Lotta Ljungberg was recently appointed as new QA/RA Director at Elos Medtech. With more than 20 years experience of working with quality and product development in well-established medical- and biotechnology companies, Lotta has gained a vast amount of knowledge. She believes in accuracy and precision, and is convinced that education, knowledge and commitment is the key to ensure quality.
Hi there Lotta! You are the new Quality Manager at Elos Medtech. What are your expectations for this new job?
I am very excited. I have been working with medical devices for many years, but not with this particular type of products. The overall laws and regulations are equivalent for all medical devices, so I know the basics already. But I will be learning about new products, applications and users, and that is a challenge in itself! In recent years, I have worked a lot with operational procedures. Now I get the opportunity to work on a more strategic level with questions like “How do we ensure that we are top of the line?” Being top of the line means that we exceed our customers’ expectations when it comes to knowledge and support to ensure compliance with the latest updates of regulatory requirements. and we provide this to our customers in an efficient way. It is important to think ahead and be proactive.
You have wide experience in quality and product development. What is the most important thing you have learnt along the way?
I believe it is very important to understand that we cannot control our way to quality, we must steer us to it. Making final inspections and controls late in processes are costly, inefficient and uncertain. Instead, we must ensure that we have good working platforms, defined processes and smooth workflows, so that our conditions are optimal at all times. We need to always be accurate and precise, no matter what we do. The goal is to provide our customers with, not only high quality products and services, but also high quality working processes. It’s about focusing on quality in every single part of our performance.
To reach that goal, we need to have well trained, competent and dedicated employees. I strongly believe that education, knowledge and commitment is the key to ensure quality! It is necessary to involve the entire organization; from the employees purchasing the raw material, to the employees working by the machines as well as the ones handling the documentation. The organization must also understand what it means if we do not have accuracy and precision in everything we do, i.e. the relationship between defect and consequence.
What is the biggest challenge when working with quality?
Over the years there have been many different trends in the interpretation of the Quality Management regulations we are obliged to follow. When things do change, it is important to keep updated and get yourself involved in order to understand and analyze how the changes will affect our business . You need to know in which direction the wind is blowing. It includes not only what the authorities require, but also what they are choosing to focus on at the moment.
The laws are often intact and valid for many years, but there is also room for interpretations and expectations from the authorities. It is also important to remember to continuously ask yourself one question: Why are we doing things in a certain way? If we can answer that question it will benefit both us and our customers, as well as the end users.
What qualities are useful in your position, do you think?
One important quality is the ability to let go of the details and assign them to the experts. As the new Quality Manager I have an advantage in this matter since I don’t know all the details yet. This gives me an opportunity to look at everything from a helicopter view and to stay there. It is easy to get caught up in details, but the risk is that one loses the overall picture. We already have experts with extensive knowledge in their specific areas. It is important to utilize their expertise.
Another important quality is to have a strong incentive to strive forward and be open to change. You need to have a future vision and see the possibilities, and not only look back even if it is important in order to understand what you have done good or bad in the past, and learn from those mistakes. Last but not least, it is important to have the ability to collaborate with other people. Working together as a team and making everyone feel involved is crucial.
The regulatory landscape is constantly changing. How should Elos Medtech navigate to meet the needs and expectations from customers and authorities?
An important area to focus on is to prepare the organization for changes in the regulations. Regulatory requirements become increasingly stringent. The authorities are approaching manufacturers and practitioners in the medtech industry through an increased number of inspections and higher demands on documentation. We need to prepare our organization for unannounced inspections from authorities and notified bodies.
FDA has implemented a new regulation requiring that all medical devices must be documented and tracked. The product is marked with an UDI code (Unique Device Identifier) to trace what type of product it is, where it is and who the manufacturer is. The purpose is to rapidly and definitely identify a device and it is intended to lead to more accurate reporting of adverse events as well as more effective way to carry out a field corrective action. The updated medical device regulations for Europe will follow the same requirements for UDI.
Why are the regulations tightened?
The regulations are tightened because of incidents where people have been injured due to defective products. But they are also tightened to promote welfare. Authorities don’t want to make it difficult for manufacturers. They want to encourage more innovation in Europe and prevent companies from moving their operations overseas. They are there to help people!
So, how important is it to have high requirements for validation processes and documentation?
It is crucial. Validation of equipment and manufacturing ensures that the processes are stable and repetitive, and that the products are equivalent and meet specification. Documentation is proof of what we have done and what we plan to do. It is essential to be transparent and able to support our own operations and the authorities, as well as our customers. In the future, authorities will extend their controls and therefore we must have an orderly and well structured documentation.
Can you see any specific trends in the medtech industry?
Yes, customers are looking at the bigger picture to a greater extent. They want a contract manufacturer that takes responsibility for all steps throughout the process, not only the manufacturing part, but also development, documentation and validation.
One important upcoming trend is that authorities are getting more interested in continuous clinical evaluations carried out by manufacturers. Previously, manufacturers worked extensively with validation of products before they were released on the market, less with postmarket evaluations. We will need to have a better monitoring of the clinical value and safety of our products subsequently and strengthen the mechanisms for postmarket surveillance.
The manufacturing industry in general is now focusing more on IPC (In Process Controls); checks that are carried out during the manufacturing process to complement or replace QC checks on final product, the earlier the better to be able to make effective adjustments and decisions to ensure the product’s quality.
One well known change will be a more intense scrutiny program by competent authorities and notified bodies. This will require fast and secure access to documentation to accomplish effective audits and to please the auditors.
Another trend is the demand on speed. Everything is supposed to be faster; development processes, manufacturing processes and lead times. This places enormous demands on us to streamline working processes and have well defined workflows, so that we can develop and manufacture a product in a safe and efficient manner, in the shortest time as possible and without compromising on quality.
It sounds like you will have your hands full in the coming future! What do you do when you are not working?
I enjoy spending time with my family and friends. I have two sons who take a lot of my time. Together we like to go skiing and hiking, and my sons play football and table tennis. I also play a racquet sport called padel, which can be described as a cross between tennis and squash. It is pretty easy to get started and you typically play in doubles. It is great fun!
What part of the job are you looking forward to the most?
I enjoy working together with other people. Naturally, the quality management organizations in each business centre will be those that I have most cooperation with but I very much look forward to getting to know all employees in the organization. I want to have many allies!
Thank you so much for talking to me Lotta. We are very pleased to welcome you to our team!