As manufacturers are well aware, healthcare professionals and their patients alike demand that the medical devices they are using be made smaller, convenient, and discrete, while retaining complete efficiency and effectiveness. For most areas of medicine, this is a challenge for the companies serving this industry. It is an even greater obstacle to the success of a product when working with a technology that requires extensive experience to deliver optimal results. Fortunately for medical device manufacturers, Peter Desloge—Watlow’s president, CEO and chairman of the board—recognizes this and has continued to move the company to a position that enables it to be relied on as a source of expertise for the full range of heating solutions required in many medical devices.“The shift toward smaller and more ambulatory equipment has challenged our traditional design and manufacturing processes,” explains Desloge. “Advancements in these areas, along with new advanced ceramic materials, polymers, and conductive films allow us to design high-performance heaters in small packages. This was impossible just five years ago. Due to the speed of the industry, it is important to be able to turn around product designs and prototypes in a timely manner. We spend a lot of resources on ‘leaning’ out our design and manufacturing processes.” Addressing a range of thermal solution needs—electric heaters, temperature sensors, temperature controllers, power controllers, software, and systems—in a variety of industries, Watlow is one of the largest custom designers and manufacturers of these types of components. Under the direction of Desloge, the company will continue to develop new innovations and offer its expertise as a leader in heating technologies. In this interview with him, Desloge shares his thoughts on challenges serving this highly regulated industry, reflects on his company’s capabilities and offerings, and comments on the industry as a whole.
Q: What significant changes have you observed in the medical device industry over the last 10 years?
A: There are many trends and shifts that have impacted the industry over the last 10 years. For starters, there have been economic changes—mergers, consolidations, and continued pressure to reduce costs—that look very different than they did in 1996. Regulatory changes such as FDA, UL, CE, RoHS, and WEEE are also impacting the industry and forcing changes in the supply chain. Technology drivers like scientific discoveries, new technologies, and new OEM equipment designs are focusing on real-time data and equipment portability and the speed of tests have also changed the landscape. In addition, general business changes like the focus on lean manufacturing and product speed-to-market have created positive changes in our overall manufacturing process, which allows us to best serve the demands of the industry.
Q: RoHS and WEEE are hot topics for U.S. medical device manufacturers. Can you comment on these further?
A: RoHS and WEEE are a fact of life, and Watlow has embraced the regulations. A couple of years ago, Watlow committed to meeting these excellent global environmental standards and we are compliant. Most, if not all, of our medical customers simply expect us to meet the standards, and we do.
Q: How will these regulations affect device manufacturers in the future?
A: Medical device manufacturers will continue to meet future standards, because it is a requirement in a global environment.
Q: What is the biggest challenge you face with regard to the demands of medical device makers?
A: Globalization of our customer base has driven Watlow to establish technical support and manufacturing centers in Mexico, Europe, and China. With localized support, we are able to satisfy the demands of our customers in a timely manner. Building that infrastructure, while not “difficult,” is challenging technically and logistically. One of the other continuing challenges is the miniaturization of medical products, which mandates constant innovation on our part. We welcome that challenge.
Q: What has been your experience with medical device manufacturers being more open to outsourcing and partnering with experts in specific technologies?
A: Most of Watlow’s medical device customers are looking for suppliers that provide design services and advanced solutions. Watlow has responded to this requirement by establishing Single Iteration. Single Iteration provides our customers with the partner and expertise they need to quickly take their products to market.
Q: Can you explain Single Iteration further?
A: As a division of Watlow, Single Iteration brings together the collective knowledge of engineers with experience designing and applying heating technologies for multiple industries. Single Iteration generates new ideas and then evaluates, designs, and prototypes them to get products to market quickly. Single Iteration solves difficult thermal problems in shorter time frames than that achieved using conventional iterative approaches—helping clients get better thermal products to market faster.
Q: Can you briefly share an experience where this service has enhanced a medical device?
A: Customers engage this level of thermal systems engineering for a variety of reasons. They may be in search of new creative ways to improve a heating approach or they may be seeking engineering counsel from subject matter experts to ensure that success of their chosen direction. Either way, close engagement of the development effort is always done with an assurance not to disclose the nature of the developments. Single Iteration has worked to improve the heat efficiencies involved with intravenous fluid holding and transfer into the body to increase patient comfort. Additionally, we have worked directly on solutions to enhance cauterization techniques, provide fail-safe neonatal warming, and incorporate improved methods for applying heat to tissue for surgical devices used to perform various procedures.
Q: Will collaboration in the industry continue to be the trend?
A: Most device manufacturers have excellent engineering groups that are focused on their core competency, which is usually not thermal system design. The result is that Watlow is able to become part of our customers’ design team. We expect this trend to continue. By outsourcing, our customers are able to focus on their core competencies because they trust the fact that we focus on ours—thermal expertise.
Q: Please share an experience where you encountered a problem or a difficulty that resulted in a positive outcome.
A: Recently, we had a medical device customer that experienced some random field failures of their device. The failure was not life threatening but if the device was not working, the patient’s comfort might be compromised.