Medical Device Design & Development

INDUSTRY PERSPECTIVES

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.

From Principles To Practice: Building Quality Into Generative AI-Assisted Pharma Operations

Learn what regulators are already asking about AI, what quality must mean in this new context, and how organizations can begin building the governance infrastructure.

Why Medtech Should Retire The "One-Size-Fits-All" Mindset

A systemic bias in medtech design continues: a failure to account for female-specific data. Teams often resort to a dangerous shortcut: scaling down men's measurements. But we must design for the real-world diversity of human physiology for the future of care.

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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

Flexible Heaters for Medical Devices

Heatron designs, and manufactures highly engineered flexible heaters and heating solutions for the medical device industry. These flexible heaters and heating elements are found in some of the world's most innovative and award-winning medical devices.  Heatron offers a range of flexible heaters designed to meet any challenge your engineering team is facing with product design.  If there is not a flexible heater solution, Heatron’s engineering team will work directly with you to develop a customized solution that fits your need.  The lines of flexible heaters for medical devices are:

Value Added Operations

While cleanroom manufacturing of silicone components for medical devices is at the core of what ProMed does, their Value Added Operations services are currently the fastest growing portion of their business. High-quality, value added components are delivered on time with the help of ProMed’s experienced production and engineering personnel, their New Product Development Processes, and their ISO-quality system.

Thick Film Aluminum Heaters

Heatron’s line of thick-film aluminum heaters are ideal for a wide variety of medical devices. This includes machines for dialysis, DNA analysis and blood testing, surgical devices, MRI equipment, and CPAP.

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Medical-Grade Collagen Components And Devices

DSM Biomedical offers the best-in-medical grade collagen platform, trusted for its safety, performance, and ability to enhance medical device offerings. This fibrous and soluble collagen has been implanted in over 40 million patients over the past three decades. DSM manufactures collagen-based devices with a range of architecture, hydrophilicity, resorption time, and mechanical properties that address a wide array of regenerative medical applications.

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CarboSil® Thermoplastic Silicone Polycarbonate Polyurethane (TSPCU)

DSM’s CarboSil® Thermoplastic Silicone Polycarbonate Polyurethane (TSPCU) is a copolymer that combines the biocompatibility and biostability of conventional silicone elastomers with the processability and toughness of thermoplastic polycarbonate-urethanes. The silicone portion of CarboSil® TSPCU works synergistically with the polycarbonate component to improve stability. This medical-grade polymer is highly biocompatible and well suited to be used in many types of medical devices.

Insert Molding For Medical Devices

Insert molding techniques can streamline the production of your next medical device and eliminate the need for additional secondary operations. This type of molding can result in consistency, stability, the potential for reduced size and weight, and design flexibility.

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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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