These products meet the very high standards for hygiene and safety required in medicine and nursing.
Providers of excellent medical and patient care have to increasingly contend with growing economic pressures on the one hand and limited human resources on the other.
Patients and healthcare professionals alike are demanding solutions which ensure safety, high quality and precise handling, but are also economically acceptable. Another key quality parameter is sustainability. Easy disposal and recycling, not to mention the savings due to not needing the water, cleaning agents and energy required for re-processing reusable instruments, are clear advantages for single-use instruments.
Many process steps are involved in producing a product portfolio that satisfies these diverse requirements, so it generally takes many months before a certified premium product can be launched.
Our magazine team spoke with representatives from three departments at L&R that played a role in getting the Sentina Single-use instruments to market.
3 questions for
Maria Nettesheim, Claudia Schneider, Bianca Eiden (ltr)
3 questions for Maria Nettesheim, R&D:
R&D has been involved with this project from the beginning. The regulatory requirements concerning documentation were so complex that none of our suppliers completely met them. So, among other tasks, our to-do list included the following: Collect stability data, develop and validate new test methods for colour marking, to name just a few. L&R modified the single-use products to meet the regulatory requirements in very close consultation with one of our suppliers.
The process began in September 2015. While that may sound like a long time, people in the industry know that this is how much time needs to be blocked out for a new market launch. In addition, regulatory requirements for approvals keep getting stricter, the long-ranging appointments for acceptance by TÜV needed to be taken into account, and so on. So it is all the more exciting when the product finally gets put on the market.
We are getting very positive feedback. Healthcare professionals are very happy with the product quality and the advantages that Sentina Single-use instruments offer.
3 questions for Claudia Schneider, Global Marketing:
It started with a market analysis of the European territory. L&R has had very positive experiences with single-use products in the medical environment with its OR drapes, OR gowns and Kitpack product groups. We know very well the increasingly strict hygiene and safety requirements, as well as the tough economic pressures and the search for efficient solutions at hospitals, medical practices and for patient care. Sentina Single-use instruments offer an attractive solution to these issues.
Definitely. As a first phase, we introduced our Sentina Single-use instruments to our focus markets. To date, we have had very positive feedback – from every sector where these products are used. The synergy of hygiene, safety, sustainability and time savings is perfect. We are already thinking about additional markets and expanding the product range.
These plans are more theoretical than not at the moment, but in addition to expanding the product range, we could also consider, for example, small instrument sets. We are consulting closely with our customers about this, so we are in a position to respond to their needs. We are very excited about the next chapter of the success story that is our Sentina Single-use instruments.
3 questions for Bianca Eiden, Strategic Procurement:
Strategic procurement has been very intensively involved in the product development processes early on. While selecting the best supplier early in the process is important for the development process it is also the key to successfully marketing the product. It influences quality and competitiveness to a great extent. We developed a special strategy to address this that we call “right supplier@first time”.
In addition to the bottom line concerns, we also of course have to tackle regulatory and quality-related issues. To do this, we established standards based on the quality management system ISO 13485, which applies to medical devices, using a risk-based approach. These standards have to be met by our suppliers.
L&R stands for high-quality products and solutions and the certified quality standards apply to our entire supply chain. Standardised processes and complete documentation of activities create transparency. Our suppliers must guarantee that they will comply with the standards defined in our code of conduct by signing it. This code includes social and ecological elements, among others.