Medical Device Design & Development
INDUSTRY PERSPECTIVES
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![working cogs-GettyImages-165681566]( "Causal Mechanism And Effect Analysis (CMEA): FMEA's Simpler, Effective Alternative")
Causal Mechanism And Effect Analysis (CMEA): FMEA's Simpler, Effective AlternativeThis article describes causal mechanism and effect analysis (CMEA) as an alternative to failure mode and effect analysis (FMEA) for analyzing and managing the industry’s risks.
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.
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 highlighting the importance of drug and device team alignment on control strategy, defining what to control and which controls can and should be implemented.
Defining combination product CQAs across drug and device enables an end-to-end control strategy that improves product quality from the start of development.
WHITE PAPERS & CASE STUDIES
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![GettyImages-614956020 textile factory]( "Color Consistency In UHMWPE Medical Textiles")
Color Consistency In UHMWPE Medical TextilesColor consistency improves surgical visibility, differentiation, and workflow efficiency, requiring medical textiles that deliver strength, compliance, and reliable quality in every color.
Deterministic, non-destructive seal integrity testing delivers validated, quantitative results. Learn why this method outperforms traditional approaches in ensuring patient safety and product quality.
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.
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.
Discover how a top medical device manufacturer accelerated product launch by digitizing assembly processes, streamlining training, and ensuring compliance.
DESIGN COMPONENTS & SERVICES
MPC Series couplings add ease of use and security to your most critical fluid handling applications. Choose from a full line of connectors and configurations, including pressue sealing caps and plugs in sizes to fit 1/4" and 3/8" tubing.
These high speed solenoid valves can dispense microliter and nanoliter volumes at up to 1200 Hz and are ideal for high throughput screening in medical devices, as well as drug discovery. They feature a 250 million cycle (minimum) lifetime, response times as fast as 0.25ms, and operating pressures up to 120 psi.
AR’s 150W1000 is a class A solid state amplifier that provides 1500 watts of output power from 80 to 1000 MHz. It has superior gain flatness, an exceptional noise figure, and better efficiency and harmonics than competitive products.
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
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Discover Medbio's End-to-End Medical Manufacturing Expertise & Scalability At INTERPHEX 20263/30/2026Visit Medbio at Booth #3912 on April 21st through 23rd at the Javits Center in New York City to discover end-to-end medical manufacturing solutions trusted by over 300 healthcare and medical customers, including the top 30 global medical device and BioPharma manufacturers.
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Lifecore Biomedical Signs New Agreement With Indomo To Support Innovative Drug/Device Combination Acne Treatment3/4/2026
Lifecore Biomedical, Inc. (NASDAQ: LFCR) (“Lifecore”), a fully integrated injectables contract development and manufacturing organization (“CDMO”), and Indomo, a clinical-stage company dedicated to expanding access to quality healthcare via innovative device-enabled therapeutics, today announced that the companies have entered into a new development services agreement through which Lifecore will provide Indomo with a range of CDMO services to support the continued development of its corticosteroid drug candidate, DT-001.
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Strategy Beyond The Bench: Eurofins Launches New U.S. Consulting Chapter In Medtech Strategy & Policy2/19/2026
In launching this key offering, Eurofins Medical Device Consulting marks an inflection point for its Medical Device, Combination Product, and Diagnostic service portfolio – moving from testing services provider to full-lifecycle partner in strategy and insights.
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Accumold Makes Pharmapack Europe Debut To Support Next-Generation Drug Delivery And Pharma Packaging1/15/2026
See how precision micro molding enables scalable, reliable drug delivery and pharmaceutical packaging designs as industry experts debut at Pharmapack Europe 2026 in Paris, January 21–22.
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AbbVie To Buy Device Manufacturing Facility From West Pharmaceutical Services1/14/2026
The acquisition of the Tempe, Arizona facility will expand U.S.-based drug delivery device capacity and support the company’s $10 billion manufacturing investment.
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Accumold Brings Micro Molding Precision To Photonics West 2026 As Optical Innovation Accelerates1/13/2026
Accumold, a global leader in precision micro molding, will exhibit at SPIE Photonics West 2026 (January 20-22, San Francisco, USA), the premier event for lasers, biomedical optics, optoelectronics, and technologies supporting biophotonics, quantum, and vision applications.
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Accumold Returns To MD&M West 2026 To Help Medical Oems De-Risk Miniaturization And Scale Micro Parts1/6/2026
Accumold returns to MD&M West 2026, Booth 2828, showcasing medical micro molding expertise, Design for Micro Molding guidance, and scalable, high-precision production for next-generation devices.
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Accumold Showcasing Micro Molded Components Powering Optical Networking's Next Keap At OFC 20261/6/2026
Accumold will exhibit at OFC 2026, the premier event for optical networking and communications, from March 17–19 at the Los Angeles Convention Center.
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Accumold Achieves ISO 13485 Recertification, Reaffirming Commitment To Precision In Medical Micro Molding11/24/2025
Accumold secures ISO 13485 recertification, reinforcing its commitment to precision, quality, and reliability in micro molded components for demanding medical device applications worldwide.
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Accumold To Exhibit At Medevice Silicon Valley, Showcasing Micro Molding Expertise For Cutting-Edge Medtech11/11/2025
Accumold will showcase its world-leading micro molding expertise at MEDevice Silicon Valley, Booth #1034, helping medtech innovators accelerate design, de-risk production, and achieve micron-level precision.