Medical device product development for Medical Device Manufacturers is a complex process that requires a high level of quality. If you want to ensure the safety and efficacy of your products, you need to focus on quality systems throughout the entire process starting with design and development. In this whitepaper, we will discuss 10 ways to improve quality in medical device product development.
A key place to start with improving the quality of medical devices is product development because it is the initial opportunity to impact the overall quality of what will be delivered. During product development in the medical device industry, there needs to be a clear understanding of the requirements, design inputs, and design outputs of the device and a clear goal. You also need to have a well-defined process for device design and a system for tracking progress and identifying issues. Additionally, you need to have the right tools and resources in place, and you need to make sure that everyone involved in the device design process is trained and understands the requirements, design inputs and design outputs.
Although we could have focused on the business model, business case, supply chain, manufacturing process and other aspects linked to the release of a medical device, the design and development along with the quality systems ensure that the initial device release will be successful.
Common Issues in Passing Regulatory Oversight for Medical Devices
The last thing any company wants to hear is that their medical devices pose a risk. By addressing issues upfront before more serious problems arise, you can develop risk management methods, decide how those risks can be managed effectively, and systematically reduce them where possible.
Typically, a medical device is unable to pass regulatory oversight because of one or more of these issues:
- Medical device design procedures have not been established correctly.
- Medical device design procedures, once established, have not been maintained.
- Records are not kept adequately and/ or do not furnish enough data about the medical device product quality.
- There is a lack of medical device design control management.
- Quality audits have not been established or are not carried out.
- There is no effective corrective and preventive action (CAPA) process.
- Product controls are not firmly established and/or not followed.
- Compliance with regulatory requirements is not verifiable, stored, or validated.
- Ability to manage all of the key elements in an accessible manner.
There is a clear opportunity to improve all aspects of quality early in the design process. For this reason much of what we will cover will be focused on early steps of establishing clear design goals.
Organizations should view this a part of their overall quality journey. The 10 key ways to improve medical device product development are:
- Climbing the maturity curve to better quality
- Focus on ways to improve the cost of quality
- Establish a clear review process
- Define a clear audit procedures
- Utilize feedback loops to improve performance
- Content Management – Clear Documentation
- Corrective Action
- Training Management
- Reporting & Submission
- QMS Tools
1. Climbing the Maturity Curve to Better Quality
The FDA has been aware of medical device malfunctions since 1976 and is working to improve quality while ensuring patient safety.
To ensure that medical devices are safe and effective, the FDA has developed a three-phase approach to quality management for manufacturers:
- Premarket review, when the FDA evaluates a manufacturer’s product before it goes on the market.
- Postmarket surveillance, when the FDA continues to evaluate a product after its release.
- Recalls and corrections, when the FDA takes medical devices off the market if they are deemed unsafe or ineffective.
Medical device manufacturers must comply with these three phases in order to ensure that their medical devices are safe and effective. Climbing the maturity curve to better quality means complying with these phases and taking steps to improve quality throughout the product lifecycle, including items as early as the initial medical device design.
Medical device manufacturers can improve quality by implementing a quality management system (QMS). A QMS is a framework that helps companies identify and control the risks associated with producing and selling medical devices. It also helps companies improve their processes and products to meet regulatory requirements.
A quality management system (QMS) is not just for large medical device companies. A QMS can also benefit companies, and medical device developers, from small through large. Implementing a QMS can help large medical device companies and small medical device companies ensure that their medical devices are safe and effective while complying with FDA regulations.
The bottom line is that medical device manufacturers must take steps to improve quality throughout the product lifecycle if they want to climb the maturity curve to better quality.
2. Focus on Ways of Improving the Cost of Quality
What is the cost of quality today?
For any organization that is just getting started your cost of quality might be zero. However, for any organization that has a device on the market the first question to ask is what is the cost of quality today? Even if you are not managing a recall or patient complaints many businesses can see where there might be problems based on what is happening with the device in the world.
The cost of quality is a term that is often used in business, and it refers to the expenses associated with producing high-quality medical devices. These expenses can include the costs of inspections, testing, and reworking defective medical devices. In the medical device industry, the cost of quality is a particularly important issue to medical device companies because any mistakes can have serious consequences for patients.
One of the most important ways to improve quality in medical device companies is to create a culture of quality, starting with product development. This means that everyone in the company, from top management to the production line workers, is committed to producing high-quality medical devices. A culture of quality starts with leadership and vision, and it must be supported by policies and procedures that are aligned with the company’s goals.
Internal Quality Failures
The definition of internal quality failure is the deviation of a product from its design specification. For the most part, these costs will represent direct costs to the organization. This can be caused by errors in manufacturing, the initial medical device design, or processes that are directly internally managed by a company. To improve the cost of quality, a company can look internally at improving manufacturing, design, or processes that are impacting quality.
External Quality Failures
External quality failures are defined as problems with products that are not caused by the company that manufactured them. These problems can be caused by faulty components, incorrect assembly, and poor manufacturing practices. External quality failures can be very costly for medical device companies because they can lead to product recalls and lawsuits. Correcting external quality failures will require vendor quality oversight and working with suppliers on improving their quality system.
Indirect quality costs
In addition to the direct costs of quality, indirect costs can be associated with poor-quality medical devices. Indirect quality costs can include things such as lost sales, warranty claims, and rework. These indirect costs can be particularly damaging in the medical device industry because they can lead to product recalls and lawsuits. Quality issues that come from indirect quality costs can be just as costly as issues that are internal or external to your organization and they may feel like they are even further outside of your control.
3. Establish a Clear Review Process
It might sound fairly basic. But medical device manufacturers need to have a single review process that drives all product activity.
The review process is a company’s most important quality measure. It should take into account all aspects of medical device design and delivery and ensure that requirements are established with a proper approval process allowing medical devices to move forward for release.
At the core is the issue of quality. Sign-offs are not nearly as important as the need to define and adhere to creating a quality product. Quality assurance needs to be checked and validated at each step in the process.
The results of the review process need to be documented to serve as the reference point for how quality decisions are made within the organization. These documents should describe what happens during the review process and explain why it happened. It won’t be too helpful if you just jot down a checklist of tasks without explaining why they were done or what was found during each activity.
One thing to keep in mind: this document should be easy for anyone at your company to understand and use. That way, they can make decisions based on quality principles instead of simply checking boxes.
So, how do you develop and implement a review process that will help your medical device manufacturing business? The following steps can serve as a guide:
Step One: Define the Process
To start, you need to define what the review process will look like. This includes understanding and documenting the steps that will be taken, who is responsible for each step, and what is expected of them.
It’s important to understand the product development cycle, so everyone is on the same page. This includes understanding the different types of reviews that will be conducted and when they are needed.
Step Two: Assign Responsibility
Once you have defined the process, it’s important to assign responsibility for each step. This will help ensure that tasks are completed in a timely manner and that everyone knows who is responsible for what.
It’s also important to have a designated contact person who can help answer questions and provide guidance throughout the process.
Step Three: Establish Guidelines and Requirements
In order for the review process to be effective, you need to establish guidelines and requirements that everyone must adhere to. This includes developing standards for product design, manufacturing, and testing.
It’s also important to define what is considered a quality product and establish procedures for handling non-conformances.
Step Four: Implement the Process
Once you have defined the process and assigned responsibility, it’s time to implement it. This includes providing training to all employees who will be involved and establishing procedures for documenting the review process.
It’s also important to have a system to track products throughout the development cycle. This will help you ensure that all requirements are met prior to releasing a product into the market.
Step Five: Evaluate and Improve
The final step is to evaluate and improve the process. This includes assessing how well it is working and making changes as needed.
It’s important to continuously evaluate and improve the review process to ensure that your products are of the highest quality.
Having a review process in place is essential for any medical device manufacturer. It will help you define and adhere to quality standards, ensure that products are ready for release, and improve the overall process. By following these steps, you can develop and implement a review process that meets your specific needs.
Define Clear Program Requirements
Medical device manufacturers need to understand and define the critical steps in the design and development process.
This includes all activities from the definition of a requirement through validation, including reviews for each step. In some cases, additional review programs are needed to track particular aspects of medical device design or production. Standardization is key here; without it, there will always be questions.
Program requirements often change due to the evolving needs of manufacturers and regulatory bodies. These changes can include new requirements that must be met or revisions that need to be made in order to maintain compliance with current standards. As such, it’s important for all parties involved in a program — engineers, managers, and quality assurance personnel — to stay abreast of these changes.
Discovery and Concept to Design Controls
It is not enough to simply have a process. You also need to implement the necessary checks and balances.
Quality points should be identified in your QMS and then implemented as per checkpoint protocol: design review, prototype validation, or verification of requirements fulfillment, for example. This will ensure that important steps that may get overlooked are being completed.
Consider validating your process to ensure it is working as intended and meeting standards. Validation could be in the form of tests, inspections, or verification testing. Either way, it will give you feedback on how well your processes are operating and allow for adjustments if needed.
4. Audit Procedures
While establishing audit procedures is a good starting point, it isn’t quite enough. The more important part of this step is using the audit process to identify where quality is not being met and rectify it immediately for your medical device. This alone can help medical device manufacturers increase the quality of bringing their medical devices to market.
In our experience, there is a direct correlation between the time quality issues are detected and the speed at which a medical device passes regulatory compliance scrutiny and is brought to market. The quicker you can detect and address a quality issue, the better for your company.
Taking audit and driving actions to strengthen the processes in your organization will not only help the quality of a product it will also improve organizational performance.
5. Utilize Feedback Loops to Improve Performance
Quality is not a goal. It’s a guiding north star that is never fully achieved.
Every action in the product life cycle requires a new review to ensure the appropriate level of quality is maintained in each medical device. One of the best ways to make certain that a quality issue has been caught as early as possible is to create an environment where employees feel comfortable reporting any mistakes or anomalies they find in their work product. The longer the feedback loop, the more opportunities for delays and potential problems. If you’ve got slow-moving feedback loops, it’s time to adjust your quality processes and find ways to tighten them.
A QMS can help your team establish and adhere to a regular loop of feedback among stakeholders and decision-makers. This allows for fast action and enables you to quickly address problems that might otherwise impede medical device development process. Feedback loops in your QMS should include discussions about process improvement and should not be limited to information sharing alone.
6. Content Management-Clear Documentation and Traceability
Standards bodies and regulatory bodies will want to review everything related to product development. If any documentation is missing — or perceived as missing because it is poorly organized — it will raise a red flag that could cause an unnecessary delay in development.
Content management best practices
- Organize the data by type and use structure to make it easy for everyone involved in the product development process or compliance workflows to find what they need when they need it.
- At a minimum, you should have these content types: standards and regulatory documents; quality system documentation, including SOPs; work instructions; and other documents.
- Make sure all related items are stored in the same location so the people who need them can find them easily.
- Create an inventory of what you have to help meet this goal. Content managers will also want to think about organizing content from a functional perspective. This would make it easier to find content that relates to specific aspects of your business.
- Distribute content regularly so people can work with the most up-to-date information.
- A key component of your QMS should be content management. This includes storing data and documents, identifying where they are stored for future reference or audits, and organizing content to make it easy to find the right items when needed.
- Simply put, content management should be a core part of your QMS — not an afterthought.
7. Corrective Action
CAPAs are meant to alleviate poorly designed processes and rectify issues before they completely derail projects. However, too often the items being corrected are not tracked. A common reason corrective actions are not taken is because they were forgotten or ignored, and there was no documentation to remind management of the issue. Documenting your CAPA helps you track how quickly you’re resolving these issues as well as show other departments in your company that you’re taking these issues seriously.
When startups and small organizations who are working toward market approval are evaluating QMS systems, CAPA isn’t always prioritized. Since your organization doesn’t have an active need for CAPA, you may simply choose to verify that a QMS offers that capability and focus on modules that meet your current use cases. However, data on the most frequent causes of FDA warning letters tells another story.
Your organization can avoid regulatory compliance risk and derive business value from your CAPA system by selecting a robust solution that’s fully integrated with your QMS suite. When CAPA processes are automated and linked to surrounding quality systems, you can avoid regulatory risk and take a proactive approach to root cause analysis and preventive/corrective actions.
CAPA’s are important to auditors because they provide a snapshot of an organization’s quality management system at a specific point in time. By identifying and resolving CAPA’s, an organization can demonstrate that it has effective controls in place and is continually improving its processes. Auditors use CAPA data to determine whether an organization has had any major issues with quality that have not been resolved. In addition, auditors can use CAPA data to track the progress of an organization’s quality management system and the risk management practices.
CAPA’s are also important to regulators because they provide insight into how an organization is managing risk. As part of its regulatory mandate, a regulator wants to be sure that organizations are taking proactive steps to identify and correct any issues before they become bigger problems. CAPA data can help regulators assess whether an organization is effectively managing risk and complying with regulations.
Self-identified CAPA’s that are resolved in the organization demonstrate to auditors and regulators that the organization has taken ownership of their quality and process improvement initiatives. A well-defined CAPA program demonstrates that an organization takes compliance seriously, is capable of effectively managing risk, and continually strives for excellence in quality.
8. Training Management
Training is a critical piece of the medical device production process. Maintaining a unified understanding of the training process and ensuring that everyone on your team understands how it fits in with their day-to-day responsibilities is critical to improving quality.
How can you prioritize training in your culture?
- View training as an ongoing process that’s based on the needs of your team and company culture, not something done once or twice per year.
- Educate your leadership team about the importance of training.
- Set measurable goals for training, and then measure how well you’re meeting those goals.
- In many ways, training is all about getting all players on the same page, and a QMS acts as a collaboration and communication tool to help make sure that happens.
9. Reporting & Submission
Reporting and submitting quality data can be a time-consuming task.
Developing the right reporting mechanisms helps ensure that teams report quality metrics in an efficient way and on time, so they’re not forgotten or overlooked.
Your QMS maintains a continuous record of all actions around the medical device product development. When you are required to communicate with the FDA or ISO, it can help to pull necessary data and deliver it for review.
In between regulatory reviews, your leadership needs to be continually monitoring what is happening with your product(s).
What’s more, a QMS helps you manage internal quality audits and other regulatory processes so they’re done in a timely manner, with no errors or omissions. That way, your company can identify the right data to report and submit while being confident that it’s accurate and compliant.
10. QMS Tools
The tools that can help with quality management starts with the evaluation of an eQMS. An electronic quality management system (eQMS) is an online quality management software system that enables you to manage quality processes in a collaborative environment.
When selecting an eQMS, make sure the solution is fully integrated with your company’s existing QMS processes. From product development to complaint handling, having a tool to rely on will make reporting easier when audited or visited by a regulatory body.
In the past, a large medical device company might custom-build an eQMS solution. However, today that same large medical device company is looking at leveraging a ready-built system that will keep them compliant. The core competency of most organizations revolves around the patients they serve rather than developing tools like an eQMS tool. Additionally, companies that build these tools can leverage more collective knowledge about the regulatory environment and how to best keep people compliant.
Even in the smallest of companies, I have seen them implement an eQMS because it helps to have a clear repository as the organization grows and an eQMS will aid the organization in ensuring that minimum regulatory requirements are met.
When shopping for an eQMS, these are some key considerations to keep in mind:
- The size of the company
- The company’s maturity curve
- Specific needs that must be met
- It is important to find an eQMS that will grow with the company as it matures
- The system should also be able to accommodate the business’s specific needs, such as product recalls or quality audits.
Note: A system that is too complex or not adaptable may not be worth the investment.
When evaluating an eQMS, it is important to consider how well it aligns with the company’s overall business strategy. The system should support quality initiatives and help the organization achieve its goals. It is also necessary to assess how easy the system is to use and whether staff members are comfortable using it. If not, adoption rates will be low and the system will not be effective.
It is important to keep in mind that an eQMS is a long-term investment, and it may take some time for the company to see the benefits. However, with the right system and commitment from management, the benefits can be significant.
Navigating Medical Device Regulations
Medical device regulations are created by the FDA, and as a result, they require all of those in the medical field to adhere to strict guidelines. However, these regulations can create challenges for companies that want to produce appealing medical devices. These guidelines must be obeyed at every step of the process, from design through manufacturing and marketing – but if your company is not large enough or has too small a budget, it may be difficult to comply with these regulations. This article will provide some tips on how smaller companies can navigate this regulatory environment successfully.
Find out what you need to know about medical device regulation before starting your project: You’ll need more than just an idea for a product; you’ll also need an understanding of how devices are classified and the specific requirements for your product type.
The medical device industry is highly regulated by the FDA. In order to produce a quality product, it’s important to be familiar with the regulations that apply to your product type. You can find detailed information on the FDA website, but here are some basics:
A medical device is classified into one of three categories based on their risk level: Class I (low risk), Class II (moderate risk), or Class III (high risk).
Each medical device class has its own specific regulatory requirements, which you can find on the FDA website.
If you are not sure which medical device class your device falls under, you can submit it for premarket review to help determine the correct classification.
Knowing the basics of medical device regulation is essential for any company looking to produce a quality product. You’ll need to understand which class your device falls under, as well as the specific requirements for that class. You can find this information on the FDA website, but it’s important to remember that these are just general guidelines – you should always consult with a regulatory expert if you have any specific questions.
Medical device regulations can be daunting, but they are in place to ensure that medical devices entering the market are safe and compliant with standards. By familiarizing yourself with the basics of regulation, you can make sure your product meets all necessary requirements and avoid costly mistakes down the road.
-If you’re not familiar with medical device regulation, it’s important to consult with a regulatory expert before starting your project.
-In order to produce a quality product, it’s important to understand the regulations that apply to your product type and seek expert advice when necessary. By doing so, you can avoid costly mistakes and ensure that your product is safe and compliant with standards.
Having a strong product development system that is aligned with your QMS will be a competitive advantage for your organization that will be key throughout the entire product lifecycle. It is essential to have a quality management system in place that will help you meet medical device regulations and improve your product quality. Additionally, it is important to have a QMS that is easy to use and adaptable so that it can grow with the company.
Climbing the maturity curve to better quality requires a commitment to quality from top management, designing medical devices with quality in mind, and continual improvement throughout the company.
Producing a quality medical device is essential for any company looking to enter the medical device market. In order to make sure your medical devices meet all necessary requirements, it’s important to be familiar with medical device regulation basics and consult with a regulatory expert when necessary. Additionally, quality must be top of mind from the very beginning of the design process, and continual improvement must be a part of your company culture. By doing so, you can ensure that your medical devices are safe and compliant with standards – and that you’re on your way to climbing the maturity curve to better quality.
Links for more Information
For more information on medical device regulations, please visit:
- The FDA website: Code of Federal Regulations
- The Medical Device Manufacturers Association (MDMA) website
- The International Medical Device Regulators Forum (IMDRF)
If you would like to talk with someone about implementing a QMS or an eQMS tool please schedule a time on our website: www.5280lsc.com.