Design thinking has become a guiding principle for new product breakthroughs in drug delivery, diagnostic and MedTech device innovations by helping to inform product performance based on patients’ lifestyles, abilities and preferences. In a human-centered design blog authored by my Phillips-Medisize colleague Brett Landrum, he stressed the critical need for form to follow function in improving patient compliance and medical outcomes.

When it comes to the practitioner side of the house, the same rules apply. The overarching goal is to provide surgeons, physicians, clinicians and nurses with the utmost confidence in whatever device they’re using—whether it’s a new tool for in-vitro diagnostics or the latest device to advance electrophysiology (EP) procedures. Not only do we need to consider the wants and needs of highly skilled healthcare professionals, but we must conceptualize how each device, tool or instrument should increase workflow efficiency while reducing risk.

Visualizing how each new device needs to fit into an overall routine to maximize productivity and avoid unnecessary disruptions requires a special set of design skills. For EP and cardiovascular procedures devices, it’s essential to understand how physicians will use and manipulate the devices. For example, “handling aspects” need to be evaluated with precision to assess the exact specifications for steering, turning and torquing the device to reach the targeted anatomy within the heart while ensuring that each maneuver can be completed easily with one hand.

Designing Solutions to Exacting Specifications

Our human factors experts and industrial designers perform exhaustive design research, which often includes first-hand observations of procedures. They focus on what’s intuitive to practitioners as well as translate sophisticated clinical requirements into terms readily understood by product designers. Sometimes, simply watching a clinician’s normal routine will illuminate an important aspect of device functionality that hasn’t been fully described or defined.

The goal is to uncover the frustration practitioners may have with existing tools, then interpret their clinical wants and needs into engineering capabilities that enable next-gen solutions to perform with increased precision. Equally important is developing a sense of how to create the desired look, feel and function of every new tool or instrument, paying as much attention to performance expectations that are specifically expressed as those that aren’t.

For instance, an Electrophysiologist may describe wanting a catheter to turn 180 degrees during an EP procedure. Our engineers will try to understand the specific use case to enable catheter rotation and design options to achieve the function to better understand the specific use case before offering alternatives for consideration.

World-Class Tools for the Practitioner’s Toolbox

According to the Centers for Disease Control and Prevention (CDC), healthcare systems require continuous innovation to meet the needs of patients and providers. However, these stakeholders haven’t always been part of the design process, which has contributed to decades-long gaps between intervention development and implementation. Design thinking offers an important avenue to close those gaps by actively engaging providers in the design process while rapidly iterating prototypes to maximize success. Countless critical factors need to be considered to determine which next-gen tools or surgical instruments make it into the practitioner’s toolbox.

Phillips-Medisize has been collaborating with a major OEM on a next-generation EP catheter, which necessitated a game-changing design to meet high-density requirements. Engineering excellence is applied to each iterative design to ensure distinct components are integrated into a complete solution. Additionally, we’re already looking at unique manufacturing processes, including fine wire termination to accommodate the high-density technology.

New, game-changing designs incorporating advanced electronics, as well as ever-increasing connectivity and sensor technologies, can take performance to the next level. But they also require proven engineering expertise, especially in dealing with communication technologies, such as RF, Bluetooth and Near Field Communications (NFC). At Phillips-Medisize, we’re also working with a multinational medical device and healthcare organization on design concepts for a disposable diagnostic device that incorporates connectivity. The objective is to communicate test results from a tissue sample to a mobile app that is smart enough to interpret the data and then instruct a healthcare provider, and ultimately a patient, on next steps. While it’s still early in the overall conceptual process, the potential for this device is tremendous, especially in rapid-testing to detect communicable diseases in developing countries.

For that reason, the ability to rapidly scale volume manufacturing, measured in billions or trillions of units, already is a topic of discussion. For most device manufacturers, manufacturing speed and agility can pose significant roadblocks to market entry. That’s why it’s so important to align with a partner adept at delivering end-to-end solutions from concept to commercialization.

Making the Move to Volume Manufacturing

Phillips-Medisize continually invests in technology accelerators to streamline the development process while reducing cost and risk. Let’s face it, every fraction of a penny matters when you are producing hundreds of millions of drug delivery or diagnostic devices. Bringing products to market in the fastest, most economical ways requires a global footprint and world-class manufacturing capabilities. To that end, Phillips-Medisize just announced an expansion in manufacturing capacity and capabilities worldwide, including a new manufacturing site in Poland, as well as expanded capacity in the U.S. and China.  

Our global reach now includes 36 facilities delivering a full range of capabilities, encompassing front-end innovation, human-factors engineering, mass production, complex molding, drug and reagent handling, as well as final packaging, high-speed labeling and serialization—all bolstered by a rigorous quality management system. We assure stringent compliance with regulatory requirements around the world while maintaining Class 7 and 8 cleanrooms, climate-controlled warehouses and cold-chain storage to guarantee the highest levels of product integrity.

In-depth experience with automation, miniaturization and material expertise also play major roles in helping us develop the best devices for use by practitioners along with the fastest and most cost-effective commercialization path. Molex’s acquisition of Fiberguide Industries last year is an excellent example of our unwavering focus building capabilities that will meet the changing demands of the healthcare industry.

In this particular case, we can now provide specialty optical fiber capabilities to address emerging EP applications as well as high-power laser surgery, DNA sequencing and flow cytometry. In the fast-paced world of EP, in-vitro diagnostics and the broader healthcare market, nothing but the very best is good enough for practitioners. This endless pursuit of excellence fuels our development of precision-driven solutions designed to deliver the best possible outcomes.