MEDICAL DEVICES
“ THE MEDICAL DEVICES SECTOR IS FAST BECOMING A HIGH-VOLUME CONSUMER ELECTRONICS MARKET FOR WHICH TECHNICAL INNOVATION, COST CONTROL AND IP MANAGEMENT ARE COMPETITIVE IMPERATIVES. COMPANIES FAILING TO EMPLOY A RIGOROUS PROGRAMME TO PROTECT, MANAGE AND ASSERT THEIR INTELLECTUAL PROPERTY RIGHTS RISK COSTLY LITIGATION, LOST REVENUE AND WEAKENED MARKET SHARE.”
and home-based self-care. Similarly, traditional semiconductor and consumer electronics giants are levering their technology to penetrate these markets. For example, wireless technologies first developed for WAN (cellular), LAN (wifi) and PAN (Bluetooth) purposes are rapidly appearing in personal fitness and medical devices ranging from heart rate and vital signs monitors, to blood glucose meters and wireless stethoscopes.
As these companies converge on this market opportunity, expect a ‘clash of cultures’ when it comes to managing intellectual property. Te medical devices sector is fast becoming a high-volume consumer electronics market for which technical innovation, cost control and IP management are competitive imperatives. Companies failing to employ a rigorous programme to protect, manage and assert their intellectual property rights risk costly litigation, lost revenue and weakened market share. When entering the medical devices sector, they must be aware of well-honed IP practices in the semiconductor and consumer electronics domains, and prepare for the aggressive use of IP for business purposes.
Even companies well versed in IPR and patent protection, such as drug developers and professional-grade medical instrument makers, may not be ready for the challenges of the consumer medical electronics market. Te
typical drug-coated stent, for example, may have dozens of patents attached to it. A sophisticated blood glucose monitor, on the other hand, can have thousands, related to its user interface, soſtware, battery, memory, power management system, integrated circuits (ICs) and wireless or Internet connectivity.
Based on an analysis of approximately 1,000 patent families in each industry, all with priorities earlier than 2008, it is clear that pharmaceutical and semiconductor firms have taken dramatically different approaches to protecting IP. Pharmaceutical companies have focused on depth of coverage for each invention (median number of global patents per family of eight) and have filed in a median of seven jurisdictions to protect the variations of their innovations in many countries. Tey have attempted to tightly lock up their market positions and maximise product sales opportunities in an industry where R&D investment is enormous and the pace of new product introduction is slowed by safety and regulatory concerns.
In contrast, companies in the semiconductor industry, with its frenetic innovation and new product introduction, have spread IP protection across a broader range of inventions (median number of global patents per family of only three), but have been more selective about the countries in which they file (median of two
60 World Intellectual Property Review November/December 2010
jurisdictions). Teir strategy has been to create patent ‘thickets’ to hamper competitors. With a less stringent regulatory and safety approval regimen than the pharmaceutical industry, and widespread use of semiconductor technology, the patent environment of the consumer medical devices sector will likely bear stronger resemblance to the semiconductor sector.
So how does a medical device-maker effectively manage and police innovation to both protect its IP and ensure rock-solid defence against allegations of patent infringement from competitors? Using reverse engineering (RE) to inform strategy and decision-making across the IP lifecycle is an important part of the answer. RE is the systematic analysis of what lies inside a particular device to understand how it works and what IP went into its creation. Tis is a legal and proven method to:
• Benchmark a product against others in the market
• Identify technology trends and key innovations that could impact market dynamics
• Determine if a competitor’s product is implementing patented inventions.
Product teardown analysis lies at the core of the RE process. By disassembling and analysing the device in detail to identify the materials, manufacturing processes and components used, it is possible to develop an estimated bill of materials—an essential
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