The Design for Cleanability: Avoid Costly Delays for Your Product Launch

Designing medical devices with cleanability in mind early in development can help prevent costly cleaning validation failures, regulatory delays, and manufacturing challenges after the design is frozen. Cretex Medical | QTS offers Cleanability Assessments to identify high-risk design features, optimize manufacturing processes, and develop cleaning strategies that support successful validation and a smoother path to market.

September 22, 2026

Early Design for Cleanability reviews from Cretex Medical | QTS can help identify cleaning risks before design freeze, reducing validation challenges, costs, and potential product launch delays.

Imagine this scenario. Your engineering team has spent years developing a groundbreaking implant. The mechanical testing is complete, the clinical data looks promising, and the marketing team is preparing for a high-profile product launch. The design is officially frozen, and you transition into the final phase of manufacturing validation.

Then, you hit a wall.

During the cleaning validation (CV) phase, laboratory testing reveals that manufacturing residues are consistently trapped inside the device. Despite adjusting the wash cycle times and increasing detergent concentrations, the device cannot be cleaned reliably. Because the design is already frozen, making even a minor modification to the device to improve fluid flow would require a complete restart of the regulatory submission process. The launch is delayed by months, cost projections skyrocket, and your competitors seize the opportunity to capture market share.

This scenario is far too common in the medical device industry. In the rush to optimize a device for mechanical performance and clinical efficacy, cleanability is frequently treated as an afterthought. However, a device that cannot be cleaned consistently cannot be safely sterilized or implanted. Cretex Medical | QTS can partner with you to employ a Design for Cleanability mindset early in the development cycle. Working together, we can minimize the risk of CV-driven delays and help you get your product to patients successfully.

The Danger of the Frozen Design

In medical device development, freezing a design is a major milestone. It signifies that the physical specifications of the device are locked and the device is ready for regulatory approval. Any subsequent device changes will be subject to rigorous design control procedures. While this process is necessary to ensure safety and consistency, freezing a design before evaluating how it will be cleaned is a high-risk gamble.

If you wait until the design is frozen to think about cleaning validation, your options for resolving cleaning issues are severely limited. You cannot easily add a flush port, enlarge a lumen, or round out a sharp internal corner. Instead, you are forced to try to optimize a cleaning process around an unnecessarily difficult geometry. This often leads to overly complex, highly sensitive cleaning protocols that are difficult to maintain in a production environment. That can lead to quality issues, longer production times, and higher costs.

By integrating cleanability reviews into the early stages of design, engineers can identify potential issues when they are still easy and inexpensive to fix.

Common Design Red Zones

When evaluating a new device design for cleanability, there are several common geometries that should immediately raise red flags. These design features are notoriously difficult to clean and validate.

Press-Fit Surfaces: When two metal components are pressed together without a hermetic seal, a microscopic gap is created. During the machining process, cutting oils and coolants can migrate into this gap through capillary action. However, during the cleaning process, water and detergents cannot easily penetrate the same gap to flush those residues out. Over time, these trapped contaminants can slowly leach out, resulting in failed biocompatibility tests or adverse patient reactions.
Permanent Assemblies: Devices that are welded, pinned, or riveted together before cleaning present a unique challenge. These assemblies often contain hidden, internal spaces that are shielded from the direct action of wash sprays and ultrasonic energy. Proving to a regulatory auditor that these interior surfaces are completely clean can be incredibly difficult.
Small-Diameter Lumens: Long, narrow tubes and cannulations are common in many instruments and delivery systems. Because of surface tension, liquids do not flow easily through very small openings. If a cleaning solution cannot pass freely through a lumen, the contaminants inside will remain. Additionally, rinsing these channels thoroughly to remove detergent residues can be just as, or more, difficult as removing the initial manufacturing soils. Pure water has a higher surface tension than detergent solutions, which makes small spaces harder to rinse.
Porous Networks: Porous surfaces encourage osseointegration and can be achieved through Additive Manufacturing (AM) or plasma spray coating. These porous networks can retain lubricants and microscopic metal particulates. Without an optimized cleaning protocol that is developed in tandem with the device's geometry, these surfaces will retain enough residual material to exceed predefined residue limits.
Deep Blind Holes: Another common pitfall is the inclusion of deep, narrow blind holes that inhibit the cleaning process. It is particularly troublesome if the planned cleaning process is an ultrasonic system. Ultrasonic cleaning relies on cavitation, which is the rapid creation and violent collapse of microscopic bubbles in the cleaning solution. If a blind hole is too narrow or deep, air can easily become trapped inside, creating a physical barrier that prevents the cleaning liquid from filling the cavity. Without direct liquid contact, cavitation cannot occur, and manufacturing residues can be retained where the feature terminates.

If your design process doesn’t account for these red zones, then your engineers are essentially designing blind.

The Strategic Value of Early Collaboration

The best way to navigate these cleaning challenges is to bring manufacturing and validation experts into the discussion long before the design is frozen. This is where partnering with Cretex Medical | QTS provides a distinct competitive advantage.

At QTS, we encourage our partners to engage our technical teams during the initial concept and prototyping phases. We offer formal Cleanability Assessments where our experts review your CAD models to identify potential cleanability risks.

During these assessments, we will use Design for Cleanability principles to recommend design or manufacturing changes that can mitigate the risks to CV, such as:

Adding or modifying features to help with the flow of detergents and rinse water.
Enlarging lumen diameters to improve fluid flow.
Designing assemblies that can be terminally cleaned prior to final assembly.
Adding a critical cleaning operation, such as vapor degreasing, to remove nonpolar residues (oils) better than aqueous detergent solutions, prior to final cleaning.

Of course, experts from Cretex Medical | QTS will not just look at the physical geometry of the device. We look at the entire planned manufacturing sequence. We analyze the types of manufacturing fluids that will be used, such as cutting oils, grinding coolants, and polishing pastes. Some of these fluids are highly resistant to water-based cleaning, while others can be easily removed. By helping you select cleanable manufacturing lubricants and identifying geometric "red zones" early, we can help you optimize your process for validation success.

Our team has years of experience in establishing validated cleaning processes for some of the most complex devices on the market. Because we actively participate in the development of industry standards like ISO 19227, we know exactly what regulatory bodies are looking for. We help you design a validation strategy that is robust, scientifically justified, and compliant with the expectations of today and tomorrow.

Designing for a Smooth Launch

In the medical device industry, time to market is everything. A delay of just a few months can cost a company millions of dollars in lost opportunity. In many cases, engineering resources are focused on the form, fit, and function of device design. Failure to consider design for cleanability can impact these device attributes, and inability to meet final residue criteria can present the same risk to project success.

Partnering with the experienced specialists at Cretex Medical | QTS allows your design team to focus on innovation while we ensure that your manufacturing and cleaning validations are successful. Contact us early in your next design cycle to learn how our Cleanability Assessments can help you streamline your path to market and ensure the highest standards of patient safety.

Please visit our website for more information about Cretex Medical | QTS and our services.