Q&A: Pre-Certified Pumps Speed Medtech Design, Cut Compliance Hassles

When bringing new equipment to market, navigating the complex landscape of safety, electrical and EMC standards can be a time-consuming part of the design cycle. That’s because the certification status of components matters as much as their technical performance. 

Eric Coulombe, senior technical specialist at Watson-Marlow Fluid Technology Solutions, notes OEM designers can streamline this using pre-certified solutions. 

Coulombe points to Watson‑Marlow’s DriveSure panel‑mount pumps as a principal example. “Watson-Marlow DriveSure panel mount pumps deliver comprehensive, global certification through TÜV, helping equipment manufacturers meet GMP and medical device regulatory requirements with minimum effort,” he noted. 

The Nationally Recognized Testing Laboratory (NRTL) certification is recognized by the U.S. Occupational Safety and Health Administration (OSHA)​ and the CB Scheme approvals enable access to more than 50 international markets. 

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In addition, the pumps meet the harmonized Low Voltage Directive safety standard (UL61010), carry the CE marking under the EMC Directive and meet FCC 47CFR requirements for the U.S. market. For OEM design engineers, these comprehensive certifications mean less time caught up in certification red tape and greater focus on refining performance and accuracy.

Less hassle translates to greater effort toward safer patient outcomes. 

Machine Design asked Coulombe several technical questions about the DriveSure panel-mount pumps. The following are his responses.

Machine Design: Explain how closed-loop control systems handle changing back pressure, fluid viscosity and duty cycles.  

Eric Coulombe: Watson-Marlow DriveSure panel mount pumps are designed for peristaltic motion. Unlike other motion control applications, peristaltic pumps create a varying load, which the motor and control need to overcome in order to deliver fluid with accuracy. Traditional, open-loop stepper motors are often selected for peristaltic pump applications for size and cost benefits, but the fixed phase current required to overcome start-up torque can result in wasted energy during running.

Wasted energy typically results in heat or noise, which is an increasing concern as laboratories, diagnostics and bioprocessing environments adopt higher-throughput automation, tighter equipment integration and more energy-conscious designs.

The pump features our next-generation digital, closed-loop control technology, which delivers enhanced speed control for accurate flow rates, coupled with cool and quiet performance. High speed accuracy and stability across the range is achieved by tuning specifically for peristaltic pump applications. Cool running is achieved by continuously adjusting motor phase current in response to the torque requirement, avoiding excess current and therefore heat. 

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Being designed for peristaltic motion, DriveSure can manage changes in the process—for example, pressure, viscosity or tubing characteristics—in a controlled and safe manner, aligning with broader industry shifts toward data-driven process control and reproducibility amid regulatory scrutiny of flow accuracy and long-term stability in clinical and laboratory settings. 

MD: How do your pump and fluid path technologies reduce risk and lifecycle maintenance for OEM medical devices?

EC: Manufacturers of medical devices need reliable, easy-to-use, low-risk fluid handling solutions. Watson-Marlow addresses these needs in several ways. Our peristaltic pump technology keeps fluid contained within the tube, eliminating contamination risks. When clinical staff change tube sets in the pump heads, often in high pressure situations, their familiar and user-friendly designs allow them to do so without extensive training.

This approach also reduces lifecycle maintenance by simplifying cleaning and validation requirements, and also lowering the chances of unplanned downtime. Predictable, preventative maintenance strategies support consistent performance over the life of the device. This is especially important for OEMs seeking to reduce total cost of ownership while meeting stringent clinical and regulatory demands.

Finally, WMArchitect single-use solutions are designed for biopharmaceutical and life science companies to streamline processes, safeguard products, reduce regulatory burden and resolve challenges for end-to-end, single-use fluid path management.

MD: Does Watson-Marlow Drivesure panel mount pumps support connectivity?

EC: DriveSure supports EtherNet/IP and PROFINET protocols as well as analog control. This simplifies integration into advanced distributed control systems and benefits end-users by improving process control, reducing operating costs and minimizing downtime. 

In addition, EMC certification and features such as IP66 capable mounting plates, integrated cover-open sensor, analogue signal scaling/smoothing, prime switch inputs and fault detection make DriveSure attractive to OEMs, designers, engineers and installers.