Innovative Approaches to Medical Device Development, Part One
Medical device development is one of the most rigorous business activities a company can undertake. Development is an extremely variable, highly dynamic process—especially these days, with higher-complexity medical device solutions, an ever-changing and demanding regulatory environment and a cost-conscious healthcare marketplace. Success can be a seemingly elusive goal, but successful projects have common elements (and complete failures do, too). These challenges demand high-performance innovation from companies not only to survive but to prosper in the current worldwide economic climate. It can be tempting to take a leap and try to achieve optimal innovation quickly.
However, prior to this leap, the creation of a strong innovation foundation and the building of a solid framework to support second order activities is absolutely crucial for long-term success. This article is the first in a series of three that outlines the foundation, framework and sustainable actions a company can take to turn their innovations into a strategic competitive advantage. This installment will cover the basics of new product development.
Product Development 101
Determining the viability of an unmet market need and establishing the clinical end-point to achieve successful patient outcomes is just the beginning of the process. The sheer number of stakeholder voices (such as physicians, nurses, patients, technicians, hospital administration, insurance companies, regulatory, etc.) that inform the product requirements can be daunting. The current volatility of U.S. Food and Drug Administration (FDA) guidance for new innovative solutions, the labyrinth of reimbursement codes along with changing insurance landscapes, and continued downward pressure on all healthcare costs make for significantly uncertain go-to-market strategies.
Combination devices are a prime example of a product category facing each of these challenges. Simply determining if the product is considered a drug or device is a lynchpin to many of these aspects which ultimately may be determined by basic architectural or system configuration decisions that address other usability, functional or business needs.
And if that wasn’t enough, development, by its nature, is a highly variable process with continuous cost-performance tradeoffs, schedule pressures and technology maturity challenges which all become even more volatile as the market and competitors shift over long development life-cycles. This volatility makes for the good, the bad and the ugly projects we see over our careers. Simply stating one is innovative (repeatedly), reorganizing into innovation silos or bringing in the consultants to put innovation management tools in place will not suffice. Additionally, most organizations these days try to instantaneously become high-performing innovators overnight and then are surprised when, a couple of months later, they return to management reporting no tangible return on this investment.
Given all of this, success by any measure can be a moving target. But, there are patterns inherent to those who are successful innovators and those who are not.The first attribute to success is creating a foundation where innovation can take root and success can be cultivated.
Start With the Basics: People, Structure and Culture
First and foremost, keep it simple. Too many companies try to emulate high-performance
behavior prior to getting the basics right—basics that create the foundation necessary for consistent success and truly innovative solutions. Companies that focus on getting the basics right first have a far better chance of avoiding drawn out schedule slips that wear management patience and ultimately destroy value creation. Additionally, these basics help avoid project crashes that have tremendous project costs from both a financial and human capital perspective. This is seemingly obvious but surprisingly overlooked or completely undervalued as the foundation.
Excuses for not focusing on the basics range from “we’re too busy,” “we’re experts and know
what we’re doing,” or “it’s just boring, let’s get on with the innovative stuff.” In some cases, companies simply skip elements of the basics because they are saturated with the day-to-day demands of the business. In these instances, it ultimately is better to slow down and get it right the first time to gain greater efficiency in the long run. Success at any company is born from the basic foundation that includes an organization’s people, structure and culture.
Team: It’s AllAbout the People
Great innovation comes from great people—period. There is no substitute for a competent, diverse, experienced, socialized and motivated team. All the process in the world is no replacement for a highly competent team. Process is critical. But, for example, to confuse a good quality system with good design surely will land a company in an on-market adverse event. Experience and diversity are obvious additional attributes. When you find it, be sure to hire and retain this talent; it is your most strategic advantage. Socialized and motivated are less obvious traits and have somewhat different meanings to different organizations.
Socialization comes from collaboration and team interaction on a daily basis during a long period of time. For instance, walking three cubes down to discuss an issue face-to-face rather than sending an email is a clear sign of social intelligence.
Motivation comes from the opportunity to work on engaging projects with other people that are as good as or better than they are themselves while being provided everything necessary to successfully perform at the best of their abilities. Management needs to understand this motivation attribute as key to the innovation process and hire accordingly. Complex compensation plans have their place but will never provide long-term motivation that results in the expected success as enabling someone to achieve their own personal potential.
Capable, socialized and motivated individuals are essential to forming a true culture of collaboration, which is imperative for success. The best people create the best products.
Process: Without Structure There is no Success
People absolutely are irreplaceable, but without structure a team never will get to the finish line or perform at the best of their collective abilities. Having the right processes in place contributes significantly to efficiency, safety, and eventual successful introduction of innovative solutions to the market. Conversely, the lack thereof is a significant contributor to failure. Using the best practices and having new product development process discipline are key attributes for any organization.Hierarchy or heavy-handed bureaucracy will kill innovation quickly. Organizing in flat, cross-functional teams made up of a diverse group of people will help foster creative problem-solving and generate efficiencies in communication that speed development and reduce risk.
Additionally, simple-to-implement processes for market/user needs-assessment, requirements-definition, risk analysis, ongoing project issue resolution, visible scheduling with progress monitoring, highly iterative development cycles and project management all contribute to successful innovation. However, most unsuccessful projects are missing a majority of these elements or have dysfunctional implementations of these simple processes. By contrast, a good process—combined with talented people—creates fertile ground for the fruition of innovative solutions.
Collaboration: CultureDrives Performance
Culture is the secret of all great, high-performing teams and truly innovative solutions. It is the most intangible aspect of the basics. It is difficult to quantify a culture’s influence on innovation, and there is no formula. However, it is glaringly obvious to users, thought leaders, and competitors when a company’s culture has risen to produce excellence. Gauging culture requires understanding the current and future vision of what is internally meaningful to the company. It also involves constantly taking the temperature of the organization to challenge and adjust norms or assumptions along the way as needed. For medical companies, part of this meaning is inherent with being in the healthcare continuum. For instance, meaning might be partially captured in a company’s mission statement to save lives, to better patient clinical outcomes, or to improve the quality of life for someone with a chronic disease.
A culture that positively influences innovation includes a highly diverse set of key contributors and support for individual risk-taking, motivated by achievement and an extreme focus on the details. A culture like this is individually empowering and self-reinforcing. Culture changes over time, albeit slowly, and is the culmination of many small, subtle actions by management and grassroots influence. While subtle, intangible and sometimes mysterious, the underlying culture of an organization can mean the difference between just getting the job done and creating a solution that embodies an optimal product offering. Most of all, it actually might mean the difference between the life and death of a patient. Building culture takes patience and requires leadership by example. However, once built, the returns on this investment precipitate a real difference in value creation when it comes to the success of a product in the market.
Foundation Complete:Next Steps
Great people, a supportive structure and a culture of collaboration embody the foundation for the evolution of truly innovative solutions. With this foundation in place, the framework for consistently achieving and sustaining innovation can be implemented. The second and third articles to follow in this series will cover the next steps for an innovative approach to medical device development. The threats that typically challenge teams and put project success at extreme risk will be explored. Then, further opportunities to add second order high-performance activities to the basic foundation will be presented.
Design professionals and organizations that ensure the basic foundation is firmly in place next can focus on insulating projects from threats and adding high-performance elements to development efforts. The reward will be optimal innovation, product excellence and ultimate success in the marketplace.
With more than 20 years of experience as a business manager and engineer, Sean MacLeod is an expert in systems engineering, product strategy, new product development and venture starts. He is an evangelist of progressive product management practices. After holding positions in engineering, business development and marketing, Sean was appointed president of Stratos in 2004. He is a board member of the Technology Alliance in Seattle, Wash., and an active member of the Washington Biotechnology and Biomedical Association, Washington Technology Industry Association and several national entrepreneurial networks. He holds an MBA from the Foster School of Business at the University of Washington and a BS in Mechanical Engineering from the University of Massachusetts, Amherst. He regularly lectures for Business and Engineering programs including those at the University of Washington, the University of Oregon and the Rochester Institute of Technology. Prior to joining Stratos in 1994, he was a consultant in the aerospace industry and an engineer with United Technologies.