Medical Devices

We provide custom and creative advice to our clients to help them leverage design-around opportunities while developing and executing regulatory strategies to bring their life-saving products to market and keep them there.

We draw on the experience of our dedicated team in a range of technologies, including combination drug-device products and surgical instruments.   

The firm has handled or is handling a number of major patent matters concerning a wide variety of medical devices, including auto-injectors, pre-filled syringes, surgical instruments, stents, suturing devices, immunoassays, inhalers, applicators, and over-the-counter hCG devices. 

In addition to providing patent evaluation and litigation services, we routinely advise our clients on device-specific regulatory approval requirements, based on our vast experience with approval requirements of combination drug/biologic-device products, including FDA’s sameness standard and human factor studies.  We also counsel clients on patent listing considerations related to device patents in FDA’s Orange Book.  

Our representative drug delivery device expertise includes: 

• Spiriva^® (tiotropium) (dry powder inhaler) 
• ProAir^® (albuterol) (dose counter/actuator) 
• Axiron^® (testosterone) (applicator)  
• Perclose^® (vascular closure device) 
• MIVS^® (surgical eye instrument) 
• Glucose monitoring devices 
• Biometric sensors 
• Various immunoassays (pregnancy/ovulation)