At Sensors Summit 2019, the presentation, The Process to Commercialize a Medical Device for Scale, Quality, Performance and Profit, was given as a tutorial. A white paper was also written. It is often mistaken that the commercialization process begins with a design, a lab prototype and experimental testing. So often entrepreneurs and companies come with design, prototype and validation in hand without a customer or an understanding of their needs, consideration for manufacturing and quality nor any evaluation of a supply base. This presentation challenges this thinking and presents an alternative process that starts with an idea accompanied by the end customer’s specifications, a thorough review of the method for manufacturing, definition of a quality plan and an understanding of your validation requirements at the component and device level. There should also be a consideration of your potential supply base and their capabilities. Furthermore, a plan should be developed for the path through the FDA approval process.
At Sensors Expo 2018, the presentation, Rapid Prototyping of Wireless Sensor Solutions for Future Applications, was given at the pre-conference symposium, MEMS and Sensor Technologies Coming to an LoT Solution Near You. Many new sensor applications inherently require wireless technology or use it to simplify implementation and lower cost in the field. Rapid, high performance and reasonably priced prototypes of these ideas facilitate the collection of data that demonstrate proof of concept necessary to solicit investor funding or obtain management approval to proceed. This presentation covers solutions to hardware challenges that require integration of multiple hardware components. Furthermore, it highlights equally important software solutions using a combination of off-the-shelf modules and custom code to get desired function in weeks not months or years. The presentation concludes with a case study of a wireless medical sensor developed with a world renown surgeon that demonstrates this process and reviews a future application of this technology.
At BioMEMS 2013, the presentation, The Revolutionary Change in Sports from MEMS and Sensor Enabled Products, was given to highlight how MEMS and sensors in sports are seeing explosive growth. Enabling factors such as their unobtrusive micro size, reduced cost, accuracy, use of smart algorithms, low power consumption, wireless connectivity, simplified interfaces for data interpretation and mobile computing are making this available to everyone not just elite professional athletes in an expensive laboratory setting. As a result, revolutionary changes are occurring in how we learn, our overall understanding of humans in sports and our resulting behavior enabling us to increase performance and achieve our goals in shorter intervals. In addition, sensors and MEMS products are providing useful data to help engineers make sport protection gear more effective, people lose unwanted pounds and athletes avoid health danger zones.
- A Sellable Plan
- Importance of First Prototype
- Critical Design and Process Steps for Successful Prototypes (Part 1)
- Critical Design and Process Steps for Successful Prototypes (Part 2)
- The Technology Development Process and Design Review Checklist
- Necessary Attributes for a MEMS Engineer for New Product Development
- Importance of Product Validation
- Patent No. 6,672,170, Hermetic Pressure Transducer, issued 2004
- Patent No. 6,763,724, Hermetic Pressure Transducer, issued 2004
- Patent No. 7,112,749, Sensor Mounting Apparatus for Minimizing Parasitic Stress, issued 2006 (80% contribution to claims)
- Patent No. 7,779,701, Pressure Sensor Apparatus, issued 2010
- Patent No. 7,939,772, Electrical Switch System for Use with Vehicular Transmissions, issued 2011
- Patent No. 8,707,774, Sensor System for Differential Pressure Measurement, issued 2014