Engineering Innovation for Better Care

MEDICAL DEVICES

Protecting the Technology Behind Better Care

Medical-device inventions can range from relatively simple mechanical instruments to sophisticated systems incorporating electronics, sensors, processors, communications, and software. Patentable innovation may reside in the physical structure of the device, the relationship between its components, the manner in which it performs a procedure, or the way the device interacts with a patient or another system.

We work to understand how the device actually operates, what clinical or technical problem it addresses, and what the inventors changed to solve that problem. That analysis may reveal multiple opportunities for protection, including the device itself, individual components, methods of operation or use, disposable or replaceable elements, and supporting systems.

Medical products can also present opportunities for both utility and design patent protection. While a utility patent may protect how a device functions, a design patent may protect aspects of its ornamental appearance. Depending on the product, a coordinated strategy may be appropriate.

WEARABLES, SENSORS & PATIENT MONITORING

Turning Physical Signals Into Useful Information

Wearable and patient-monitoring technologies frequently combine physical devices with sensing, electronics, communications, and data processing. Innovations may involve how physiological information is detected, how a sensor interfaces with the body, how measurements are acquired, or how the resulting signals are filtered, transformed, transmitted, and interpreted.

We work with technologies involving physiological sensors, electrodes, optical sensing, motion and position sensing, remote patient monitoring, connected devices, and other systems designed to measure or monitor physical and biological conditions.

The innovation is not always the sensor itself. It may reside in sensor placement, mechanical configuration, calibration, signal acquisition, artifact reduction, combining measurements from multiple sensors, or converting noisy physical measurements into reliable information.

TIP: Follow the signal. How it is sensed, conditioned, transmitted, and interpreted may reveal several distinct inventions within the same product.

Where software, cloud processing, or artificial intelligence forms a substantial part of the system, we consider those technologies as part of the overall invention while drawing on our separate experience with digital health and medical software.

DIAGNOSTIC & MEDICAL IMAGING TECHNOLOGIES

Technology That Helps Identify What Cannot Be Seen

Diagnostic technologies transform physical, biological, chemical, electrical, or visual information into information that can be used to identify or evaluate a condition. Protectable innovations may arise from the device used to obtain the information, the manner in which measurements are generated, the processing of acquired signals or images, or the interaction among multiple diagnostic components.

We work with diagnostic instruments, medical imaging technologies, sensing and measurement systems, point-of-care technologies, and related systems. These inventions may involve optics, electronics, signal processing, image acquisition, calibration, filtering, reconstruction, or techniques for improving the accuracy, speed, sensitivity, or reliability of diagnostic information.

For systems incorporating software or artificial intelligence, patent strategy may also address how acquired data is processed and how the resulting information is generated, while maintaining a focus on the underlying technological improvement rather than merely the diagnostic result.

SURGICAL & THERAPEUTIC DEVICES

Technology Designed to Intervene

Surgical and therapeutic inventions present unique engineering challenges. Devices may need to navigate constrained anatomy, deliver forces or materials with precision, withstand sterilization, provide feedback to a clinician, or safely interact with tissue, fluids, and other medical equipment.

Our experience includes technologies involving guidewires, catheters, specialized surgical tools and instruments, minimally invasive devices, delivery systems, implants, and related therapeutic technologies across applications ranging from cardiac and vascular procedures to gastrointestinal and other medical interventions. Depending on the invention, patent protection may extend to the device as a whole, individual components, mechanical structures, actuation and positioning mechanisms, methods of deployment, and the manner in which multiple components operate together during a procedure.

Innovation may also reside in how a device is used. New surgical and therapeutic methods can involve particular sequences of steps, techniques for navigating or positioning a device, approaches for accessing or treating anatomy, or methods developed to improve safety, precision, efficiency, or patient outcomes. We consider both the physical technology and the methods developed around its use when identifying potential areas for patent protection.

Seemingly small engineering or procedural decisions can solve significant problems. Changes in geometry, materials, flexibility, movement, placement, deployment, or interaction with anatomy may distinguish a new device or technique from conventional approaches and form an important part of the patent strategy.

NEURAL ENGINEERING & NEUROTECHNOLOGY

Engineering at the Interface of the Nervous System

Neural engineering combines principles of engineering, neuroscience, physiology, electronics, and computing to measure, interpret, stimulate, or otherwise interact with the nervous system. Technologies in this field can include neural sensing and stimulation, electrophysiology, brain-computer interfaces, neuromodulation, neural prosthetics, and systems for acquiring and processing neurological signals.

Patentable innovation may exist at several levels of these systems, including electrode or sensor configurations, stimulation techniques, signal acquisition, artifact reduction, signal processing, decoding of neural activity, closed-loop feedback, or the interaction between neural hardware and associated computing systems.

Our biomedical engineering background, including academic focus in neural engineering, provides a technical foundation for working with inventors in this area and understanding both the physical system and the physiological signals with which it interacts.

PHARMACEUTICALS, FORMULATIONS & PLANT INNOVATION

Protecting Innovation From Formulation to Delivery

Pharmaceutical innovation can extend well beyond the identification of an active ingredient. Protectable technology may arise from new formulations and compositions, methods of preparing formulations, drug-delivery technologies, dosage forms, combinations of ingredients, manufacturing and processing techniques, and methods of administering or using a pharmaceutical product. We have experience working with inventions involving pharmaceutical formulations, preparation techniques, and delivery technologies designed to control how a therapeutic agent is prepared, administered, released, absorbed, or otherwise delivered to a patient.

Drug-delivery innovation can take many forms. Depending on the technology, patent protection may involve the formulation itself, a physical delivery device, a particular dosage or release mechanism, the interaction between a formulation and its delivery system, or methods developed to improve stability, bioavailability, dosing, targeting, or administration. We look at these different aspects together to identify where the innovation resides and whether multiple forms of protection may be appropriate.

Patents & Trade Secrets

Not every valuable pharmaceutical innovation necessarily belongs in a patent application. Formulation techniques, manufacturing parameters, processing conditions, ingredient ratios, quality-control procedures, and other proprietary know-how may sometimes be difficult for competitors to discover from the finished product or manufacturing process. In those circumstances, trade secret protection may provide an alternative or complement to patent protection.

We help clients consider what should be patented and publicly disclosed, what may be better maintained as confidential know-how, and how the two forms of protection can work together. That analysis can be particularly important where a product contains both externally identifiable features that may benefit from patent protection and internal manufacturing or preparation techniques that can remain confidential.

Cannabis, Cannabinoids & Plant Innovation

Plant and cannabinoid technologies can present additional intellectual property considerations. Our experience includes obtaining plant patent protection involving cannabis varieties, as well as working with innovations involving cannabinoid formulations, extraction and processing techniques, delivery technologies, and related products. Cannabis and hemp businesses may also develop valuable intellectual property involving cultivation methods, equipment, proprietary processes, packaging, trademarks, and branding.

Because marijuana remains restricted under federal law, cannabis-related intellectual property requires additional attention to the particular technology, product, goods, or services involved. We account for those distinctions when developing patent, trademark, and trade secret strategies while treating cannabis as one part of a broader pharmaceutical, formulation, and plant-innovation practice.

OUR APPROACH

Understand the Problem Before Protecting the Solution

Understand the Problem Before Protecting the Solution

Healthcare inventions are often developed to solve very specific problems. A physician may identify a limitation with an existing procedure. An engineer may discover that a sensor produces unreliable measurements under certain conditions. A development team may devise a different device architecture to improve accuracy, safety, manufacturability, or usability.

We begin by understanding that problem and the engineering decisions made to solve it. We then look at the invention from multiple perspectives: the overall system, its individual components, how those components interact, how the technology is used, and which features may provide meaningful points of differentiation from existing approaches.

TIP: Tell us what was difficult to solve. The design decisions made in response to clinical and engineering constraints are often where important inventions are found.

We also consider how the technology is likely to evolve. A medical product may begin as a prototype and later incorporate new sensors, revised hardware, additional indications, connected functionality, or entirely new generations of the device. Patent strategy can account for that development through initial applications, continuation practice, and subsequent filings directed to improvements as the technology matures.

The objective is to understand the science and engineering behind the product well enough to identify what is actually new, why it matters, and how it should be protected.