Disruptive market conditions and the pressures exerting on medical device and diagnostic (MD&D) manufacturers is unprecedented. Today’s increasingly sophisticated personalized medicine, value-based care, real-world evidence models, demographic differences across regional economies and the new FDA and EU Regulatory implications have led to a point that even the most seasoned professional has difficulty navigating them. Today, Medical Manufacturers competing in this industry necessitate the proper digital infrastructure foundation tailored for the MD&D industry to address growing requirements that support regulatory authorities’ quality best practices and also simulate manufacturing scenarios through the usage of digital twin technology. Now, small- to medium-sized businesses (SMB) in MD&D are looking to create the same infrastructure to get their own innovation to market, rapidly, cost-efficiently and at high quality that achieves regulatory compliance. In this issue of Ask the Experts, James Thompson, responds to questions about how digital infrastructure is leading the way in medical device advancements and innovation.

MedTech Intelligence: How did COVID-19 change the MD&D Manufacturing Industry and which challenges did you face and how?

James Thompson: The COVID-19 pandemic has disrupted global supply chains on a monumental scale, therefore MD&D manufacturers had to quickly readapt and respond with increased speed to market, while managing the lengthy process of regulatory approvals. The impact on the medical manufacturing process has included more complexity in tracking and tracing, as well as supply quality processes.

As a result, big countries such as the United States have started to batten down the hatches with important investments on their domestic supply chain and manufacturing processed in the MD&D industry due to semiconductors shortage in order to provide high-quality profitable and ready-to-use products within the States for future crisis. Also China, with its “Made in China 2025” program is aiming at improving their own R&D capability so that they can achieve manufacturing and technological innovation level from Western countries. Thus, medical device manufacturers from outside the country are facing more challenges and barriers to enter Chinese market.

Taking this all together, in the future, also due to COVID-19, MD&D manufacturers will face an increase in the number of new product development, regulatory approvals and introduction (NPDI) processes. New technologies and products will drive competition in the upcoming years. Therefore, MD&D manufacturers need to be ready to accelerate their time-to-market and reduce costs while maintaining high-quality standards.

The FDA and European Union Commission’s proposal for the Medical Device Regulation are still a significant constraint on innovation and speed to market. Quality inspections will become more difficult to manage and product recalls are still rising. With social media and consumer engagement, the repercussions of recalls will be increasingly damaging to medical device company brands.

This means, that MD&D manufacturers will be facing new competitors, mainly small and medium sized business (SMB) and startup from reference market while continuously increasing their efficiency with superb product performance. To improve project efficiency and execution, MDD manufacturers will need to reduce their cost of delivering projects. To do so, they will have to be selective to implement cost-effective improvements and to increase employee productivity and collaboration by simplifying and standardizing work processes, enabling improvement of project cycle time performance and on-time deliveries.

MedTech Intelligence: The MD&D Manufacturers Industry is a complex highly regulated environment with large, medium and small (SMB) sized businesses. According to your experience, what are the specifics for each one?

Thompson: All MD&D manufacturers face the same challenges: They must deal with an increased complexity in products, with growing regulation requirements and, due to COVID-19 pandemic, also with a global supply chain uncertainty. But for the SMB, which are the emerging leaders in this market, there are additional factors.

First, they have to fight against resource constraints, which means that these manufacturers have limited funding and also limited time, they must get their products manufactured, complete the regulatory process and place their product on market faster than their competitors. The high-value role of MES is seen in basic work-in-process tracking and genealogy because, during this stage of development, MD&D manufacturers need to stabilize their process, make it repeatable, and achieve their objectives.

The second factor concerns the less experienced users and staff, so it is critical for SMB operators to quickly implement new technology with minimal training. Moreover, SMB manufacturer compliance processes are usually less structured than larger enterprises. For examples, typically in SMB companies their employees are often covering multiple roles at the same time, while the validation process for high-risk medical devices is both time-consuming and resource-intensive. By automating process compliance, MES helps ensure consistent quality with “right first time” execution avoiding errors.

Third, MES helps eliminate the inefficiencies of paper-based systems that emerging medical-device manufacturers typically have relied on. This means, no “paper travelers” around the facility. In paperless manufacturing, records are digital and integrated into higher-level systems like ERP.

Taking this all together, there are three principal benefits are driving emerging medical-device manufacturers to invest in MES:

1. The high-value role of information
2. Error proofing
3. Achieving paperless manufacturing

Both large and small-medium MD&D manufacturers are challenged to meet the strictly international regulatory requirements as technology, supply chain factors and products are becoming more complex. The validation process has a pivotal role in the MD&D industry for all business sizes as it’s both time-consuming and resource-intensive. This is an important constrain as speed to market is essential, not only to establish a market position, but to bring potentially life-saving products to patients who need them.

MedTech Intelligence: What is the Siemens answer to the FDA – Case for Quality program and the new EU MDR requirements?

Thompson: Siemens Digital Industries Software has been a leader in developing a digital infrastructure aligned with Medical Device Regulatory Authorities, since it has been working alongside the FDA throughout its Case for Quality program. As a result, this program identifies 6 key quality manufacturing pillars which allow MD&D manufacturers to shift from detecting to avoiding quality issues.

1. Traceability
   Manufacturers can demonstrate traceability through their production process, suppliers, distribution products
2. Control
   Manufacturers can demonstrate a focus on establishing, and improving control over their production, supply chain and product quality
3. Visibility
   Manufacturers can demonstrate visibility in their data and metrics. The relevant metrics are visible through all levels of mgt. and staff
4. Analytics
   Manufacturers can demonstrate an effective use of metrics and advanced analytics capabilities
5. Safety
   Manufacturers can demonstrate a high patient safety focus and responsiveness to issues and speed in identification
6. Prevention
   Manufacturers can demonstrate a strong focus on proactive prevention and continuous improvement

The MDR is a full regulatory overhaul of the European framework for medical devices. It includes changes affecting many economic operators such as manufactures, importers, distributors, etc.

The major theme that links all these changes is a focused view of the entire device lifecycle, with an emphasis on traceability and transparency. For medical device manufacturers this means in more rigor required during development but also in an increase of expectations in terms of clinical outcomes and safety with improved regulatory and public visibility throughout the life of the product and distribution. Let’s briefly have a look at the key 4 areas.

Safety and Performance Requirements

Manufacturers must document which requirements are applicable and develop rationales for those that are not. These requirements expand from the Essential Requirements and have wide ranging scope (from particulate matter, to mobile computing platforms and cybersecurity).

Vigilance and Post Market Surveillance

Post market surveillance requires true vigilance across all issue reporting. It’s required on any issue that has statistically significant increase in frequency or severity. Regular public updates are expected providing a summary of safety, performance, and clinical evaluations. This requires a continuum of feedback into a risk management system and evidence of subsequent actions to manage risk effectively.

Labelling

Changes include the integration of UDI (Unique Device Identifier), inclusion of warnings and precautions on the device label, and disclosure of certain substances such as blood & tissue derivatives or carcinogenic, mutagenic, reproductive harm, or endocrine disrupting substances. All devices must have a new medical device symbol on their labelling. These labelling changes are intended to give the public more visibility and clarity of the identity, precautions, and content of their medical devices, but it does add significant complexity to the manufacturer to execute and manage.

Registry and Database

It is tasked to manage company and device registrations, notified body accreditation, vigilance reporting, UDI attributes, and much more. Periodic safety updates must be generated by the manufacture and reported in the database. For class III implantable devices manufacturers must create a summary of safety and clinical performance that is clear to the intended user and will be available and made public through EUDAMED. This paradigm of increased reporting and greater transparency of information to regulators and the public is structured to improve trust and accountability.

So, what is a manufacturer to do? The examples above are just some aspects of the complexity of MDR and what is expected from a medical device manufacturer. Companies that develop medical devices have basically two choices (1) work harder or (2) work smarter to meet these demands. In order to work smarter, MD&D companies must really invest in a lifecycle view of their products and the infrastructure that support them.

Siemens has championed the systems that support these quality best practices. This system gives access to the MD&D with a scope that meets their critical competitive requirements while reducing the cost, error rates and time for implementation and maintenance. The result is a solution that speeds up the realization of digital manufacturing, self-auditing to achieve regulatory compliance and produce better products.

MedTech Intelligence: As a MD&D Expert, how can Siemens support with its solutions in these special times?

Thompson: Siemens has recognized Medical Devices & Diagnostic market needs and has developed solutions that allow MD&D manufacturers to meet their critical competitive requirements while reducing costs and time for implementation and maintenance. For instance, Siemens Opcenter™ EX MD&D software is the central component to the leading manufacturing execution system (MES) needed by medical device manufacturers to meet their challenges in the industry. The solution enables a rigorous detailed manufacturing traceability, parallel processing to reduce queue and lead times, and systematically controlled specifications to enforce product quality and ensure “First-Time-Right.” Moreover, Medical Manufacturers competing in this industry can now rely on a proper digital infrastructure specific for the MD&D industry called “Operational Excellence through Smart Manufacturing”. This means to develop a digital infrastructure by using production digital twins to design and simulate manufacturing scenarios, schedule and execute production, enforcing routes, quality inspections to deliver high quality devices.

MedTech Intelligence: You mentioned Siemens Opcenter EX MDD as a central component for the MD&D manufactures. What are the key pillars of Opcenter EX MDD today and for the future and how does it fit to the Siemens Digital Enterprise portfolio?

Thompson: Siemens Opcenter EX MDD SMB is the leading solution that helps MD&D companies accelerate innovation, reduce cost and achieve the highest quality products while making compliance a by-product of excellent manufacturing processes. Implementing such a solution means to digitalize manufacturing operations, enforcing highly efficient, compliant manufacturing processes that accelerate the delivery of innovative products, at the highest levels of quality. Opcenter Execution Medical Device and Diagnostics eliminates paper from the shop floor and reduces non-value-added activities by automating the control of the 5Ms:

• Material
• Man
• Machine
• Measure
• Method

Further, it provides self-auditing eDHR and eBR, enforces good manufacturing practices (GMP) and regulatory compliance, and accelerates and controls the change management.

For MD&D industry it can be considered as the best-in-class manufacturing execution system as it builds quality into the manufacturing process at every step, rather than relying on testing quality coming out. From raw materials to finished goods, quality is enforced while producing a complete, self-auditing eDHR/eBR.

Taking this all together we can clearly identify 6 key pillars of Opcenter EX MDD that MD&D manufacturers can benefit from:

• Accelerate time to market
• Support regulatory approval process
• Improve product quality with paperless manufacturing
• Reduce time and cost of implementation
• Scale efficient production
• Expedite the change management process

We can state that Siemens MD&D solution has been deployed with impressive results in a variety of medical device product segments, including diagnostics, orthopedics, cardiovascular, hospital and wound care, diabetes care, renal, blood care, vision and imaging.

For example:

• Reducing lead time across all products by 15 to 20%
• Reducing device history record (DHR) review time by 80%
• Reducing nonconformance reports (NCRs) by 80%
• Completely eliminating paper costs
• Taking only two months from project rollout to measured benefits

Looking at future, to make the platform more accessible to Small- and Medium-Sized businesses which are emerging MDD leaders, Siemens developed the Opcenter EX MDD Rapid Implementation package, which is already the leading digital infrastructure for this segment because it’s tailored to meet the needs of a resource-constrained environment and serving as an extensible platform as the manufacturer grows.

About James Thompson, Ph.D. Jim Thompson, Ph.D. has worked in the engineering software industry for 30 years, in various leadership and management positions. Currently, at Siemens Digital Industry Software, Thompson is responsible for the global business strategy for the Medical Device & Pharmaceutical industries. Prior to Siemens, Thompson worked for IBM in software development & consulting, and for GE as a mechanical engineer. He received his doctorate from the University of Illinois at Urbana-Champaign, where his research focused on AI-based engineering decision making.