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Stay ahead of the Market with Single-use Scopes
Why OEM's should partner with a vertically integrated supplier for their single-use scopes and complex catheter needs
Market requirements are changing faster and faster in many areas today - including medical technology.
OEMs are caught in the middle: they have to serve the changing market requirements but are also dependent on suppliers, their know-how and cooperation.
In the case of single-use scopes, this presents a particularly complex picture for OEMs: competitive and regulatory pressure is becoming ever greater, while the time-to-market must be as short as possible and development/manufacturing costs kept low.
The clinical landscape for single-use scopes
The FDA ordered the major OEMs on the market to conduct expanded post-market surveillance studies. These studies were to determine contamination rates after clinical use and reprocessing of reusable scopes.
With important findings: Contamination rates after cleaning, disinfection and sterilization were found to be higher than expected - posing a risk of cross-infection in the clinical setting.
The danger: drug-resistant superbugs could potentially be associated with deficiencies during reprocessing and downstream patient cross-contamination.
Based on these studies, the FDA endorsed a transition to scopes with innovative designs in 2019. So how do you reconcile all of these requirements and what can innovative design look like?
The advantages of single-use scopes
The main proposed solution is to use single-use scopes instead of reusable scopes. This is also advocated by the FDA, which states that either scopes with disposable components or fully disposable scopes should be used to increase patient safety. The COVID-19 pandemic further accelerated this single-use market - as a result of increased infection controls across healthcare systems. For example, in 2021, the FDA also recommended the use of disposable bronchoscopes in patients to control the virus.
A detailed look at single-use scopes illustrates the advantages:
- Elimination of infection risk
- Optimized flow
- Cost efficiency
The design of single-use scopes
The above illustration shows how diverse and unique the requirements for flexible scopes can be. It is important to consider these requirements in practical use. For example, the maneuverability of the scope is crucial from the perspective of the shaft, but also from the perspective of the handle. There are different functional design requirements that need to be considered, such as the torquability, pushability, flexibility, kink resistance and dimensional stability of the shaft. It is important to keep in mind the corresponding design choices that influence these factors: Material selection and configuration, the extrusion process, the assembly processes and finishing operations play a critical role. For OEMs, it is important here to have an experienced partner at their side who can translate the relevant functional requirements into a suitable solution.
Let's take a closer look at this using the torquability of the shaft as an example.
The torque behavior of the scope, also known as "torquability," can be very important in certain applications. Torquability in physics is a vector that measures the tendency of a force to rotate an object about a particular axis. For optimal use, the response of scopes should aim achieve the desired 1:1 ratio between the handle and the distal tip, regardless of the length and routing of the shaft. Parameters that influence torquability include the material selection, metal reinforcement configuration (braid/coil – pattern, pitch, wire size, etc.) and processing techniques utilized. All of these parameters must be considered and harmonized for the best result - to achieve excellence in clinical use.
The optimum partner for single-use scope design, development & manufacturing
Freudenberg Medical has extensive experience taking all these parameters into account over a wide range of products, involving disposable scopes. Our experience is developed over many decades as a leading CDMO within the medical device industry. We draw on a wealth of experience in the design, development and manufacture of complex catheters across our global team. In-depth knowledge in the field of material selection, extrusion, moulding, coatings and complex assembly processing makes it possible to translate the product requirements into tangible solutions.
Broad sprectrum of solutions
Our OEM customers benefit from our broad spectrum of disposable scope and complex catheter experience. Each device and each customer need are often highly individual. Freudenberg Medical can leverage and adapt its existing development platforms (including handles, valves and shafts) to meet specific customer requirements. This has been a proven option to fast-track customers time to market as a trusted partner.
Vertical integration, dedicated resources and state-of-the-art technology ensure unmatched performance. A major advantage for our customers: We have all the capabilities and know-how inhouse that are required in the design, development and manufacture of scopes and other complex catheters. This makes partnering with Freudenberg Medical particularly attractive for our customers.
We share knowledge and experience internationally: The standardized equipment at our production sites enables close global cooperation and cross-divisional exchange. With technical expertise in the manufacture of customized assembly process equipment and dedicated development resources, we can provide short project lead times - and thus accelerate our partners' market launches.
Single-use scopes: short trend or sea change?
The market demand for innovative solutions will continue to grow in the future - as will the regulatory requirements. Here, disposable scopes offer a safe, easy-to-use and flexible solution where infection risks due to cross-contamination can be eliminated, with the associated advantages as highlighted earlier.
In this context, it is important that OEMs can rely on an experienced partner at their side - one that not only supplies innovative solutions, but also has holistic expertise to meet customer requirements quickly, cost-effectively and with the highest quality standards.
