Critical Action Planning – How To Manage Both Product And Project Risk

Any kind of Project Plan should build in tasks to mitigate both product and project risk. It’s fundamental, but we don’t always do it.

Product risks are the risks addressed by your plan already. In the concept phase, product risks relate to feasibility. For example, can we get adequate torque transfer along our thin flexible catheter in a tortuous anatomy? Can we achieve adequate signal-to-noise in our imaging system? In later phases, product risks relate to reliability. For example, will we meet the tensile spec with 0.95 reliability at 95% statistical confidence?

What do I mean by Project Risk?

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Critical Action Planning – How To Build A Baseline Plan

Critical Action Planning is my attempt to combine key elements of Critical Chain planning with an Agile/Kanban philosophical approach, specifically for companies developing physical/hardware products. Like the Critical Chain, Critical Action project management is based on a detailed best-case task list for the complete project. Like Agile/Kanban, we don’t define task dependencies or projected task start or end dates. Also like Agile/Kanban, we estimate the amount of best-case work-units required to complete each task (e.g. in person days). Eliminating dependency and date planning dramatically simplifies the planning process, and makes the project plan parseable. Like Critical Chain, we add a buffer to the best-case plan, by including tasks to represent potential re-work or project iterations. We estimate work-units for these tasks too.

That’s the Project Plan – a comprehensive list of tasks with estimated work-units for each. I keep the list in a spreadsheet, which I share with the project team. Adding, modifying or subtracting tasks is lightweight, making it easy to update the project as we go along, but we’ll discuss that more later. Today I just want to concentrate on the initial Project Plan, and introduce some terminology.

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Kanban Project Management – Beyond Agile

My colleague Jeff really opened my eyes when he introduced me to Kanban project management.

I returned the favor by telling him about the best project management book I’ve read in years: Agile Project Management with Kanban, by Eric Brechner

You can read an excerpt here.

While I loved the Agile approach in concept, in practice the learning curve was really steep. My team would have to learn sprints, scrums, and velocity management. Team members would need to learn new roles. It’s easy to find semester-long courses on how to run Agile projects. How were we going to take this on while we were busy doing our day jobs?

The Kanban approach seems more straightforward to me, and apparently to many others. In fact, Kanban project management is now starting to supplant Agile in many places.

What is kanban?

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Address Your Project Capacity Issues with These Five Questions

If your New Product Development (NPD) project management reliably delivers new products better, faster and cheaper than your competition, I’m impressed. Most of us are working hard to improve our NPD performance.

When capacity constrains a project to an undesired timeline, we must face reality:  If we simply execute the plan, we’ll be late.  Timelines matter.  What’s a project manager to do?  Here are five questions that the project team can ask, to match the capacity to the timeline. Continue reading “Address Your Project Capacity Issues with These Five Questions”

Ten Ways Agile Project Management Differs From Traditional Gantt-based Management

The adoption of Agile project management techniques has been a key driver of improved new product development (NPD) productivity in tech and software companies (along with Moore’s law and industry adoption of technical standards). Here are ten ways Agile project management differs from traditional gantt-based management.

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Improving New Product Development Productivity – the Agile Approach

I’ve been writing recently about the wholesale abandonment of Gantt-based project management (including critical chain) by software and tech companies. In the software world, the Gantt approach has been wholly supplanted by Agile Project Management. Agile Software Development is a class of new project management techniques that has become standard practice at modern software companies, including Google,  Spotify, Amazon and practically every software startup. Agile-based new product development (NPD) leads to products that better meet customer and business needs, with shorter development timelines and with less development investment. What’s not to like?

What is Agile?

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Top Five Ways You Can Tell Your Project is Capacity-limited Not Critical-Path-limited

In a recent post http://jaycaplan.com, I explained why medtech companies should look to software and tech companies, to improve project management techniques to drive increases in new product development productivity. Today I’d like to re-emphasize that despite common belief, new product development is rarely limited by the classical critical path. Instead, I assert that our timelines are almost always capacity limited. You’ve been trained not to believe me, but I beg you to look at the evidence dispassionately. Read on to learn more.

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Top Five Reasons Why Tech and Software Companies Abandoned Traditional Project Planning

Of all the important elements of medical device new product development (NPD), project planning and management gets the least attention and is the most poorly performed. Full stop.

We expend tremendous product development effort to deliver patient safety, product performance, and physician ergonomics. We design for cost, manufacturability, and reliability. We agonize over the wording and acceptance criteria of every requirement. Our drawings are exquisitely toleranced. No spec is left unverified or unvalidated. Instruments and fixtures are IQ’d, OQ’d and PQ’d. Manufacturing processes are thoroughly validated. We justly take pride in these achievements. One medtech engineer told me that he sleeps better at night knowing his risk analysis was well-done.

Yet when it comes to planning a project, our attention wanders. We put in some effort, get frustrated by the complexity and ambiguity of the project tasks and dependencies, and call it “good enough.” We don’t put nearly the effort into planning that we put into FMEA’s or inspection instructions. We write something up, get it signed, and a couple of weeks later, project plans lie quietly buried and already outdated in a design history file. Most of the time, we don’t know how to make the plan any better, even if we wanted to.

Sound familiar?  Software companies have shown us that there is a better way.

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Critical Action Planning – A New Approach to Project Management for Medical Device Companies

English: A sample burndown chart as used in Ag...
English: A sample burndown chart as used in Agile software development methodologies, for example Scrum. (Photo credit: Wikipedia)

I’m not going out on much of a limb when I say that, as an industry, medical device companies are not particularly strong in project management. A tool (like Microsoft Project) is not a management technique. Program management offices abound in larger companies, but rarely do you find a systematic approach to defining the activities of project management. The Critical Chain approach has advantages over a traditional Gantt chart, but at the end, it’s still only a tool. We’re really stuck in last century thinking.

There is a better way.  Read on to learn more.

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New England Venture Funded Medical Device Startup List 2014 Q4


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The New England medical device startup community is an amazing innovation ecosystem, producing great products and great companies over several decades. New startups are the lifeblood of that ecosystem, so I’ve been tracking first-time venture financing of medical device companies in New England since 2005.

I’m way overdue for an update. You’ll find my 2014 Q4 New England Venture Funded Medical Device Startup List linked below.

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