It's no secret that MedTech companies are growing rapidly, often struggling to keep up with their own pace. Evolving regulations and rising customer demands add to the challenge. All these factors make it difficult to maintain efficiency and deliver consistent innovation.
While there is no silver bullet, one core area MedTech companies must focus on is quality management. Investing in high-quality management solutions is crucial for upholding the highest standards in products and services, complying with regulatory requirements, and adhering to safety protocols.
In this Q&A, we sit down with Jimmy Graveley and Sara Örsing, quality management experts at Columbus, to discuss the challenges MedTech companies face and explore effective strategies to address them.
What do you see as the biggest challenges facing MedTech companies today?
Sara Örsing: One of the major issues is managing the complexities of growth. Many MedTech companies experience rapid expansion, with some even reaching ”unicorn” status. This rapid growth brings with it unique challenges, such as scaling operations efficiently while maintaining consistent product quality and compliance across different regions.
Despite their success, it's quite common for these companies to struggle with transitioning from traditional paper methods to digital solutions. This reliance on outdated systems makes it harder for them to meet compliance with rules and regulations, especially when they need comprehensive traceability and version history.
Jimmy Graveley: True. I would also add regulations to the equation. We have seen just how important it is for companies to align with FDA and EU regulations, especially when launching new products and expanding globally. Take, for example, a case with a company that recently got inspected by the FDA. They found out this company had not fixed issues from 10 years ago, leading to some of their products being pulled from the US market. This type of regulatory enforcement can be a huge hurdle. Even though there might not be fines, losing market access can be devastating.
The MedTech industry has also been dealing with changing regulations in recent years, affecting Class I, II, and III products. For example, there have been significant changes in Class I, which now includes products such as cosmetics, skincare, and plasters. Many of these companies are new to these regulations and are still figuring out what they need to do. There's a bit of a learning curve as they adjust to regulatory requirements.
The EU has also introduced the Eudamed database, where all products need to be registered and produced devices given a unique identity number (UDI). Although this has been postponed several times and currently registration is mandatory from Q4 2024 and UDI from Q2 2026, it remains a significant challenge for MedTech suppliers to understand these new requirements and align their processes.
How can MedTech companies overcome these challenges?
Jimmy Graveley: As companies cannot impact the number of regulations and requirements, they should focus on simplifying the processes surrounding them and the ways they track compliance. At the core of this are quality management solutions. They can help MedTech companies streamline operations, optimize workflows, and improve traceability during product development and manufacturing.
Digital quality management solutions also help to automate several key processes. For example, when an updated version of a document is released, these solutions can automatically notify relevant team members for training, ensuring compliance and making life easier for quality managers. With information accessible for any user anywhere and various user interfaces and portal access, these systems are designed to meet diverse needs.
As Sara mentioned earlier, many MedTech companies still rely on paper, which might be fine for now, but rapid growth can make this outdated quickly. Managing documents and training with paper is tough.
Digital solutions help meeting requirements in an efficient way, with comprehensive record management, which is crucial for FDA standards and other regulations. Plus, you need solutions that are flexible enough to grow and adopt with and to your business. These systems have been validated many times by other businesses, proving they are indeed reliable.
Sara Örsing: I totally agree with Jimmy—going digital simplifies everything for MedTech companies, helping them be ready for any scenario. For example, we see when MedTech companies in Sweden enter significant agreements with the healthcare system, they must guarantee consistent delivery and product safety. To achieve this, they need a quality management system to minimize risks.
Trying to manage this with paper trails to show version history and signoffs is extremely difficult. While many companies use systems like SharePoint for QMS, it's not a dedicated solution, making audits and daily tasks challenging for quality managers. Solutions should be configurable as the company grows, allowing for flexibility in adapting to changing regulatory requirements and operational needs over time.
Both of you emphasize the importance of configurability in quality management solutions. Is that really so important?
Sara Örsing: Yes, it’s extremely important. Some MedTech companies think they can get by with a non-configurable solution, but as they grow and need to comply with different regulations in various countries, it gets complicated. A locked solution can't be adjusted, so future growth means needing a new system, which is risky. This is because data might not transfer smoothly, or you might have to do it manually, which could turn into a massive project. A new system usually also means new processes, new training for people, and new investments.
Jimmy Graveley: MedTech companies are often not aware of the benefits of configurable solutions.
We had a client working with Class I products. The UK market considers their products Class II, requiring stricter control and documentation. They switched from SharePoint to our QMS because they needed better control over their documentation and records. So, when market requirements change, having a flexible system is crucial. The solution we work with also supports compliance with regulations such as FDA or MDR/IVDR, ensuring robust compliance features are in place.
How would you recommend implementing quality management solutions?
Jimmy Graveley: Implementing quality management solutions is not just about the software; it is about making sure processes and documentation are easy for everyone to access and maintain, no matter what business systems they are using—ERP, CRM, or so on.
That is why integration is so important. For example, having the relevant standard operating procedures (SOPs) or work instructions directly accessible in the ERP system during daily work easily accessible reduces effort and helps ensure compliance. Another key part is validation.
When companies introduce new systems, they also need to make sure everything works as intended and meets regulatory standards. So, delivering a quality management solution means you must validate it to ensure it ticks all the regulatory boxes.
A good partner will offer comprehensive support here. They should also provide test scripts, installation guides, and procedures to help with this process. Often, the validation project runs alongside the implementation and can be just as big or even bigger. This support extends to ensuring full control of internal and external audits and resulting CAPAs, which are crucial for maintaining compliance and quality standards.
For example, we worked with a MedTech company where we provided a comprehensive QMS solution. We integrated it with their existing ERP and CRM systems to streamline their documentation and training processes. This not only ensured compliance but also significantly reduced the burden on their quality managers.
What are some other real-life examples of MedTech companies that have benefited from implementing new quality management solutions?
Jimmy Graveley: I recently worked with a company that went from a small team to over 100 employees. They were growing quickly and needed to move away from paper-based systems. The main challenge was managing documentation and compliance as they scaled.
We helped them transition from paper-based processes to a comprehensive QMS solution, adapting to their rapid growth. Now, they have a fully digital QMS that supports their growth and compliance needs.
Another company we worked with was using SharePoint for their QMS. But it was not giving them the automation and oversight they needed. They required more than just document storage; they needed a system to support daily processes and track compliance, such as for example tracking who has completed what training.
We are about to kick off a QMS project for them soon, which will provide the automation and process support they need. The system acts like a co-worker, telling you what to do and when through advanced workflows and assignments.
How can advisory services help MedTech companies maintain high-quality management standards?
Sara Örsing: When I work with my clients, I always emphasize the importance of starting with a robust digital system. Transitioning from paper or outdated systems to digital quality management solutions is crucial for ensuring compliance and scalability right from the beginning.
My role is to provide strategic advice to help MedTech companies implement and scale their quality management solutions effectively. Our comprehensive, integrated solutions encompass more than just a quality management system; they include document management, training management, and automated workflows to ensure both compliance and efficiency.
Jimmy Graveley: From my experience, it is not just about going digital; it is about seamlessly integrating every part of your quality management. When working with clients, we offer template solutions that can be customized to fit each company's specific needs.
This approach ensures the system is effective yet straightforward, especially for those transitioning from paper-based systems. By automating these processes, we help companies stay compliant and reduce risks, allowing them to focus on what they do best.
For MedTech companies, our advisory services extend beyond quality management systems. For instance, our product documentation system ensures compliance and traceability, which is crucial for product development.
We also provide solutions for managing accounting documents to maintain accurate records of all business activities, like test protocols and transaction records. Additionally, I help develop and validate governance models to ensure clients have robust systems for efficiently handling regulatory requirements and quality management.
Want to know more?
The MedTech industry knows disruptions can happen at any time, now more than ever. That's why it's crucial to have preventative measures in place to keep things running smoothly when changes arise. The right infrastructure and quality management solution will give you better information, process control, and foster collaboration and visibility. Plus, it helps meet those essential quality standard regulations by mitigating risks.
At Columbus, we're here to support MedTech companies at any stage of their journey. But our expertise doesn't stop there. We also offer data and AI services to leverage advanced gen AI & ML for predictive analysis, like forecasting and trend identification, to anticipate future needs and guide strategic decisions.
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