Why convergence in agile and health care is driving the hottest PM jobs!



In November 2010, the Healthcare Information and Management Systems Society (HIMSS) acquired the Life Sciences Information Technology (LSiT) Global Institute to create Good Informatics Practices (GIP) that can be universally applied. Think of the GIP like A Guide to the Project Management Body of Knowledge (PMBOK® Guide)—Fourth Edition, (Project Management Institute [PMI], 2008). It is a “guide” developed by a team of content experts defining the processes and knowledge areas that organizations—commercial, not-for-profit, nongovernmental organizations, and regulatory agencies—can use to determine the safest and most reliable methods to produce results that comply with the necessary high standards for safety. Whether the organization is involved in the pharmaceutical, medical device, or health care industries, the GIP will transform health care globally by establishing best practices for the effective use of information technology and management systems to improve the quality, safety, and cost-effectiveness of everything from drug molecules to patient care.

Because every aspect of health care—pharmaceutical, medical device, or patient-care industries—is forecast to experience immense growth in the coming decades, the GIP will be the key to an immense future of opportunity for any project manager with the wisdom to engage it. This presentation will unveil the major components of the GIP; identify how to align a career to this red hot, emerging trend; and offer an invitation to compelling professional growth through participation within the teams focused on articulating the content expertise of each member. This presentation will be a unique and powerful glimpse of the future combined with step-by-step instructions how to engage it. It will be as powerful as it is different from anything else presented at the PMI 2011 Global Congress. Don’t miss it!

What Does the Convergence of Agile and Health Care Mean to Project Managers?

State of the World in 2011 and Beyond

The Reality

At some point, every project manager wonders about creating a long-term career opportunity for his or her future. If you are taking a strategic look at your career and wondering, “Where is the future going to be hottest for PMs?” The answer is at the convergence of Agile and health care systems implementation. That is true because regulatory and competitive pressure—worldwide—is driving pharmaceutical, health care, and medical device providers to find better, more comprehensive system solutions.

Consider the comments of Andrew Witty, CEO of GlaxoSmithKline, in the “The World in 2011, 25-Year Special Edition” published by The Economist (Andrew Witty, CEO, 2010). He said, “In the past, the problem of R&D in big pharmaceutical companies has been ‘fixed’ by spending more and by using scale to “industrialise” the research process. These are no longer solutions: shareholders are not prepared to see more money invested in R&D without tangible success” (p. 140). (Emphasis ours.) He went on to identify these two key issues:

“First, we need to recapture the ability to empower creative talent in the discovery phase of R&D by creating an environment in the labs that reflects the fact that discovering a drug is as much an art as it is a process. But this needs to be combined with a more rigorous method for allocating resources only to where the prospects for success are greatest” he said. And that could well be a definition of Agile project management.

Mr. Witty went on to say, “The industry in five years’ time will look very different from today. Companies will need to put a premium on management and human capital. The pharmaceutical industry is hugely innovative. But it now must apply that innovation to its own business model.” And that could well be the definition of the GIP. (Andrew Witty, CEO, 2010, p. 140)

The Challenge

The challenge was aptly identified by reporter Vijay Vaitheeswaran and summarized by Bridget van Kralingen of IBM North America in the “The World in 2011, 25-Year Special Edition” published by The Economist (Vaitheeswaran, 2010). Mr. Vaitheeswaran said, “…the Obama administration passed the Health Information Technology for Economic and Clinical Health Act (HI TECH for short) in 2009. Starting in 2011, this imposes conditions on providers encouraging them to adopt health information technology (HIT). It also allocates more than USD$36 billion in incentive payments to reward providers whose electronic medical records (EMRS) meet the government’s test of “meaningful use” (p. 133). Therefore, the push will be on and available resources will be scarce. Then van Kralingen clarified the focus when she said, “Health providers and insurers are about to be hit financially as the HIT requirements kick in just as the health reforms passed by Congress in 2010 squeeze margins. ObamaCare caps the profits of many insurers (by requiring that they spend 85 percent of premiums on actual care, rather than on paperwork or padding profits). And the subsidies offered for hospitals to embrace HIT do not come close to covering the likely cost incurred” (p. 133). (Emphasis ours.)

Using Agile to Deliver Healthcare Solutions

Having a Single Lexicon

Challenges in Healthcare and Life-science Environments

When I ask students in my seminars, “Did you find the vocabulary in the PMBOK® Guide natural, intuitive, and easy to understand when you first started using it and preparing for the PMP exam?”, it usually draws howls of laughter. Most of us can remember our mighty struggles to get comfortable with, and eventually master, the lexicon of A Guide to the Project Management Body of Knowledge (PMBOK® Guide)—Fourth Edition (Project Management Institute [PMI, 2008]). As strange as that lexicon seemed when we first started mastering it, the idea of doing project management today without it seems laughable. Almost single-handedly, it has become the Rosetta stone for cross-industry collaboration. It has driven many revolutionary improvements over the past 50 years.

Moreover, just this year PMI has taken the bold step of officially recognizing that there are major facets of Agile project management that can contribute to the continued growth of the theoretical underpinnings and practical processes of project management in the ever more time-pressured world we live in.

The reality outlined has set the wheels in motion for pharmaceutical, health care, and medical device providers to proactively find a way to improve and integrate their practices so that “good informatics practices” —there’s that GIP again—can contribute to safety, effectivity, and efficiency. And within the GIP, a hybrid of Agile and traditional project management practices will need to be defined, developed, and deployed to implement the system solutions that are now required!

Good Informatics Practices (GIP)

The 50,000 Foot View

Because the GIP is currently being written, we simply do not know a significant amount yet. Some of what we do know includes a proposed content outline with 15 categories plus a glossary and index. These 15 categories have been identified:

1. Good Informatics Practices (GIP) Introduction

2. IT Governance and Corporate IT Policy Management

3. Risk Management

4. Training and Practices

5. Process Management

6. Architecture (information and management systems)

7. Infrastructure Operations

8. Application Management

9. Data Management

10. Verification and Validation

11. Security (defense and countermeasures)

12. Program and Project Management

13. Electronic submissions

14. Computerized Machines and Instruments

15. IT Strategy

16. Glossary

17. Index

Looking Deeper at Two Categories

Beyond the 15 categories mentioned previously, we have a more detailed view of two of them. The Verification and Validation (V&V) category and the Security category were judged to be among the most critical and far reaching, so they have been the subject of the most development effort so far. Generally, the content of those two areas has been defined more deeply.

Verification and Validation

  1. Introduction to V&V
    • Product
    • Process
    • Persistence
    • Returns
  2. V&V Key/Guiding Principles

  3. Risk Based V&V
    • Integrated GIP risk input model
    • Alternative risk models
  4. System Categories
    • Infrastructure
    • Software applications
    • Software for medical devices
    • Equipment
    • Processes
    • Vendors
  5. Best Practices & Policies
    • Verification and Validation
    • Life cycles—SDLC vs. project vs. validation
    • Vendor selection/audit
    • Environments
    • Development/configuration
    • System acceptance
    • Production
    • System Control (e.g., change management)
    • System retirement
    • Reviews (code, protocol, procedure)
    • Testing
    • Internal audits
    • Change management
    • System retirement
    • V&V maturity model
  6. Example Use Cases

  7. Example Policies and Documentation
    • Requirements document procedure
    • Software documentation review
    • Software requirements review checklist
    • Safety risk management procedure
    • Design verification procedure
    • Design review checklist
    • Code review checklist
    • Test readiness review
    • Master validation plan
    • Validation summary report

Security (Defense and Countermeasures)

  1. Physical Security
    • Laptop security
    • Desktop security
    • Server security
    • Data center security
  2. Logical Control
    • Identity authentication and access management
    • Access control
    • Desktop security
    • Server security
    • Encryption
    • Personnel training
  3. Network Security
    • Mobile devices
    • Firewalls
    • Intrusion detection
  4. Malicious Logic Protection
    • Desktop security
    • Server Security
  5. Incident Management

  6. Business Continuity
    • Backup and recovery
    • Service continuity

Aligning a Project Management Career for Entry into Healthcare

Demonstrating (or Developing) Expertise by Volunteering
It is reputed that Henry Ford once said, “Thinking is the hardest work there is, that is why so few people do it!” Well, there is a truly global opportunity calling to those with the wisdom to recognize it and the willpower to marshal the discipline to envision and define the future. It is a life or death call; a call to make a contribution that has significance—as well as probable career success attached to it.

Robert Goldberg, co-founder and vice president of the Center for Medicine in the Public Interest, said,

For those with life-threatening diseases or painful chronic conditions, time is not on their side. When promising treatments languish waiting for approval in a bog of bureaucracy, the cost must be reckoned in lost lives and diminished quality of life.” He continued, “And the problem is not limited to medicines. The development of tools that tailor treatments to our individual needs is, drowning in a sea of endless confusion. Tests and medical products that can help detect and prevent disease and eliminate useless or even harmful care are ironically being held up in the name of “patient safety.” (2011, p. F-3)

Operating rooms and ICUs are fast paced, complex, stressful environments. Pharmaceutical laboratories deal in amazing complex “puzzles” that need to be solved. Medical device manufacturing means lives enabled—or not— based on the success of nearly miraculous engineering. All of them will be enabled to serve millions more —or not—based on the development and delivery of the GIP.

The GIP today might be where PMBOK® Guide—Fourth Edition was 10 or even 20 years ago. Without the dedication and vision of true leaders in the project management field, the profession definitely would not be where it is today. Without the dedication and vision of true leaders willing to invest themselves in creating the GIP as a lexicon to a brighter future, then promising treatments will languish and the cost will be reckoned in lost lives and diminished quality of life for a great many.

Progress is not cheap. Neither is significance. However, both are well worth the price when it is paid by those willing to step out and lead the fight to find solutions that will work in this complex field. The LSiT group within HIMSS has been, and is, looking for those who are willing to be part of the history making effort now underway.

We invite you to join us in this effort by identifying which content categories represent areas where you currently have expertise. Or alternately, areas where you’d enjoy developing expertise and are willing to volunteer as a project leader, especially as an Agile project leader. If you are willing to pay the requisite price in self-discipline, then the future joy of being able to say, “I helped create the GIP and it is saving and enriching lives around the globe!”

Along the way, you will work with equally dedicated, and truly amazing, individuals. You will form life-long friendships that will vastly enrich your career network. But only if you choose to answer the call!

Andrew Witty, CEO of GlaxoSmithKline, calls on the pharmaceutical industry to do more with less—and still be innovative. (2010, November) The Economist, The World in 2011, 25-Year Special Edition, p. 140.

Goldberg, R. (2011, March 13). Government is stifling medical innovation. San Diego Union-Tribune, p. F-3

Project Management Institute. (2008). A Guide to the Project Management Body of Knowledge (PMBOK® Guide) (4th ed.). Newtown Square, PA: Project Management Institute.

Vaitheeswaran , V. (2010, November). A very big HIT: America’s health industry is preparing for a $30 billion splurge on information technology. The Economist, The World in 2011, 25-Year Special Edition, p. 133.

© 2011, John Stenbeck, PMP, CSM, CSP and Bryan Berthot, MBA, PMP, CSM, CSPO, CPHIMS
Originally published as a part of 2011 PMI Global Congress Proceedings – Dallas, TX



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