Medical Device Design & Development

INDUSTRY PERSPECTIVES

Beyond Validation: How Meeting Only Minimum Usability Requirements Can Affect Devices After FDA Approval
Beyond Validation: How Meeting Only Minimum Usability Requirements Can Affect Devices After FDA Approval

Because FDA requirements focus heavily on usability issues related to safety, device developers can fall into the trap of assigning less meaning to usability problems that won’t cause harm. But, it is not always possible to catch all unanticipated use errors during validation, and usability problems not directly related to safety risks can still affect purchasing decisions and device acceptance.

  • Genetic Screening, Digital Biomarkers, And Cancer Diagnostics
    Genetic Screening, Digital Biomarkers, And Cancer Diagnostics

    This article, focused on the opportunities for innovation in cancer diagnostics, is the last in a four-part series exploring the role of medtech innovation as it pertains to the distinct stages of cancer care.

  • What’s Next In Inhalation Drug Delivery?
    What’s Next In Inhalation Drug Delivery?

    A combination of human-centric design and new sensor, analytics, and data transmission technologies may soon make inhalation devices easier to use, more consistent, and more useful for patients and healthcare providers.

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WHITE PAPERS & CASE STUDIES

  • 3 Key Elements To Consider When Designing Injection-Molded Parts With Rapid Overmolding
    3 Key Elements To Consider When Designing Injection-Molded Parts With Rapid Overmolding

    Injection molding is a parts manufacturing process used for a wide range of products including medical devices, children’s toys, household appliances, and automobile parts. Sometimes a second molded part is added as a grip, handle, cover, or sleeve to cover vibration resistance, slippery surfaces, poor ergonomics, and cosmetic concerns. Instead of trying to assemble two different molded parts together, manufacturers can use a rapid overmolding process as an alternative solution. This article touches on three key elements to consider when designing injection molded parts with rapid overmolding.

How To Ramp Up High Volume Bioabsorbable Micro Component Production While Decreasing Part Price

Many OEMs will utilize multi-cavitation tooling to reduce piece part prices while preparing to increase the production volume of a micromolded component. While this may be a cost effective approach for simple thermoplastic parts, it may not be the best technique for micromolded parts, especially those made of bioabsorbable or high dollar value materials. This article discusses overcoming expenses such as material waste, and mold and automation issues, and presents four key areas for cost savings in bioabsorbable products.

Using A Component Management Process To Scale Up Manufacturing Of Drug Delivery Devices

The best practice for fitting multiple parts into a single assembly at tight tolerances is to choose a single component supplier with a sufficient array of core competencies in advanced device manufacturing methods. The chosen supplier should also utilize a well-designed component management process that includes close attention to important elements, proper planning, and high performance levels to provide an affordable, highly scalable drug delivery device.

IoT-Enabled Medical Devices Are The Wave Of The Future

Winning in the medical devices market of the future requires mastering advanced technologies – or finding a partner with these capabilities. The global Internet of Things (IoT) in healthcare market is forecasted to reach $410 billion by 2022. To succeed in this arena, device companies need to stay out in front of manufacturing innovations so they can quickly integrate information technology (IT) functionality into their products, accelerate time to market and control costs.

Assuring Component Reliability In Medical Electronic Devices

Rapid technology advances in medical microelectronics, driven by increased service life, miniaturization, lack of redundancy and functional integration, requires a rigorous development, manufacturing and monitoring methodology to assure reliability. Such an approach must be relevant throughout the product lifecycle and, for every component in a system hierarchy. It must also be effective and efficient. This article discusses a smart end-to-end solution for capacitor reliability that can yield better, more dependable medical electronic devices.

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DESIGN COMPONENTS & SERVICES

Actuators for Medical Dosing & Micropump Design Actuators for Medical Dosing & Micropump Design

PICMA® Stack Ceramic-Insulated Piezo Actuators for Pumping and Dosing

  • Sub-Nanometer sensitivity
  • Superior lifetime (>100 billion cycles)
  • Non Magnetic and High Vacuum compatible
  • Microsecond response and high stiffness
  • Very large operating temperature range
Semiconductor Technology for Implantable Medical Devices Semiconductor Technology for Implantable Medical Devices

All mission critical functions are accessible within the MST group to provide miniaturized packages. Capabilities include design, substrate manufacturing, component selection and validation as well as all major semiconductor packaging processes.

Uni-Patch™ PolyHesive<sup>®</sup> Blue Gel Electrodes Uni-Patch™ PolyHesive® Blue Gel Electrodes

Medtronic offers Uni-Patch™ PolyHesive® blue gel stimulating electrodes that are designed specifically for patients with skin sensitivities. The PolyHesive® conductive blue gel provides a clean, efficient, temporary bond to skin surfaces for the most comfortable treatments possible.

Silicon Photodiodes for Blood Analysis and Point-Of-Care Devices Silicon Photodiodes for Blood Analysis and Point-Of-Care Devices

Hamamatsu’s silicon photodiodes feature high-speed response, high sensitivity, and low noise, and are available in metal, ceramic, and plastic packages with a wide variety of surface-mount types available. This page provides an overview of their use in medical applications.

Multi-Pixel Photon Counters (MPPC) for Medical Devices Multi-Pixel Photon Counters (MPPC) for Medical Devices

Multi-Pixel Photon Counters, or MPPCs, are devices comprised of multiple avalanche photodiode pixels. They offer low voltage operation as well as insensitivity to magnetic fields, and are used to count photons. Hamamatsu’s line of MPPCs are particularly well suited for several different kinds of medical devices such as flow cytometers, PET (positron emission tomography) scanners, and in instruments for in vitro diagnostics (fluorescence and luminescence assays).

Optical Solutions For Medical Devices Optical Solutions For Medical Devices

Ross Optical’s medical optics experts have assisted in turn-key design engineering for ophthalmic instruments, spectrum analyzers, laparoscopic instruments, endoscopes, medical eyeglass binoculars, and instrumentation for Lasik eye surgery.

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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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