Explore MedTech at PTC

Patricia Sanchis and Thomas Back together highlighted the Brainlab´s journey in service and support, which began 20 years ago. They emphasized the significant growth in their connected devices, with over 3,000 devices now connected and a 120% increase in the last two years. The team also noted the high connectivity of radiotherapy devices in EMEA and the US, with over 70% connected, and the impressive number of service users and remote sessions conducted monthly. They have successfully resolved 73% of service requests for radiotherapy applications remotely, showcasing their commitment to maximizing the utility of Brainlab equipment.

The discussion on Brainlab Connected Care focused on three interconnected areas: increasing value, empowering colleagues, and addressing connectivity roadblocks. Brainlab Connected Care is a multifaceted solution that continuously integrates with the Brainlab product portfolio. The team shared their learnings, emphasizing the need for different strategies in agent and platform development. They highlighted the importance of anchoring agents in product design versus retrofitting and focusing on sovereignty, security, and scalability for platforms.

Collaboration with partners like PTC and doubleSlash has been crucial in accelerating and scaling their development process. The team addressed the challenges posed by growing local regulations and fragmentation, stressing the need to adapt while maintaining resilience. Despite these challenges, connectivity remains essential for keeping up with evolving cybersecurity controls, uptime guarantees, and value-based contracts. Leveraging power users and regional multipliers has been vital for testing new approaches and acting as regional representatives. Demonstrating incremental results and tangible evidence has been key in driving internal acceptance, adoption, and sponsorship.

Thomas Back and Patricia Sanchis together highlighted the Brainlab´s journey in service and support, which began 20 years ago. They emphasized the significant growth in their connected devices, with over 3,000 devices now connected and a 120% increase in the last two years. The team also noted the high connectivity of radiotherapy devices in EMEA and the US, with over 70% connected, and the impressive number of service users and remote sessions conducted monthly. They have successfully resolved 73% of service requests for radiotherapy applications remotely, showcasing their commitment to maximizing the utility of Brainlab equipment.

The discussion on Brainlab Connected Care focused on three interconnected areas: increasing value, empowering colleagues, and addressing connectivity roadblocks. Brainlab Connected Care is a multifaceted solution that continuously integrates with the Brainlab product portfolio. The team shared their learnings, emphasizing the need for different strategies in agent and platform development. They highlighted the importance of anchoring agents in product design versus retrofitting and focusing on sovereignty, security, and scalability for platforms.

Collaboration with partners like PTC and doubleSlash has been crucial in accelerating and scaling their development process. The team addressed the challenges posed by growing local regulations and fragmentation, stressing the need to adapt while maintaining resilience. Despite these challenges, connectivity remains essential for keeping up with evolving cybersecurity controls, uptime guarantees, and value-based contracts. Leveraging power users and regional multipliers has been vital for testing new approaches and acting as regional representatives. Demonstrating incremental results and tangible evidence has been key in driving internal acceptance, adoption, and sponsorship.

Steve Dertien and Christian Vogelei highlighted the increasing number of regulations, noting that global regulations have more than doubled since 2020. This has created significant challenges for companies in the medtech industry.

In their conversation they spoke about the evolution of product development at Fresenius: Christian described the evolution of FME’s product development process. He mentioned that the company has focused on continuous improvement and adaptation to meet the growing demands and regulatory requirements.

They went on to discuss some of the challenges FME faced, such as navigating the complex regulatory landscape and making strategic decisions to stay compliant and competitive.

Asked about OCM as part of the digital thread, Christian explained how FME is addressing Organizational Change Management (OCM) as part of their efforts to drive the Digital Thread. This involves integrating various digital tools and processes to create a seamless flow of information across the organization.

They also explored the roles of Product Lifecycle Management (PLM) and Enterprise Resource Planning (ERP) systems at FME. Christian noted that while PLM focuses on managing the entire lifecycle of products, ERP is used for broader business operations. The integration and use of these systems are evolving to support the company's digital transformation journey better.

Finally, they discussed the potential impact of AI, particularly Generative AI, on FMC. Christian expressed optimism about the transformative potential of AI in improving efficiency, innovation, and patient outcomes.

The USDM presentation, "Reliable Data Pipelines in Regulated Environments: Keys to Enable Compliant AI Solutions," emphasized the importance of reliable data pipelines for medical device manufacturers. These pipelines are crucial for facilitating validation and maintaining compliance throughout the system's operational life. The presentation highlighted the role of data pipelines in driving meaningful impact through consolidated insights, real-time decision-making, and faster time to market for MedTech manufacturers. Key components discussed included the anatomy of a reliable data pipeline, built-in compliance features, ethical AI with human oversight, and building trust through data pipelines. A case study on AI in European healthcare illustrated these principles in action. The presentation concluded with a reminder that thorough preparation and understanding of the account and pain points are essential for success.

Prof. Dr. Johner's spoke about the importance of business transformation. He addressed why business transformation is crucial for medical device manufacturers. Secondly, he looked at the advances with AI. He highlighted some of the latest advancements in artificial intelligence (AI) and other technologies that are driving innovation in the medtech sector. These advancements are enabling more efficient and effective processes, from product development to patient care. He spoke about organizations in particular needing transformation pointing out how manufacturers must embrace change to remain relevant. He provided insights on how organizations can successfully embark on their transformation journey. This includes having a clear vision, investing in the right technologies, and fostering a culture of continuous learning and improvement. Finally, Prof. Johner described what the transformation will look like and the necessary interfaces to achieve a digital organization with automated processes. He envisioned a future where seamless integration of digital tools and automated workflows will be the norm, enhancing efficiency and patient outcomes.

Jose presented the advances by the Tel Aviv Medical Center together with PTC and Hexagon, the groundbreaking story and key design considerations for a patient with Ewing sarcoma:

Background:

A 16-year-old female was diagnosed with Ewing sarcoma, experiencing pain, swelling, and restricted motion in her right shoulder for several months. Initial MRI imaging showed significant bone involvement, affecting two-thirds of the scapula, and a substantial soft tissue mass involving the rotator cuff muscles. The question was: Can modern technologies be used to create patient-specific implants in a scalable approach.

Key Design Considerations for the Scapula rebuild:

• Preservation: Maintain the patient's original anatomical volume, shape, and kinematics.
• Optimization: Enhance the implant's mechanical properties while minimizing weight.
• Anchoring Points: Provide optimal anchoring points for muscle attachment.
• Lattice Structure: Implement an advanced lattice structure to facilitate the regeneration of connective tissue and muscles, using a Design for Additive Manufacturing (DfAM) approach to minimize supports and distortion.
• Minimal Surfaces: Introduce minimal surfaces to ensure smooth joint kinematics.
• Mechanical Simulations: Use advanced mechanical simulations to verify the implant's load-bearing capacity for shoulder and arm movements.

Critical End-to-End Workflow:

For the initial design it was critical to ensure the shoulder blade boundaries were preserved, the implant matches the mass and material properties of human bone, and provides robust protection to the shoulder region. For this the team needed to validate the additive manufacturing process and qualify the parts for use.

The Outcome:

The surgical intervention was successful, achieving clear resection margins and effective reconstruction of the scapula as per the preoperative plan. The patient is now currently undergoing rehabilitation. Without this innovative reconstruction approach, the patient would have faced a functional loss of the arm due to the absence of the scapula.

Leopold Islinger spoke with Benjamin Kirsch from PDSVision on “Streamlining Compliance and Innovation: The Windchill+ for MedDev Advantage" and the journey Gerresheimer took. He delved into the company's global presence and production, which includes production facilities in 16 countries and 35 plants producing locally for global markets.

He continued detailing the journey of selecting a Product Lifecycle Management (PLM) system with their partner PDSVision and the steps they took to get to where they are today. Outlining those steps he looked at:

• Ideal State: Reliable and high-quality data is crucial. The roadmap for digital transformation starts with a Product Data Management system.
• Evaluation Stage: Requirements were gathered from each department, and over 15 system suppliers were considered. Six suppliers advanced to the next stage, with PTC being the only supplier allowing multiple integrators.
• Further Evaluation: Five demo sessions were conducted with four suppliers. Evaluation criteria included user feedback, cost, and IT security. Two systems by two integrators were selected for the next phase.

He went on to discuss the critical steps to initiate the project:

• Pilot Project: Setting up a pilot project and understanding that finding the right fit takes time.
• Project Mindset: Balancing agile and waterfall project methodologies.
• System Integration: Making the system available and integrating it into the network, which also takes time.
• User Training: Conducting user training to gain initial insights into the system.
• Implementation: Starting the implementation process with user stories and user testing.

Christian Vogelei and Steve Dertien highlighted the increasing number of regulations, noting that global regulations have more than doubled since 2020. This has created significant challenges for companies in the medtech industry.

In their conversation they spoke about the evolution of product development at Fresenius: Christian described the evolution of FME’s product development process. He mentioned that the company has focused on continuous improvement and adaptation to meet the growing demands and regulatory requirements.

They went on to discuss some of the challenges FME faced, such as navigating the complex regulatory landscape and making strategic decisions to stay compliant and competitive.

Asked about OCM as part of the digital thread, Christian explained how FME is addressing Organizational Change Management (OCM) as part of their efforts to drive the Digital Thread. This involves integrating various digital tools and processes to create a seamless flow of information across the organization.

They also explored the roles of Product Lifecycle Management (PLM) and Enterprise Resource Planning (ERP) systems at FME. Christian noted that while PLM focuses on managing the entire lifecycle of products, ERP is used for broader business operations. The integration and use of these systems are evolving to support the company's digital transformation journey better.

Finally, they discussed the potential impact of AI, particularly Generative AI, on FMC. Christian expressed optimism about the transformative potential of AI in improving efficiency, innovation, and patient outcomes.

Together with Leopold Gomez Islinger, Gerresheimer, Benjamin Kirsch spoke about how organizations need to take control of their digital transformation Journey. He first introduced the company as a leading provider of product design, systems engineering, simulation, and product lifecycle management (PLM) software and services. He went on to discuss the importance of harnessing digital data to reduce costs, improve efficiency, and maximize revenue growth. This involves building a comprehensive roadmap, project plan, and digitalization strategy.

Key Components:

• Windchill+ for MedDev: Positioned as the backbone of the digital transformation for manufacturers of Medical Technologies.
• Med Dev Templates: Custom templates for the medical device industry, ensuring compliance from day one.
• USDM Pre-Validated Environment: A pre-validated environment to streamline compliance.
• myPDS Applications & Solutions: Additional applications and solutions to enhance functionality.
• IT Outsourcing: Utilizing a true SaaS solution for faster enterprise PLM implementation.
• Scalability: The solution is scalable at the touch of a button.

Finally, Benjamin Kirsch spoke about PLM & MedTech competence as he highlighted the company's expertise in PLM and medical device solutions through PDSVISION. He spoke about agile project methodology to ensure flexibility and responsiveness. And in conclusion emphasized best-in-class collaboration between all parties involved.

The presentation by Deloitte and Fresenius, titled "Beyond Compliance: Turning Regulations into Real Impact – Leveraging Regulations for Strategic Advantage and Meaningful Change," focused on the evolving landscape of sustainability in the Life Sciences and Health Care (LSHC) sector. They discussed the current challenges and focus areas, emphasizing that regulatory requirements, investor interests, consumer demands, and environmental concerns are driving long-term trends in sustainability.

Key Drivers and Trends: The presentation highlighted the importance of navigating the regulatory landscape, noting that stronger regulations are pushing companies to act on sustainability and disclose relevant information to comply with national and EU requirements. Although the Corporate Sustainability Reporting Directive (CSRD) has not yet been transposed into German national law, companies should remain proactive in their sustainability efforts.

Fresenius' Mission and Vision: Fresenius is committed to saving and improving human lives through affordable, accessible, and innovative healthcare. To be successful, companies need to set the right ambition level, have a clear implementation plan, and manage data effectively.

Benchmarking and Social Focus: Benchmarking in the LSHC sector shows that MedTech manufacturers are adopting both standard and independent approaches to Environmental, Social, and Governance (ESG) implementation. Unlike other industries, the social aspect is more relevant in the life sciences sector, with a strategic focus on sustainability and clear Key Performance Indicators (KPIs) driving long-term impact.

Closing the Sustainability Gap: The team stressed the importance of closing the gap between sustainability strategy and operational measures. This involves identifying white spots, defining joint priorities, and initiating execution. Deloitte supported Fresenius with the ESRS S1 Reporting project, focusing on the workforce to ensure compliance with the CSRD. KPIs play a vital role in assessing the effectiveness and impact of sustainability initiatives.

Outlook: Regulation is only one piece of the puzzle. The key to long-term success in the LSHC industry is the "social" component. Effective steering and a well-thought-out, compliant sustainability approach are essential for strengthening a company's success in the long run. Sustainability is here to stay, and starting now is strategically essential for future success.

Is Your Lean Production System Still Human Focused in Times of AI & Co?

David Stokar discussed this intriguing question. He highlighted how we have been living in an era of rapid technological advancement, where digitalization, AI, and robotics have become integral parts of lean production systems. These changes brought significant challenges and transformations. Yet, despite these shifts, the human-centric approach in lean production remained strong. This was because human oversight, creativity, and decision-making were crucial for continuous improvement processes. Stakeholders, whether close to the shop floor or further away, influenced this approach in various ways. Balancing digital tools with human factors was essential, but did this new digital version of a lean production system still keep humans at its core?

The USDM presentation, "Reliable Data Pipelines in Regulated Environments: Keys to Enable Compliant AI Solutions," emphasized the importance of reliable data pipelines for medical device manufacturers. These pipelines are crucial for facilitating validation and maintaining compliance throughout the system's operational life. The presentation highlighted the role of data pipelines in driving meaningful impact through consolidated insights, real-time decision-making, and faster time to market for MedTech manufacturers. Key components discussed included the anatomy of a reliable data pipeline, built-in compliance features, ethical AI with human oversight, and building trust through data pipelines. A case study on AI in European healthcare illustrated these principles in action. The presentation concluded with a reminder that thorough preparation and understanding of the account and pain points are essential for success.

The presentation by Deloitte and Fresenius, titled "Beyond Compliance: Turning Regulations into Real Impact – Leveraging Regulations for Strategic Advantage and Meaningful Change," focused on the evolving landscape of sustainability in the Life Sciences and Health Care (LSHC) sector. They discussed the current challenges and focus areas, emphasizing that regulatory requirements, investor interests, consumer demands, and environmental concerns are driving long-term trends in sustainability.

Key Drivers and Trends: The presentation highlighted the importance of navigating the regulatory landscape, noting that stronger regulations are pushing companies to act on sustainability and disclose relevant information to comply with national and EU requirements. Although the Corporate Sustainability Reporting Directive (CSRD) has not yet been transposed into German national law, companies should remain proactive in their sustainability efforts.

Fresenius' Mission and Vision: Fresenius is committed to saving and improving human lives through affordable, accessible, and innovative healthcare. To be successful, companies need to set the right ambition level, have a clear implementation plan, and manage data effectively.

Benchmarking and Social Focus: Benchmarking in the LSHC sector shows that MedTech manufacturers are adopting both standard and independent approaches to Environmental, Social, and Governance (ESG) implementation. Unlike other industries, the social aspect is more relevant in the life sciences sector, with a strategic focus on sustainability and clear Key Performance Indicators (KPIs) driving long-term impact.

Closing the Sustainability Gap: The team stressed the importance of closing the gap between sustainability strategy and operational measures. This involves identifying white spots, defining joint priorities, and initiating execution. Deloitte supported Fresenius with the ESRS S1 Reporting project, focusing on the workforce to ensure compliance with the CSRD. KPIs play a vital role in assessing the effectiveness and impact of sustainability initiatives.

Outlook: Regulation is only one piece of the puzzle. The key to long-term success in the LSHC industry is the "social" component. Effective steering and a well-thought-out, compliant sustainability approach are essential for strengthening a company's success in the long run. Sustainability is here to stay, and starting now is strategically essential for future success.