Design/​Engineering

Product Development

Learn about risk assessment, design validation, and the many phases of medical product development.

Stories

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Trivia: Design
What wearable medical device uses tumor-treating fields delivered through adhesive transducer arrays to treat advanced non-small cell lung cancer?
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INSIDER: Design
Pulsed field ablation (PFA) is emerging as a transformative modality in the field of electrophysiology, offering potential for increased...
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From the Editor: Medical
A recent report from MasterControl delivers a sobering statistic: more than 8 in 10 physicians (82 percent) have questioned the quality or safety of the medical products they prescribe. For medical device engineers and designers, that figure should be a wake-up call. Read on to learn what Editor and Director of Medical Content Sherrie Trigg thinks about the matter.
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Trivia: Regulations/Standards
What consumer technology device became the first FDA-approved over-the-counter (OTC) assistive hearing device for adults with mild to moderate hearing loss?
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From the Editor: AR/AI
Artificial intelligence is emerging as a tool to balance challenges and facilitate the goal of bringing new innovations to market faster. And while AI undoubtedly has the potential to play a transformative role in medical device R&D, it must be approached with caution and utilized in a supportive capacity. Read on to learn more.
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Briefs: Medical
Researchers from the University of Cambridge have developed a handheld device that could potentially replace stethoscopes as a tool for detecting certain types of heart disease. The device can also be used over clothing, making it more comfortable for patients — especially women — during routine check-ups or community heart health screening programs.
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Trivia: Medical
What is the first FDA-approved cardiac stent specifically designed to grow and expand with infants and young children?
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Trivia: Design
What implantable system was the first to university-developed medical device to receive FDA 510(k) clearance?
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INSIDER: Nanotechnology
A new gene therapy delivery device could let hospital pharmacies make personalized nanomedicines to order. This democratized approach to precision medicine could revolutionize...
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Features: Medical
Ablation therapies have become indispensable in modern medicine, and their influence will only grow as innovation drives less-invasive, more-effective solutions. The next wave of advancements is likely to emerge from the convergence of technologies, leveraging engineering, biology, and clinical insights to overcome current limitations. Read on to learn more.
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Features: Design
At a time when many medtech firms are grappling with regulatory headwinds, pricing pressures, and geopolitical disruptions, Boston Scientific is focused, aligned, and thriving. Read on to learn about the company’s growth in electrophysiology, strength in LAAC, disciplined margin expansion, and much more.
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R&D: Medical
A paper-based diagnostic device can detect COVID-19 and other infectious diseases in under 10 minutes, without the need for sophisticated lab equipment or trained personnel. Read on to learn more about it.
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R&D: Design
A research team has developed DeepNeo, an AI-powered algorithm that automates the process of analyzing coronary stents after implantation. The tool matches medical expert accuracy while significantly reducing assessment time. Read on to learn more.
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From the Editor: Medical
Tariff uncertainty adds another layer of complexity to an already fragmented global regulatory environment. With PFA currently approved in only a handful of markets, the U.S. remains critical to commercial viability. Read on to learn more about what Sherrie Trigg, Editor and Director of Medical Content, has to say about the matter.
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Briefs: Design
Chronic stress can lead to increased blood pressure and cardiovascular disease, decreased immune function, depression, and anxiety. Unfortunately, the tools we use to monitor stress are often imprecise or expensive. Now a Tufts team has devised a simple device using specially designed floss that can easily and accurately measure cortisol, a stress hormone, in real time. Read on to learn more.
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Trivia: Medical
What implantable sensor system became the first FDA-cleared continuous glucose monitor designed to remain in the body for up to 90 days?
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INSIDER: Materials
Electrospinning has been used to produce polymer fibers containing the well-known antibacterial drug metronidazole. The mats formed could potentially be used as wound dressings, thanks to an...
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INSIDER: Design
Scientists have made a key breakthrough for treating respiratory diseases by developing a new drug-delivery system that transports genetic therapies directly to the...
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INSIDER: Medical
Inspired by the way viruses attach to cells, scientists have developed a method for engineering ultra-selective aptamers. These synthetic molecules bind to specific targets like viral...
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INSIDER: Medical
Researchers have created a new hydrogel to improve drug delivery for treating post-traumatic osteoarthritis (PTOA). The hydrogel, which is designed to...
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Features: Electronics & Computers
The lack of compatibility between high electrical and highly dynamic requirements in cable design is not solved but taken to a new level with medical megatrends such as AI, robotics, and miniaturization together with indispensable sustainability and safety demands. Read on to learn more.
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From the Editor: Design
As the pace of innovation accelerates across the medical device industry, staying informed on core technologies and market trends is more important than ever. With that in mind, we are proud to introduce the 2025 summer edition of the Medical Design Briefs Resource Guide — a new, semi-annual issue designed to deliver essential insights into the components, materials, and services that power medical device development and manufacturing. Read on to learn more.
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Trivia: Regulations/Standards
In May 2004, FDA issued a guidance document that reclassified certain dental implants from Class III to Class II, thereby reducing regulatory burdens while maintaining safety standards. What type of dental implants were...
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Blog: Medical
The Trump administration’s 2025 trade policy has presented a challenge for U.S. medical device manufacturers: how to respond to escalating tariffs on...
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Trivia: Medical
In April 2004, FDA approved what kind of system allows to treat epilepsy?
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Briefs: Medical
Researchers have developed comfortable, washable smart pajamas that can monitor sleep disorders such as sleep apnea at home, without the need for sticky patches, cumbersome equipment or a visit to a specialist sleep clinic. Read on to learn more.
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Trivia: Design
March 3rd is recognized as World Hearing Day. One of the most significant medical device innovations for hearing impairment is the cochlear implant. In what year was the first commercially available multi-channel cochlear implant...
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INSIDER: Design
Screening methods for the cancer can be unreliable and result in false positives. To remedy this problem, scientists are developing a less-invasive portable device that would use blood...
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Blog: Manufacturing & Prototyping
As device designs become increasingly sophisticated, medtech companies are understandably seeking contract design and manufacturing partners that can accompany them on...
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Ask the Expert

Eric Dietsch on the Benefits of Nitinol Wire
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In collaboration with the Fort Wayne Metals Engineering team, Eric Dietsch focuses on supporting customers with material recommendations, product development, and education. Eric is available to help you and your company with any Nitinol-related questions or needs that you may have.

Inside Story

Inside Story: Establishing Safe EO Sterilization for Medical Devices
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To find out more about the expertise required to establish a safe and effective EO Sterilization for medical devices, MDB recently spoke with Elizabeth Sydnor, director of microbiology for Eurofins Medical Device Testing (Lancaster, PA).

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