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2006 Product Development and R&D MVP Award Winner: Kenneth Brown

Kenneth Brown. Senior Manager - Design Assurance, Boston Scientific Corp. was the winner of the 2006 Management Roundtable Product Development and R&D MVP Awards, an annual event recognizing excellence in managing product development. Finalists participated in structured interviews regarding their company's processes and measures. The interview discusses the role of leadership, the composition of teams, and the challenges of a world-class development organization.

1. Please describe how the R&D/NPD process is viewed and measured in your organization?

In general, BSC’s Product Development Process (PDP) has become additionally complex, more burdensome for project teams, and more expensive since its’ original inception in 1999. It is recognized that there are few barriers to the creation of new “value-added” PDP requirements – especially by well-intentioned functional leaders. Bringing LEAN new product development concepts to bear has driven critical review of the inputs to the PDP. It has also started to drive a cultural thought change throughout the organization; specifically, that reduction of waste (in all forms) is an important part of the PDP, and that everyone has a role in identification and actions to eliminate that waste.

In addition to the six LEAN PDP scoreboard metrics submitted in the original MVP application, there exists other organizational infrastructure to insure that PDP project activities are effectively and efficiently reviewed. Those include the following:

Project teams must report (typically monthly or quarterly) to the Project Investment Board (PIB). The PIB is a steering committee of ~ 20 senior, cross-functional leaders, and is charged with monitoring, approving, and/or canceling projects based on metrics and presentations by each team’s Core Team Leader (CTL). Each project operates under an approved PIB contract to deliver a specific product that meets specified performance requirements, timeline, and cost.

Each month the PIB reviews the following PDP project metrics (in addition to the LEAN PDP metrics previously cited):

-- Launches by Region
-- Project Impact (Anticipated Revenue, ROI, etc.)
-- Actual vs. Planned Spending
-- Spending vs. World Wide Sales
-- Project Spend Distribution (Labor, Inventory, T&E, etc.)
-- PDP Spend by Development Phase, Time-to-Market, and Milestones

How are R&D/NPD efforts linked to corporate strategy and success?

Prior to a PDP being presented to the PIB, a small group of strategic leaders (known as the Business Planning Team, or BPT) reviews all applications for project approval to insure that they are clearly linked to the larger strategic goals of the entire organization. This is a very different role then that of the PIB – as the BPT decides which projects will be pursued while the PIB administers those same projects to assure they are meeting the business intent as approved by the BPT.

Once the BPT formally approves a project, success of that project is formally attached to the yearly objectives of those senior leaders on the PIB. They, in turn, assure that those same objectives roll down to those in their respective functions that support those projects. PIB-approved projects have a significant impact on the year-end merit review and bonus process at BSC.

How has this played a role in what you have been able to achieve?

Once the BSC PIB began earnestly tracking the cost and time to develop projects within the PDP, it became readily apparent that product development was taking longer and becoming more costly with each new product generation. The desire to evaluate BSC’s overall PDP approach and reduce these costs was the impetus for the LEAN PDP Initiative. A business commitment to LEAN as a whole was the means by which I was empowered to achieve the changes I made to BSC’s approach to NPD.

How did you measure the success of your specific project(s)?

As part of LEAN PDP, all of my changes targeted either (1) an outright project cost reduction or (2) a project cost avoidance through anticipated labor, cycle time, and/or material inventory reductions. Depending on the focus of the LEAN project in question, one of these elements represented the most significant savings for that project. For labor reduction and cycle time reduction projects, quantitative customer feedback was also used as a measure of success.

2. You have described yourself as leading Boston Scientific’s LEAN Product Development Process and your role in such initiatives as Real-Time Aged Products, Normality Screening, Process Validation of Line Extensions, and LEAN Risk Management. Please explain your role in each of these initiatives, the issues you addressed, the steps/tools introduced, and the accomplishments achieved.

Real Time Aging Initiative

Role:
I was the primary driver on the Real Time Aging initiative. I brought it to Lean PDP Team and explained why this particular policy change would be excessively burdensome and expensive for PDP activities. I identified the root cause of this change as being a miscommunication with our notified regulatory body in Europe on a specific product. I setup a discussion with the applicable parties and straightened out the misunderstanding. With the approval of the senior management on the LEAN Steering committed, I subsequently changed the shelf life SOP to resolve the matter.

Issues Addressed:
The primary issue was that the newly released product shelf life SOP defined real time aging as being a nominal statistical condition. Historically, real time aging had always been treated as a limit statistical condition. By defining real time aging as a nominal condition, hundreds to thousands of additional aging units would need to be produced and stored (per PDP project) to safeguard against future normality failures during variable sample testing. This could then trigger the need for large attribute sample testing. Since aged product cannot be produced once the need is determined, large quantities would need to be built years in advance to protect against this scenario or expiration date validation requirements would be jeopardized.

Steps/Tools Introduced:
The steps I took were to (1) clear-up misunderstanding with our notified regulatory body in Europe, (2) educate the approvers of the policy change, and (3) build consensus around the changes and the need for the changes throughout the organization. The only “tool” or output of this effort was a new revision of the Shelf Life SOP with a revised definition of real time aging.

Accomplishments:
The accomplishment was the revised SOP which will result in millions of dollars of cost avoidance (see definition provided earlier in this application). This is due to the prevention of the need for thousands of additional product builds for shelf life testing across all product development projects throughout BSC.

Normality Screening Initiative

Role:
The Normality Screening Effort was a solo effort that I took on as part of the LEAN PDP Team. I received assistance in determining the overall project cost savings from Finance team members, and some statistical suggestions and document review from some of my colleagues with deep statistical aptitude. Otherwise, the approach, the policy, the justification and promotion of the approach were all developed and conducted by me.

Issues Addressed:
The primary issue I addressed was to develop a statistically defendable approach to permit variable data sets that vastly exceeded their normal-based acceptance criteria to be deemed acceptable even if they should fail current requirements for normality testing. This prevented non-value added work in the areas of further analysis and possibly additional product testing on these data sets. This ultimately resulted in significant labor and material savings and helped project teams better maintain their schedules.

Steps/Tools Introduced:
The steps I took were to (1) develop the initial strategy, (2) identify vulnerabilities to the initial strategy, (3) add safeguards to the initial strategy to account for the vulnerabilities, (4) promote and gain approval for the overall strategy, (5) thoroughly document the statistical justification for the overall strategy, and (6) develop a procedure and training to use the strategy.

Accomplishments:
The immediate accomplishment has been a divisional level SOP that has been very favorably received. This procedure has not only benefited PDP project teams, but also some sustaining engineering efforts on existing products as well. I have received considerable feedback on how the availability of this approach has greatly eased the burden of non-value added statistical analysis. Furthermore, the approach has now gained the respect of the BSC corporate statistician, who was initially opposed to permitting the approach. Plans are now in place to including normality screening along with some other statistical tools in the next revision of the company-wide Normality SOP.

Process Validation of Line Extensions Initiative

Role:
I was a co-leader on this initiative along with additional LEAN PDP team members from the Operations, Quality Systems and Process Development functional groups. We jointly developed a reasonable alternative to an existing burdensome approach. We then set about advocating this proposal to our various management groups. Agreement by Quality, Operations, and Process Development management was needed to implement the proposed change. Since Quality (my group) had the least to benefit from this change and was the original source of the burdensome approach, selling Quality senior management on the change was more difficult than the other two groups.

Issues Addressed:
The BSC Process Validation SOP called for conducting Limited Operational Qualifications (OQ) for all line extensions. This requirement was added at the time when BSC developed our first medical/pharmaceutical combination device, due largely to uncertainty of the product development approach in this novel technology arena. However, the requirements became very burdensome for product development teams, and offered little value to the finished version of the products in question. My team members and I successfully changed the requirement and replaced it with a requirement calling for better justification, showing that the proposed manufacturing line was equivalent to the original manufacturing line and then relying on the nominal Process Qualification (PQ) runs to demonstrate the acceptability of the replicated manufacturing line.

Steps/Tools Introduced:
The principal steps we took were to create the alternative validation approach and promote the approach to appropriate levels of management. Once management bought in the concept, the BSC Process Validation (PV) SOP was revised accordingly.

Accomplishments:
The primary accomplishment was the revised PV SOP. This change is saving thousands of dollars in labor time and material cost for projects and significantly reducing the cycle time for line extensions.

LEAN Risk Management Initiative:

Role:
I was the lone project leader on the LEAN Risk Management Initiative. My primary goal was to lean out the massive Failure Mode and Effects Analyses (FMEA) approach – a standard risk analysis approach throughout BSC - and to add some statistical rationale to better relate failure modes to clinical harms by assessing the occurrence of harm (e.g. likelihood of injury) instead of the occurrence of cause (e.g. likelihood of failing specification).

As the effort continued, many issues became apparent within the BSC risk management system. I soon realized that significant work was need to overhaul BSC risk management in it’s’ entirety in an effort to better align with critical regulatory requirements (specifically: ISO 14971:2003A). The current system was a “patchwork” of smaller initiatives that did not cohesively work together to truly manage risk. My lean effort on that existing system would have been little more than another patch. As such, with my recommendation, the LEAN PDP Director, in conjunction with Corporate Quality, decided to elevate Risk Management to a corporate wide activity. This resulted in radically increasing the staffing and focus of the effort in an effort to build a new, comprehensive risk management system (virtually from scratch) to fully meet regulatory intent, enhance the business and become an industry leader in quality risk management. I am still a core team member on this greater effort and will achieve my initial goals in the structure of the larger initiative. The new system is expected to launch business wide at the end of 2007.

Issues Addressed:
The initial issues targeted were FMEA inefficiency and needless risk elevation due to inadequacies in the risk analysis approach. The corporate risk management project is additionally targeted at driving better compliance with intent and spirit of ISO 14971:2003A as well addressing the lean items that I initially embarked upon.

Steps/Tools Introduced:
My initial steps involved evaluating BSC’s risk management system and proposing some changes while also addressing the original LEAN PDP concerns. Upon discovering problems with overall system (especially in terms of effectively managing risk through out the product life cycle), a corporate wide risk management activity was formed to deal with all identified issues. This effort has established multiple work streams to comprehensively address all aspects of quality risk management.

Accomplishments:
My primary accomplishment was in highlighting the problems with the current quality risk management system, and subsequently educating senior management to issues and consequences of these issues. With the creation of the corporate risk management team, I’m confident BSC will now have a comprehensive, efficient, valued-added, integrated and fully compliant risk management system at the completion of this activity.

3. What motivated and inspired you to drive these particular initiatives?

As a Quality Engineer (and then Manager) and working in product development for many years, I witnessed the creation of all of these burdensome approaches and experienced the anguish they caused as teams did their best to carry them out. I understood the thought process behind their creation. I also knew there were better ways to address these situations. That said, until the creation of the LEAN PDP team, a platform to advocate significant change didn’t really exist.

While I knew these burdensome approaches were costing the company unnecessarily, I was more motivated by the frustration of engineers. These burdensome approaches caused engineers to work longer hours than they should have and, in some cases, were part of the reason some very good people left the company. LEAN PDP has given the entire BSC engineering community hope that things are improving for the better!

As a manager, more than anything, I wanted to show I understood and cared enough to take positive action once I was empowered to do so as part of the Lean PDP Team. I’m particularly energized when an engineer I don’t know, recognizes me and thanks me (as one example) for initiating the LEAN Normality project, and tells me how it has helped him personally. To me, more than anything, that it what it is all about!

Our newly released corporate-wide quality policy is “I improve the Quality of Patient Care and all things Boston Scientific.” To improve quality, we need not only to strive to do our very best on activities that are value added, but strive to remove non-valued added activities that distract from the quality mission. All of these motivations were my inspirational for me on these particular initiatives.

4. Since product development is a team sport, please tell us what the team was like and why it succeeded.

The team is composed of cross-functional members that have both multi-project experience and also have the vision, creativity and motivation to both educate and drive action against the inertia of current business processes that are in place. There is a broad range of experience – from mid-level engineering to Sr. functional managers. Our team was comprised of both full time LEAN and ‘part time LEAN support.

Who were the key players? Did you add/delete team members along the way?

The Lean PDP Team consisted of cross-functional members from Process Development, Manufacturing Engineering, Industrial Engineering, Research and Development, Training, Project Management, Quality Technical Writing, Quality Design Assurance, and Quality Systems.

Team members were both added and deleted - for many reasons. Our team members had dual roles (both sub-team members and sub-team leaders) – and everyone on the team had to be skilled in both areas. Most times this occurred with a good balance, but sometimes not – this unique dynamic has driven some team member changes. Other team changes were driven by the functional support model used by some functions (affecting part-time members more), and also by particular areas of focus of the LEAN team.

5. How did you go about building organizational support around your program? What was your biggest challenge in doing this? What was your biggest success? What were the major lessons learned?

Consensus building was a big part of all of my initiatives. Many of the initiatives were initially opposed by those responsible for the functional and/or project areas each initiative addressed. Overcoming these objections was by far the biggest challenge.

My biggest success would have to be turning hard skeptics into advocates on the LEAN Normality project. Both the corporate and site level statistician were initially opposed to my normality screening approach. I worked diligently to strengthen those relationships and move them to the point where they were willing to pilot the approach. Six months later they have both embraced the approach and are working to make it available corporate wide.

The major lessons learned were about consensus building. Specifically – how to identify your opposition early and working with them to win them over or (at the very least) acknowledge their concerns and contend with them. A particular lesson learned is discerning between what people say and what they really mean.

Case in point - A certain stakeholder within the LEAN Shelf Life activity initially indicated their opposition to defining real time aging as a limit statistical condition was due to a regulatory concern. However, even after all of the regulatory concerns were addressed, this individual continued to oppose the change. Working through their real issues took considerably longer. In the future, I will strive to be more intuitive in determining whether they have disclosed all of their concerns. I will do so by attempting to get conditional agreement that if the stated concern is resolved, we have agreement. If not, the full agenda can subsequently be scoped and addressed as part of the initiative.

6. What obstacles stood in your way and what did you do to overcome them?

As covered in the previous question, consensus building was by far the biggest obstacle to overcome. See the answer to that question for details.

7. What are you most proud of?

I am most proud of being able to affect positive change in the way BSC does product development. I have felt an empowerment throughout this process that is starting take hold across the product development workforce. A real cultural shift is occurring, as is evidence by more people talking about and thinking of LEAN as more of a common point as opposed to an initiative “buzzword” they feel they need to know.

What do you feel has contributed the most value to your organization?

The educational element of the LEAN PDP team and its’ leadership has led to the constant communication of outcomes that various functional areas and teams are having now as a result of aggressive waste reduction. It is now widely accepted that waste reduction is everyone’s role – this is not a common occurrence, especially within the medical device industry (where naturally high gross margins often allow for inherently wasteful product development approaches).

8. What are your next steps (i.e. will you be building on your earlier efforts, or are you now tackling new challenges)?

My next steps are to concentrate on the corporate risk management project (mentioned earlier) to enhance and lean out our quality system and add value while simultaneously improving patient care.

Most of the LEAN PDP Team was reassigned to FDA remediation efforts (due to a corporate warning letter) in March 2006. Up until recently, the challenge was keeping LEAN alive and continuing to pursue LEAN projects that were in motion. BSC remains highly committed to the LEAN product development philosophy! Next steps include adding a couple of new full time LEAN team members (new positions) and to change our focus from LEAN projects to working specifically with all our project teams on execution of LEAN tools. These tools are all targeted to drive waste reduction at the base project level – subsequently increasing time for team members to execute their project tasks.