For a bit of fun, we took a look at our current President and his project management prowess in light of our previous work on hierarchies of teams… i.e., would he be a great project manager????

Leadership Style

President Trump is known for his confrontational style of negotiation and high energy. As a business leader who enjoys competition and a need to win, he emulates another President, Teddy Roosevelt. Both men are marked by wanting to do great things and leave their mark on the world. As President, Roosevelt oversaw the building of the Panama Canal and significant additions to the National Park system, amongst many others. We shall see if Trump leaves any similar marks on the world during his presidency.

Having a high level of energy can be great in a Project Manager. Challenges will come and having zeal to embrace those challenges can be a useful asset. However, an excellent Project Manager must also rise above negotiating every aspect of a project. Team members must feel empowered to win – at minimum as an individual or, even better, as a team. Some team members might feel challenged to rise to the occasion under a challenging project manager. Others might feel like the only winner on the team will be the Project Manager.

In a Business Insider article on Trump’s management style, they dive into his lack of warmth as a manager.[1] This style of management attacks the sense of team that is needed to anticipate crises and work through issues together. Harshness will put barriers between team members as they weigh who is friend or foe. This can also prevent team members from being vulnerable and open for coaching and suggestions when struggling with responsibilities.

In his book, The Art of the Deal, Trump openly admitted that he thinks big and is not afraid to employ hyperbole to manipulate a situation. While this can be effective as a negotiation tactic, it is not helpful to be uncertain as to the goals of a project as well as the status. Further, using deceit (or hyperbole) as a management tactic creates distrust of other things the Project Manager says. This will derail projects by causing uncertainty with the stakeholders (in this case, us) and within the project team.

Turnover

A recent Brookings Study revealed that President Trump has had a significant amount of turnover in the first eighteen months of his presidency. To be sure, as current Chief of Staff, General John Kelly stated, working in the White House is a high-pressure environment. However, Trump’s turnover is twice as high as Reagan in his first years.

At Waddell Group, any time we see high turnover, it raises concerns about the stability of the team, the skill of the leader of the team, and whether the project will be able to complete on time and within budget. When turnover is high, weakness occurs, negating the building of Esprit de Corps, which is key for teams to handle challenges. As with all teams, the leader is who establishes the core values of the team.

Results

Under our work on hierarchies of teams, we point out that on good teams, individuals win. On great teams, the team wins. Under elite teams, the company – or in this case, the country – wins. In the case of President Trump, we see a mixed bag of results. While the economy is doing well, other nations are becoming more hostile, questioning their standing with us. Further, the United States doesn’t have certainty with the direction the country is taking. What will he do next? To not know what your project manager will say or do next is unsettling in the realm of project management.

At Waddell Group, we would advise our countries’ “project manager” (President) to hire great people and empower them, be transparent and honest with his team and the country, and set directions for his projects early and drive them consistently. True greatness means he wins, we win, and the Country wins. Time will tell how that’s going to turn out.

[1] https://www.businessinsider.com/trump-management-style-2017-3#

In our previous blog post, we highlighted how the right approach to your quality system can improve your development time to clinical studies. The impact of that is you can do more projects at the same time, and, should those projects be successful, improve your profits. In this post, we will continue the conversation by looking at three approaches taken by companies and how that will – or won’t! – align with your product development strategy.

The three kinds of companies we will look at:

1. Start Ups: They don’t have a quality system and need one
2. Mature Company: Have a robust quality system
3. Some companies customize each system for the project

Start Ups: Building from the ground up

We worked with a client who was down the development path, raising money, designing his product when we started asking about his quality system. The blank look made us panic – and his panic matched ours when we explained our concerns. However, this presented us with a clean slate with which to start.

The great thing about starting with a clean slate is that there are no preconceived notions around previous experiences, custom solutions carried over from a specific situation or programs developed for a beginning to end solution when that might not be needed. We try to identify the specific quality modules needed for the project to get to the company established goals.

Ideally, startup companies know they need a quality system and they build it around what they anticipate for the product’s development life cycle. Our small client has a product they need to get to proof of concept (i.e., limited clinical studies). They also placed a priority on minimizing their investment burn rate. To get them where they needed, we held off on developing a management quality system and just built the development portion of it. This would allow them to get the proof of concept. They then have the choice of selling off the product to a company that can take it through manufacturing or raising more money to do that themselves.

Mature Companies: Comprehensive systems in place

We have several mature medical device company clients that have extremely comprehensive quality systems in place. On its face, this makes sense: A mature company should have a thorough quality system. On some occasions this proves to be a problem when the company makes all projects go through the full quality system. In our previous post on profitability, we highlighted how companies try to build a system that anticipates every possible problem and build a plan to remediate it.

This is bloat and does not drive profits. While a small company is forced to be efficient to save cash, mature companies do not have to so will put a new product through their manufacturing quality system despite the fact that they haven’t achieved a proof of concept yet. There are times when this makes sense, such as when you are 98% sure the product will go to market or your product is a development of another proven product already on the marketplace.

Still, this is a prime example of how a very robust quality system erodes the profitability of your company. Major market companies have often turned to outsourcing their projects to avoid this erosion.

A Customized Approach: Applying modules at the right stage

We have seen companies effectively stage their quality system requirements for each level of production and only do what is necessary to hit the next benchmark. In thinking like a small company, profits abound in efficiency. For example, when you approach the design element of your project, have just the quality system needed for design work. When you complete clinical trials and you know what you have, then you can see. Are you going to the next step?

At this point you need to go back, review and implement the quality manufacturing portion of your system. For an individual project, this might be more expensive as you must customize what you do for your product. However, you can realize an increase in your profits by not spending time running products through complex quality systems when they won’t go to market for failing clinical trials or are scrapped afterward for other reasons.

For example, when you are building prototypes for a clinical trial, you might just approve a simplified inspection process for each product. There may only be 30 units to inspect so doing so manually makes sense. When you approach manufacturability, and you will be making thousands or more, you will need to build a system that encompasses the machines you used, automation of your inspection tools, auditing systems, and many more elements. Why spend the time and money building these systems unless you know they are going to be used?

If you are looking for help to right size your quality system, we should talk. Waddell Group has world class project managers that are smart about the business drivers of projects – including profits!

This is a series of blogs geared around accelerating product development through clinical study (animal, cadaver, or FIM).

Successful medical device companies have been developing products for decades but along the way some have developed quality systems no longer adequate to achieving competitive speed to market in the current landscape. There are many reasons for this:

• additions due to internal issues,
• embracing all FDA “suggestions” for improvement,
• general institutional scope creep inside the best intended methodologies of creating safe, effective, and approvable medical devices

The results have yielded quality and regulatory requirements that far outweigh the minimum requirements of the FDA or other regulatory systems. Both result in an overburden on development projects.

One way to speed development is to outsource it to capable partner companies.

In many cases they are streamlined to do it better. This is not exclusive to medical devices as small companies are always more nimble, but medical devices are competing in an already highly-regulated landscape. Bringing a medical device to market is onerous, but the established companies have made it difficult for themselves.

Since speed to market means greater market share for new products, we wanted to find out how to accelerate that timetable. One of the ways? Right-size your quality system for the kind of study you are doing.

What causes scope creep in a quality system?

We list several ways to add items to a quality system: FDA suggestions and internal issues that need addressing among just a few. But often steps are added to a quality system that are relevant for one kind of project but not another. Especially in established companies, quality systems are built to accommodate every possible situation from concept all the way through manufacturing. In reality, not every system works for every project.

For example, if the goal of your project is strictly clinical, why would a company insist a manufacturing quality system be included in the program? When you lay out the project at the front end, you should identify what elements of a quality system you need to accomplish your goals for the project.

As with every other form of scope creep, one small addition does not a problem make. However, tolerating small additions leads to many small additions, which makes a huge problem when taken in the aggregate. From the project manager’s or QMS responsible person’s perspective, here are some good questions to ask:

• Are additions to the quality system really needed for each product being developed?
• Is there a definition that is clear enough to define a quality system that works for speed?
• Does this element of the quality system have broad application? Or could it be applicable in only this instance?

How can scope creep be prevented?

It is very hard to remove elements that have been added to a quality system. Perhaps the reasons for adding it aren’t known or were thrown in because of a specific situation. One rule to consider for quality systems is to make it just as hard to add items to the quality system as it is to remove them. In this case, an ounce of prevention on the front end can be worth millions of dollars of cure on the back end.

When you create an addition to your quality system, identify why you are creating it. Then identify which product goes with a particular quality system attribute. For example, if you know on the front end that your product will have to go all the way through manufacturing, then you need to put it through manufacturing quality system at some point anyway. So, you might as well include that system on the front end.

The trick is to find a quality systems expert that understands the differences between these types of systems and can help you define the minimum quality system in a product development with the need for speed.

How do you overcome hurdles in removing scope creep?

In your quality system, define how to remove requirements up front as one of your processes. This would be spectacularly pro-active and almost unheard of. One way to motivate such behavior is to have the quality system owner have their bonus affected by product development speed. Most quality systems people are policed by lack of quality “issues” but speed to market is rarely assigned to a quality system executive. But they have a great deal to do with speed to market. Yes, this creates conflict of interest, but best to deal with it.