Estimated reading time: 1 minute
Medical Devices: Delivering Digital Health Innovation
Medical device innovation is playing a pivotal role in the future of digital health. Wearable devices, remote monitoring and health data analytics are just a few examples of the next generation devices and apps being widely adopted. They are already changing the landscape of healthcare treatment and service delivery. At the heart of this transformation is the concept of patient centricity, attention towards preventative health and a laser focus on leveraging emerging technologies to ensure device quality, safety and effectiveness to improve patient outcomes. The medical device market is driven by an aging population, increasing incidence of chronic conditions and an explosion of clinical data, and is expected to reach $800 billion by 2030. KPMG11
Even with high growth expectations, medical device companies are under tremendous pressure to navigate the forces of change behind the market’s transformation. Device manufacturers must innovate rapidly, leveraging transformative digital health technologies to stay ahead. At the same time, they must learn to navigate new business and collaboration opportunities, as well as combat surging competition, cost pressures and regulatory requirements.
To capitalize upon the opportunity within the industry and to become market leaders, device manufacturers are taking a much more holistic and integrated approach to their entire end-to-end processes, from product development to commercialization.
In this ebook, we will take a closer look at the forces shaping the industry and the impact they are having on the future of medical device innovation. We will examine how the shift to value-based care, emerging technologies, and the journey to the cloud are coming together to yield new opportunities for device manufacturers to overcome today’s challenges and build success for tomorrow.
Estimated reading time: 5 minutes
Forces of Change
Medical device companies are being affected by forces of change that are shaping the future of the industry. While some view these changes as industry disruptors, others see them as enablers of new market opportunities. Device manufacturers will need to pursue each of these opportunities, focusing on device effectiveness, patient safety and regulatory compliance to successfully commercialize the next generation of medical devices and remain competitive.
Pace of innovation
The pace of innovation in the medical device sector is at an all-time high. It’s fueled by consumer desire for more control over their health, provider requirements for more minimally invasive devices, and the explosion of health data, as well as changing population dynamics worldwide.
As a result, manufacturers are under increasing pressure to constantly innovate new and existing products that drive growth, improve patient outcomes and stay ahead of the competition.
To keep pace, device manufacturers are leveraging data and emerging technologies to extend their product lifecycle and interact more closely with providers to gather real-world outcome evidence. Emerging technologies like AI, Internet of Things (IoT), blockchain and machine learning (ML) are being used for everything from predicting future disease to tracking devices across the value chain.
Digital health transformation
As medical device manufacturers struggle against rising price pressures and lower reimbursement levels, it has become critical for digital health—including mobile health, wearables, telemedicine, and remote monitoring solutions—to remain cost competitive in a market that is clearly evolving.
Patients and consumers are rapidly adopting digital health to better manage and track their health and wellness activities and prevent the onset of more serious health issues. In turn, clinicians are now receiving and analyzing inordinate amounts of data from wearable and remote monitoring devices, to better monitor, diagnose and prevent disease, and help provide more personalized, value-based patient care.
The number of patients being monitored remotely grew by 44 percent in 2016 and is projected to exceed 50 million by 2021, while the global market for remote patient monitoring devices is expected to reach US$1.9 billion by 2025. 2
As a result, medical device manufacturers have a unique opportunity to leverage these market disruptions as enablers by delivering a new generation of digital devices that employ transformative technologies, such as new sensors and AI. These devices are connected, safe, and meet the needs of a rapidly evolving industry.
“Over 60 percent of consumers are ready to use wearables as a preventive measure for checking abnormalities and countering chronic ailments.” Ericsson3
The widespread adoption of electronic health records and the digitization of clinical information is promoting a change in the way device and drug manufacturers, along with healthcare providers, collaborate. Greater collaboration around the use of aggregated clinical data is resulting in the development of new combination products for specific diseases, the ability to achieve faster regulatory approvals, and the acceleration of new treatments going to market.
Due to privacy concerns over protected health information (PHI) and the complex nature of newer combination and products, regulators have struggled to keep pace, though this is clearly the future direction.
The medical device, biotechnology and pharmaceutical sectors are facing various challenges, including lower reimbursements, the high cost of product development, increased competition, and demands for greater efficacy from patients, providers, and payers. Converging the sectors would therefore be mutually beneficial.
A Deloitte4 and AdvaMed survey conducted in 2018, indicates that twice as many companies (82 percent) plan to collaborate outside medtech than those that do so today (41 percent).
Outcome based pricing
Though primarily a United States model, value-based care is expected to proliferate over time as all countries grapple with unsustainable healthcare costs. It is estimated that up to 15 percent of global healthcare spending will be aligned to value-based models by the end of 20195. This will increase pressure on medical device manufacturers to justify their pricing based on demonstrated treatment results compared to traditional alternatives.
Just as payers and providers must focus on cost and outcomes, manufacturers also need to prove the value of medical devices based on performance and correlated outcomes. Using real-world data from sensors, devices, and electronic medical records for instance, will make aligning pricing to device performance more effective.
Understanding outcomes and increasing transparency across the healthcare continuum will require medical device companies to further leverage and securely share information. This will mandate a stronger focus on the use of outcomes data, protected health information (PHI) security, device performance and open collaboration between providers and producers. The success of this strategy will depend on increased adoption of new products by the medical community.
Value chain disruption
New market entrants are transforming the traditional medical device value chain and putting pressure on traditional medical device companies. These new entrants are utilizing emerging technologies, logistics capabilities, and bundled offerings without the legacy of complex supply chains to slow them down, enabling them to innovate faster and compete with agility.
Supply chain efforts are typically about improving process efficiency in ways that incrementally reduce costs or risks for the company. Value chain restructuring instead focuses on how new approaches might be used across the entire value chain, from development to patient care, in order to meet evolving market needs in different ways that can deliver greater value to the patient or provider.
As the medical device industry continues to transform, manufacturers will need to expand their capabilities beyond traditional supply chain and manufacturing, to more holistic value-chain approaches to new product development. They will need to offer new differentiated services and solutions with an emphasis on reducing the cost of care and improving outcomes.
Security, privacy and regulatory compliance
With the high number of new medical devices introduced into the market each year, and the associated number of recalls, regulators continue to push for standards that promote higher quality, increased patient safety, and assurance that a device has been manufactured in accordance with its design.
Modern medical devices also increasingly include software and are susceptible to theft, cyberattacks and data privacy threats. Smart devices offer great benefits to patients, but their connectivity and the proliferation of data exposes medical device manufacturers, healthcare providers, and patients to cyberattacks. There is the potential for hackers to tap into the security flaws in medical devices, take control, and alter their functions.
To prepare, manufacturers need to ensure they are in compliance across all design, manufacturing, labelling, distribution, and customer complaint processes. However, regulations are country specific, and must tie back to a quality system rooted in documentation. Therefore the need for traceability, unique device identifiers, medical device reporting, and the ability to protect clinical data are just some of the regulatory mandates device manufacturers must address.
Estimated reading time: 4 minutes
Medical Devices and Digital Disruption
The increased adoption of smart devices and interconnected devices, along with the emergence of disruptive technologies like cloud computing, IoT, and AI, is creating new business models and opportunities for medical device manufacturers. Capitalizing on these technologies enables them to innovate faster, streamline operations, and better engage with patients, care teams, suppliers, and partners, helping to increase prevention and early diagnosis while keeping costs lower. The challenge for traditional medical device companies is how to adapt their businesses quickly enough to exploit these new digital technologies.
Internet of Things (IoT)
By 2023, the medical device IoT market is forecast to expand to US$63.43 billion.6 As traditional IoT use cases evolve towards more patient-centered health applications, the term Internet of Health Things (IoHT) is now more commonly accepted in the industry. IoHT reflects the growing connected ecosystem of consumer wearables, medical devices, equipment, sensors, and software applications capable of communicating device and clinical information when needed. From remote patient monitoring to predicting device failure, the demand for IoHT solutions, especially when combined with the power of AI and machine learning, will continue to increase.
“48 percent of consumers would like to have sensors at home to monitor the elderly, to detect emergency situations, and to dispatch ambulance services when required.” Ericsson7
AI and machine learning
AI and ML are increasingly being used to mine the vast quantities of clinical data and reveal trends that can shape future innovations and treatment pathways. With the explosion of connected devices, and increasing numbers of patients, more insight can be gained on specific conditions, the effectiveness of different treatments, and the performance of those devices. Medical device companies are leveraging AI and ML for data management, precision medicine, assisting with repetitive tasks, designing treatment plans for patients, and helping patients make better lifestyle choices.
These capabilities are also being embedded into newer devices to give faster, more accurate results. For instance, medical imaging systems for cancer diagnoses are required to process huge amounts of information, while smart electrocardiogram devices will leverage machine learning to detect patterns and irregularities in heart rhythms. The aggregation and analysis of this data and the ability to cross-reference with existing datasets are becoming increasingly crucial to the delivery of personalized care.
While still in its early days, the potential for blockchain to change intercompany interactions and transactions is already being recognized and piloted across many industries
In the medical device sector, the blockchain use cases that show the most promise focus on supply chain and product development processes that avoid sensitive patient data. The need to keep permanent records of the development and design details shared between suppliers is a constant challenge due to the nature of design changes. Tracking and tracing medical devices across the value chain also remains problematic due to the lack of reliable data. Devices are exposed to temperature issues, poor handling, and the risk of theft. Blockchain provides a secure, shared ledger to record events, along with an audit trail associated with the manufacture and distribution, from raw materials, all the way to the hospital.
While most of the early uses for blockchain have been in financial services, it offers enormous potential for medical device companies as well.
“We’re using blockchain technology in conjunction with Oracle Database Security to tie together the laboratories, physicians’ practices, and hospitals to create a decentralized network of healthcare providers that can better benefit patients.” Steve Chamberlin, CIO, Quality Metrics Partners (QMP)
Managing, accessing, and utilizing the wealth of data being created and recorded by medical devices is leading to an increasing demand for faster access to real-time data at a lower cost. The Oracle Autonomous Database delivers self-driving, self-securing, and self-repairing capabilities that reduce manual intervention and human error. It also ensures higher reliability, security, and operational efficiency for both online transaction processing and data warehousing.
“Oracle’s autonomous technology has been quite a paradigm shift for our DBAs. Now we don’t need to have a DBA constantly involved in managing the system. We can grab the data we need from another database, another cloud service, or lab files, and then load it directly into the warehouse. Oracle establishes the architecture and manages the process—and it’s actually more efficient than what our DBAs constructed.” Steve Chamberlin, CIO, QMP
Underpinning all these innovations is the cloud, with its ability to connect technologies and deliver benefits to medical device manufacturers, patients, and healthcare providers by driving efficiencies across the entire value chain. From optimizing and streamlining back office functions to sharing real-time data between patients and physicians, the cloud is a fundamental foundation that connects the other disruptive technologies and has the ability to scale with requirements.
The next chapter explores practical applications for cloud technology within the medical devices industry, focusing on five key areas.
“Interoperability is the biggest device challenge today, with the hurdles of data exchange at its core. The answer lies in a connected ecosystem that unifies imaging and medical devices, supported by advanced AI analytics and a vast repository of images, hospital data (Electronic Medical Record (EMR), Picture Archiving and Communication System (PACS), Radiology Information System (RIS)) and other clinical data. Many hospitals, doctors, and surgeons are pushing towards this integrative experience for patients.” Rama Kondru, Chief Technology Officer, Acorn AI, a Medidata company
Estimated reading time: 6 minutes
Your Journey to the Cloud
Acquisitions and integrations in the medical device industry are among the most common sources of growth in the industry. However, this pursuit of growth can result in an organization with redundancy and the costly overhead of having multiple systems that must be maintained and somehow tied together. To transform and drive out cost, it will be imperative to standardize systems across business units and functions. Moving towards cloud, without the need for data centers or costly upgrades, is clearly the path forward for an agile organization.
One of the essential elements to growth is the constant ideation that drives innovation of new products designed to improve patient health. The core components of an effective innovative strategy are aligning the medical device innovation process by understanding market and customer needs, and prioritizing new ideas. These will enable medical device companies to set the stage for new medical device development.
Oracle Innovation Management Cloud provides the tools and insights to capture ideas and invest in the ones that will provide the best return on investment. Embedded analytics aid in the development of financial business cases and the monitoring of the portfolio performance, allowing for the best return on investment.
Reduce time to market
Streamlining the product development process, accelerating preclinical and clinical development, obtaining regulatory approval and commercializing medical devices to meet the window of opportunity is a complex endeavor.
Transforming business processes into a data-driven product value chain is critical to accelerating the product innovation strategy while keeping costs down. Oracle Product Lifecycle Management (PLM) Cloud helps to achieve this goal by accelerating the launch of medical device products and services at a reduced cost, while ensuring regulatory compliance and meeting strict quality standards. Overall, Oracle PLM Cloud and its suite of capabilities can facilitate the speed, productivity, and security of product development and launch.
Streamline technology transfer
Technology transfer, from research and development (R&D) to commercial operations, is an area ripe for improvement. It can reduce time-to-market and ensure compliance with all design and quality specifications.
Accurate documentation for the approved device should be readily available in the device master record (DMR), with a complete audit trail of changes reflected in the design history file (DHF). These are essential elements for medical device design transfer from R&D to downstream operations, as well as a requirement for compliance. Labelling and packaging designs must also be considered, and are dependent on target markets for initial launch. If done incorrectly, this can result in a regulatory non-compliance action.
Tech transfer is a critical element to ensuring the successful movement of the design from product development to manufacturing and supply chain management, with PLM being the key link. Oracle enables this process by offering a complete suite of products including Product Hub Cloud, PLM Cloud, ERP Cloud, Manufacturing Cloud and Supply Chain Management Cloud, with capabilities expected by medical device manufacturers.
Optimize supply chain
The basic need for today’s manufacturers to plan, source, make, and deliver products as cost-effectively as possible has not changed, but the ability to connect and optimize these core processes has improved dramatically.
Integrating demand and supply planning with material and vendor sourcing for medical device manufacturing, enables cost reduction, improved operational efficiency and compliance, and reduced risk of obsolescence from overstocking.
Ensuring compliant manufacturing under current good manufacturing practices (cGMP) and quality systems regulation (QSR) is a core mandate for any device manufacturer. These capabilities, coupled with sales and operations planning, distribution planning, import/export compliance, as well as warehouse management and managing inbound materials and contract manufacturer subassemblies, are all part of creating an optimized supply chain.
Oracle Supply Chain Planning Cloud integrates forecasting with supply and distribution planning to provide time-phased plans for manufacturing (including contract manufacturing), procurement, and logistics, to meet the medical device market demand while minimizing inventories. Oracle Manufacturing Cloud enables medical device manufacturers to adhere to Quality and GxP requirements, and Oracle Logistics Cloud ensures efficient warehousing, fulfilment and trade compliance.
Improve safety and service
Monitoring the safety of the medical device post-launch through medical device reporting (MDR) of adverse events to the regulatory bodies, ensures patient safety, and can avoid expensive recalls. It is critical to have tools that can detect risks early in the development or post launch and ensure regulatory reporting compliance while reducing costs.
Regulatory authorities are implementing rigorous post-market surveillance, making it challenging for medical device manufacturers to remain compliant. Poorly managed post-market surveillance can also result in safety and efficiency problems, high administrative costs, loss of brand reputation, reduced market share, as well as possible regulatory implications.
Oracle Health Sciences Safety Cloud provides a market-leading solution for processing, analyzing, and reporting adverse event cases originating in pre- and post-market drugs, biologics, vaccines, devices, and combination products. It is an integrated suite of the market-leading safety case management and safety signal management solutions, enabling uniﬁed multivigilance.
Journey to the cloud
The accelerated pace of innovation, improved efficiencies across the value chain and the ability to make better insight-driven decisions for better patient outcomes is fueling the adoption of cloud-based technologies in the medical device industry.
From optimizing and streamlining back office functions to sharing real-time data between patients and physicians, the cloud is a fundamental foundation that connects transformative technologies (IoT, AI and ML, and blockchain), enables faster regulatory compliance, and the flexibility to scale. As market pressures continue to escalate, an effective cloud strategy is essential.
Wherever healthcare organizations are in their cloud journey, Oracle can help. With a complete portfolio of SaaS, PaaS, and IaaS capabilities and state-of-the-art security and data encryption, only Oracle Cloud can meet the needs of the medical device industry, from understanding evolving market requirements to product development, technical transfer, supply chain management, launch, and post-launch management.
Estimated reading time: 3 minutes
Hologic: Streamlining compliance across borders
As an innovative medical technology company focused on women's health, Hologic needed to remain compliant with shipping agreements worldwide, while delivering new products faster and saving more lives.
For a company with a turnover of more than US$3 billion, the previous solution lacked the scale and stability to effectively manage global trade and compliance in an FDA-regulated world.
By adopting Oracle Global Trade Management Cloud, Hologic has streamlined the screening process for products, ensuring trade compliance and accelerating business processes.
“Because partners like Oracle are out there solving those problems for us in the cloud, we can deliver better analytics and better information, so people can make better decisions and ultimately, deliver better products to our customers faster, and save more lives.” Dave Rudzinsky, CIO Hologic
Profound Medical: Increases scalability and profitable growth
Based in Canada, Profound Medical is an innovative multinational medtech company that develops customizable incision-free therapies for prostate cancer. Experiencing explosive growth, Profound Medical needed a manufacturing and supply chain solution that would help it to keep pace and allow it to transact and report in multiple currencies, locations and languages.
With Oracle PLM, Product Hub Cloud and Manufacturing Cloud, it achieved faster time to market with an integrated system that led to increased productivity, improved supply chain tracking and reduced reporting times.
“Our technology is used to treat prostate cancer and we needed a tool that is scalable and will help us grow exponentially including QC and serialization control. Oracle ERP and Manufacturing Cloud products have offered us the agility and efficiency.” Kirk Boivin, Director of Operations, Profound Medical
ResMed: Improves supply chain planning for better customer service
ResMed delivers medical devices that help people with sleep apnea live better lives. The company was challenged with how it was going to manage its long-term planning sessions. The preference was for a demand cloud solution that would help it evolve its solution not just in terms of the system but in terms of the processes and the way ResMed operates to support the supply chain.
For ResMed, customer service is everything. If the customer has high expectations, ResMed is focused on having products when they’re needed, where they’re needed, managing inventory, and enabling manufacturing to communicate back to suppliers. Oracle’s cloud system enables better long-term planning, ensuring ResMed can aggregate and analyze the data to make more informed, educated decisions.
“Oracle Demand Planning Cloud will allow us to do our long-term planning in large time buckets and plan processes in product families. We can aggregate and look at planning from a much higher acquisition and make more informed and educated decisions.” Philip Brown, Global Demand Manager, ResMed
Estimated reading time: 3 minutes
Latest News and Updates
To keep up with new approaches in medical devices and take full advantage of the emerging technologies that are transforming the industry, you’ll need all the facts, figures, and insights you can get. But it’s impossible to read everything. That’s why we’ve handpicked a selection of links to provide you with the best information and opinions on the hottest topics in medical devices.
Challenges of managing quality in a global enterprise
As new technologies, markets, regulations and competitors emerge, organizations are finding that their current quality management procedures are not keeping pace. In response, many create manual processes or add niche quality management applications. Yet, these types of approaches rarely offer long-term solutions.
Three tenets of modern product lifecycle management
Global competitive pressures and the current pace of change has created a growing challenge to produce a steady stream of successful new products. Innovation waits for no one. PLM is a strategic, systematic approach to managing the entire lifecycle of a product, from selecting and translating the best ideas, requirements, and concepts into development portfolios and projects to the product development and release process, and through to the supply chain and manufacturing commercialization processes.
Blockchain for intelligent track and trace
Today’s supply chains produce multiple data points, often resulting in thousands of daily transactions that need to be validated and confirmed. Blockchain technology offers greater transparency and a single source of truth for participants using supply chain networks. They cut down on operational inefficiencies when using centralized databases and offer greater security and trust due to their decentralized nature and dispute resolution capabilities for transaction. With blockchain, medical device manufacturers can produce higher quality products and facilitate faster shipments.