In the dynamic and rapidly advancing field of medical technology, the development of advanced vascular products holds a special place. These products are among the most frequently utilized devices in healthcare and play a vital role in both diagnosing and treating various conditions.
With patient outcomes heavily influenced by these commodity instruments, it is critical that these devices reliably perform the functions they were designed to do. However, achieving consistency in a system as diverse as healthcare is much easier said than done. At Avia Vascular, nothing is prioritized above our efforts to ensure safety, effectiveness, and reliability within our products.
The Significance of Quality Assurance in Vascular Products
Quality assurance encompasses a set of systemic activities and processes that ensure products meet specified standards, are safe for use in high-stakes medical situations and perform as intended when it matters most. In the context of blood collection products, which have a significant impact on a patient's health and well-being, the importance of QA can never be overstated. These medical devices are designed to communicate with the cardiovascular system, and defects, malfunction or poor design could result in a serious adverse event. QA is not just a regulatory requirement; it is an ethical obligation to the patients and healthcare providers who will be interacting with these medical devices.
Avia Vascular's Holistic Approach to Quality Assurance
At Avia Vascular, our primary motivation in providing safe and effective blood collection products does not come from a government agency or regulatory bodies but rather a personal mission to provide a viable solution to the issue of pain and discomfort associated with needlesticks in hospital rooms across the world. “Quality Assurance is more than a set of principles and procedures, it’s a commitment we make to our customers and community. An unreliable device, no matter how attractive, is not a viable solution” said Kevin Cook, Co-Founder and CEO. The company's commitment to QA is evident in its comprehensive approach that emphasizes quality at every stage of product development, manufacturing, and post-market surveillance.
1. Design
For Avia Vascular, the process of creating efficacious medical devices starts with identifying an issue in our medical industry that has not been properly addressed. With our flagship product, the Ally™ Needle Free Blood Collection Device, several kinks in the blood collection process were identified by our team. Venipuncture is painful, and often a pinch point between staffing and timing for hospitals. The design of the Ally™ is such that it works with the body and the variability that practitioners expect when dealing with real people.
Each body has variations in the way that the vascular system is arranged on the skin, with these variations of where turns might be present, the Ally™ was designed to work under these circumstances- allowing for positive outcomes for patient and provider. Designed to work with PIV catheters placed in the hand, wrist or elbow, the Ally™ is designed to fit with the majority of situations that could be expected. With a keen understanding of the variability of vascular formation, our team designed the Ally™ with firm backing to support the collection tube of the device as it is pushed through a patient's catheter and into their vein. All of this being said, Avia Vascular’s design process includes a plethora of iterations to ensure that the final product is preferable for patients and providers.
2. Manufacturing
The manufacturing phase is a critical juncture where the design transforms into a tangible product. Avia Vascular maintains the highest standards in its manufacturing process by partnering with trusted pillars in medical device manufacturing. Manufactured in these world-class facilities by teams with extensive experience in a variety of methods and medical devices, the Ally™ is produced with the highest level of quality and care. Stringent quality controls are in place to ensure that each product adheres to the approved specifications. These controls encompass raw material inspection, assembly procedures, packaging, and sterilization processes. By ensuring tight control over manufacturing processes, Avia Vascular maintains consistency and reliability in each device that bears its name.
3. Regulatory Compliance
Adherence to regulatory standards is non-negotiable in the medical device industry. Avia Vascular diligently follows the guidelines set by regulatory bodies such as the FDA (Food and Drug Administration) and ISO (International Organization for Standardization). The company's QA team collaborates with regulatory experts to ensure that products not only meet but exceed these standards. This commitment extends to maintaining proper documentation and traceability throughout the product's lifecycle so that no issues would be able to slip through the cracks if issues were ever to arise.
4. Post-Market Surveillance
QA does not conclude with regulatory clearance and a product launch. Avia Vascular continues to monitor the performance of its products in the market through a robust post-market surveillance system and collaborative interactions. Avia Vascular works with healthcare systems, gathering feedback from healthcare providers and patients, tracking adverse events (if any are to arise), and implementing necessary corrective actions. By staying vigilant, Avia Vascular ensures that any emerging issues are swiftly addressed to safeguard patient well-being and continue our mission to bring more comfort to patients during their stays in a hospital.
5. Continuous Improvement
A hallmark of Avia Vascular's commitment to QA is its personal connection and network within the medical space. Dedicated to continuous improvement, Avia Vascular actively seeks feedback from practitioners who use the Ally™ device. The information gained from that feedback may be used to refine Avia Vascular’s processes, enhance its products, and elevate the overall quality of its offerings to the medical device market. This approach will help to ensure that Avia Vascular remains focused on medical device innovation and providing solutions to meaningful problems.
Conclusion
In the medical sector, where innovations made with precision can lead to remarkable breakthroughs, the importance of Quality Assurance cannot be overstressed. At Avia Vascular, our dedication to safety, efficacy and reliability for our blood collection products is a testament to our company's unwavering commitment to creating a better, more patient focused approach to medical care. By embracing a comprehensive approach that spans research, development, manufacturing, regulatory compliance, bench top testing, post-market surveillance, and continuous improvement, we strive to stand as an example in the medical device industry of the proper and ethically sound direction for creating cutting edge medical devices. As technology continues to advance, our best practices stay at the forefront of methods that we implement to ensure that patient safety and comfort along with practitioner protection and ease of use remains the paramount concern in all stages of product development and deployment.