Guidance and introduced the concept of a cybersecurity bill of materials (CBOM) for medical devices. Some medical device manufacturers have since raised concerns regarding mandating CBOMs in the 510(k) or premarket approval packet.

Chief Quality Officers: Redesigning Quality For The 21st Century

With input from FDA and regulators, CQOs are pursuing means to analyze huge data sets, manage complex manufacturing systems, and operate smoothly between varied products, languages, and cultures.

WHITE PAPERS & CASE STUDIES

Keys To Successful Design For Manufacturability

A product’s manufacturability is influenced by the materials used, requested tolerances, part geometry, process control limitations, and more. A successful DFM process considers each of these factors from the start.

NovaPure® Components: A Proactive Approach To Reducing Particulate Risk

A biotechnology company that manufactures injectable large molecules was seeking to evaluate elastomeric components that would help them to attain the highest quality standards for their manufacturing lines. The company took a proactive approach to meeting and exceeding regulatory guidelines concerning the cleanliness of their lifechanging medicines and were keen to learn how a supplier’s tight packaging specifications could help them with their approach.

Medical Device Design & Manufacturing Challenges: 2020 And Beyond

Medical device manufacturers and designers must overcome various challenges to succeed in an expanding global marketplace, challenged along the way by aspects of design, research, validation, and bringing their devices to a competitive market in a cost-effective manner.

Turning To Integrated Driver Electronics For BLDCs

Despite advantages, brushless DC motors (BLDCs) have presented their own challenges in terms of technology, design, and capabilities. Typically, complex and bulky cabling has been required between motor and amplifier to attach discrete logic components “outside” the motor frame. With the latest advances in driver electronics that now can be integrated directly into brushless motor designs, BLDCs are evolving rapidly to become faster, smaller, more versatile, more controllable and more cost-effective.

DESIGN COMPONENTS & SERVICES

Raytheon ELCAN takes your innovative medical concepts, adds our design for manufacturability and deterministic processes to give you ready-for-market, cost-effective solutions. World-class designers and engineers at Raytheon ELCAN become an integral part of your team, to find the optimal solution - nothing we do is off-the-shelf. It’s all about realizing your medical ingenuity and making truly one-of-a-kind products. Vertical capabilities in optical, mechanical and electronic systems make Raytheon ELCAN your “one-stop” global supplier, for even the most complex medical technology requirements.

Of all of Proto Labs additive manufacturing services, stereolithography (SL) offers the widest selection of available materials, the best feature resolution, and the smoothest surface finish. This industrial 3D printing process is used to create concept models, cosmetic prototypes, and complex parts with intricate geometries in as fast as one day.

Parker Hannifin’s T2-05 series of air and gas micro diaphragm pumps are used in patient therapy and patient monitoring applications. Their compact size allows them to fit into tight spaces, making them ideal for integration into handheld devices, such as portable negative pressure wound therapy devices.

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
Setting new standards through breakthrough research and development is at the heart of our business. As the manufacturer of the world's first UV Non-Solarizing (UVNS) optical fiber, CeramOptec® continues to find ways to break down the barriers for simplifying UV spectroscopy and sensing applications.

Applications that involve minimally invasive/micro surgery require precise visualization in very small spaces. Precision Optics, through the use of their proprietary microprecision™ technology, has the ability to develop micro optic lenses, precision lenses, and micro objective lenses as small as 0.37mm in diameter.

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