Note: This is the fifth in a six-part series that explores the legality, methodology, and application of reverse engineering as it pertains to the IP lifecycle to help companies moving into the market for consumer-grade medical devices understand how and why they must protect their intellectual property rights.

Other articles in this series:

• Part I: Look Before You Leap
• Part II: Defining the IP Life Cycle
• Part III: The Right to Reverse Engineer
• Part IV: Using Constructive Destruction to Look Under the Hood
• Part V: Seeing Inside Very Small Components
• Part VI: The Hard Facts About Software

In March of this year, STMicroelectronics announced a new development program for a device called the Sensimed Triggerfish that will allow glaucoma patients to benefit from earlier diagnosis and more effective, tailored treatment thanks to a “smart” contact lens. Using a new development platform from Swiss company Sensimed AG, Triggerfish uses a contact lens that includes an embedded strain gauge to monitor the curvature of the eye over a period of time. The developers claim that this will provide more valuable data than can be obtained from conventional ophthalmic equipment.

At the heart of this system is a wireless microelectromechanical system (MEMS) sensor in the contact lens that acts as a transducer, antenna, and mechanical support for read-out electronics. A tiny dedicated processing circuit and an RF transmitter communicate the measurements to a small receiver worn around the neck.

This is just one example of how advanced, and how small, medical device technology is becoming on an almost daily basis. MEMS devices, in which electronics circuits and mechanical devices are manufactured on a single silicon chip, are evolving alongside implantable micromachines with controlled moving parts and bioelectrical interfaces that allow for non-intrusive diagnostics—such as reading body chemistry from the surface of the skin to measure blood glucose levels without pricking a finger.

In the previous article, we talked about the crucial role that device tear down analysis plays in managing an electronics maker’s IP life cycle, particularly as it pertains to the market for consumer-grade medical devices—a market in which managing and reducing the costs of materials and manufacturing without sacrificing device efficacy is an ongoing challenge.

Rigorous management of one’s patent portfolio becomes all the more important as the state-of-the-art becomes more sophisticated. When it comes to MEMS and bioelectrical technology, the very materials and manufacturing processes used can themselves be subject to patent protection. Beyond the data gathered from simple visual inspection of a device’s components through a tear down, the more advanced processes used to analyze semiconductor technology must be employed for detailed cost estimating, time to market and competitive analysis, and patent infringement analysis.

Structural analysis
Once a device has been torn down to its constituent components, it’s time to look beyond what even a microscope can reveal. Structural analysis uses a number of devices and processes, some of which can themselves be patented, to create cross sections and analyze chemical composition. This includes mass spectrometry, scanning electron microscopy, and energy dispersive spectroscopy, among others.

This depth of analysis is particularly important when dealing with nonstandard devices such as MEMS with different moving parts, as well as sealed packaging designed to maintain the sterility required for anything that will go inside the human body. Again, the very processes and materials used in manufacture may themselves be proprietary. Only this depth of analysis can reveal if a patent is being infringed or provide the intelligence an electronics maker needs to bring a competitive product to market that is not in violation of another’s patents.

Circuit extraction
After structural analysis comes circuit extraction. At this stage, a chip is taken apart, layer by layer, to the most basic level to study, not only its design, but how its design dictates how it works to achieve its desired function—all areas that can be subject to specific patents. A complete circuit extraction provides all of the information necessary to reproduce the chip. This, the most complex aspect of reverse engineering, is a highly specialized field that can employ proprietary processes that have taken years to develop. Even with a top-tier engineering team, this process can take anywhere from a few weeks to a few months.

Take for example, the disposable strip used with consumer-grade blood glucose monitors. A drop of blood is placed on the strip. An electrical current is applied that causes a chemical reaction. A chip will receive and amplify the signal generated by the chemical reaction. The device’s processor and software will interpret this data and provide the user with a reading of their blood glucose level on a digital display.

Each step in this process can be subject to one or more patents. How is the signal taken from the chemical reaction? How is the signal delivered to, and processed by, the chip within the monitor? Only circuit extraction can provide these answers, and solid evidence that’s admissible in court to defend or assert a claim of patent infringement.

In the next and final article in this series, we will explore emerging software RE for infringement analysis.

Mike McLean is the vice president of intellectual property rights and professional services at UBM TechInsights. He holds a Bachelor of Science, Engineering with First Class Honours from Queens University and is a licensed member of the Association of Professional Engineers of Ontario.