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Why do some orthopedic companies drive greater market share and higher return on R&D investment? In simple terms, it’s likely a factor of delivering the product to the market at the right time and tackling crucial steps during product development. But how does a company properly execute those initiatives?
Doug Billings, the Managing Director of Deloitte’s medtech practice, has advice. Billings has worked in medical device consulting for most of his career, advising companies and performing analysis across the sector. He previously authored a study based on benchmarking data collected by Deloitte and AdvaMed that looked at what high-performing medical device companies are doing differently during their innovation and product development (I&PD) process. The study measured benchmarks like predictability and revenue contribution to understand better I&PD performance at 20 companies.
When asked about the essential best practices that orthopedic device engineers and product development decision makers should be paying attention to the most, Billings split his recommendations between historical tried-and-true best practices and what he called a “new wave” of rules. The emerging best practices he highlighted are driven by digital technologies that are changing the innovation and product development landscape rapidly.
Traditional Best Practices
Companies that follow basic principles of research and development often succeed. Among these best practices are planning and preparing properly, allocating the right resources and retaining steady leadership.
Properly Plan
Companies that perform due diligence on the market landscape and product development roadmap are often more successful. These companies prioritize proper preparation that ultimately leads to speed to market.
“One of the things that was very consistent in our benchmarking data was that investment upfront in market and technology understanding pre-full development and pre-design controls pays off with faster cycle times, faster productivity and more innovative products,” Billings said.
Billings noted that many medical device companies struggle to thrive in I&PD due to an overeagerness to jump into development activities without forming a comprehensive understanding of the market needed to de-risk the feasibility of their products.
“Every time I’ve done benchmarking and with every client I’ve ever worked with, that upfront time and energy pays off downstream enormously,” Billings said.
Allocate Resources
Intentional resource-focusing is another historically proven vital best practice of high-performing companies.
“In a medtech company, R&D is the dominant function, but the rest of the functions––quality, regulatory, clinical, commercial––all play a critical role in innovation and product development,” Billing said. “It’s a very cross-functional activity. A lot of times, some of these other functions don’t have focused resources to support innovation and product development activities, and they unintentionally become bottlenecks.”
Billings argued that when product development teams are forced to wear multiple hats, their work ultimately suffers. Focusing resources allows engineers and managers to thrive in their roles instead of going “back and forth” to put out fires and address issues that would be best handled by other teams.
Maintain Leadership
Consistent leadership throughout the commercialization of a product plays a critical role in the day-to-day decision making and, ultimately, market success.
“You have a lot of situations where innovation product level projects for medtech companies might take two, three, four years to get to market,” Billings said. “If there’s a new business leader every two years, there’s really an inconsistency between the decisions made by new leaders and a commitment to the pipeline. And if you have programs midstream, that just throws a lot of sand in the gears. So, decision effectiveness is really key.”
Emerging Best Practices
After sharing traditional best practices, Billings pointed to emerging best practices in I&PD. These practices are linked to ever-advancing digital technologies.
Embrace Digital Tools
“It’s using things like simulation process automation and AI,” Billings said. “These technologies do really change very significantly how we do innovation and product development. So, instead of the ‘make it and break it’ kind of a product development where I design a prototype, test it, and then learn from that experience before going back and redoing it in the physical world, it’s doing more things in the digital world.”
Not confined to just simulating product designs, Billings said digital simulations are now assisting teams with everything from complex customer problems to large clinical trials. The main impact of incorporating digitally-driven simulations into a medical device company, Billings said, is faster results. While he cited perceived regulatory issues as barriers that once might have kept companies from adopting AI and digital simulation technologies, Billings credited FDA for launching programs aimed at accommodating the trend.
According to Billings, the pandemic has accelerated I&PD trends that were already well underway, such as medical device engineering teams opting to integrate digital simulations in their research of specific customer problems, for example. Some trends have been somewhat predictable, like the broadening acceptance of telehealth on behalf of patients and medical experts. But others were less expected, said Billings.
Collaborate Virtually
COVID-19 gave rise to what Billings called “distributive engineering,” the trend of socially distanced engineers bringing inexpensive 3D printers home, tinkering with designs, and collaborating with their colleagues from afar. “That was something that no one would’ve ever thought to do pre-COVID. But now it’s a thing that can be done and the systems that are available.”
Billings pointed to the industry’s increasing emphasis on digital products as another trend accelerated by the pandemic. “It’s the recognition of the need for connected data––the data about somebody’s health as well as data about their sickness and the ability to do things virtually.”
Think Beyond the Hospital
While the pandemic caused patients, physicians and engineers to adjust to getting more done at home, Billings said that alternative sites of care have boomed in recent years and will continue to play a role in I&PD.
“The U.S. government under the prior administration was already making a lot of moves to foster this movement through reimbursement and regulation, things the current administration have kept so far,” Billings said. “COVID put an accelerator on that.”
According to Billings’ research, over the past two years, patients in need of medical care have avoided big hospitals and searched for healthcare environments that are smaller, more controlled and more convenient.
“Now, companies are saying, ‘Hey, we’ve got to think about how our products need to change to be in those care environments. How do we service those care routes, and how do we provide products for those care environments?’ The government changed how it’s doing reimbursement for orthopedics, and hips and knees and all these kinds of things that used to be in the hospital only can now be performed at alternate sites of care. The fastest growing segment of ambulatory surgical centers is orthopedic procedures. So, how we had to sell to these organizations is totally different, how we engage with them. Their products may need to be adjusted––not their implants necessarily, but the robotics and the other things that support implants. COVID significantly accelerated this already existing significant trend.”
Steps to Move Forward
Orthopedic device companies don’t need to recreate the wheel to succeed in getting a product to market. Following traditional best practices and emerging trends can help a company execute on innovation and product development.
