Medical Device Design & Development

INDUSTRY PERSPECTIVES

Understanding The Impact Of New European MDRs And IVDRs On Quality And Regulatory System Resources
Understanding The Impact Of New European MDRs And IVDRs On Quality And Regulatory System Resources

As a result of the European Union's new Medical Device Regulations (MDR) and In-Vitro Diagnostic Regulations (IVDR) adopted earlier this month, many adjustments will be required in the roles and responsibilities of medical device companies, manufacturers, importers, distributors, and authorized representatives.

  • 3 Design-Related Partners For Medtech Development
    3 Design-Related Partners For Medtech Development

    This article is the second in a series exploring some of the important relationships involved in each phase of medical device development. Here, we'll look at key relationships during the design phase.

  • Killer Experiments Help Coulter Spur Innovation
    Killer Experiments Help Coulter Spur Innovation

    I previously wrote about phase one of the Coulter Foundation's Translational Research Partnership Program, which assists universities in developing and commercializing medical technologies by forming working partnerships and promoting translational research. Today, I focus on phase two, going inside the Coulter Foundation for perspective, exploring how the second phase benefited from the experiences of the first, and visiting with program leaders from one of the phase two schools.

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WHITE PAPERS & CASE STUDIES

  • A Better Approach To Developing Medical Device Instructions For Use (IFU)
    A Better Approach To Developing Medical Device Instructions For Use (IFU)

    The common approach to designing and developing an Instructions For Use (IFU) has been largely unchanged for years: once a product is designed and made ready for manufacturing, an IFU is then written and tested. When errors are found, changes are made, and the cycle repeats until there is an acceptable IFU version that most users will be able to comprehend. Clearly, this approach is often time consuming and costly.

Keys To Bioabsorbable Process Development: Consistency And Control

A medical device company developed a bioabsorbable fixation design and concept that was commended by many surgeons in the industry. Unfortunately, after several years of working with a reputable molder, there was limited consistency and success in producing the part that was in their original drawings. MTD assisted the company by guiding them through material characterization and the development of a unique tooling construction concept to reduce secondary operations. MTD’s micromolded parts achieved minimal and consistent IV loss and were much more consistent shot to shot.

3 Consideration When Designing Injection-Molded Parts With Rapid Overmolding

Rapid overmolding sidesteps assembly hassles, simplifies product design, and can improve the characteristics of many injection-molded parts.

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.

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.

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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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