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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To micromanage or not to micromanage: that is not the question. Rather you should ask yourself how each member of your project needs to be managed. And to answer that question, you need to be very aware of the strengths, weaknesses, and personalities of each member of your team.
Some people need the constant attention and are only effective when they are micromanaged. They need the daily check in with the positive (or negative) reinforcement that comes with that. Their ability to focus requires they feel aligned with you and know that they are on track with the project. They need to feel that you care about what they are doing. Are you engaged with them, with their success on the project? Regular reinforcement that you are giving will keep them motivated and driven to accomplish the tasks you have set for them.
Other people are driven by independent accomplishment and do not want to see you on a regular basis. They prefer to be heads down, digging into a project and getting things done. If you stop by their desk for a check in, they assume you don’t trust their ability to get the project done. In effect, they feel their competence, work ethic, or commitment to the team is in question. In some cases, they may shut down if you provide what they perceive as too much oversight. Some people will even quit the project – or the company.
The danger for you as a project manager is that if you get it wrong – you may have a project going off the rails. Did someone need more attention than you provided? They may be way behind. Did someone find your daily chats irritating but refused to confront you about it? You might lose that key person from your team! This is why it is essential from the very beginning of the relationship to invest your political and personal capital in your team members. Find out what kind of management style they prefer and need. And align yourself to that.
In previous blog posts we talked about how projects can go off the rails and also how to prevent them from going off the rails. But those only apply if you are actively involved in the project. If you have Project Managers who report to you, what should you be looking for to know when their / your project is having trouble.
The big “E” on any Project Management eye chart is always whether the project is on time and on budget. The other issues tend to revolve around team chemistry, managing team engagement and holding the team leader accountable. If you think that the project manager isn’t giving you the full status, ask for the next level of detail on tasks that should be completed. If you include slack in your schedule, ask for how much of the slack is used. If you can spend an hour with your manager, have them lay out the full project schedule and ask them to show you where they are.
Here are some additional items to watch for.
Is the Team Energized or Struggling?
When you meet with team members there are clear issues to look for. The best indicator is whether they are interested and excited to be working on the project. When a project is being managed well, the team should be excited to work on something this big, this important and with people so talented. This is true for any good team, whether a medical device project team, sports team or music group. They should enjoy working together and the outward messaging from the team is “enthusiasm”.
Another good barometer for this is whether they buy in to the project. Do the team members believe it will be done on time and on budget? Or do they second guess other team members or the Project Manager? The sense of team cohesion will reveal a great deal about the health of the project.
Third on the health of the team centers around communication: Do they hide issues or work through them honestly? When you have a well-run team, there should be a balance of respect for each other as team members but also a commitment to intellectual honesty to fight for positions they believe are valuable. There will be issues to deal with: working through them respectfully and honestly demonstrates team health. The opposite would be refusing to discuss issues in team meetings and instead gossiping and complaining outside of the structure.
Fourth, it is important to ask how many hours a week the team members work. If you have team members who are burning the candle at both ends on a project, working nights and weekends, the team is poorly managed and you risk burning out quality talent. Often the people who are willing to work too many hours are people most vital to the project or who have embraced a level of responsibility not healthy for the good of the project.
What does the Project Manager need to prove on a regular basis?
Your Project Manager needs to be held accountable just as much as their team members are. We start with the big E: Is the project on time and on budget? The Project Manager needs to be able to prove this on a consistent basis. This means they need to have scoped the project properly, with built in contingencies, plans and even slack. Many things can be anticipated, but there will be things that won’t be.
Your Project Manager must also be able to show that the project will continue to be on time and on budget for the next number of months. To this end, they need to not only show what resources they will need and also how they will garner those resources when they need them.
Finally, your Project Manager should be able to prove that they know what contingencies they should plan for, explain how they anticipate them. There are many tools for this, but that is for a future blog.
These are simple and effective ways for you to know if your Project Manager is doing a good job and whether your project will be completed on time and on budget.
When you are in the medical device space, there is a level of competence and intelligence that you expect from every member of your team. The fact that your team has the ability to design, manufacture, and put a product through FDA testing means they are above average intelligence and capability.
With that said, we also know there are some people who excel even among this rarified air. These are people who are smarter and more clever than the rest of us. They see through to a solution immediately while the rest of us have to work through problems and conundrums to achieve a solution.
When it comes to project management, caution is advised with superstars. Working on a project is a team effort; not one shining star with a supporting cast. Any exceptional talent who works on a team must be able to play well with others, be held to the same standards as each member of the team, and be willing, and even eager, to have their solutions challenged.
Some superstars do not play well with others. And it can be dangerous to have them on your project. You might think you can’t live without them, that they are too important. Their genius tempts you to think they are the only one who knows – or has the capacity to learn certain technical details. Worse yet, perhaps the superstar is favored by management.
Superstars can be solid contributors or they can be a cancer. And if you have a superstar who does not play well with others you must get rid of them immediately. Do not put it off as it can destroy your team and derail your project. It may be one of the hardest decisions you’ll make, and there will no doubt be consequences… but it’s the best plan.
We all know that person who thinks everything will be smooth sailing and there won’t be any problems on a project. The great thing about these team members is that they are positive about the project and bring an upbeat energy. However, balancing a team out with people who recognize there will be hurdles and obstacles to overcome is useful. These realists should help hold the team accountable.
As a project manager, you need to identify which team members are optimistic and pessimistic. If someone is predicting things will be done very quickly and with low stress, challenge their assertions. One method? Dive into the details and learn about the assumptions together.
Further, the whole team should have buy in. To accomplish this, the team has to build the plan, link the tasks, and identify the timelines for what needs to be delivered and when it needs to be delivered. The completion of the whole project depends on each member of the team delivering their part on time and on budget. Intimate knowledge of those interdependencies will help motivate the team with both positive energy and accountability. Regular review of these schedules with the team will both keep the optimists grounded and the project on track.
As the project manager it is vital you know each member of the team, their demeanor for the project, their history with other projects, and what issues they might have with scheduling. Factor that information into your project plan. You also need to know yourself. Are you too optimistic? What is your own history? If you have a history of being too optimistic, be intentional about inserting slack time into the project so that you will hit deadlines and achieve goals.
Finally, with almost every project, the end of the project is a challenge for both the optimists and realists… With your entire team, build enough interpersonal capital in the first two thirds of a project so that when crunch time comes, they know you have their back. And they will have yours. Then the optimists will be right… the project will go well.
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.
In an earlier blog post we discussed how a project can go off the rails. A key cause is failing to scope a project properly. So this begs the question – how DO you scope a project properly?
What belongs in your Project Scope:
There are two key ways to look at this:
- Scope is set by defining what you are going to do
- Scope is set by defining what you will NOT do – this is critical
When crafting a project plan draw a firm line around your product and crisply define what it is and what it is not. At Waddell Group, we put a box around the product that is 25 words or less. The simple version is: what, by when, by whom, and for how much. You may respond that your project is way too complicated to fit into 25 words. Consider this: John Kennedy said in 1962, we will “land a man on the moon and return him safely to earth by the end of the decade”. He could have improved it by adding “for less than $10 Billion….” But you get the point.
Creating a clear and compelling project definition is not something the Project Manager does alone. This must include the team so you have complete buy-in. It will take some time and may not get done to your satisfaction in the first meeting, so be patient and be willing to work for a great definition. This allows the Project Manager and the team to hold everyone accountable to the vision they all agreed upon.
Defining what is specifically not in the project doesn’t go into the 25 words or less. What’s out gets defined in the project plan right under the project definition statement. Useful categories for defining exclusions are: features; where created, where sold (geographies); market; compatibility with other systems; regulatory requirements; technologies; suppliers… The most important exclusions to list are those likely to get included sometime during the project.
Other exclusions to consider: look at what risks you already know. Plan to include those risks or not.
How do you anticipate risks:
We generally see (at least) five different categories of risks, and several of them are not medically driven in nature. These risks are:
- Access to developers/human resources
As you look at the features of a new – or upgraded – product, meet with your team and assess the level of risk for each element and evaluate what is tolerable for the project and what is not. There are many tools for risk assessment. Choose one that you like, and use it.
- For the technology, assess whether the product can be made with what is currently available, and if not what the risk is.
- For cost, do market research to see whether the product can be made profitably in the existing market.
- Human Resources for some areas are in high demand. How confident are you that the ones you need will be there when you need them?
- What is your competition doing and how should you react to them in this space?
- Finally, what regulatory issues will be hard to overcome?
These items have implications company wide and answers might come from areas that don’t normally talk to each other. As you prepare the scope for a project and look to manage the risks, a good Project Manager will include the right people at the table so everyone can make an informed decision about the scope and risks. And frankly, sometimes you must say, “Too Much” – a risk cannot be overcome and so the feature or even the project must be scrapped. It’s better to get this information now. Waiting until your project is well underway can be an enormous waste of time and resource for both you and your company.
How you create accurate estimates and timelines for your scope:
This is less about a calendar and more about the members of your team. In gathering your experts around a table, the Project Manager must put together the best team possible and establish the culture of the group that will drive the project forward. The right team working together on an agreed upon vision can be held accountable to timelines and be amazingly successful. This is less about the Project Manager wielding a stick and more about the excellent team holding one another to the high standard of performance that they themselves want to be held to.
Not choosing the right team or inheriting a team with members who don’t fit may lead to conflict. Even superstars – in medical device as in sports – can either align with the culture or change the culture. If you have a team member who does not play well with others, will they change the culture positively or negatively? If they can’t work with the rest of the team, they need to be kicked off the team. If the Project Manager is responsible for the timelines, then they are also responsible for putting together the team to accomplish that timeline. But that is a blog for a future time….
Once you have created the scope, identified potential risks, and assembled the team who can deliver on time and budget – all you have to do is manage the heck out of the project! But without the proper scope, this task can prove very difficult for even World Class Project Managers.