Why It Takes So Long to Develop a Medical Technology (Part 10)

Written by Mark Carol, MD

Technology Advancement 

The NOMOS Peacock system, consisting of novel hardware and innovative software, was developed in the early 1990s for intensity-modulated radiation therapy (IMRT). At that time, using state-of-the-art desktop computers, it took more than 48 hours to run the computations required to generate a single treatment plan. The hardware was designed, developed, and manufactured initially in a garage and had an industrial look and feel to it. It also ran off bottled compressed air that was difficult to obtain and required constant refilling. The system worked, but it was not optimized for use in a busy radiation oncology clinic. Turning the prototype into a clinical system took two years. In the end, the time required to generate a plan was reduced to minutes, bottled air was replaced with a compressor, and the system was able to be retrofit to almost every linear accelerator in use at that time.  

The company’s successful introduction of its technology resulted in a level of encouragement from the Board that enabled the team to expand to other medical fields. Led by the company’s founder, scientists and engineers were given free rein to explore ideas in neurosurgery, electrophysiology, medical imaging, and image-guided surgery. By 1996, NOMOS, a four-year-old company with limited sales and growing competition from the larger players in the radiation oncology field, had as many as six large-scale research and development projects across these disciplines, each of which had the potential to be worthy of a separate company.  

While intellectually exhilarating, this expansion caused the company to lose focus on its primary product, resulting in a lack of progress on its core technology. It also led to a rapid depletion of funds that were needed to grow a domestic sales force and implement aggressive marketing. By 1998, only one of the development endeavors was still in existence at NOMOS as a moderately profitable product, while the money that had been spent on the other technologies (that which was necessary to grow the IMRT business) could not be replaced. 

Stock image depicting laboratory or innovation

The pain, cost, and sheer complexity of building a new platform from scratch is enormous. These factors can be further hampered by unrealistic schedules, false starts, leadership turnover, changing strategies, talent shortages, technology obsolescence, competition, corporate underfunding, and conflicting goals on the part of management, the Board, investors, employees, and customers. The bottom line is that it takes a great deal of courage, conviction, and resilience to start a company to develop a new and innovative medical technology and bring it to market. 

There are many causes for delays in developing a technology that are often discussed. Less described, but nonetheless at the top of the list and therefore deserving of specific attention in this series, is an early loss of focus. Medical technology companies often have “eyes bigger than their stomachs.” Let’s examine this scenario in an imaginary company.  

The Cost of Losing Focus  

The imaginary company has taken on too many projects and has planned each in isolation from the other. It caters to the whims of a founder who, while brilliant, is on to the next idea before the first one is turning a profit. The company fails to anticipate resource conflicts, loss of attention, and other inefficiencies that result from having multiple parallel projects. These failures have had an impact on the employees, who are struggling to complete their tasks and losing the desire to work for the company. 

Beyond these challenges, the employees are excited about the technology they are developing, but they are also realizing how much better it could be. As the product’s blemishes and warts become obvious and fixes are worked out, the employees begin to conceptualize a path forward to an even greater technological advance. The engineering team responsible for the technological leap has spent the past years slogging through the documentation required by quality and regulatory bodies to commercialize the technology rather than improving and advancing the technology. They are bored and ready to be engineers again, to innovate like they did in the beginning. The Board is also excited, wowed by the new ideas and willing to invest the dollars required to immediately make the improved version a reality. Meanwhile, customers are anxiously awaiting the product. 

No matter how strong the temptation, this path should be avoided. It will take time for the medical community – patients, physicians, payors, and professional societies – to adopt the level of enthusiasm required to justify the next generation of the technology. It will also take time for the first generation of the technology to penetrate the market, creating a base of customers that will ask for and appreciate new versions. All funds raised should be used to achieve market penetration and general adoption with the device as it exists. There will time enough for advances after the technology becomes a ‘must have.’ Resources should be marshaled to protect against factors that cannot be controlled, such as delays in adoption and insurance coverage and the next pandemic, which will tax the organization to the limit.  

Steps to Fight Commercialization Fatigue 

To meet their needs for innovating, the development team could instead be provided with “free time” each week to explore, in a preliminary and low-cost manner, some of the ideas they will be developing down the road after the existing technology is generating a profit. This will keep them engaged, intellectually challenged, and excited for what is to come while preserving capital for when the time is right. But it will also send the message that the priority is to finish what they started, to ensure that the idea they are turning into a product is not necessarily all that it could be, but rather the best that it can be. 

In conclusion, the ability to maintain focus and commercialize a singular product is essential to the success for start-ups. Future innovation is important and necessary for the company’s long-term staying power, but it should be saved for post-market approval and incorporate feedback from the purchasers, users, and patients.  

Mark Carol, MD, is a senior consultant at the Focused Ultrasound Foundation.

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