Medical Device Design & Development

INDUSTRY PERSPECTIVES

Building World-Class Global Quality Teams That Break Down Silos

Over 25 years leading global quality and regulatory organizations, I've learned that the most difficult challenges aren't regulatory or technical; they're organizational and cultural. 

Mastering Cultural Intelligence In Global Quality And Regulatory Leadership

The medical device industry has gone global, but most quality and regulatory leaders still operate with regional mindsets. Leaders who master cultural intelligence build quality systems that leverage diversity as competitive advantage.

A Better Interpretation Of POH In ISO 24971

Probability of harm (POH) is critical to appropriately scoring risks, so how should it be done? POH needs to show all probabilities, not suppress them.

Why Pharmaceutical And Medical Device Risks Must Be Analyzed By Their Risk Mechanisms

Current risk analysis methods focus on the possibility and severity of bad events instead of focusing directly on analyzing and improving the performance of systems and processes producing the bad events. 

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WHITE PAPERS & CASE STUDIES

Life Sciences Corporation Implements eLogbooks Across 15 Sites

New regulations challenged how surgical kits were tracked and processed across 15 U.S. sites. Discover how one team balanced compliance and efficiency to keep life-saving procedures on schedule.

Implementing A Next-Gen MES At A Fraction Of The Cost

Discover how a top medical device manufacturer accelerated product launch by digitizing assembly processes, streamlining training, and ensuring compliance.

Custom Orthodontic Aligner Manufacturer Ensures Compliance With Tulip

A pioneering orthodontic startup is transforming custom aligner production using 3D printing and software to cut time and costs in half while scaling rapidly to ensure quality and compliance.

Laerdal Error-Proofs Medical Kit Assembly With AI-Powered Vision Verifications

Discover how Laerdal Medical implemented an automated kit assembly solution that enhances quality control and supports continuous improvement through real-time monitoring and visual documentation.

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DESIGN COMPONENTS & SERVICES

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PMC Series: Couplings
The 1/8" flow PMC coupling covers a wide variety of general-purpose applications. Featuring the Colder thumb latch, the PMC is easier to use than ball-and-sleeve designs. One-hand connection and disconnection and integral terminations make the PMC the choice for ease of use and manufacture.
UV Curing Light Sources

Hamamatsu offers UV-LEDs for curing adhesives in stents, catheters, needles, hearing aids, and other therapeutic medical devices. Their high output power makes them especially ideal for UV curing, and their low power consumption makes them an energy saving and environmentally friendly light source.

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.

NIR Light Source: Vivo

VIVO is a NIR light source that provides NIR drug analysis, food safety analysis, and more. The system contains four tungsten halogen bulbs that can be turned on or off individually. The risk of overheating the sample is mitigated through active cooling. This protects the sample and ensures accuracy every time. The four halogen tungsten light sources make the Vivo a high-powered VIS-NIR source, allowing users to integrate their spectrometers for a shorter time than conventional methods.

Brushless DC Servomotor: 1218...B Series

With MICROMO’s brushless DC electric motor, the ironless, self-supporting, skew-wound copper coil is a component of the stator.

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Component Realization (Thermoplastic, Silicone, Micro)

Since our inception, complex thermoplastic injection molding has been a core competency at SMC. We specialize in programs that rely upon complex geometry and challenging quality requirements. Using “scientific molding” practices we assure premium components with each press cycle. With our vast array of molding options, we are confident we can align a process that best fits your medical device.

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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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