This post is sponsored by IQVIA MedTech.
The global medical device market is in a period of steady growth, with sales revenues and international trade value expected to hit $543.9 billion and $289.2 billion, respectively, by 2020. However, individual companies face growing uncertainty and risk as they navigate the changing healthcare landscape.
In particular, medical devices are less protected from competition than other industries like pharmaceuticals. Competitor devices can hit the market quickly with minimal modifications to the original product’s design, grabbing large chunks of market share. With the increasing focus on value-based care amid rising healthcare prices, lower-cost competition poses a significant threat.
Mergers and acquisitions also continue to be a disruptive force in the industry, upending the competitive landscape while allowing companies to achieve new scale. With considerable capital available to MedTech firms, this is not likely to slow down.
Finally, new hurdles presented by Medicare reimbursement constraints, the EU Medical Device Regulations (MDR), the EU In Vitro Diagnostics Regulations (IVDR), and other compliance-related restrictions can slow the growth of MedTech companies and divert their resources from the core focus of product innovation.
Fortunately, medical device companies can position themselves to come out ahead of the competition by focusing on three key strategies.
Operational excellence depends on the tight orchestration of processes, people, and departments, from product concept all the way through to post-market compliance and data collection. Internal silos must be bridged, then brought down, enabling every aspect of the business to work together in an orchestrated fashion.
When operations are harmonized, real-time information can be leveraged across the enterprise, including product generated treatment data, post-market data, and clinical experience better benefiting R&D to guide development of new products. Data on those new products must then be shared with the other departments so manufacturing can begin planning for production, the clinical team can lay the groundwork for trials that will best demonstrate product value, and the marketing team can prepare for product launch.
In the context of mergers and acquisitions, harmonization is achieved by evaluating which pieces of the existing and newly acquired company are central to the parent company’s core strategic goals and migrating and integrating data and processes, enabling visibility and leverage while staying focused on achieving primary objectives. The streamlined company that emerges will be stronger and better positioned to face its competitors.
It is also essential that coding of data be standardized across the organization, including any newly acquired units, so that information from all parts of the business can be shared internally and fed into analytics engines to guide strategy across the enterprise.
To achieve this kind of seamless data sharing, MedTech companies need the right infrastructure for data transfer and high-quality analytics to make the best use of the data available. Partnering and outsourcing to those with specific domain expertise in doing this is often the most cost-effective solution.
Leverage new markets
With significant market dilution from competitor medical devices, a key component of staying competitive is discovering new markets for existing products. The most successful MedTech firms find additional markets for their products and can offer a longer and more sustained competitive advantage. However, new markets can present their own challenges as well.
“Some markets are easy to get approval in, but other markets are tough because they have different regulatory requirements that can include totally different packaging and marketing,” says John Stanick, head of global commercial and technology solutions for IQVIA MedTech.
This is exacerbated for companies that have leveraged CE-marks to gain certification in non-EU markets that will now be further impacted if a new CE-certification is needed for reclassified products under the MDR/IVDR.
Identifying the right target markets can make all the difference for maximum success and effectiveness, and Regulatory Intelligence Data (RID), Regulatory Information Management (RIM) and Quality Management System (QMS) solutions and a strategic partner can help. These solutions can provide information and streamline the regulatory processes and expertise to help MedTech companies identify markets with the best chance of extending their product lifecycle while assisting in tracking and complying with fast-changing regulations in these regions. IQVIA’s Regulatory Intelligence solution, for example, is updated every 20 minutes and tracks regulatory changes across 100 countries. Integrated global compliance means Regulatory Intelligence works in concert with Regulatory Information Management and Quality Management Solutions for reporting, management, auditability and risk management and offers built-in MDR support for reporting compliance.
High-quality data management over the entire MedTech operation is also critical to achieving and maintaining quality maturity across the enterprise. This information on all aspects of a business’s quality processes must feed into and drive compliance for each business function – R&D, supplier, manufacturing and commercial.
Ongoing access to relevant data from outside sources can inform product updates and fine tune product functionality. Combined with artificial intelligence and machine learning tools, data can be used to predict problems before they happen, enabling development and manufacturing teams to prevent issues that would cause product problems, downtime or other ramifications.
Manual processes and disparate systems will not provide this level of quality maturity to help device manufacturers improve products and processes while reducing costs, giving them additional leeway to price their products advantageously for today’s value-focused market. One needs integrated enterprise quality management solutions to achieve this degree of quality maturity and lower total cost of quality. Companies are also able to focus on core processes and essential tasks while entrusting other tasks to partners with deep domain expertise to take responsibility for other aspects of their operations or data, analytics or regulatory needs.
The global medical device market was worth $425.5 billion in 2018 and is seeing significant growth. With strategic efforts to stay competitive while producing high quality products, MedTech firms can continue to earn their share.
IQVIA MedTech solutions and services help medical device and diagnostics companies to innovate with confidence, maximize opportunities, and, ultimately, drive human health outcomes safely forward. Learn more at www.iqviamedtech.com.