Medical Device Design & Development

INDUSTRY PERSPECTIVES

Selecting The Right eQMS To Maximize Quality Maturity

Let's take a closer look at the current electronic quality management system (eQMS) landscape in pharma/biotech and what a future-ready eQMS must enable to support continuous improvement.

How To Stop (Most) Medical Device Recalls Before They Happen

Supplier quality failures are a leading cause of medical device recalls. This article distills a practical framework for managing supplier quality, from standard off-the-shelf items to custom contract-manufactured components.

A Case Study: Control Strategies For A Multi-Dose Pen Injector

A case study highlighting the importance of drug and device team alignment on control strategy, defining what to control and which controls can and should be implemented.

Control Strategies For Injectable Drug Delivery Combination Products

Defining combination product CQAs across drug and device enables an end-to-end control strategy that improves product quality from the start of development.

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WHITE PAPERS & CASE STUDIES

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    Color Consistency In UHMWPE Medical Textiles

    Color consistency improves surgical visibility, differentiation, and workflow efficiency, requiring medical textiles that deliver strength, compliance, and reliable quality in every color.

Deterministic Nondestructive Seal Integrity Testing

Deterministic, non-destructive seal integrity testing delivers validated, quantitative results. Learn why this method outperforms traditional approaches in ensuring patient safety and product quality.

Choosing The Right PCD Configuration For Reliable Sterility Assurance

Accurate PCD configuration ensures sterility assurance. Learn how to align validation strategies with ISO standards, optimize cycle efficiency, and select the right BI format for EO sterilization success.

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.

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DESIGN COMPONENTS & SERVICES

Drug Eluting/Combination Products

ProMed Pharma is a division of ProMed that specializes in manufacturing polymer-based drug-releasing implantable medical device, and combination device components. ProMed’s 25 years of experience working with silicone-based implantables, combination products, and solid implants has allowed them to leverage their molding expertise for established and start-up medical device and pharmaceutical companies.

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Adhesive Films Coatings And Sealants Technology

DSM Biomedical delivers a versatile and tunable hydrophilic polymer technology designed for adhesive applications. This technology mimics the proteins of marine mussels when they bond to underwater surfaces.

Medical Device Manufacturing

With over 35 years of experience in the medical industry, PTI Engineered Plastics is poised to take on your medical device’s manufacturing process. They specialize in handling multi-part programs and medical device molding for a variety of different types of medical devices, no matter how complex.

355-400 UV LEDs

Marktech Optoelectronics offers a UV LEDS in a variety of standard and custom packaging to match application requirements. UV LEDs with wavelengths ranging from 355nm to 400nm offer advantages in UV sensing applications, standard detection and UV curing processes. UV LEDs are widely used in general sensing applications, which include airport identification and inspection equipment, coin and bill validation and medical sensing and purification.

3863 CR DC Micro Motor

MICROMO presents  the 3863 CR DC Micro Motor from FAULHABER.  The 3863-CR has ZHN48 magnet material for benchmark torque performance of 150 mNm at 8,000 RPM. The new DC Motor is available in 12, 18, 24, 36, 48 volts and can be equipped with a three channel encoder  (also available in  a Linedriver design) as well as combined with a wide range of precision gearheads.

Ceramic 5mm Multichip LEDs

Marktech’s line of 5mm multichip LEDs are ideal for currency validation, medical and biofluorescence applications, push button backlight applications, and other applications involving general indication. They’re most often used for high reliability indicators, switch backlighting, and panel illumination.

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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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