Originally Published MD&DI June 2009
Insights
30 Lessons Learned
Industry veterans share some insights based on their years of experience.
Bill Hawkins, Chairman and CEO, Medtronic
1 Core Values. Discipline. Respect. Duty. These are deceivingly simple concepts that seem to recommend themselves to everybody, but are practiced consistently by few. Having been taught these values at an early age, they have played a role throughout my career in medical technology. From my first sales position to leading a great company like Medtronic—I’ve never found a replacement for core values like perseverance and loyalty.
2 Thinking Differently. Like other high-tech industries, the medical device field requires that we think differently: boldly, creatively, and unconventionally. Challenging norms and assumptions is requisite in order to push the innovation envelope as aggressively as possible. Push hard—and then some. Don’t ever stop. When we get too comfortable, we lose our edge and fail our customers.
3 The Patient. The Patient. The Patient. I strive to stay focused on the patients we serve—no matter how challenging or difficult running the business may seem. There’s no better way to maintain the passion required for success than to believe in what you can do for your customer. In medical technology, it’s simple; it’s the patient. The moment I feel the balance shift away from the patients, who are the ultimate beneficiaries of our products and services, is the moment passion wanes, productivity decreases, and business begins to suffer.
4 Innovation. There’s a belief in some business circles that in challenging economic times, the best companies double-down on marketing in order to win share from competitors. This may be true, but I believe it’s even more important to double-down on innovation—the science, research, and development behind the new products and technologies that change how healthcare is practiced across the world. Innovation is our lifeblood—and nothing can replace its importance.
5 Technology = Value. Technology for technology’s sake is never our goal. A cool gadget may dazzle the eye, but developing truly useful technology to help physicians solve a practical problem provides value and drives market-leading performance.
6 Strive to Discover the Entrepreneur in You. Companies frequently lose their compass and the passion of the entrepreneurial spirit. In our industry, it’s critical to stay on the edge of technology. I always think about the future and what medical device advancements might do. What’s more, I retain the best engineers and physicians on staff who will share their own visions with me on a regular basis.
7 Family Matters. My greatest sense of pride in my career has been doing what I do each day with my family in mind. The work I do enables many people, including both my father and father-in-law, to enjoy full lives.
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8 Have a Mission. Medtronic’s mission is nearly 50 years old and has served us well through both good and difficult times. Every company should have a mission to guide its purpose and serve as a reminder of why it exists and who it serves. We all should have individual mission statements as well, to ground and guide us through thick and thin.
9 Live a Little. Working to alleviate the chronic disease burden around the world is serious business. That said, take some time to live a little and remind yourself of the kind of life you want the patients who use your therapies to have. This reminds you that you’re not just saving lives—in many cases you’re enabling better quality, livability, and happiness for those lives.
10 Give a Little . . . Or a Lot. I can think of few better ways to measure one’s success than by giving back and giving back often. Those who do will know the powerful and invigorating sense of purpose and satisfaction that comes from helping others and be humbled by the gratitude expressed in return.
Edward Ludwig, Chairman and CEO, Becton, Dickinson and Co.
11 Right Person in the Right Job. If you have the right person in the right job with the right strategy, your chances of success are very good.
12 Know the Customer. Success in business is less about asking customers what they want but all about discovering what they really need.
13 Develop Talent. Leaders in every organization must first see themselves as teachers and developers of the outstanding talent within their organizations.
14 Live by Your Values. The most successful organizations are the ones that live by their values and are devoted to their purpose. Leaders must teach this by their example—the way they work and live.
15 Implement Healthcare on a Local Level. Healthcare is a global industry, but very much managed and implemented on a local level.
16 Transparency Is Key to Success. The United States has a precious resource in the form of our medical technology industry. It is a source of value for the whole world . . . helping people live healthy lives. We must ensure its continued success by developing and maintaining the most effective and transparent reimbursement and regulatory systems in the world.
17 Reduce Healthcare Costs. We can provide more access to outstanding healthcare services to all people if we address the enormous costs associated with waste and errors in our system. We must focus on prevention, screening, early care, and fundamental health. If we do this, we can expand access and lower overall costs.
Wayne Taylor, Chairman, Taylor Enterprises
18 Training Should Focus on Tasks—Not Tools. Teaching someone to use a control chart and Pareto chart and then asking them to set up a trending system is akin to teaching someone how to use a saw, a tape measure, and hammer and then asking them to frame a house. I wouldn’t want to live there.
19 Compliance Is the Result of Good Systems, Rather than Good People. I graduated with a PhD in statistics and yet I had never heard of a control chart or sampling plan when I started to work at Baxter more than 30 years ago. Most engineers start their first job having never taken a course on statistics. Most designers also start their first job without ever having taken a course on designing products. Even though we are all good people, just hiring good people doesn’t ensure compliance.
20 Identify the Root Cause. No matter how well a corrective and preventive action (CAPA) system is designed to track and manage CAPAs, without the ability to quickly, efficiently, and correctly identify the root cause, the system will perform poorly. The secret is to think like Sherlock Holmes: “When you have eliminated the impossible, whatever remains, however improbable, must be the truth.” By eliminating possible root causes using hard data and facts, the solution will be found. Focusing too much on confirmatory evidence is the error that Dr. Watson makes, which at best leads to a weak circumstantial case.
21 Focusing Too Much on Being Compliant Is Detrimental. Focus instead on producing designs and processes that consistently produce product that meets customer needs. As one is doing this, ask: “How do I know it will work, and how will I ensure it continues to work?” Of course, make sure to document all of these activities.
Andrew Dallas, President and CTO, Full Spectrum Software
Over the years we’ve had the good fortune of working on an incredible variety of medical and diagnostic products. These range from pulse oximeters to deep-brain stimulation systems. During that time, we’ve learned a few lessons that help us to better serve our clients and ultimately patients.
22 Clear Requirements. One of the primary reasons projects fail is because software requirements were not well defined and therefore not understood by all stakeholders. Part of our quality control occurs in a requirements review meeting. In this meeting both the QA and development team should participate. This is a quality review and QA must have visibility into this process. There can be variations on this process, but for each item you should ask the questions: “Is there anything in this task or feature that is ambiguous? Does everyone understand exactly what this task means? Can it be verified and mapped to a QA traceability matrix?” It is important to note that for a requirement to be verifiable, the QA team must be able to describe how it will test the feature, what the test criteria or protocol will be, and how to define success and failure of the requirement. If QA can’t describe how they will test a feature, it is not clearly defined.
23 Test Early, Test Often. We have seen so many projects that were described as “90% complete,” but which, in reality, were miles away from being done. In software engineering, it’s easy to make a product look done when in fact there is a substantial amount of work to do to complete it. With little or no testing, a product can look “feature complete” in very little time. This false sense of completion is what happens if software developers are allowed to continue writing code without first testing their own work and then allowing the QA team sufficient time to complete their testing. A successful software project is built from the ground up, on a rock-solid foundation of thoroughly tested software modules. Although developers enjoy writing code and making things work, they are generally less enthusiastic about testing all of the boundary conditions on the code that they have just completed. Mature software processes are inherently test driven. Developers understand that before they release their code to QA, they must test every line and every function. Only then can they move on to their next coding task.
24 Work Incrementally. All software project tasks should be broken down into small subsections or modules, which are sometimes called logical work units. By defining software tasks down to this level of granularity, it allows experienced software teams to see where there may be code that could be used in multiple places (reusability). It also allows the team to quickly and easily measure progress.
25 Prioritize. Most software projects have critical features that often represent the most complex aspects of the project. In addition, they often have features that would be desirable, but could be added in a later release. Good project planning addresses those critical features first. Once the critical areas of the system are completed, desirable features can then be prioritized and added depending on budget, time to market, and other external factors.
26 Reduce Risk by Hiring Highly Experienced and Exceptionally Talented Engineers. Writing software for an FDA-controlled project is no place for youngsters straight out of college with a freshly minted computer science degree. With proper mentors assigned to them, young engineers can make minor contributions. Exceptional talent is expensive, but not nearly as expensive as missing a window of opportunity for a perfectly timed product launch. In addition, the cost of fixing bugs grows exponentially higher the closer the project gets to completion. Fixing bugs in the field is astronomically expensive. Finally, a product recall can ruin a small company. A large company can lose significant market share to a competitor that will be enormously expensive to gain back. It’s far more prudent to utilize the most experienced, most talented—and frankly the most expensive—software teams to design and build new products or new versions of existing products. Less-experienced (and less-expensive) engineers can then be used for sustaining engineering and maintenance throughout the life of the product.
27 Maintain a Great Relationship by Communicating Effectively. A good working relationship based on effective communications and professional respect is a huge asset when problems arise. In any software project, it is not a question of whether difficult problems will be encountered, it is merely a question of when. Working toward a mutual goal of resolving issues and being successful is far more productive than bursts of angry e-mails or unprofessional heated discussions. Establishing professional guidelines for appropriate communications, proper project management, and building a team based on professional respect is essential in creating a high-performance team.
28 Process Doesn’t Guarantee Performance. An organization may feel it has a bulletproof process for development, but it will only work if everyone is following it. Trust that people are following your quality system but verify that procedures are being followed. Periodic quality audits are very effective and should be performed on a regular basis. When all of the development teams know they will be audited at least once per project, it virtually ensures that quality systems will be followed. Ensure that project managers routinely verify that procedures are being followed.
29 Identify Risks. At the earliest opportunity, identify the critical risks of a project. Ensure that you have a strategy to address them early. This is simply a matter of professional project planning. Identifying risk factors is a process that is done during the project design and planning stage. Again, experienced software teams will recognize risk factors almost the moment they see them. They are trained to identify risk early. If a component of the system is critical to the project’s success, it is far more prudent to develop a strategy to address those risk factors early in the project, rather than wait and deal with high-risk or high-complexity issues late in the project.
30 Use the Best Tools You Can Afford. Working with freeware or open source tools can be a terrific way to save initial investment dollars. However, if that tool is less productive than a commercial tool, over time, the cost of the “free” tool will be realized in slower time-to-market and employee satisfaction. Identify where tools are costing you time and frustration and decide whether there’s room for improvement through investment. Open source tools are fine for prototyping and proof of concept, but FDA-controlled software projects should never be developed in an open source environment. If you are developing professional software, use professional tools.
Copyright ©2009 Medical Device & Diagnostic Industry
