Medical Device Design & Development

INDUSTRY PERSPECTIVES

Missed Diagnosis Motivates Entrepreneurial Response
Missed Diagnosis Motivates Entrepreneurial Response

In his final year of medical school, Matt Kesinger realized that a clinical examination was never going to be good enough for early stroke detection, and he began to develop the technological solution that would become Forest Devices’ ALPHASTROKE.

  • Plastics Selection For Medical Wearables: Key Material Families
    Plastics Selection For Medical Wearables: Key Material Families

    The process of material selection often begins by evaluating the characteristics of a given polymer family, and comparing and contrasting them with the characteristics of other polymer families. This evaluation is done in concert with a thorough review of the performance requirements of the device. 

  • Clear And Present Danger: Act Now On Medical Device Cybersecurity
    Clear And Present Danger: Act Now On Medical Device Cybersecurity

    Medical device interconnectivity has obvious benefits, but it also introduces new cyber-attack vectors for hackers to insert malware, compromise connected technologies, steal patient data, or even jeopardize patient health. The current state of medical device cyber readiness and compliance requires an immediate, industrywide call to action

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WHITE PAPERS & CASE STUDIES

  • 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.

Mind Over Machine

As a part of a fast-track effort to bring the exoskeleton from science fiction to real-world use, Proto Labs will provide custom-machined aluminum-joint housings for a futuristic brain-machine robotics system that would help paraplegics walk again. The plan is to have a working model ready for a user by the time of the powered exoskeleton race at Cybathlon, an international competition in Zurich in October.

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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.

LATEST HEADLINES

  • Blood-Repelling Titanium Surfaces Could Lower Implant Rejection Rates

    Scientists from Colorado State University (CSU) have demonstrated that hemophobic surfaces significantly reduce platelet adhesion and activation, a process that can lead to life-threatening blood clots.

  • SpineGuard’s Surgical Guidance Integration Modal Makes Pedicle Screws “Smart,” Earns FDA Clearance

    SpineGuard (FR0011464452 – ALSGD), an innovative company that develops and markets disposable medical devices to make spine surgery safer, announced recently it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new DSG (Dynamic Surgical Guidance) integration module to be used in combination with Zavation’s spinal fusion system to make its pedicle screws “smart.”

  • Philips Introduces Augmented Reality Surgical Navigation Technology

    Royal Philips, a leader in integrated image-guided therapy solutions, recently announced the development of an industry-first augmented-reality surgical navigation technology that is designed to help surgeons perform image-guided open and minimally-invasive spine surgery.

  • New Technology Targets Vagus Nerve Stimulation To Treat Inflammatory Disease

    New technology from the Georgia Institute of Technology targets vagus nerve stimulation (VNS) to improve its therapeutic benefit as a treatment for chronic inflammatory disease. 

  • FDA Clears World's Smallest CPAP, ResMed AirMini™

    ResMed (NYSE: RMD) announced today at the 35th annual J.P. Morgan Healthcare Conference that the U.S. Food and Drug Administration has cleared ResMed's AirMini, the world's smallest continuous positive airway pressure (CPAP) device.

  • First Real-Life Study Tests Feasibility Of Solar-Powered Implants

    Researchers in Switzerland have produced real-life evidence that implanted devices could one day be powered by solar energy. Study participants who wore solar power measurement devices throughout their regular daily activities generated the energy required to power the average contemporary pacemaker, regardless of the weather, season, or age.

  • Breathalyzer Diagnoses 17 Different Diseases Using A Single Breath

    A team of Israeli scientists has further developed its breathalyzer technology, and a recent clinical study demonstrated an 86 percent success rate identifying 17 different diseases. The researchers’ nanoarray uses data collected from over 1,400 subjects to establish “breathprints” for diseases like cancer and multiple sclerosis, and then relies upon artificial intelligence (AI) technology to make a diagnosis.

  • Implantable Drug-Delivery Device Could Treat Cancer, HIV, Or Chronic Disease

    A multidisciplinary team of scientists from Texas has developed an implantable drug delivery device that uses nanochannels to regulate dosage of drugs over time. Researchers say the implant is “drug agnostic” and could potentially be paired with a variety of pharmaceutical treatments for a host of diseases or ailments, such as cancer therapies, HIV drug cocktails, immunotherapy, or cortisone injections for joint pain.

  • “Neural Tourniquet” Uses Electrical Signals To Staunch Bleeding

    A recent advance in bioelectronic medicine may be able to stop internal or external bleeding by stimulating certain nerves in the brain using a “neural tourniquet.” Researchers from the Feinstein Institute for Medical Research (FIMR) believe the treatment could be used in battlefield medicine, emergency care, surgery, or post-partum treatments to treat or prevent hemorrhaging.

  • Scientists Create First "Water-Wave" Laser

    For the first time, scientists have generated lasers from the interaction of light and water waves. This "water-wave" laser can find future application in optofluidic devices and "lab-on-a-chip” devices for studying cell biology and delivering drugs at the nanoscale.

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