Jon Speer’s picture

By: Jon Speer

When it comes to making medical devices, quality is key. That’s a concept that nearly every medical device professional agrees with, but what does it mean? Why is quality so important, and how should it be pursued? These are the questions that medtech executives and company stakeholders should be asking themselves and their teams.

At Greenlight Guru, we work with many medtech executives who are making incredible innovations in the space; their insights are invaluable.

The best way to explore the value of quality is by learning actual examples of how and why it works. We’ve taken it upon ourselves to put together five of our favorite pieces of wisdom from medical device executives on the value of quality.

1. Start with why quality matters

We spoke with Devon Campbell, founder of Prodct LLC, and he made an excellent point right off the bat on how true quality starts with educating your team.

Mark Rosenthal’s picture

By: Mark Rosenthal

The idea of doing the little things consistently over time is a powerful one that we often overlook in our hurry to show a spectacular result this week. We don’t get results from the big action we are taking today. We get results when business-as-usual is getting the little things right the vast majority of the time.

In the following video clip, author and speaker Simon Sinek articulately explains why the things that matter most aren’t measurable, nor can they be created over the short term. Watch the video, then I’d like to extend his thought process into continuous improvement.

Let’s extend his line of reasoning down a level.

Bruce Hamilton’s picture

By: Bruce Hamilton

Several years ago, I was asked to address a startup meeting at a new client, a large manufacturer of medical devices. The company was resource-rich, but after several years of trying had not yet gained significant traction with its lean efforts.

There were perhaps 40 people in the room, half from line management and half from the company’s continuous improvement staff. I addressed the group, first describing my organization, GBMP, and then sharing a little bit about my previous experience as an operating manager. Specifically, I described the challenge to shift from a bounded thinkers vs. doers paradigm to one where every employee is a thinker-doer. (GBMP’s slogan, Everybody Everyday, is derived from that experience.) “Managers can’t take on this lean challenge all by yourselves,” I cautioned my audience. “There’s just too much to be done. It’s crushing to have just a few problem solvers.”

Maureen Metcalf’s picture

By: Maureen Metcalf

Many organizations feel the need to be leaner, faster, stronger, more adaptable, and more profitable. The right toolset to get them to that outcome may not be intuitive or singular.

Building organizational agility is a solid approach to help organizations develop the capacity to perpetually evolve. It enables them to accelerate their ability to sense and adapt to the volume, complexity, and rate of change organizations face in the current environment. Yet the right tool set to get them to that outcome may not be intuitive or singular. We believe business agility comprises four main elements: strategist leadership, nimble culture, lean principles, and agile methods.

The challenge

Change is accelerating across all sectors of organizational life, largely driven by technology, geopolitical changes, and strong academic research. This accelerating change in disparate sectors collectively drives organizations to develop the capacity to perpetually evolve, often quickly; to set trends; or to respond to forces that are changing the market. Although this volume and pace of change seem daunting, the most successful organizations are addressing it by developing organizational agility.

Suman Sarkar’s picture

By: Suman Sarkar

Most people attribute business disruption to technology, thinking of the iPhone, 3D printing, robotics, and artificial intelligence. However, technology alone does not cause disruption. The iPhone didn’t succeed because of its technology; it succeeded because it met customer needs better than any other product at the time did.

If we’re all driving electric cars in five years, we will point to Tesla’s technology as disruptive—yet the electric car was invented in 1837. Electric car technology was not disruptive in 1839 or even in 1939 because customers didn’t want it then. But even if they are subconscious at times, customer needs and demands change, and those changes are the real source of disruption.

Donald J. Wheeler’s picture

By: Donald J. Wheeler

Last month I looked at how the fixed-width limits of a process behavior chart filter out virtually all of the routine variation regardless of the shape of the histogram. In this column I will look at how effectively these fixed-width limits detect signals of economic importance when skewed probability models are used to compute the power function.

Power functions

A power function provides a mathematical model for the ability of a statistical procedure to detect signals. Here we shall use power functions to define the theoretical probabilities that an X chart will detect different sized shifts in the process average. To compute a power function we begin with a probability model to use, and a shift in location for that model. Figure 1 shows these elements for a traditional standard normal probability model.

Figure 1: Normal model with a 1.0-sigma shift in location


Jesse Lyn Stoner’s picture

By: Jesse Lyn Stoner

Have you created a vision? You might be excited about it, but are others? Does your vision inspire, motivate, and guide decision making?

It’s better to test your vision now than to find out later that it’s simply a wall decoration.

And if you already created a vision a while ago, it’s still important to find out if people understand and buy into it.

Over the years, working with countless leaders and organizations on creating a shared vision, we have learned that a useless vision statement is actually worse than having none at all.

Leaders lose credibility when they put out a vision statement that is boring, vague, or worse, turns people off.

So even if you are clear about your vision, don’t assume others are as well. Ideally you have involved people in the process of creating it, and it reflects their hopes and dreams and incorporates their good thinking. Even so, you need to test your vision to see if you have accurately captured their input.

Note: You are welcome to duplicate and share the 20/20 Vision Test and the Scoring and Interpretation Key as long as you include the authorship.

20/20 Vision Test

by Jesse Lyn Stoner and Ken Blanchard

Jim Benson’s picture

By: Jim Benson

Editor’s note: Read episode two in the Respect for People series here.

I was standing in a back room of the Honolulu Museum of Art that was off limits to the public. In this one room, protected from bugs, humidity, and light, was the world’s largest collection of Japanese woodblock prints. (My childhood friend, Shawn, is an unlikely expert of Japanese woodblock prints.)

One of the things I geek out on is watching other geeks geek out on what they geek out about. I love to listen to people talk about what they really love, and Shawn did not fail to deliver. Through him we met the people, the business models, the supply chains, the evolving use cases, the ink choices, the artists, the engravers, the labor disputes, the burnout, and so on, of an industry centuries in the past. It was gorgeous detail.

Annette Franz’s picture

By: Annette Franz

I write about organizational culture and core values quite often. One of my most recent articles on this topic was about whether employees believe in their companies’ core values. I shared this statistic from Gallup: Only 23 percent of U.S. employees believe that they can apply the core values to their work, while only 27 percent believe in the values. That’s pretty dismal, and I think I know why that’s the case. When executives and managers don’t live the values, why should the employees?

Yes, just like with everything else in the organization, executives and managers are not immune from any changes, any required behaviors or actions. As a matter of fact, they are the role models. They must be the catalyst. When they do things right and do the right things, so will their employees. If executives exempt themselves, employees won’t take any of it seriously.

Inderjit Arora’s picture

By: Inderjit Arora

Every company uses a system to understand the requirements and inputs of its customers, and then plans to deliver outputs meeting those requirements as a conforming product or service. The International Organization for Standardization (ISO) publishes management system standards that, when correctly interpreted, enable companies to systematically and consistently provide desired outputs while addressing risks.

Using the framework provided by ISO, companies can design systems and processes that work together to deliver desired outputs (i.e., products or services). An organization should endeavor to define its outputs accurately, after understanding customer requirements, both stated and unstated. ISO standards allow companies of any size and industry to implement them; hence, a lot is left open to interpretation.

Despite this, certification to these management system standards delivers confidence to potential and existing customers that the company is implementing a process with the intent of continual improvement. Across the globe, an ISO management system certification, such as ISO 9001, gives confidence of a certain basic framework being implemented and followed.

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