Medical Device Design & Development

INDUSTRY PERSPECTIVES

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.

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.

More Industry Perspectives

WHITE PAPERS & CASE STUDIES

  • GettyImages-614956020 textile factory
    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.

More White Papers & Case Studies

DESIGN COMPONENTS & SERVICES

Miniature Diaphragm Pumps

Parker Precision Fluidics offers a line of miniature pumps used in medical devices requiring precision and high performance.  These miniature pumps offer a variety of features like a compact efficient design, low power, small size, and light weight ideal for medical device applications like patient monitoring, clinical diagnostics, analytical chemistry, portable gas detection, and medical instrumentation. 

High-Temperature Injection Molding

High temperature plastic resins such as PEEK (Victrex), PPA (Amodel), PAI (Torlon), PPS (Ryton, Fortron), and PEI (Ultem) provide physical and dimensional stability and excellent elasticity. They’re resistant to harsh chemicals and hydrolysis and feature exceptional electrical properties and low flame and smoke toxicity. PTI works with a wide range of high-heat materials to obtain these types of resins in a variety of colors.

Medical Silicone Processes
Medical Silicone Processes

Flexan is committed to providing the highest quality of silicone components for medical devices. Using the highest process controls alongside the most rigorous quality tools, Flexan is able to ensure patient safety and 100 percent inspection of every single component before it ships.

Orifices in Male to Female Luer
Orifices in Male to Female Luer

The Lee Company’s highly accurate Orifice is preinstalled into a male and female luer adapter, featuring an integral safety screen for protection against rogue contamination. Designed for both liquid and gas applications, the orifices are 100% flow tested on either nitrogen or distilled water, ensuring that each part is within ±5% of its nominal flow rate, and providing more accuracy than orifices specified by hole tolerance.

Avalanche Photodiodes

An Avalanche Photodiode (APD) provides higher sensitivity than a standard photodiode. It is ideal for extreme low-level light (LLL) detection and photon counting. Offered in Silicon or InGaAs materials, these devices provide detectivity from 400 nm - 1100 nm. Multiple configurations are available to provide a wide range of sensitivity and speed options.

Secondary Operations Saving Time And Money

PTI has exceptional plastic joining experience, technical expertise, and responsive services in place to meet secondary assembly challenges. This experience alongside their designs for manufacturability enables PTI to provide the best methods for matching important assembly requirements and other add value services.

More Components & Services

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.

LATEST HEADLINES

More News