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Mike Russell

Compliance and agile success – another common hurdle

November 9, 2020 by Mike Russell Leave a Comment

Another common hurdle to achieving compliant agility - forgetting intent

From a post for the SoftwareCPR.com website:

In a prior blog, we discussed a common hurdle to achieving agile benefits: focusing on isolated software process changes and not considering all four organizational factors.

Another common hurdle to agile success is thinking only about making agile “compliant.” You will miss the full power of agile if you do not consider the intent behind compliance activities and how agile can help better achieve intent.

Let’s start with the intent behind medical device software “compliance.” What’s the point? At the top level, it is building devices that fulfill intended use and do no harm to any user or patient. From a simplified compliance point of view, that means two things:

  1. Assessing and mitigating any risk of harm before the device is used.
  2. Establishing ability to determine if and how a device contributed to an actual harm or potential harm situation after the device is used. Corrections can then be made to prevent recurrence.

How can agile help?

[Read more…] about Compliance and agile success – another common hurdle

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These are the best we can do?

November 3, 2020 by Mike Russell Leave a Comment

That’s a paraphrase of Joseph Epstein’s 2016 Wall Street Journal commentary “These Five Are the Best We Can Do?” lamenting the U.S. presidential candidate slate. Some feel the question can be applied to this election.

Regardless of the election, here’s the question for you: Is your business succession slate any better off?

[Read more…] about These are the best we can do?

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A digital marketing fail

October 30, 2020 by Mike Russell Leave a Comment

Don't make it hard for customers to do business with you www.mikerussell.com

Businesses, especially restaurants, are fighting for customers in the tough pandemic climate.

So why do so many commit basic marketing and customer service errors?

Here’s another example of a fail that should be simple – very simple – to fix.

On the way home from an appointment, I decided to pick up lunch from a new restaurant. I looked on Google maps at my route to identify a place to try and review the menu to decide what I wanted. I then called for a to go order.

Here is a paraphrase of the conversation that ensued after greetings:

me: I’d like the [name of dish] as an appetizer.

OK – got it.

me: I’d like the [name of dish] as the main.

We don’t have that dish anymore. Are you on our current website?

[Read more…] about A digital marketing fail

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A crucial insight … and critical flaws

September 28, 2020 by Mike Russell Leave a Comment

Stage gate document production may be just vanity metrics

Recently I saw a case study about how a very large consumer packaged goods company  “improved” their product development process.  I put “improved” in quotes for reasons explained below.

The study identified a important insight about the company’s stage gate type process.  Project teams were doing insufficient definition work at each stage, especially early stages.  This caused poor decisions that:

  • continued projects that should be canceled,
  • delayed projects that would actually provide a positive impact, and
  • overburdened teams with too much work in process, reducing productivity.

The company’s solution?  Do what was obvious on the surface:  more definition work on deliverables in each stage.

The insights about the effects of an ineffective process were good as a start.  It increased the efficiency of each stage, reducing rework and the need to revisit earlier stages.

There are, however, two flaws in the solution:

  1. The solution focused on improving each stage individually and perfecting the stage “deliverables.”
  2. The solution was really more about vanity metrics, instead of a root cause in not meeting customer and company needs.

[Read more…] about A crucial insight … and critical flaws

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Is your customer service on empty?

August 27, 2020 by Mike Russell Leave a Comment

Is your customer service on empty?

Businesses are having a harder time staying viable and profitable this year.

Business failures continue to mount, and consumers generally have less money to spend on those that remain.

Why, then, would a business provide anything other excellence in its contacts with prospects and customers?

Here is a cautionary tale from an experience I had this month.  The failures have easy fixes and can be implemented quickly.

Does your business have any similar failures that are driving customers away?

[Read more…] about Is your customer service on empty?

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A common hurdle to achieving agile benefits

July 27, 2020 by Mike Russell Leave a Comment

achieving agile benefits can be like wandering through a maze

From a joint article with SoftwareCPR:

“Agile” remains a hot topic in general, and “compliant agile” is a goal in many medical (and other regulated) companies.

However, “agile” benefits also remain difficult and elusive for many.

This article will examine one of the most common hurdles to achieving agile benefits from well-intentioned initiatives.

First, let’s address agile and medical device development in general.  Common questions we get regarding agile are:

  • Can we use agile in medical device software development?
  • Can it be compliant?
  • Can it be safe?
  • Is it a wise thing for us to do?

The short answer is “yes.”

“We find that many agile methods, when implemented properly, are not only compliant with regulatory law & guidance, but are better than traditional methods for ensuring safety and effectiveness.”  -Alan Kusinitz, Founder SoftwareCPR®

After answering the above questions, the next common question we get is “Can’t we just change part of our process and succeed with agile?”

The short answer is “no, in most cases.”

Why?

Every organization, and every level in an organization, effectiveness can be evaluated across four factors illustrated in the quadrants of the diagram below:

 

Optimal business model

As the name implies, optimal business performance occurs when all four quadrants or factors are functioning optimally.  The four factors also interact and are dependent on each other, so a major change in one area can affect one or more of the others.

Using the model as a foundation, the question can be rephrased as “Can we just change a part of the Processes & Systems factor? The answer is “no” because agile if more than just a process change.

common hurdle to achieving agile benefits

Transitioning to agile has many challenging aspects … an “off the shelf” “plug and play” is unlikely to work for most medical device companies.  While agile does imply development process changes, there are also changes usually needed around:

  • culture (agile is very different from deterministic approaches like waterfall or pure stage-gate development)
  • people (e.g., different competencies, roles)
  • other processes beyond device development (e.g., financial planning, performance management, marketing)
  • strategy (e.g., product release cycles)

Therefore, your agile success and how you achieve it will necessarily involve other parts of your organization.   We have found that the most successful implementations have one or more of these key attributes:

  • Senior executive sponsorship and commitment
  • Critical mass culture change across three or more functional groups
  • Desperation – general knowledge that company will fail without change
  • Hopelessly committed to customer satisfaction

The benefits associated with agile are clear and have been demonstrated in both regulated and non-regulated environments. Unfortunately, the hurdles are also clear and have been encountered by those struggling to achieve the benefits.

If you or your organization has been struggling, look at what changes you are making. Have you sufficiently addressed all four optimal business performance factors?

Filed Under: Uncategorized

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