There are multitudes of articles and books that contain advice on how to be a great leader. But what if you’re like most of us and not at the top of the food chain? In most teams, there is one leader and a team of people doing the work. While we like to place the responsibility for a project’s success or failure on the leader, every team member has ownership and influence in how a project turns out. Your contribution to the project must make a difference, otherwise you wouldn’t be there for long. The core responsibilities of being a good team member will help you stand out and succeed no matter where you fall in the chain of command.
Integrity in a team is doing what you said you would, doing what you know you should, and holding team members to account for what they said they would do. This positively influences those around you. For core principles, none are as important as integrity. If you lack integrity, the whole project is at risk no matter where you are in the chain of command because all the following core responsibilities discussed here will fail.
Without doing what you say you will, the team will not trust you. Lack of honesty creates unpredictability within the team structure. You must do what you should as well. More than merely following through with your commitments to the team and the project, doing what others will expect of you positively builds at the core competency of the team. Simple examples are to be on time, work hard, and contribute to the team.
Finally, integrity involves more than self-discipline. It also involves holding your team members accountable for what they said they would do. It may be that they need your help in getting their part of the project done, and providing the information or help they need can be critical to the overall execution of the project.
The great thing about integrity though, is that no one’s integrity is perfect, and we can all improve starting now. Haven’t been doing what you said? Create some structure such as writing down what you agree to or get a planner. Every improvement in this core principle makes a very positive improvement to a team.
Like any good team or partnership, running a project requires strong communication between team members and the project manager. Strong communication between team members with the project manager allows the project manager to do their job effectively. Strong communication between team members works to educate the whole team on the issues addressed in different parts of the project. You and your team members are smart people. Review project issues with your team members and you will find better questions and better solutions for your problems.
If we want to be able to trust that our communications will be effective, we must be honest and observant. We must understand each other’s communication style. If we are always direct, we may come across as harsh to someone who wants things presented more gently. Conversely, “gentle” may come across as “salesy” or “fake” to your team members who prefer their facts undiluted. Keeping in mind how others in your team communicate will help you be an effective team member.
Things change. We can either be adaptable to change or not, and all of us should understand that things change. Your level of adaptability to change makes you more or less valuable to your team and the project. Our adaptability gives us the potential to learn new skills and work with different people to make projects flourish.
As an effective leader, fostering an environment that allows the team to handle change, and even thrive when it arrives, will help your project excel. Adaptability means that you and your team won’t be tied to a specific solution; you are given the freedom to choose the best solution under the circumstances. One way to foster this kind of environment is by anticipating that things will change and factoring that into the roadmap for the project. Having a buffer of extra resources – time, talent, or money – will help relieve pressure to conform to the strictures of the project.
Treat others the way they want to be treated. Apply integrity to respect; this rules out disrespect and gossip. Team members who do not respect each other will kill projects.
Each of us wants our boss to know how best to motivate us; money, praise, and special favors are common ways they can do that. Similarly, when we work together on a team, we can do the same thing for each other. It is not uncommon to ask people to do something extra on a project or to call on favors for your project. Figure out how you can reward those sacrifices to show that you appreciate the team member making that sacrifice.
Perhaps you are in one of these camps: “Yes We Can!” or “Make Our Project Great Again!” Having a positive attitude has an extraordinary effect on the project outcome. This attitude can be encouraged from the top but if it really exists, it does so because of the belief of the team members. When it comes to projects, you might be in one of two camps: Team Team, or Team Project
Each team, at its core, basically states that we know we can all get the job done if we work together. The difference between the two is whether they rally around either the greatness of the team or the greatness of the project. Sometimes this might be an individual sense of contribution to be on an amazing team doing something so important.
Our education doesn’t end when we graduate from college, or when we get our various certifications. You have a great opportunity to learn with every project you work on. You get to see what does work and what doesn’t work. You’ll experience up close how “things change” can impact a project and its team members. Take this opportunity to learn.
Learn what works best. Learn how people respond to adversity. Learn about your team members, how they communicate, how they are motivated, how they deal with change, how they exemplify integrity.
Ultimately, understand what works and why it DOES work. This will prepare you for the hurdles of future projects where you can continue to be an outstanding team member.
By Tom Waddell: [email protected]
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:
And these are from top tier industry consulting groups:
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.
Begin with the End in Mind: This is the second habit Steven Covey lays out in his famous book, The Seven Habits of Highly Effective Sales Leaders.
The reason this habit is so important is that it aligns all tasks, projects, and talent toward a single purpose. This habit also provides a framework to eliminate tasks and projects that will not help accomplish the end goal.
With major regulatory shifts occurring in the medical device industry it is imperative that device manufacturers know exactly which “end” to keep in mind. Falling out of compliance with these new regulations comes with a tough consequence: your device may be pulled from the market.
When it comes to staying compliant with MDSAP, MEDDEV, ISO 13485:2016 or MDR, resources are going to be constrained across the board. Audit times are increasing, Notified Bodies are swamped or are closing, access to talent is becoming more scarce, the timeline is tight, and there is a lot of competition. It is vital that you manage medical device compliance projects as efficiently as possible.
So, Where to Start?
In simple terms, a Gap Analysis is needed. Create a comparison document between the current state of compliance and the required future state of compliance. This analysis will identify which compliance requirements are already being met and which ones the product fails to comply with. This gives a clear “end” to which the team can focus. Anything which does not align with these goals must be eliminated to best maintain efficiency.
Once the Gap Analysis is complete, identify the new regulations to comply with and create a list of changes from the previous regulatory standards. Also consider the regulatory impact changes will have on the product under each particular governing country.
With standards changing in Europe, Canada, Asia, and Australia, there may be overlap in regulations. This may enable reuse of some work for multiple regulatory bodies. Dig into and understand what documentation standards you will need to meet. Streamline this process by compiling a list of clinical trials, testing standards, and post-market surveillance to compare against new requirements.
Connect with your Notified Body.
Some Notified Bodies no longer exist and you may need to find a replacement. If yours is still operating, find out where each of your products are in their queue.
Find the Talent.
Begin identifying the talent and resources needed, and when, for this project. With all the competition for talent, it may take extra time to secure the right people on the best timeline. Both the timeline for available talent as well as placement in the queue for the Notified Bodies will require quality project management skills.
Make sure your project is ready when those resources are allocated to you.
The stakes are high and you have a lot on your plate.
If you are concerned about the upcoming medical device compliancy changes, the time to act is now. A Gap Analysis from the experienced team at Waddell Group will get you pointed in the right direction. We work with companies to perform gap analyses for medical device compliance, help maintain compliance, and manage the projects that spin out of these compliance initiatives.
See how we can help you!
The Notified Bodies are already very busy and our medical device manufacturing clients are already seeing increased audit times. Several European Notified Bodies are no longer taking new clients with the onset of MDSAP (inclusive of ISO13485:2016), MEDDEV 2.7.1 Rev. 4 & MDR. This is the beginning of a 3 year debacle for medical device companies.
These substantial regulatory reforms are now underway and will be required over the next 3-5 years:
MDSAP will become the mandatory replacement for the CMDCAS certification to support Canadian device approvals on January 1, 2019
This is only 3 months before the end of the ISO 13485 transition. The timing is unfortunate, so starting that process now is a necessity.
NOTE: Europe will likely also have joined the MDSAP program, making additional effort for the notified bodies. Brazil, Japan, Canada & Australia are currently a part of this common audit.
The ISO 13485:2016 transition will occur between March 1, 2016 to March 1, 2019
Issue of new certificates to ISO 13485:2003 are no longer permitted or almost impossible to get (but expire March 1, 2019), and those seeking new certification after March 1, 2018 must be to the 2016 version of the standard.
MEDDEV 2.7.1 Rev 4
Update from Rev 3 includes these significant items:
- Clause 6.4 introduces specific requirements for expertise & experience of CER authors / evaluators
- Revision 4 makes the requirement for the objectives of the CER to be linked to specific safety, performance and risk-benefit endpoints clearer
- Clause 8.2 provides more detail with respect to establishing and documenting the state of the art and available treatment options
- The new revision places much greater emphasis on demonstrating the scientific validity of data, including statistical considerations
- Appendix 2 describes key considerations relating to device risk and how manufacturers should determine if they have sufficient clinical evidence
- Appendix 7 provides guidance on the analysis of data to demonstrate device safety and performance
- The links between clinical evaluations, PMS and PMCF are reinforced. Appendix 12 highlights the requirement for Notified Bodies to ensure that PMCF is planned and appropriately justified in light of the data retrieved and conclusions documented in the CER
MDR has been approved and published as of May 5, 2017 (enforceable May 26, 2017)
This kicks off a 3 year transition for medical devices ending in early May 26, 2020 (the IVD regulation has a 4 year transition).
Notified Bodies must become accredited to the new regulations and it won’t actually be possible to start issuing certificates to the new regulations until early 2018.
The European Union is already considering granting grace periods to medical device manufacturers whose current certificates expire in the middle of the MDSAP transition, in case the Notified Bodies are not yet qualified to certify to the new regulations. Your medical devices may also be reclassified under this new standard to require more vigorous standards.
What does this all mean to medical device manufacturers?
It’s going to be unbelievably busy over the next two years.
By then, the European Notified Bodies especially will be trying to deal with CE and ISO 13485 transitions at the same time, while also meeting the higher assessment standards under the new regulations. Their international (especially North American) divisions are going to be in the thick of MDSAP audits as well as ISO 13485 transitions.
The four big questions you need to ask are:
- What devices do you need to prioritize?
- Have you performed a gap analysis to help you decide what you need to do?
- How long will it take you?
- What resources will be required to recertify?
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.
Deciding which devices to prioritize, providing an accurate scope of your medical device compliance project, and constructing a plan to make sure your recertification happens on time and on budget. Waddell Group is here to make you more efficient and effective.
Our project managers are familiar with the regulation changes reviewed above, and are eager to help your company with preparation of changes.
Call us today to learn how we can help your company through this transition!
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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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.