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.

If you manufacture a medical device that is CE marked, you are required to comply with the latest MEDDEV 2.7.1 publication. This revision is a major rewrite from the previous publication of Rev 3 as the authors sought to bring clarity and lay out stricter expectations for Clinical Evaluation Reports (CERs). Compliance expectations ultimately fall on the manufacturer, and the Notified Bodies are being given greater responsibility in enforcement as they perform audits.

Rev 4 is 50% larger than its predecessor because of the level of detail. Fortunately, the document was written by many of the same people who wrote the latest MDR requirements published in May of 2017 so we hope to see these documents aligned. It is anticipated that there will be a gap analysis performed after MDR is fully implemented. After which, we can all look for a Rev 5.

There are several excellent descriptions of the changes required, and here are a few:

This article is from BSI – a top tier Notified Body:

https://www.bsigroup.com/meddev/LocalFiles/en-GB/Documents/BSI-md-meddev-271-clinical-guidance-brochure.pdf

And these are from top tier industry consulting groups:

http://resources.rqteam.com/registration-rq-intelligence-series-on-demand-webinar-may-2017

https://www.namsa.com/european-market/meddev-2-7-1-revision-4-stricter-requirements-for-clinical-evaluation-reports/

https://www.emergogroup.com/blog/2016/07/meddev-271-closer-look-updated-guidance-european-clinical-evaluations

So, what does this mean for my clinical and regulatory teams, and for both new submissions and required updates???

In short, more work, and more expensive people doing the work…

If you are concerned about this – we can help you put together a Gap Analysis and help manage the increased workload. Please contact us at [email protected] or call us at 952-221-3333.

The stakes seem high and the risk is real, but in a very large sense executing your MDR project is just another project. This is the fifth blog post in a serious on the changing European regulations in Europe. The previous four discussed what MDR is and why it is a concern, how to prioritize your devices in preparation for the new regulations, what to be thinking about as you perform a gap analysis, and finally, how to build a plan.

A normal development project will typically have five phases, from 1) concept, through 2) development, to 3) design and process validation, and any sort of 4) product validation before you submit. Once you have approval, you 5) launch and do post-market surveillance. The shift from MDD to MDR has a few variations, but they stay consistent with these five phases.

First, return to your Gap Analysis. Do you have to redesign your product? Is there additional testing required? Or do you have to just provide more documentation? The process is the same – but it is a question of how to make that happen.

Next, revisit your Risk Analysis. Are there potential design changes to be made? If you have to do new clinical trials, are there any unexpected results to consider as a contingency? It may cause you to rethink the plan to include the corrections. Are there new risks to mitigate, or are those risks justifiable in light of the modifications to the product?

One significant change is more cultural than procedural: How you work with your Notified Body. Notified Bodies were always considered  an advocate to the industry. Now there is more emphasis that they confirm that regulations are being fulfilled – more auditing and policing. They have more clout. And while in the past, they may have worked with you to get your product to market, this is no longer expected to be  the case. Just as you are being held more accountable, they are also being held more accountable and they will be very busy.

Back to the main theme: this is just another project; an important one, to be sure. Put good people on it and project manage the heck out of it.

This is the fourth blog post in a series on the changing European regulations in Europe. The previous three outlined what MDR is and why it is a concern, how to prioritize your devices in prep for the new regulations, and what to be thinking about as you perform a gap analysis.

This blog post concentrates on how to build a plan of action. If you need a refresher, please see the other posts or reach out to us and we can discuss how these apply to you. They are important as you must prioritize each device as well as understand the gap between where you are and where you need to be before you can create a plan to get on track to compliance.

There are four key elements to getting a plan completed: You need good planning, accurate budgeting, smart resource management and someone who will captain the ship (or Program Leadership).

Your plan must be sufficiently detailed to cover what your resources are going to be doing, with clear milestones along the way to measure progress and to create predictability to complete the project on time and on budget. This presents a great place for a strong project manager to meet/exceed your expectations. When you have done the gap analysis, you should identify how long it will take for this project to be completed. If it is a six-month project, you may wish to outsource the project to a team like Waddell Group. If it is a multi-year project, you may wish to use in house talent or permanent employees.

You must also review your budget for this project. Where will the money come from? Odds are that you might be putting other projects on hold so that you can make sure your products stay on the market in Europe. In an earlier blog post, we discussed prioritizing your devices to get through MDR (and/or IVDR). Something similar might take place here where you weigh prioritization of products on the market vs. those you are working to get to market. What makes some projects higher priority than others?

Resource management is going to be key. As with any project, you have to know who you need (required skill set), when you need them, and how long you can keep them. Managing human capital along a timeline will be critical to getting your products compliant with MDR for your Notified Bodies.

Finally, you need strong project management. Because of the stakes for your company– your plan has to be credible, the plan must be executed on time and within budget, and you need experts who can manage all of your talented staff to this necessary end.

When you sit down to address your gap analysis between MDD and MDR, there are a host of questions you will want to think about. This list is not expected to be comprehensive but it should be a good place to start.

You need to begin by comparing what the changes are for your device: what is new or different under MDR that you did not have to comply with under MDD. Once this is compiled, you should consider the regulatory impacts and how that will impact your product in the EU versus the US. Can you use the US product once you have met the regulatory standards or will you need to come out with a EU specific product?

You may need to redesign the product. You must resubmit it to FDA if you do that – or go with two models for different geographic targets.

What documentation standards will you need to meet? Will that require re-testing? More clinical studies? Or can you use post-market surveillance to meet the new documentation standards for your product?

We are also seeing some questions about Single Use vs. Reuse. While many devices are made to be single use, we all know that some physicians will reuse products. Do your products need single use limiters such as device identifiers or re-use prevention methods? This will impact product labelling, and potentially the instruction manual.

We are seeing some companies also have to recertify their supply chain to demonstrate complete traceability and documentation for their Notified Body.

Speaking of your Notified Body, there are a number of issues to address in your Gap Analysis regarding the Notified Body: Where are you in their Queue? Are they even still in business? Have they notified you or have a transition plan?  Will they be a Notified Body when you are ready to recertify? How is your Notified Body prioritizing you over  other clients?  The number of Notified Bodies has dropped dramatically in recent years.

When you are creating a priority list for your Class II and III Medical Devices, you need to take many things into consideration. Most people look for the simple answer: How much revenue and profit is generated in Europe by my list of products? This can be a good litmus test, and might even be the right one for you. But we encourage you to take a step back and look at the bigger picture.

You should ask yourself what the impact is of each of your products going off the market in Europe. When we look at that question, we tend to see what products are inter-dependent on each other (e.g. accessory kits and/or tools), what products open the European market to other products, and how your company generates revenue in Europe.

Do you have products that require the existence of other products to work? If that is the case, that might move both of those higher up your priority list. If you make significant revenue, but not profit from those products, that might lower their prioritization.

Another factor important in prioritization is determining how long your time frame is for getting each of your products recertified. The variables in managing the group of products getting recertified will also shuffle the list. If you have one product that won’t take very long to get recertified, then you might prioritize ones that will take longer.

However – and this was said in the introductory blog post about MDR: the reduction of Notified Bodies will impact the recertification process and will almost certainly stretch out the time it will take to get your devices up to the new MDR (no longer MDD) standards.

Finally, you should assess what other regulatory issues exist that will come into play and how that will impact your profits, timeline and prioritization.

The European Union (EU) is set to shift the regulatory structure of medical devices from MDD to MDR compliance. Simply put, Class II, Class III, and other high risk medical devices are going to require recertification under a new set of rules to remain on the market. The EU will not allow any devices to be grandfathered in. When your existing certification ends, you will be required to make sure you are in compliance. If this is not taken care of, your products may go off the market in Europe.
If your business has products that need recertification, the three big questions you need to ask are:

• What devices are a priority?
• Have you performed a gap analysis?
• How long will it take to recertify?

 
Prioritizing your Class II, Class III, and other high-risk medical devices is vital. You will need to assess how much European revenue and profit you garner from any one device to determine when to recertify. Be sure to take into account that some devices are reliant on the existence and implementation of other devices, and that some devices might take longer to get recertified than others will.

Performing a gap analysis on your products is a necessary step as it will provide you with an idea of the scope of the recertification process. This will allow you to construct a plan to assure that recertification happens on time and on budget.

Getting an accurate time frame is key in this process. With the expected reduction of the number of Notified Bodies in Europe, there will be a backlog. You need to get started as early as you can to make sure you recertify inside the required window.
As leaders in Medical Device Manufacturing Project Management services, the Waddell Group has the experience and team to help you and your company through the recertification process.

Contact us to schedule a review of your recertification needs today!

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Waddell Group consultants have worked with all sizes of companies. One of the questions asked quite often is “why would a small company hire an outsourced project manager?” The question of hiring a Project Manager is driven by balancing the needs of investors, the experience and talent of the CEO and staff, and the market opportunity of the product.

Project Managers are often seen as only useful in big companies.   In our experience that isn’t the case at all. An effective PM keeps projects on time and budget, communicates status and issues to the people that need to know and generally has the project team operating as efficiently as possible.  The added cost of the PM versus the potential efficiency is the reason large companies hire PM’s – both internal and outsourced.  Does the same hold for a small company’s projects?

The worst thing that can happen to a small company is that they run out of money. The CEO has to be focusing on funds. For companies that are adequately funded, the CEO is always aware that the next tranche comes with milestones. In both cases, project management needs to happen, and it’s a question of who is doing it.

A CEO of a lightly funded company must show potential investors a solid plan that is realistic and well thought out. This includes risks and how they’ll be handled. If you look at the plans that good project managers put together, it looks a lot like what companies looking for early funding put together. It can be very useful to have someone who has taken many products through this process and partner with the CEO on creating that plan.

For companies that are funded and focused on hitting milestones, being efficient is key. This is done by defining interim milestones, planning around them and working the plan.  Knowing where the project is every day and that there is someone focusing on meeting every project objective is reassuring. This project focus is the role of Project Management – important no matter what size the company – with consequences being more impactful for smaller ones.

A small company CEO knows that if they miss a milestone, there may be significant consequences. The options include taking on debt, bridge funding, down round(s), or even stopping.  Establishing milestones that are very difficult or even unrealistic to hit is a major mistake, where a more realistic plan may have been just as well received by the funders. A great Project Manager can help set up reasonable and achievable milestones and then manage the plan to hit those milestones.

Finally, no matter where the company is in the process to profitability, in many small companies the CEO or founder is a visionary who thrives on company culture, raising money, crafting a vision for growing the company, and meeting present and future customers. This skill set usually differs from the execution driven nature of Project Managers. We see the Project Managers job as a simple one: Have the CEO look brilliant by making their vision a reality through hitting each milestone on time and budget.