Innovative Approaches to Medical Device Development, Part Three

It drives the creation of product value, competitive advantage and true impact in the market—impact that ultimately saves lives or significantly improves the quality of care for patients. Basic innovation, let alone high-performance innovation, remains elusive to many companies. The intense complexity of today’s medical devices and the dynamic ambiguities of product development often can lead to disappointing results if the right environment is lacking or if teams stumble due to miscues in the process of innovating. However, when the environment is right and a combination of second order activities are implemented, high-performance innovation can be achieved.

This article is the final in a series of three that outline the foundation, framework and tangible actions a company can take to turn innovation into competitive advantage in the marketplace. As previously discussed in the September/October (2011) and January/February issues of Orthopedic Design & Technology, the foundation for an innovative organization is built on getting the basics right and understanding the classic pitfalls to success. Only then is it possible to turn on the high-performance innovation engine by thinking differently and acting deliberately to achieve high-performance results.

Thinking Differently, Acting Deliberately
The first two articles of this series discussed having the right people, structure and culture as well as understanding threats to these basics in order to have the fundamental innovation capital to drive success. Realistically, these provide for a controlled and predictable environment to innovate from. Controlled and predictable may seem foreign when discussing innovation, but remember the point of the process is to deliver (emphasis on deliver) value to customers, patients and shareholders. Creating a high-performance innovation environment does not happen overnight. It takes time and patience. However, once in place, it sets the stage for implementing methodologies that will take the organization to the next level. Without this environment, teams typically are in firefighting mode, dealing with pitfalls or struggling with basic missing elements of innovation. Getting the right environment in place first allows for different thoughts and behaviors which create high-performance results.

Fully Informing the Innovation Process
Although fully informing the innovation process seems obvious, this activity needs to be taken much further than the basic structural processes outlined in the previous articles. One of the first high-performance innovation activities of any successful project is active participation by all stakeholders with an eye on the entire development life cycle, a clear vision of the desired clinical outcome and acceptance of a certain amount (even a significant amount) of ambiguity. The key to this activity is ensuring comprehensiveness in the makeup of the team, having the right voices to inform the process and a full understanding of the entire flow of development.

Comprehensiveness of the team is dependent on the innovation ecosystem of any particular company. Very few companies these days are vertically integrated when it comes to their innovation ecosystem and often exclude robust customer touch-points and the voice of the patients themselves. This ecosystem includes all internal functions (such as marketing, research, engineering, sales, quality, clinical, procurement, manufacturing, distribution and service) as well as those functions provided by external partners. This ecosystem also should include thought leaders, education institutions, industry trade organizations and like-minded, non-competitive peer companies with common interests. Buried in this activity is a healthy, well thought out and understood ecosystem that nurtures ongoing collaborations of stakeholder members throughout current and future innovation initiatives.

Visualizing the entire flow of development requires building on the basics of an experienced and socialized team. This is a collaborative effort and needs all development stakeholders to discuss the integrated and interdependent aspects to achieve the expected clinical end point. This collaborative visualization brings to light the ambiguities, risks and gaps in knowledge that will be encountered during the project. Because of the experience level of the team, they will be able to see past these challenges based on previous program work and develop a schematic or framework of the entire effort. From these ambiguities come, at minimum, the establishment of critical path activities, priorities and contingencies. And, if fortunate, unexpected opportunities for strategic differentiation, breakthrough clinical results or performance optimization will become apparent.

Since there is a lot of planning, thinking, communication and requirements-definition with few hard, tangible results, this part of high-performance innovation can be hard on management patience and attention span. However, this exercise comes with the previously-mentioned opportunity for discovery as well as the tactical upside of a focused, coordinated and efficient innovation life cycle. Throughout the life cycle there should be continuous, coordinated input from these stakeholders as the ambiguity and challenges are overcome and opportunities are incorporated to converge on the most innovative solution for the market.

Innovation Decision Optimization
Once the above process is implemented and individual critical path activities are addressed, the next high-performance activity is optimizing innovative decisions throughout the life cycle. This requires a consultative, systems-based approach to each of the ambiguities, gaps, risks, challenges or decisions needed as discovered during the informing process. This approach assumes that all value creation is unlocked by solving each of the above issues in new and novel ways. There will be multiple solutions each with interdependent cause and effect results that, based on the priorities set during the informing process, will result in different levels of value creation. Again, great people who are very experienced, with diverse backgrounds, are socialized, and communicate actively, are critical to the exploration of solutions and final selection. These key contributors are capable of visualizing product architecture, usability, technical, clinical, manufacturing, serviceability and other business aspects. They are able to weigh different solution options and provide differential analysis to make the optimal decision to move forward. Making decisions without fully informing the effort—or simply solving an issue and moving on without this type of analysis—assures unintended, late consequences or, at best, a mediocre product offering.

Decision optimization also requires the continued engagement of the original stakeholders who initially informed the process. This group of stakeholders needs to be stable throughout and will be needed to continually inform the process while the dynamics of development, market conditions and competitive moves constantly change. This continual evaluation often will reset priorities or change the intended performance end point, which in turn will influence decisions moving forward, eventually converging in the optimal set of innovative decisions.

Innovation Life Cycle Facilitation
Having a progressive life cycle management—or better yet, “life cycle facilitation”—philosophy solidly in place is the next high-performance innovation activity needed. This requires executive management to provide the infrastructure, tools and work environment for people to work at the top of their abilities. Examples include an organizational structure that fosters communication, readily available human resources and transparency of successful behaviors. Further, a culture of innovation that mutually is supportive, collaborative, celebrates victories, and shares a common vision or values is key. All of these requirements are needed to facilitate the highest individual performance within the innovation teams and within the curbs of the scope of the company’s business.

In addition to these requirements, a mature program management function is needed beyond the basic process elements discussed in the first article. Obviously, hard project management skills are needed to estimate and track progress against running costs or schedule milestones or task deliverables.
However, these skills typically are exemplified by looking in the rearview mirror and then deciding which way to drive. It is the soft skills that executive and project management teams need most to drive high-performance innovation: soft skills that are forward-looking—anticipating and recognizing roadblocks or pitfalls that are looming—while the innovation team is busy with the daily knitting. The results of this reconnaissance are used to remove obstacles or make the team aware of approaching hazards so as to adjust accordingly. These soft skills also include coordination of the above two high-performance innovation activities to help set the natural tempo of the innovation team and to disseminate the information flowing from all stakeholders. Most of all, these soft skills facilitate communication, communication, communication—formally and informally, internally and externally, as well as horizontally across the innovation ecosystem. It is by active facilitation of these high-order, high-performance activities that innovation delivers on its promise to maximize the potential impact to people’s lives and ultimately can be judged a success.

Unlocking High-Performance Innovation Potential
The high-performance activities presented above bring together the essence of taking innovation to the highest levels. Mastering innovation is a never-ending pursuit and especially elusive in the complex world of medical device development. Like any team sport, getting the basics right, anticipating trouble prior to impact and plenty of practice help consistency in performance. Also like any team sport, continual improvement and picking the right team members are critical to achieving expectations, potential clinical relevancy and success in the marketplace.

If your organization is struggling with innovation, take a step back. Today is the day to ensure the basics are in place and that everyone is clear on recognizing the threats to an innovative environment. If your organization is ready to take it to the next level, then today is the day to ensure your innovation ecosystem is what it should be and to start practicing the high-performance activities captured herein. If you take these steps to further your innovation capital, you are one step closer to improving the quality of care for someone suffering from a chronic disease or one step closer to saving someone’s life from a tragic accident. Then, indeed, can these innovative efforts be counted as a true success.

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 Product Development LLC 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 at the University of Washington, University of Oregon and Rochester Institute of Technology. Prior to joining Stratos in 1994, he was a consultant in the aerospace industry and an engineer with United Technologies Corp.