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

Precision Linear Servo Motor Table: 400LXR Series

The 400LXR series of linear motor driven, high-speed, high-precision tables combines quick response, high acceleration, high velocity, and fast settling time with micron and sub-micron-level positioning. They’re offered in 100, 150, and 300mm widths with travel lengths and have been designed to accommodate the size and performance requirements typically associated with applications involving medical device design.

AOTF Hyperspectral Imagers

Brimrose hyperspectral imagers utilize a NIR camera with an acousto-optic tunable filter as a monochromator to produce hyperspectral imaging of any target area, or to measure visible or NIR hyperspectral imaging information remotely on a variety of materials.

Manifold Technologies and Techniques
Manifold Technologies and Techniques

For over three decades, the Lee Company Electro-Fluidic Systems Group has been an industry leader in electromechanical valve and pump technology. Their expertise in fluidics is drawn from a complete understanding of the application and components involved. Using a manifold technique, it is possible to incorporate solenoid valves, pumps, passive components and active components into a complete assembly that has been functionally tested per the application requirements.

Direct Metal Laser Sintering (DMLS) for Additive Manufacturing
Direct Metal Laser Sintering (DMLS) for Additive Manufacturing

In direct metal laser sintering, a laser draws onto the surface of atomized powder to build production-quality metal parts. The process produces metal parts with the same speed as plastic parts, and it can transition into metal injection molding.

LeeImage
Solenoid Valves: Lee Interface Fluidic (LFA) Series

The LFA series of solenoid valves are available in 2-way (normally closed) and 3-way soft tube ported configurations with printed circuit board (PCB) mount or lead wire connection options. Their compact size and ruggedized enclosure make them an ideal solution for air and gas flow in blood chemistry, ventilators, respirators, and blood pressure monitors.

Precision Machining And Precision Machined Components
Precision Machining And Precision Machined Components

Accuracy is a must-have when it comes to precision medical machining. As a medical device contract manufacturing leader known for accuracy and consistency, Donatelle has created hundreds of critical surgical and implantable devices. Industry leaders rely on our full-service precision medical machining, which is available as a standalone or integrated service. Specific capabilities include:

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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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