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Case Study - Implantable Micro Component Leading cardiovascular company leverages vertically integrated capabilities for intricate implantable component
Case Study - Limits of Micro Manufacturing Pushing the limits of micro manufacturing, Donatelle helps OEM create implantable grade component to improve cardiovascular device
Case Study - Race Against Time In a race against time, startup takes advantage of Donatelle’s pure medical expertise and vertical integration for novel Class III device
Case Study - Critical Launch Accelerated time-to-market keeps critical launch on track
Case Study - Development to Deployment From development to deployment in six months flat
Case Study - Full Product Line Full product line, tight timeline
Case Study - High Stakes Tall order, high stakes
Case Study - Vertical Integration Vertical integration adds value – and viability
Molding Bioresorbable Materials for Medical Devices and Components Taking full advantage of bioresorbable materials in medtech requires an understanding of each material’s strengths, production challenges, and ideal applications.
How to Establish High-Quality, Sustainable Dock-to-Stock Programs Effective dock-to-stock programs ensure optimal outcomes by identifying risks up front, setting clear timelines, and assigning unambiguous responsibilities to all shareholders.
Before You Outsource: 10 Strategic Considerations for Partnering with a CMO for Biochemical Reagents and Formulations Should you outsource production of biochemical reagents and formulations to a contract manufacturing organization (CMO), or invest in in-house capabilities? This is a foundational business decision that requires careful consideration of capacity, capabilities, and resources. This list of 10 strategic consider
4 Challenges Custom Cables Solve and When to Consider Them Custom cables aren’t needed for every application, but sometimes off-the-shelf cables can’t meet specific requirements for medical/healthcare; industrial; automation; and government applications. If you have cases where cables slow your installations, cause repeated problems, or don’t fit/work just right, dow
CMS Coverage Playbook: How to Secure IDE Clinical Trial Reimbursement Requesting CMS reimbursement for investigational device exemption (IDE) clinical trials is nothing if not complicated. Sponsors that succeed, however, can offset routine healthcare and device costs accrued during the clinical trial. Download Avania's latest white paper to find out how to apply for coverage an
The Cost Benefits of a Lean Six Sigma-Based Continuous Improvement Approach The COVID-19 pandemic has created far more than just a health crisis. The impact of government-mandated shutdowns, restricted travel and unpredictable demand has increased costs and created imbalance among supply chains and their end markets. This impact is particularly significant in medical manufacturin
Safe Launch: A Process for Eliminating Defect Opportunities Outsourcing can bring many benefits: cost reduction, access to expertise not available in-house and reduction in working capital otherwise tied up in production resources. That said, when a medical device manufacturer outsources manufacturing, they are also outsourcing reputation. As a result, it is criti
Quick Disconnect Cyclic Study Polypropylene and Kynar Housings / EPDM O-Rings
Quick Disconnect Aseptic Study Bacterial / Sporal Ingress – Aerosol and Submersion
Composite Reinforced Coatings The future of medical device coatings
Breaking Glass: How Cyclo Olefin Polymer Syringes Are Becoming the Go-To Syringe of the Modern Med Tech Industry The glass syringe has been the mainstay in the administration of parenteral medicines due to its chemical resistance, high heat tolerance, and transparency. But in an ever-evolving medical device market, syringes made from glass-like thermoplastics are becoming an increasingly attractive option.
Actionable Steps to Eliminate Small-Bore Connector Misconnection Adopting ISO 80369
What Can the Medical Device Industry Learn from the Boeing 737 MAX 8 Crashes? In this paper, we will focus on only one very small aspect of this investigation revealed in several articles, which has relevance to the medical device risk management process of both the hardware and the software system, as it relates to cases the author has encountered in the medical device industry.
Case Study: Overcoming Barriers of Adopting ISO 80369 The high stress of an emergency room or ICU creates an environment in which the probability of human error spikes dramatically, adding a layer of risk to an already-tense situation. Asking medical professionals to make rapid diagnoses and decisions in that stress-filled state can lead to device misconnection,
How to Improve Resiliency in the Medical Device Supply Chain Supply chain breakdowns in product quality, delivery or availability are a major disruption in the medical device supply industry. In addition to adding time and cost to the device procurement process, insufficient supply of accurately performing parts could endanger patients’ health.
Flow Sensor Solutions in Modern Medical Ventilators Making the world breathe easy with world leading sensors
Medical Tray Sealing Medical tray sealing is the process of bonding a flexible, die-cut lid to a thermoformed or, in some cases, an injection molded rigid tray that contains the product. Choosing the right packaging sealing option is key the success of your business. With so many sealing materials options avai
Medical Pouch Sealing Keeping medical and life science products free from contamination is critical to the medical packaging process. Using the proper sealing will ensure products will arrive on site, sterile, ready to be used. The process typically involves two main components: a medical pouch and a medical grade he
The Benefits of Injection Molded Plastics in an EV/AV World Over the years, plastic has developed into one of the most critical materials in modern manufacturing. The advancements in plastic injection molding technology have made the entire design and manufacturing process faster, more predictable and precise, thus enhancing the functionality and application capabilit
Case Study - Developing a Custom Material for Trocar Seal Surgical Applications New custom materials help lead to the latest advances in minimally invasive surgery.
Has Your Contract Manufacturer Laid the Groundwork for A Strong Quality Culture? The largest potential cost in medical device manufacturing isn’t labor rate or cost of material. Instead, it is the cost of bad quality. Brand reputation depends on a medical device manufacturer’s ability to put superior quality product where it is promised, when it is promised. Any failure that keeps that pr
How Device Companies Can Create End-to-End Connectivity for In-hospital Equipment This paper will detail how to create a secure, scalable connectivity ecosystem based around connected medical equipment in the hospital environment.
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