We are excited to announce our upcoming participation in OMTEC congress in Chicago!
Mark your calendars for June 11th at 4 PM, as we host an engaging speaker panel “AI and Digitization within the Medical Device Industry: What is the Future?“, which will explore the transformative impact of AI on our field. Don’t miss out on this opportunity to hear about the use of AI today and in the future in our rapidly evolving medical device landscape!
On June 12th, we will be launching our new brand, and we look forward to celebrating this milestone with you at the Happy Hour in the Exhibition Hall at 4 PM.
Then, on June 13th at 9 AM, don’t miss our presentation on our latest development in titanium technology. This innovation allows us to leverage titanium’s benefits in applications requiring a hard-wearing surface. Come to our booth to hear all about this exciting development.
Finally, you can visit us on stand 415 throughout the event – It’s just by the central café.
At Elos Medtech, we take great pride in acknowledging women who contribute to our progress and innovation in the healthcare industry. Today, we direct our appreciation towards Sofia Andersson, IT Project Manager and Business Analyst, based in Skara, Sweden.
From Curiosity to Engineering Expertise
Sofia’s adventure in engineering began with a simple yet profound question: How do things work and why? Her search for answers led her to explore mechanical engineering, a field that promised endless opportunities to discover and create. Choosing to specialize in industrial and production management, Sofia found a perfect blend of creativity and logic, setting the stage for a career that would satisfy her curiosity.
A Decade of Dedication at Elos Medtech
Starting as a quality engineer at our Skara facility, Sofia spent eight years deeply involved in maintaining and enhancing our quality and environmental systems. Her work, critical to both our day-to-day operations and our long-term vision, laid a foundation of excellence that continues to support our growth and innovation. In 2023, Sofia embarked on a new challenge as an IT Project Manager and Business Analyst, leading a global project that stands at the forefront of our technological advancements.
The Heart of Working at Elos Medtech
What makes Sofia’s journey at Elos Medtech so rewarding? It’s the unique blend of our company’s rich history with our drive to constantly move forward. Witnessing the growth of our team in Skara from 23 to almost 50 members, Sofia values the impact Elos Medtech has on improving lives, making her days meaningful and fulfilling.
Championing Diversity and Inclusion
Sofia’s path through engineering to a leadership role in Medtech illustrates a positive shift towards gender balance within the industry. At Elos Medtech, we celebrate this change, recognizing the vital contributions of women in leadership positions and the importance of a balanced and inclusive workplace.
Looking Ahead with Ambition
Sofia’s goals are clear: to be where the action is, work in teams that push boundaries, and drive meaningful change. Her vision for the future is a reminder for us all, inspiring us to strive for excellence and make a difference in the lives of those we serve.
Encouraging Tomorrow’s Innovators
With an appreciation for tech and its potential to shape the future, Sofia encourages young girls to explore and join the tech field. She sees the diverse opportunities the Tech world offers and the importance of inclusive solutions that a diverse workforce can bring.
Sofia Andersson’s journey is a testament to the power of curiosity and dedication. At Elos Medtech, we’re inspired by her story and committed to continuing our journey of innovation, impact, and inclusion, shaping a healthier future for all.
More products have been added to the ELOS Accurate® product range to complement the below implant systems:
Dentsply Sirona – MultiBase EV
HIOSSEN – ET system
NEODENT – Grand Morse, Grand Morse Micro Abutment, and Grand Morse Mini Abutment
Strauman - BLX
ZimVie – Low Profile Abutment
We believe that expanding the product range will provide everyone with a greater selection to choose from.
The discerning reader or customer may observe that the product codes for the Nobel Biocare Multi-Unit Abutment NP/RP (MUA) remain consistent across the platforms mentioned above. This is due to its establishment as the gold standard among MUAs.
Over time, numerous other implant companies have adopted this same connection profile, enhancing the compatibility of the Nobel MUA with various systems. Through rigorous testing, we are pleased to confirm the compatibility with Elos Accurate products for Nobel MUA (our Analog for Printed Model products, hybrid bases, screws, and scan bodies), as well as with a range of other platforms.
In a nutshell, the crown must adhere to the titanium base. But it doesn’t always.
Bonding, often overlooked but never underestimated, is the vital measurement that determine the fit, functionality, and longevity of dental implants.
To further emphasize the significance of bonding, we invite you to read our quick guide where we take a deep dive into the do’s and dont’s of bonding. We share with you our expertise on why bonding is such an important factor for optimum restoration results. You’ll gain valuable insights into what could be the issues with de-bonding from a titanium base and what can be done to ensure success at a lab or clinic level.
IQ, OQ, and PQ are terms you have most likely come across or heard your development and manufacturing partner talk about if you work in the medical device business. But what do they actually mean? And why are they so important in medical device manufacturing? Let me sort it out for you.
What are IQ, OQ, and PQ?
IQ, OQ, and PQ are sequential activities that manufacturers carry out to validate their manufacturing processes. IQ stands for Installation Qualification, OQ for Operational Qualification, and PQ for Performance Qualification. The purpose of process validation is to establish documented evidence that the production equipment is correctly installed, operates according to requirements, and performs safely. It is also to demonstrate that the manufacturing process under normal operating conditions will consistently produce conforming products.
The ideal way to ensure the quality of medical devices
In each phase of the validation process, documents are compiled with detailed results of each qualification test. After performing IQ, OQ, and PQ successfully with the desired result and established documents that verify each phase, a manufacturing process can get underway. The defined discipline for a validation process has proven to be the ideal way to guarantee the best quality of medical devices consistently over time.
Which manufacturing processes must be validated?
Any medical device manufacturing processes where the result is not verifiable by subsequent monitoring or measurement must be validated. A validation plan should be established including the steps of IQ, OQ, and PQ for each process. The approach should be risk-based to ensure critical parameters or specifications are adequately taken care of.
IQ validates that equipment is correctly installed
IQ is the first step in the validation process. In this phase, you verify that the manufacturing equipment meets the design specifications and has been correctly installed and configured according to requirements. You need to confirm that all necessary documents, drawings, and manuals are correctly executed and available. During IQ, equipment maintenance as well as calibration schedules and procedures should be established.
OQ validates that equipment operates as intended
OQ is the second step in the validation process. In this phase, you verify that the manufacturing equipment operates according to requirements. You need to carry out tests for each component to confirm that every part of the manufacturing equipment operates as intended at pre-set thresholds. By challenging the manufacturing process using “worst-case” conditions, it is possible to determine your process window and to ensure a reproducible manufacturing process resulting in conforming products.
PQ validates process stability over time
PQ is the third and last step of the validation process. In this phase, you verify process stability over time by running the equipment several times with a load under normal operating conditions to challenge its functionality and safety. This will demonstrate if the process will produce a product that conforms to its requirements.
Why are IQ, OQ, and PQ so important in medical device manufacturing?
Medical devices are intended to be used for humans and need to meet regulatory requirements. IQ, OQ, and PQ are important steps in a validation process to prove that the medical devices meet all predetermined requirements for functionality and safety, as well as the regulatory standards. Non-conforming products could lead to human injury and result in costly product recalls. A well-planned and performed validation process is crucial for manufacturers to ensure that they have a controlled manufacturing process that consistently produces conforming products that ensure the quality and safety of the medical device.
How are IQ, OQ, and PQ carried out correctly?
IQ, OQ, and PQ should be carried out by the manufacturer according to the FDA and ISO standards. Read more about these standards and the tasks associated with IQ, OQ, and PQ validation in the links below. Also, the GHTF (Global Harmonization Task Force) provides guidance that clarifies how to act. (The guide is an internationally harmonized document recognized by both the FDA and ISO).
The global medtech industry has seen a lot of changes in recent years. Rapidly emerging technologies, ever-changing regulatory requirements as well as limited environmental and financial resources to name just a few. Each change, big or small, plays a part in how our industry develops. One very positive development to come from recent changes, in our industry and the business community as a whole, is a growing focus on the talent within an organization. Companies in all sectors are starting to realize that their greatest asset is in fact their workforce.
The approach at Elos Medtech is about investing in people, sharing experiences with each other and making the most of combined expertise. From insights about how to improve the surface-treatment on the tiniest orthopedic screw to modernizing and streamlining an entire medical device production facility.
Modernizing the Timmersdala site with the workforce
When we recently began streamlining and modernizing our Timmersdala production site in Sweden, we involved everyone at the facility. We inspired each other and focused on areas we knew we could improve and that would create a more practical, fun and rewarding workplace for everyone. And do you know what? We achieved it! Now we truly believe that the entire medtech industry could benefit, not just from having more efficient production facilities, but also from having more rewarding workplaces. Teams are not born, they’re built. And from the very beginning we worked together to get everybody onboard and contribute to the overall team effort.
Medical device facility with a cutting-edge production line where everyone focuses on what they do best
To start with, we thought long and hard about which machines to replace, taking into account maintenance costs, necessary operator skills, environmental impact and equipment bulkiness. The end result is a highly efficient, cutting-edge medical device production line.
We also invested in machines that eliminate unnecessary repetitive tasks, like our new collaborative robot (cobot) that enables the production engineers to spend m,ore time doing what they do best. And everyone knows you have more fun at work when you are doing what you are good at.
Reorganizing our layout has had a positive impact on production workflow and output
By now, you might be thinking that we just replaced a few old machines and stopped there. Not at all. Let’s talk about some of the other changes. We had a good clear out for a start and, once we’d done that, it was much easier to reorganize the layout around the new equipment. So now each machine is closer to the materials it uses, and the production engineers don’t have to keep shuttling back and forth between the two. That in itself has had a really positive impact on production workflow and output.
Then there’s our new morning scrum meetings. Every single morning, the entire production team gathers for a micro-meeting. Ten minutes later we all know exactly what we’re focusing on that day and what is expected from each of us. No second-guessing, no explaining to someone who isn’t up-to-speed, just easy communication and supercharged teamwork. You could say we’ve recalibrated our mindset.
A modern, efficient production line delivers consistent quality on time every time and gives peace of mind
With a modern, efficient production line we are able to deliver a consistently high quality, on time every time. Naturally, this means a great deal of job satisfaction for myself and the rest of the production team. But just as, if not more, important is the fact that it makes us a more cost-effective and reliable supplier which, at the end of the day, means peace of mind for both us and our customers.
By involving everyone with open and honest communication and making the workforce part of the strategic planning process and aware of the company goals, we’ve built a stronger team spirit than ever before at Elos Medtech in Timmersdala. Everyone’s highly dedicated, we cooperate and we take pride in our work. And we all want to do a good job and deliver according, and even beyond, expectations.
I hope you enjoyed hearing directly from me and the production team here at Elos Medtech in Timmersdala! If you’d like to know more about medical device production or the recent improvements we’ve made here, please don’t hesitate to contact me. And don’t forget to explore some of our other articles on the Elos Medtech Blog, where we share our industry knowledge and insights.
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