In our previous blog post, we highlighted how the right management and development approach to your quality system can achieve competitive speed to market in the current medical device landscape. It can improve your medical device development time to clinical studies enabling you to do more projects simultaneously. And should those projects be successful, improve your profits.
In this post, we will continue the conversation by looking at three quality system management approaches taken by medical device companies. And how that will – or won’t! – align with your product development strategy.
The three kinds of medical device companies and their quality system management approaches we will look at:
- Start Ups: They don’t have a quality management system but need one.
- Mature Companies: They have a robust quality system, but it’s not optimized for speed and profitability.
- Companies that customize their quality system at each stage for their current project.
Let’s take a deeper look at each of these three approaches for quality system management. And figure out which is the best for your company.
1. For a medical device start up, building from the ground up.
We worked with a client down the development path. When we asked about his quality system, he was raising money and designing his product. His blank look made us panic – and his panic matched ours when we explained our concerns.
- How would they achieve uniformity of the medical device when in mass production?
- How did he intend to meet all the quality systems regulations?
- What would be his answer when a customer asks for a QMS certification or quality assurance paperwork?
- How would he mitigate risks, if any, if one of his devices malfunctioned or was ineffective?
- How would his team know what to work on at every stage of his quality system without his input? What about new staff training without systems in place?
And on and on they went.
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. Leading us to approach number one:
Identify the specific quality modules needed for a particular project to get to the company’s established goals – WITHOUT bloating the quality system with non-essential processes.
In this case, our client had a product they needed 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 an entire quality management system and just built the development portion of it. This would allow them to get proof of concept. They then had the choice of selling off the product to a company that could take it through manufacturing or raising more money to do that themselves.
If you are a medical device startup looking for expert project management consultants to right size your quality management systems, get in touch.
2. For mature companies with comprehensive systems in place
We have several mature medical device company clients with extremely comprehensive quality systems in place. On its face, this makes sense: A mature company should have a thorough quality management system. But this proves to be a problem when the company makes ALL projects go through the complete quality system regardless of the project requirements and goals.
In our previous post on profitability, we highlighted how medical device companies try to build a system that anticipates every possible problem and builds a plan to remediate it. This is approach number 2. However, this approach may cause unnecessary bloat and does not drive profits.
While a small company is forced to be efficient to save cash, mature companies do not have to go that route. So they will put a new product through their manufacturing quality system despite not having 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 the market or your product is the development of another proven product already on the marketplace.
Still, this is a prime example of how a very robust quality system erodes your company’s profitability. Major market companies have often turned to outsourcing their projects to avoid this erosion.
3. For companies that already use a customized approach for managing their quality system
We have seen medical device companies – both small and large – effectively stage their quality system requirements for each production level, only doing what is necessary to hit the next benchmark. This approach is beneficial for projects where entry to the next level of the quality process is not guaranteed but depends on the results of the previous stage.
For example, you might approve a simplified inspection process for each product when building prototypes for a clinical trial. There may only be 30 units to inspect, so doing so manually makes sense. Only when you approach manufacturability, you will be making thousands or more. At that point, you will need to build a system that encompasses the machines you used, automation of your inspection tools, auditing systems, and many more elements. So why spend the time and money building these systems now unless you know they will be used?
However, with this approach, the profitability of the project is not always a surety.
For example, when you approach the design element of your project, you can have just the quality system needed for the design work. When you complete clinical trials for your device and know what you have, you can determine if you’re going to the next step.
If the clinical trials are successful, 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 medical device. However, suppose the clinical trials are unsuccessful. In that case, 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.
With the right project management consultant at the helm, these uncertainties can be mitigated – if not outright avoided – by effective planning and controlled staging of quality systems.
Right sizing your quality system
Any medical device project management consultant worth their salt would first identify the reason behind the project and its role in the company’s development. Then, depending on the company’s size and resources, they would choose (with appropriate customization) only those quality system processes essential for making the project reach established company goals more expediently.
Contact the Waddell Group about Your Company’s Quality System Needs
If you are a medical device company looking for help to right-size your quality system, we should talk. We provide strategic-level project leaders specifically for the medical device industry. Beyond essential project management skills, our highly experienced consultants know how to lead teams, manage in times of crisis, and influence change. With expertise, intellectual property, and proven methodology, the Waddell Group has world-class project managers who are smart about project business drivers – including profits! We get the job done so you can rest easy knowing your company is heading in the right direction. Contact the Waddell Group today at 952.221.3333