Selenium Medical: Reinventing Medical Devices Packaging and Surface Treatment
Olivier Richart, CEO
The medical device demand is on the rise with technological development, the aging population, chronic diseases, and healthcare expenditure. The global medical device market is expected to reach an estimated $409.5 billion by 2023 according to a Research and Markets report (2018). Such extensive production of medical devices is escalating the need for efficient medical device surface treatment and packaging that guarantee high performance with no risk of contamination. Addressing all these needs is Selenium Medical that is reinventing post-machining treatment and packaging of medical devices for greater effectiveness and safety. The company’s force is medical device packaging with a holistic combination of quality, process validation, and research and development skills. “Selenium makes sterile packaging more innovative, more practical, and just plain easier,” says Olivier Richart, the CEO of Selenium Medical.
In close relationship with its customers and nurses, Selenium offers its expertise, skills, and technical advice to support their packaging projects. Selenium Packaging (SP) comprises tubes, blisters, pouches, and boxes that protect the sterility, functionality, and availability of medical devices, cost-effectively. For instance, Selenium’s SoTube and SoSafe, the double tube sterile packaging for medical devices have been appreciated by the device manufacturers for their medical design excellence. “We’re on hand to support and optimize your daily activities, anticipate your projects, market trends, and the functional demands of your medical devices,” states Olivier.
Selenium’s expertise in chemical and electrochemical treatments for medical devices in titanium alloys and stainless steel is offered as Selenium Surface Treatment (S2T) processes of anodizing, nanoetching, passivation, electropolishing, laser, and cleansing.
These processes can help preserve and even improve the mechanical properties of implants (orthodontal, spinal, maxillofacial). For instance, the StarSurf structural etching chemical treatment preserves implants, enhances wettability, and helps reduce the healing time of patients thanks to nano-structuration.
With most of Selenium’s personnel having backgrounds in the medical industry, the company develops its expert Quality, Validation, and R&D processes, in-house. This helps shorten the supply chain, improve communication, and maximize control, customization, and efficiency of the company’s work. Selenium’s Quality team aims to ensure customer satisfaction and compliance with regulatory requirements. For instance, Selenium’s quality policy ensures proficiency with the International Standards Organization reference systems— ISO13485 – ISO9001 – cGMP (FDA – 21CFRs).
The company’s process validation ensures the IQ/OQ/PQ/ PPQ of manufacturing processes and guarantees compliance, stability, and reproducibility followed by final validation. Also, Selenium’s microbiological laboratory serves as the site for compression testing and integrity challenge (dye test/vacuum, and more). Engineers and technicians monitor and maintain cleanliness standards (ISO5 & ISO7) in the laboratory, which also undergoes COFRAC (French Accreditation Committee) testing to meet all contamination control requirements.
With dedicated research, testing, and prototyping for new packaging ranges, Selenium’s R&D team gives concrete form to the customers’ concepts, infusing it with commercial appeal. Keeping pace with contemporary trends, “We are using thousands of cell phones, web meetings, and interviews for our work,” remarks Olivier and adds, “Selenium communicates and collaborates with customers and nurses to understand their requirements and develops customized solutions that are long-lasting, well-designed, and well-validated.”
Selenium has developed, patented, two more types of blister and implant holder packaging products to be launched, branded SoBliss and SoEASY that are, very smart and user-friendly like a USB flash drive,” quips Olivier. The company is also working on Selenium Injection (sI) leveraging the expertise in the injection industry to develop a new factory warranty ISO 13485. Selenium’s expansion strategy aims at entering the U.S. and European mega-sized markets for packaging solutions. Selenium America (SeA) represents the recently opened Selenium base in the U.S. (Charlotte, North Carolina). Acknowledging the importance of expertise, documentation, robotics, and training in the industry, Selenium Medical aspires to innovate and evolve to succeed.
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