Health, Medicine, & Biotechnology

Product Centric QMS: A Critical Advantage for Regulated Companies

FDA regulated companies must establish quality systems for compliance. Most quality management systems (QMS) were developed to help comply with regulations with a sole focus on automating the paper-based processes around quality.

Posted in: White Papers, White Papers, Bio-Medical, Medical
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Lipid-Resistant Component Options for IV Applications

Treatment in the ICU and OR frequently involves the use of lipids and other aggressive substances that can cause cracks Environmental stress cracking is a leading cause of plastic part failure which may lead to serious patient injury and jeopardize medical professionals. Therefore, having lipid-resistant components is essential to optimal patient care.

Posted in: White Papers, White Papers, Bio-Medical, Medical
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National Institutes of Health

The National Institutes of Health (NIH) traces its roots to 1887, when a one-room laboratory was created within the Marine Hospital Service (MHS), the predecessor agency to the U.S. Public Health Service (PHS). An agency of the Department of Health and Human Services, today NIH is the nation’s focal point for health research. Francis S. Collins, M.D., Ph.D., officially became director of NIH in 2009.

Posted in: Articles, Medical
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Testing the Requirements

You can’t always visualize how a system will run just by reading requirements. That’s why early testing of requirements is such a powerful technique for catching ambiguities and errors.

Posted in: White Papers, Aerospace, Automotive, Medical
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Silicone & Thermoplastic Extrusion

When precision matters, FMI and MEDRON delivers.

When you have high-quality silicone and thermoplastic extrusion tubing requirements, we understand your high performance expectations. From simple ID / OD tubing to multi-lumen extrusion with tight tolerances, FMI and MEDRON are well-positioned to handle it all. Our robust quality system and state-of-the-art equipment ensure the highest quality, while our closed-loop control system allows for in-line statistical process control (SPC) and efficient processing. As always, we work as your partner every step of the way — leveraging our deep expertise in medical contract manufacturing to meet your specific needs.

Posted in: White Papers, Manufacturing & Prototyping, Rapid Prototyping & Tooling, Materials, Plastics, Bio-Medical, Medical, Tubing/Extrusion/Molding
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Solving Your Toughest Design Challenges with Silicones

How do you ensure efficient component molding and manufacturing? How do you solve self-healing issues with your flow control valves? How do you improve resistance to repeated sterilization? How do you minimize hysteresis and enhance resilience in your devices? The answer is simple: Momentive silicone elastomers can deliver the performance required to meet healthcare’s most rigorous design challenges – including clarity, flexibility, durability, biocompatibility, processability and more that outperform other materials.

Posted in: White Papers, White Papers, Bio-Medical, Medical
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Core Competencies: Staying Competitive in the Medical Device Industry

Outsourcing helps medical companies fill proficiency gaps and keep pace with innovation. This whitepaper explains what factors are driving the growth in the medical device industry, and how these market dynamics have led to an increased demand for outsourcing of noncore OEM competencies and processes to reliable partners. It will present the many ways outsourcing can help OEMs minimize technology investments and integration efforts to accelerate time-to-market and increase their ROI. The attributes required in an ideal outsourcing partner are also discussed.

Posted in: White Papers, White Papers, Electronics, Custom & Contract Manufacturing, Manufacturing & Prototyping, Medical
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Removing the Risk of Concentrated Salt Solutions to Precision Dispense Pumps

IVD instrument OEMs require high accuracy pumps for dispensing reagents, wash fluids and samples. The types and concentrations of fluids dispensed by these pumps vary widely and can be excessively damaging to the internal parts of pumps. For this reason, pump designers are continually challenged to create products that can survive increasingly aggressive environments.

Posted in: White Papers, White Papers, Bio-Medical, Medical
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How the Aerospace and Defense Industry is Taking-Off with Pervasive Engineering Simulation

The aerospace & defense industry is demanding more fuel efficient and environmentally friendly aircraft that keep passengers safe and comfortable. The defense sector must deliver the technological edge to the warfighter and ISR drones as quickly and affordably as possible. Space 2.0 and the New Space economy is driving accelerated innovation and disrupting the sector.

Posted in: White Papers, White Papers, Aerospace, Automotive, Defense, Bio-Medical, Medical
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Personalized Healthcare Calls for Innovative Wearables and Medical Devices

Because the world population is aging, chronic diseases are on the rise and healthcare costs are reaching unsustainable heights, it is essential to detect pathologies early. The Internet of Things (IoT) is now poised to transform the healthcare industry by providing wireless connectivity and sensing. Body-worn electronics and implanted devices, equipped with tiny sensors that continuously monitor vital parameters and securely report anomalies to appropriate physicians, will improve patients’ quality of life while delivering timely medical help. Personalized healthcare is making medicine participatory, personalized, predictive and preventive (P4 Medicine). Medical device and high-tech companies are joining forces to satisfy a growing demand that might reach 20 billion medical connected devices by 2020. Successful medical device and pharmaceutical companies are using engineering simulation to develop systems that ensure high reliability, provide data privacy and achieve regulatory compliance quickly. Learn how platform-based engineering simulation maximizes the IoT opportunities for personalized medicine.

Posted in: White Papers, White Papers, Aerospace, Automotive, Defense, Bio-Medical, Medical
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