Randy Smith Email & Phone Number

Orange County, California, United States

Salt Lake City, Utah, United States

My time at Stoel Rives has provided me the best opportunity to hone my patent prosecution skills under the tutelage of several top-notch seasoned patent attorneys. During this time, I drafted 26 complete patent applications to be prosecuted in the US and foreign countries and 272 responses to all kinds of Office Actions in the US and many foreign countries. I performed many other patent related tasks as well, e.g., patent landscape development and analysis, patent-ability search and assessment, examiner interviews, appeal brief drafting, continuation/divisional application assessment, conversion of provisional applications, etc. I will be forever grateful for the opportunity work with my friends as Stoel.

Greater Denver Area

I thrive on helping people create value out of their ideas and then protecting that value with the right patent strategy. My consulting business focused on 2 major overlapping areas as described below.Patent Consulting• Defining a well-reasoned IP/patent strategy provides framework for "beginning with the end in mind".• A patent landscape provides valuable competitive intelligence and sets the stage for building the optimal patent protection of product revenue or finding the right customer for licensing patent rights.• Prior art searching and patent-ability assessment before investing in patent filing has shown in many cases to provide valuable input to the patent application, reduce the number of Office Actions, and safe money during patent prosecution.• During this time I prepared complete invention disclosures to be turned into a patent application by an attorney and I also drafted and filed provisional applications. I also worked directly with patent attorneys during prosecution helping the client understand the patent process along the way.Medical Device Development and Engineering• Establishing a healthy culture of regulatory compliance• Customer needs assessment• Advanced Development and Feasibility• Product Requirements Definition• Project Risk Identification and Mitigation• Hazard analysis and mitigation• Innovative technical problem solving• Powerfully Effective Design Reviews

Englewood, Colorado, United States

As the VP of Technology, one of my roles was to define, establish, and manage an Intellectual Property program and then train executives, engineering, marketing, and sales personnel thereto. In this role, I reported directly to general outside or in-house counsel. My role in the IP program included many responsibilities as described below. • Define a company-wide patent strategy and product specific patent strategies.• Draft and manage all agreements including, non-disclosure agreements (one-way and two-way), third-party idea submission agreements, employee agreements, and the IP portions of contract and co-development agreements, etc. • Define and manage all confidential information and trade secrets.• Prevent contamination of innovative freedom by controlling all third-party confidential information.• Evaluate the patent value of all ideas in accordance with the patent strategies and make all patent filing decisions.• Draft invention disclosure documentation in preparation for patent application drafting.• Commission the drafting and filing of patent applications through outside patent counsel.• Review and approve all submissions to the patent office.• Perform “product clearance”/“Freedom to Operate” searches and assessments, document non-infringement arguments, and define product clearance pathways.• Manage the patent notification system.• Manage a patent budget including the payment of all maintenance fees.• Develop and analyze patent the portfolios/landscapes of competitors and monitor competitor patent prosecution histories.• One of my most rewarding experiences was managing a patent litigation suit where we sued a competitor for patent infringement. The asserted patents were forced into re-examination from which they survived forcing the defendant to settle.

Englewood, Colorado, United States

This role consisted essentially of defining and implementing the “idea to product definition” stage-gate portions of the product life cycle which comprised several processes as described below.• Meeting with doctors, pharmacists, or other healthcare providers and receiving their confidential product idea information according to an executed third-party idea submission agreement• Completing initial product clearance evaluations to ensure a low risk of infringing any third-party patents• Defining product concepts and the associated key performance factors• Identifying technical risks• Performing tests or other technical evaluations to resolve the identified risks so that products could be developed with high confidence that a realistic product development schedule could be developed and followed to completion• Performing a hazard analysis and defining a hazard mitigation plan together with a product reliability plan.• Producing a product definition to be considered for formal development.

Englewood, Colorado, United States

My final role as VP of Technology was providing technical consultation to product development teams. In this role, I was often called on to apply my critical thinking ability and technical expertise to resolve the difficult technical issues during the product development process. Some examples of consulting deliverables include:• Defining a multi-level software driven calibration process for a peristatic pump to ensure volumetric accuracy across an extreme bandwidth of delivery volumes and flow rates of fluids comprising a range of densities and viscosities through a variety of flow paths.• Developing a computerized automatic testing system to control a pharmacy compounder, record volumetric fluid delivery data, and provide statistical reports.• Design and build a computerized test station to check a selector valve for leaks while the valve was in rotational operation.

Englewood, Colorado, United States

Established in-house product development engineering capability and managed 25 + engineers and other technical people. Served on the top level management team and created yearly strategic product development plans. Developed and wrote the design control policies and procedures to ensure a healthy FDA compliance position. Successfully developed and launched syringe infusion pump, an automated pharmacy compounder and a syringe “fill cap and label” device along with the dedicated disposables and directed the life cycle of numerous other legacy products. Partnered with Quality and Operations to successfully respond to FDA inspections.Some notable examples of technical contributions.• Defined a workable patient safety limit regarding compounder delivery accuracy by working through the physiologic effects of critical ingredients on pre-defined smallest patient by engaging a pediatric nephrologist and subsequently verifying the result with key industry leading pharmacist.• Implemented an urgent design change responding to a field report of “mixing causing inaccuracy”. The innovative change cut the effect down to minuscule levels and introduced a new testing method using spectrophotometry.• Conceived and defined an “occluded line” detection method using ratios of raw pressure data that proved critically effective in maintaining sensitivity and preserving reliability.• Defined and established an innovative program for determining and applying critical flow parameters for ingredients to be used on the pharmacy compounder resulting accurate delivery.• Reduced the “shut-down” time from a projected 4 weeks to less than 1 week by envisioning, defining and implementing an automated test data collection and analysis process to urgently validate the injection molding process of a critical disposable.

Lakewood Colorado

Directed the addition of several innovative features and enhancements of a state-of-the-art hemodialysis machine. Features included blood pressure monitoring, network connection, reverse osmosis water treatment, single needle patient connection, hemodiafiltration and the high dialysate flow rate. In many cases, I was instrumental in defining software modifications regarding electrical devices such as optical blood detectors, fluid conductivity sensors, ultra-sonic air bubble detectors, hall effect sensors, solenoids, and fluid pumps.

Salt Lake City, Utah, United States

As my first engineering job out of school, I was launched into the world of medical devices. As a member of a small design team, I designed an electro-mechanical bench-top blood serum analysis machine. My specific portions of the machine included a temperature controlled housing, a disposable handling and positioning system, a cooling/ventilation system, a heat-sealed disposable, an injection molded disposable tray, etc.