GE Healthcare: Secure medical technology using PLM systems /p.14
Elekta: Hofman’s mission Connecting the dots /p.10
PLM MAGAZINE 2 0 1 7
A MAGA Z I N E P U BLIS H E D BY T E CH NIAT RANS CAT MA K I NG P R O DUCT CRE AT IO N E AS IE R
The Living Heart: Revolutionizing Human Health /p.5
Petter Sahlin:
Turning UDI compliance into a competitive advantage with PLM /p. 8 Ann Sofie Sjurseth:
What are the top 3 Life Sciences Trends in 2017 /p. 3
LIFE SCIENC ES EDITIO N
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Turn regulatory complexity into a competetive advantage 13
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ith all the new regulations and compliance deadlines coming up there is no doubt that there is increasing pressure on Medical Device and Pharmaceutical manufacturers
10 Trends: What are the top 3 Life Sciences trends in 2017 /p. 3 Jean Colombel: The Living Heart: Revolutionizing Human Health /p. 5 UDI: Turning UDI compliance into a competitive advantage with PLM /p. 8 Success Story: Elekta Hofman’s mission: Connecting the dots/p. 10 Success Story: WDH A Journey Towards Growth and Profitability /p. 13 Success Story: GE Healthcare Secure medical technology using PLM systems/p. 14
About TechniaTranscat TechniaTranscat - the #1 knowledge company in PLM. By combining your strengths with our expertise in Product Lifecycle Management (PLM) we will help you to turn your vision into value, and become the future winner. Our solutions are used worldwide in industries such as life sciences, automotive, travel, retail, offshore, telecom, fashion and food & beverage. We serve over 4000 customers worldwide, including 43 that are listed on the Fortune 500. TechniaTranscat is a part of Addnode Group, listed at the Nasdaq OMX Nordic List. For more information, please visit www.techniatranscat.com
today. Our mission, as a global PLM knowledge company with a business area specialized in Life Sciences, is to turn this regulatory complexity into a competitive advantage for our customers by bridging innovation and compliance through our PLM solutions and related services. This year we will take the Life Sciences industry domain expertise that we have in the Nordics to the northern European region to expand our customer base and help more companies address these challenges. In this special edition of the PLM Magazine we focus on PLM for the Life Sciences industry and you will find a mix of interviews with important Life Sciences PLM profiles such as Ann Sofie Sjurseth from TechniaTranscat sharing her top 3 industry trends, Jean Colombel from Dassault Systèmes telling all about the Living heart as the digital twin, Petter Sahlin from TechniaTranscat giving his advice on how to address UDI, Daan Hofman from Elekta summarizing his view on “connecting the dots” within a company and using PLM to realize the company strategy, and finally hearing Lars Lövström Nord and Hans Sjöbom from GE Healthcare Life Sciences sharing their 20year long success story with us and their PLM system MAGIC. We hope you will enjoy it. And if you have any feedback, please don’t hesitate to contact me.
With warm regards, Annelie Uvhagen Director | Life Sciences +46 (0)733 77 24 80 annelie.uvhagen@ techniatranscat.com
Publisher: TechniaTranscat AB Photo Copyrights: TechniaTranscat AB, Elekta, Dassault Systèmes, WDH Production: Felicia Grundel, TechniaTranscat AB (felicia. grundel@techniatranscat.com)
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Trends
What are the top 3 Life Sciences Trends in 2017? New regulations to follow First I would mention the changes in the regulatory laws, for example MDR
Writer: Ann Sofie Sjurseth Ann Sofie has experience working with global PLM and ERP solutions for the past 10 years, supporting large enterprises to smaller companies. Currently Ann Sofie is the Life Sciences sales lead in the northern European region focusing on key accounts and opening up new business in both Medical Device and Pharma.
(Medical Device Reporting) and UDI (Unique Device Identifier). These changes will impact companies in the Life Science industry. An important deadline was passed in September last year, namely, the Compliance Dates for UDI Requirements. Today we provide a solution for Life Science companies and will prepare for the next FDA compliance deadline falling next year. Furthermore, we will support those companies that have not already chosen the data driven solution. We will also focus on updating products during submission to FDA and the audit trace. MDR will be introduced to the life sciences companies and our focus will be to plan and prepare together with our customers so that they will have a quality, audit proof system.
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These new directives are data driven and we will support them by developing a digital thread system for improved audit tracking. Experience has shown that paper based audit systems are inferior to a digital. Our suggestion is to move from paper to digital sooner rather than later.
Usability The second topic is system usability for the PLM solution. This usability initiative started about five years ago and is now starting to show real promise and maturity. Usability is of high importance for end-users. The system should be fast, simple and audit-ready. The end-user should find it easy to use with all the regulatory demand in the system. This is especially important for the millennials who expect an intuitive and complete user interface. If it does not work they will move on to another solution.
Cloud Finally, I’ll mention Cloud, which is an excellent solution for smaller life sciences companies or segments at larger life sciences corporations. Cloud implementations enable rapid deployment of complex environments such as surface modelling and additive manufacturing. In about 30 minutes we can provision an entire solution and the customer can be live and working in the new system. This is both a cost-efficient and flexible solution. Focus in this field is the usability and the quick upgrades.
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If it isn’t documented, it doesn’t exist
Learn more with
MEDQURE Courses in medical technology regulatory affairs, standards and legislation
www.medqure.eu
Interview: Jean Colombel
The Living Heart: Revolutionizing Human Health Imagine being rolled into a surgical theatre and knowing that the specialists about to operate on you already know every little detail of your body. In fact, they’ve already simulated this particular surgery several times, and they’ve carefully selected the tools they will use to fit your specific needs, ensuring you the best possible outcome. This is the future of medical science and it all starts with the Living Heart Project.
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Interview: Jean Colombel
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very year, some 17.5 million people die from cardiovascular disease, making it the single largest cause of death in the world. In medical science, it is also one of the most mysterious, most complicated, and most risk-filled diseases to tackle. –Just think about how the individual physical makeup of each and every heart is different. No surgery is the same, and you do not want anything to go wrong. Even when all goes as planned, the recovery of your heart is unpredictable… or is it? There is a medical science revolution in the making with 3D modeling of organs. The brainchild of the Living Heart Project, Dr. Steve Levine, Executive Director, at Dassault Systèmes has brought together a multidisciplinary community to develop a virtual model of the human heart. The model allows researchers, surgeons, students, medical device- and medical treatment developers to analyze, test and explore this vital organ in the tiniest detail before, during and after working
“It’s possible to model the heart even from the level of a molecule, or the level of a cell,”
with the real thing. “Once we accurately model the organ level behavior, it’s possible to model the heart down to the cellular level or even at its molecular structure,” Jean Colombel, Vice President of the Life Sciences Industry department at Dassault Systèmes, says of the simulator. “In the future, this could allow for faster and more specific interventions, because the experts involved will already know what to look for and how to deal with it” he explains, noting that this also makes any intervention much safer for the patients. The Living Heart runs on the 3DEXPERIENCE platform which harmonizes 3D design, analysis, simulation and intelligence software in a collaborative environment. Since the project’s start in 2014, it has brought together more than 100 specialists worldwide - including researchers, physicians and engineers with regulatory experts and medical device developers - and underscores the benefits of crowdsourcing expertise in silico. Colombel says the collaborative environment is a crucial component as it enables the ability to connect multiple players around a commonly shared information referential. Should those con-
About Jean Colombel Jean Colombel is currently the Vice President of the Life Sciences Industry at Dassault Systèmes. His organization is responsible for creating and developing Dassault Systèmes strategy and associated solutions for pharmaceutical, medical device and healthcare industry segments. Since joining the company in 2009, Mr. Colombel has grown the Life Sciences business significantly and further enhanced the product portfolio by working closely with leading corporations, global regulatory agencies and various hospital organizations, while partnering and acquiring multiple business operations. Mr. Colombel has over 25 years of experience in the life sciences industry, serving various executive level positions. During the late 1980’s, he studied Organic Chemistry in Montpellier (France), Medicinal Chemistry at Pharmaceutical Institute in Tubingen (Germany) and Business in Templeton College, Oxford (UK). Jean can be contacted at Jean.Colombel@3ds.com
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Interview: Jean Colombel
tributors be joining from multiple disciplines, the impact would dramatically increase as new innovative concepts can emerged from those discussions. In the race to address unmet medical needs, this new innovative approach through realistic virtual human environments can accelerate the development of medical solutions and possibly their safety, and will ultimately benefit patient health and improve the patient experience. The need to respond to these pressures without sacrificing safety is well understood by key organizations such as the US FDA. According to a statement1 issued by Jeffrey Shuren, M.D., J.D., Director CDRH, the goal of their own Computer Modeling & Simulation initiative is ”to reduce the time and cost of bringing devices to market while improving patient safety by advancing the science around computer modeling and simulation for medical devices. These models, when of sufficient quality to be considered “regulatory grade,” can be used to assess device performance, thus reducing or obviating the need for other more expensive or burdensome types of scientific evidence (such as human clinical studies).”
With this goal in mind, the FDA has joined the Living Heart Project and is able to provide critical guidance and support to the community as it develops a regulatory grade simulation solution. The medical device community will benefit with the ability to drive innovation without increasing risk. “The simulator provides you with information from all possible angles, providing you with invaluable knowledge that just wasn’t available like this before. It provides a whole new perspective of looking at things” Colombel says. Although Dassault Systèmes has chosen to focus on the heart as its first digital simulation model in 3D, the aim is to develop an array of personalized human organs and other body parts to help us unravel the mysteries of human biology. Colombel is convinced it will have an enormous impact on global health. “By being able to personalize organs like this, we will be able to meet previously unmet medical needs which will significantly improve global health. We will be able to treat patients more accurately, in less time and ultimately make healthcare more effective for everyone” he says.
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UDI
Turning UDI compliance into a competitive advantage with PLM
The regulations for UDI (Unique Device Identification) are high on the agenda for most medical device companies. Many faced a race against time last summer to get the necessary submissions filed on time. registered, and the process can be a challenge. But the key to UDI success is to view the regulation as an opportunity rather than a challenge. By embracing the change and connect it to an already available product definition in PLM medical device manufacturers can meet the new requirements while building up a core cross-functional device change process – from idea to regulatory or sales release.
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Writer: Petter Sahlin Petter has more than 20 years of experience in implementation of concurrent engineering and reduction of lead time in global product development. He has focused on bridging innovation and compliance since 2010 and has followed a number of recent regulatory transformation in the medical device industry, such as the updates on substance regulations (EU RoHS and Conflict Minerals) and UDI. Petter is Business Development Executive Life Sciences, working in the Nordics and Germany.
Š Copyright TechniaTranscat AB 2017
UDI
a product during the engineering and product development stages can be found within PLM. TechniaTranscat offers a module within the 3DEXPERIENCE software called the Regulatory Affairs Manager that helps manufacturers to handle the entire process from start to finish making sure the correct data is created about a product and that the information goes through the required approval stages and is automatically submitted to Global Unique Device Identification Database (GUDID). In this way manufactures improve the quality of data from the start of their process – making every subsequent step easier and faster and provides them with regulatory guidance all through the submission assembly and registration processes. But the advantages are even more profound post-submission, both to handle the change, but also to benefit from reusing the information from the field and point-of-care, which the DI registration enables.
Commercial benefits
S
ince the UDI regulation kicked in on the 24th of September 2016 for the large majority of manufacturers (the Class II devices in the US) every manufacturer that wants to sell medical devices on the US market must make sure they are complying with the new rules. This is a time-consuming process, and it’s one that cannot be avoided, but it doesn’t have to be a hassle. By viewing UDI as an opportunity to improve and standardize their own registration processes companies can turn this new legal requirement into something that can help their businesses going forward. And much of this can be done by using tools that are already available.
The tools for UDI compliance already exist within PLM
If done correctly the benefits of the new UDI system far outweigh the negatives. By following the new regulations each product will have one unique ID and serial number throughout its lifecycle. That means all information about the product will be available in one system, and companies will have an easier time tracking their products once they’ve been released to the market. If something goes wrong and a product must be recalled UDI ensures that the process of speaking to suppliers, compensating
customers, and getting the product back out on the market will be much quicker. Commercially there is a massive benefit in speeding up the turnaround on warranty claims and taking care of customers in a way that leaves them satisfied.
Save time – both now and in years to come By using PLM tools the process of registering the necessary UDI information can also be partially automated. Once all the required data has been gathered and approved it must be registered with the FDA. Handling that process manually is not only slow, but increases the risk for errors. By using a PLM-driven approach companies can handle up to 10 - 200 times as many registrations or changes per day while improving the quality control and eliminating mistakes. With some companies having thousands of devices and parts to register the cost benefits of automating the process can be massive – in initial submissions, but foremost in post-submission maintenance. And keep in mind companies may have to repeat this process in years to come. While the U.S. market was the first to implement these rules the EU and Asian markets are following soon – meaning the same information would have to be registered again with those regulatory agencies. By doing it right the first time you can save both time and money in the future as well. At TechniaTranscat we understand this process and can help you get it right the first time. And even companies who don’t have 3DEXPERIENCE can use our hosted solution to manage UDI requirements. There is no way to avoid the work required to meet the UDI regulations – but with PLM there are ways of making the process work for you.
“By using a PLM-driven approach companies can handle up to 10 - 200 times as many registrations or changes per day while improving the quality control and eliminating mistakes,“
The processes necessary to register and approve the required information about
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Success Story: Elekta
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Success Story: Elekta
Hofman’s mission: Connecting the dots
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About Elekta Elekta is proud to be the leading innovator of equipment and software used to improve, prolong and save the lives of people with cancer and brain disorders. Their advanced, effective solutions are created in collaboration with customers, and more than 6,000 hospitals worldwide rely on Elekta technology. Their treatment solutions and oncology informatics portfolios are designed to enhance the delivery of radiation therapy, radiosurgery and brachytherapy, and to drive cost efficiency in clinical workflows. Read more at www.elekta.com
sing a gamma radiation knife, doctors can cut inside a brain without opening the skull. The invention is used to treat brain tumors and formed the foundation of Elekta. Some 40 years later Elekta is a leading innovator of equipment and software used to improve, prolong and save the lives of people with cancer and brain disorders. More than 6,000 hospitals worldwide rely on Elekta technology. Headquartered in Stockholm, Elekta employs 3,600 people around the world and offers wide a range of advanced cancer treatment tools. It is a success story and the company has had a fantastic growth accelerated by mergers and acquisitions, combining the strengths of the different companies, their products and technologies to create new innovative products, efficient operations and good profits. However, Management has now made it a top priority to make us one, unified company by 2020” says Daan Hofman, Elekta’s PLM Director, whose mission is to introduce interconnected technology in R&D, Manufacturing, Sales, Quality and Regulatory Affairs.
Regulatory In 2016 Elekta decided to use the existing ENOVIA PLM platform to implement the FDA requirements for Unique
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Success Story: Elekta
Device Identification, UDI, in which medical equipment parts need to be labelled in human- and machine-readable form and submitted to the GUDID database of the FDA. It vastly improves transparency and communication with regulatory authorities and through the ENOVIA Regulatory Affairs (RA) Manager, sales staff can easily follow clearance in different markets and other processes. It’s a milestone and makes Elekta one of the few companies that already now has a fully automated process for UDI submission to the FDA.
Manufacturing In the construction of hospital machines, such as a linear accelerator, documentation detailing every step of the process is still done on paper. One machine requires about 800 signatures. “It amounts to a big box of paper which is shipped to a warehouse for storage”, says Hofman who sees and an excellent opportunity to implement a Manufacturing Execution System (MES) which would make information digitally available and connected to PLM and ERP systems, creating transparency and efficiency gains.
Configuration Another exciting area is Product Configuration. Medical devices need to be tailored for different hospitals and purposes. It can involve language, voltage and hundreds of other variations and – being a life science activity – is strictly
Daan Hofman, Elekta
So much to gain
regulated. Commercial and technical configurations need to be connected, to simplify the sales process while managing the changes in a controlled way. Configuration Management in PLM, due to be rolled out in 2017, will be a major step in the right direction.
Strategic alignment of tools Elekta has several R&D centers, partially as a result of its history of acquisitions. There is a need now to align the tools in the different R&D centers. The goal is not to cut down on the range of tools, but to increase transparency and efficiency and reduce the number of vendors. A strategical tool alignment group has been assigned the task.
Quality management “We also see a lot of benefits harmonizing our Quality management tools” Hofman says. It is a matter of integrating the customer complaints, manufacturing findings, audit findings with the corrective actions and the required medical device reporting to authorities. “Doing this through integrated tools will make the process more efficient and
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reduce the compliance risks considerably,” says Hofman who want to inspire other companies to do the same.
© Copyright TechniaTranscat AB 2017
“Our initiatives call for a mind shift” says Hofman. However, he is optimistic about the future, because he has the backing of Management and there is so much to gain. Annelie Uvhagen, Director Life Sciences at TechniaTranscat, works closely with Elekta and Hofman on the PLM journey and the technological unification of tools. “It is about overcoming the regulatory complexity with the help of smart technology. To successfully land these initiatives will not only fulfill regulatory demands, it will further improve the company’s processes” she says. Hofman likes to take a bird’s-eye view on Elektra’s current technological status and he sees PLM as a strategy enabler by connecting the dots.
Success Story: WDH
A Journey Towards D Growth and Profitability at William Demant Holding
About William Demant Holding
The William Demant Holding Group develops, manufactures and sells products and equipment designed to aid the hearing and communication of individuals. The Group focuses on two business activities: Hearing Devices and Diagnostic Instruments. Group companies collaborate in many areas and to a wide extent also share resources and technologies. Read more at www.demant.com
anish Diagnostic Instruments is part of the William Demant Holding Group (WDH) and works primarily with the manufacture, development and sale of diagnostic equipment for hearing and balance impairments. “We realized that we needed a unified platform to be able to connect the companies. With respect to the PLM system, our colleagues in the Group had already chosen Technia [TechniaTranscat] and the ENOVIA system, so we went ahead with them. It was the very best from a group perspective,� says Claus Fromm, responsible for production and logistics at Diagnostic Instruments. Read the full article at www.techniatranscat.com/wdh
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Success Story: GE Healthcare
Lars Lövström Nord and Hans Sjöbom, GE Healthcare
About GE Healthcare GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Their broad expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, drug discovery, biopharmaceutical manufacturing technologies, performance improvement and performance solutions services help their customers to deliver better care to more people around the world at a lower cost.
Secure medical technology using PLM systems TechniaTranscat’s collaboration with GE Healthcare and its PLM systems celebrated 20 years in 2016. With the help of these PLM systems, GE Healthcare is well equipped to meet the tough product development challenges for time-to-market as well as ever-growing requirements for legal and regulatory compliance from US and European regulators.
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Success Story: GE Healthcare
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E Healthcare is part of General Electric, one of the largest companies in the world, with roughly 300,000 employees and operations in 100 countries. GE Healthcare offers a wide array of products and services for improving productivity and safety in healthcare, and makes it possible for healthcare providers to better diagnose and treat patients with conditions such as cancer, Alzheimer’s and cardiovascular disease. Products include CT scanners, MRI cameras and ultrasound systems. The company also provides products used in developing and manufacturing pharmaceuticals. TechniaTranscat has been a supplier of GE Healthcare’s PLM systems since 1996, and the largest and most important system, Magic, now has approximately 2,500 users worldwide.
efficiency and simplifying day-to-day activities for thousands of users. “The upgrade entails that we now also have a system that fully meets the requirements made by the authorities and customers, and that offers better access control, ensuring that information is accessible only for the users who are authorised to access it,” explains Hans Sjöbom, Project Manager at GE Healthcare. “This is an important requirement particularly with respect to the American authorities, since the technologies we work with are of the same type that could be used by someone trying to produce a biological weapon, such as anthrax bacteria.” Thanks to the long-standing cooperation between GE Healthcare and TechniaTranscat, the system upgrade has worked superbly, according to Sjöbom. “TechniaTranscat know us well and understand our needs,” he says. “Many of the people at TechniaTranscat have previously held roles as project managers for us. When we say something is important, our message is taken seriously. And the fact that we are located close to each other geographically also facilitates our collaboration.”
“The upgrade entails that we now also have a system that fully meets the requirements made by the authorities and customers,” “TechniaTranscat has basically been there and built up our entire PLM system from the start,” says Lars Lövström Nord, Leader Life Sciences PLM at GE Healthcare. “We have used many of their technical solutions and thereby gained a more user-friendly system than what the base platform (ENOVIA) can offer. Today we use Magic for all types of product and project information.” Because GE Healthcare is a supplier to the pharmaceutical industry, special requirements are placed on the PLM system. “We have numerous validation requirements that we must meet, such as with the US Food and Drug Administration, its European equivalent – the European Medicines Agency – and various ISO standards,” Lövström Nord says. “Magic makes it easier for us to meet these requirements.” A major upgrade of Magic was implemented recently featuring improved
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Making product creation easier TechniaTranscat is a global and leading knowledge company in PLM with more than 360 experts in ENOVIA, CATIA, SIMULIA and DELMIA. Our consultants are passionate about sharing their industry experiences from Aerospace & Defense, Automotive, Energy, Industrial Equipment, Life Sciences, Consumer Products, Retail and High Tech. As the #1 knowledge company in PLM, we will guide you to enhance your business and transform your vision into value. As a TechniaTranscat customer you will benefit from: • Access to world class knowledge about CAD/PLM, Product Data Quality Tools and methodology • More than 30 years of industry experience from successfully implementing PLM projects with global leaders • Global delivery capacity for Dassault Systèmes' 3DEXPERIENCE platform • Innovative complementing products, such as Value Components, Integration Framework, Q-Checker, xCompare, CAVA, myPLM and Lite3D.
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