Helping you succeed despite relentless change
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?
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:
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:
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.
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:
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:
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?
Here’s a post I did for SoftwareCPR on the shortcomings of viewing “agile” as just a routine process change:
It has been a difficult time for many businesses.
Some will survive the crisis, some won’t.
Some have had a more difficult time than necessary. Some have closed for good.
Why?
Because of an inability to change with the changes.
Your organization made needed changes to survive the crisis thus far. Changing to remain successful amid external change is a mark of organizational agility.
There is a crucial question to answer to remain successful.
How hard was it to make the changes? Was it harder than it should have been? If so, one of your tasks as a leader is make future change easier when (not if) the next crisis occurs or if a market opportunity appears.
You may be thinking “How can I make change easier? Change is hard!” Change can be hard. It can also be easy! See an earlier post about the nature of change.
Think of organizational agility like a form of organizational Parkour.
The COVID-19 virus has radically changed day-to-day life for individuals, businesses, and governments around the world.
The daily question on everyone’s mind is “when do we get back to normal?” Organizations are asking “how do we prepare to get back to normal?”
These should not be the only questions for you as a leader.
Once you have safeguarded lives and stabilized operations, your priority is also to think about future improvement. Your key question should be the opposite of others who are focusing on “normal.” Your question is: “which of the changes we’ve made are worth keeping, and what further improvements can we make?”
This article helps you do that: to “innovate forward” rather than “revert backward.”
[Read more…] about Waiting to get back to “normal”? Innovate forward instead of reverting backward!
