ZIEN Medical Technologies: Holistic Services for Regulatory Compliant Medical Devices
Tim Nieman, CEO
The medical device manufacturing industry has witnessed significant growth in the last few years, with an immense emphasis on design and simplicity. Although this trend of continual innovation has introduced innovative products to the market, it has generated a unique challenge for medical device manufacturers in achieving regulatory clearance. Regulatory authorities across the globe have restructured the compliance rules to ensure the safety and efficacy of products raising the hurdles to commercialization. As such, players across this field today have increased obligations to monitor the quality, performance, and safety of devices while staying updated with the ever-changing regulations and compliance requirements.
The situation clearly highlights the need for a partner like ZIEN Medical Technologies (ZIEN), who simplifies the process of adhering to regulations and compliance by acting as a ‘medical device integrator’ and providing a wide range of design, quality systems, regulatory, and contract manufacturing/packaging services within an ISO 13485 certified quality system. Most importantly, the company often registers and obtains CE Mark and FDA clearance for the medical devices they help develop. “Companies, have to undergo lengthy quality control and certification processes to achieve regulatory approval for their products with increasingly burdensome processes to achieve CE mark,” asserts Tim Nieman, CEO at ZIEN Medical Technologies. “ZIEN breaks down this barrier for clients by helping companies bring their products quickly to the market under its own ISO certification.” By taking a holistic approach to their customers’ needs, the company supports each step of product manufacturing, packaging, sterilization, and traceability requirements and ensures products meet all the stern regulations allowing for the most efficient path to market. “There are many companies that perform contract manufacturing, help in medical device development engineering, or provide regulatory affairs and quality systems assistance.
ZIEN blends it all to enable our clients to market their products in the fastest and most cost-efficient possible way,” mentions Nieman.
With its in-depth engineering and quality systems experience, ZIEN brings all the infrastructure to the table that companies need to take their product from concept to commercialization. While the company performs manufacturing, packaging, and sterilization of most of the products in-house, they also outsource molding, assembly, and packaging to other pre-qualified entities to help clients ensure the lowest possible cost of goods and highest margins. Recently, ZIEN helped a client contract with the right partner for developing safety scalpels. The safety scalpels couldn’t be manufactured in the U.S. due to cost constraints. Therefore, ZIEN partnered with the client and contracted with a Chinese company that provided the molding, assembly, packaging, and sterilization services under its guidance and controls. Thus, ZIEN delivered more than 50,000 units of safety scalpels in a month in partnership with the client.
To best serve clients, ZIEN always takes a phased approach to the development, manufacturing, and commercialization of a product and shares insights and knowledge of each of these steps with their client organizations. This enables businesses to make better decisions for their product manufacturing and allows ZIEN to remain in lockstep with clients’ needs and objectives to achieve those goals. Although ZIEN primarily focuses on emerging technologies or startups that are seeking a path to commercialization, it also delivers to large and medium-sized organizations that are looking to expand their engineering capabilities to increase the speed and capacity for developing new products. For instance, ZIEN worked for a medical device startup whose technology was acquired by a large multinational company. The acquiring company chose to keep ZIEN as the legal manufacturer for an extended period to make the additional desired improvements to the product because of the efficiency of its quality system and staff. With its nimble system, ZIEN could make all the necessary changes in the products within a shorter timeframe than the acquiring company. Honing such capabilities, ZIEN has grown consistently every year and has accelerated that growth in the last two years. Continually expanding its services, recently adding packaging and sterilization to its contract manufacturing capabilities, the company is dedicated to helping organizations take their products to market by serving as a regulatory backbone. “We take all the regulatory responsibilities for our clients, which enables them to focus on the market success of products.” Nieman concludes.
Description ZIEN Medical Technologies (ZIEN) simplifies the process of adhering to regulations and compliance by acting as a ‘medical device integrator’ and providing a wide range of design, quality systems, regulatory, and contract manufacturing/packaging services within an ISO 13485 certified quality system. Most importantly, the company often registers and obtains CE Mark and FDA clearance for the medical devices they help develop. By taking a holistic approach to their customers needs, the company supports each step of product manufacturing, packaging, sterilization, and traceability requirements and ensures products meet all the stern regulations allowing for the most efficient path to market
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