ZIEN Medical Achieves CE Mark, Supporting SAM Medical in Europe

Overview of ZIEN Medical Technologies

Founded in 2009 and headquartered in Salt Lake City, ZIEN Medical Technologies is a dynamic player in the contract manufacturing space for medical devices. As a portfolio company of Banner Capital, ZIEN specializes in comprehensive design, manufacturing, and regulatory services. Their expertise allows them to assist medical device companies with product development, sterilization, packaging, and navigating regulatory landscapes. With a focus on innovation, ZIEN positions itself as a key partner for healthcare companies looking to bring cutting-edge medical solutions to market quickly.

Achieving the CE Mark

Recently, ZIEN Medical Technologies proudly announced the achievement of its first CE Mark under the EU Medical Device Regulation (EU MDR 2017/745). This milestone not only underscores ZIEN's capabilities but also reflects their commitment to regulatory excellence and their role in accelerating market entry for vital medical technologies. In particular, this CE Mark was awarded in support of SAM Medical Products, a company known for its advanced solutions in emergency medical care.

Supporting SAM Medical Products

SAM Medical has been at the forefront of innovations aimed at enhancing patient outcomes during emergency medical procedures. The company specializes in devices that aid in fracture management, hemorrhage control, and respiratory management. With the recent foray into the Intraosseous Access Market, SAM Medical sought ZIEN's expertise to establish a presence in Europe and reach a broader patient base. ZIEN’s ability to act as a Manufacturer of Record (MoR) enables SAM Medical to focus on diversifying their product portfolio while ZIEN navigates the regulatory complexities surrounding their Intraosseous Access solutions.

Regulatory Acceleration and Market Benefits

Kyle Sims, Director of Product Development at SAM Medical, articulated the significant advantages of partnering with ZIEN. By transferring regulatory and technical oversight for the strong Intraosseous Access product line to ZIEN, SAM Medical can enhance their engineering support capabilities. This strategic collaboration not only streamlines operations but also creates a scalable pathway for introducing new patient solutions as they expand their presence in the medical market.

Tim Nieman, CEO of ZIEN, stated, “Our role in providing regulatory support is crucial in overcoming the challenges posed by EU MDR. By facilitating faster market entry for medical devices, we can prevent innovative solutions from being sidelined due to regulatory hurdles.”

Impact and Future Outlook

The collaboration between ZIEN and SAM Medical signals a significant advancement in the availability of emergency medical devices in Europe. ZIEN has demonstrated that with the right certification and engineering support, medical products can be brought to market within a year, as opposed to the traditional timeline of more than two years. Moreover, ZIEN estimates that their comprehensive services can save companies upwards of $100,000, making the entire process more economically viable.

Conclusion

As ZIEN Medical Technologies continues to break through regulatory barriers, it opens doors to crucial medical innovations that enhance patient care globally. Their partnership with SAM Medical represents a model for future collaborations that prioritize health technology advancement and market accessibility, ultimately leading to improved outcomes for patients worldwide.