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:
- Start Ups: They don’t have a quality system and need one
- Mature Company: Have a robust quality system
- 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.
Abraham Maslow theorized that we as humans have a hierarchy of motivation that transcends from getting our basic human needs met to stay alive all the way through self-actualization. As a team of project managers, we see the same kinds of dynamics at play in the hierarchy of what a project team needs. Waddell Group segmented four levels of team quality and identified the qualities of each. Further, we have identified attributes of these stages to enable identification of the level or stage at which your team operates.
The categories of teams are Adequate, Good, Great and Elite. Within each category exist several consistent sub-categories: The level of talent of people you have, how these teams deal with challenges, how risks are dealt with, what kind of manager oversees the project and how they motivate the team.
Project teams all have certain needs: they need people, tools, funding, a communication structure. Without these, no project can get done. With an adequate team you must have enough people and funding to make sure the project gets done. These projects have a project manager who runs the project.
However, these projects face hurdles because of the talent of the team. Adequate teams often get derailed by things like scope creep, unanticipated delays, costs, or quality issues. The product or service meets baseline requirements. Sometimes a superstar dominates team performance which can cover up the shortcomings of other team members or inhibit team members from fully participating.
Adequate teams can be proving grounds for new team members. They will have to learn how to deal with challenges like scope creep, superstars, funding and hurdles. These can be very educational. Team members who can succeed here will move up the hierarchy of teams. Team members who remain here are likely a corporate liability.
Good project teams differentiate themselves from Adequate teams in the level of quality of their team members. These teams have the appropriate level of talent for their project. A sense of teamwork exists which motivates each member to do their best. The Project Manager inspires individual team members to be great in their role on the team. And because of the level of talent and experience on the team, risks are anticipated, and a plan is put in place to manage them.
Good teams get projects done on time and on budget most of the time. While a good team might encounter scope creep, it is usually managed. These teams also have good communication and an Esprit de Corps. And the result of having a good team on a project is that they product a quality product or service.
When you want a project done on time and on budget always, you put together a great team. A great team anticipates challenges because they have the level of experience and talent to know when those will arise. The team is committed to each other and to the team winning and the project manager in place inspires moments of team greatness.
When you have this level of talent on a team, the product or service exceeds the customer’s expectations. The morale of the team is heightened because of their ability and enjoyment of working at that level. Challenges are embraced by the team to grow and learn.
Members of Elite Teams tend to get scooped up to lead other teams. But when they are allowed to exist the company wins because that is what the team members are committed to. These teams anticipate and embrace challenges. And the project manager inspires continuous team greatness.
Because of this, these teams execute at a level other teams seek to imitate. These teams are in high demand because of their rarity.
Team members have a better work life – and quality of life in general – when their projects are meeting milestones and communication is really working. Companies benefit from the improved ROI on their teams’ output as well.
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.