John Conklin Email & Phone Number

San Diego, Ca, Us

Overseeing efforts to advance and commercialize our NaviCap platform, a novel, regulated combination medical device platform to improve the life of individuals affected by incurable gastrointestinal diseases.Grew and leading a top-tier team of SW, HW, Systems, Mechanical Engineers, and Technicians for organic development efforts that advanced a smart pill into phase 1 clinical trial use.Helped company earn FDA’s first ingestible, combination medical device IND approval for clinical trial use.Full development life cycle management from feasibility to manufacturing and clinical trials to commercialization vision with comprehensive knowledge of electromechanical, combination medical device development for high-volume production, verification and validation, transfer to manufacture, and regulatory approval and clinical trial processes.Collaborate with pre-clinical and clinical teams to facilitate study and trial protocols and endpoints, data analysis, and reports.Work and collaborate with Quality on development-related procedures, work instructions, and methods to ensure functional area alignment and Device Development meets QMS requirements throughout the product development life cycle.Help grow and maintain a culture of transparency and accountability based on milestones leading to long-term goals while working closely with Program Management.Oversee development budget including resource needs and consistent interaction with Finance ensuring proper project accountability.

Carlsbad, Ca, Us

Product Management and Development leader for $14M business consisting of Class II Medical Device company and Durable Medical Equipment provider. Coach-Player role overseeing and participating with teams for product definition-development, regulatory approval, market introduction, and ongoing maintenance of devices, SaaS solutions, patient engagement, and automated data processing SW. Increased product capabilities and device performance by 18%. Reduced product cost by 35%. Resolved initial quality and production issues with Chinese manufacturer and suppliers that scaled production volume to support 5K+ customer shipments/month. 1 non-provisional patent in process. Define requirements, manage roadmap and software development efforts of 4 for cloud-based physician office portals and RPA software (Robotic Process Automation) that ingests and validates health insurance data for eligibility and provider claims submissions. Managed DME Intake operations staff of 12.- Revitalized global product development activities that launched 3 Class II medical devices- Managed SW development efforts for AWS hosted portals, health insurance data processing software- Authored three, Class II 510(k) applications with 3 awarded- Ensured medical device development and manufacturing activities adhered to design controls, cGMP- Standards: ANSI X12 270/271, 837/835, IEC 62304 / 60601, CFR 820, ISO 13485 / 14971 / 10993

Various engagements working with bootstrapped startup to $3.3B annual revenue organizations.Consulted to startup with novel messaging solution that desired to enter the commercial healthcare marketplace. Consulted to Medical Device company for 2+ years:- Performed product management, development, and marketing efforts.- Researched/analyzed market and compiled competitor data, roadmap, and requirements documentation- Lowered product cost up to 30%, improved overall design-aesthetics and end-user functionality- Ensured technical design and firmware allowed product enhancements per roadmap- Evaluated product design risks, worked with off-shore contract manufacturer to ensure proper design outputs- Oversight of development efforts ensuring alignment to project plan and company’s SOPs- Initiated 510(k) submission documentation for FDA marketing/sales approvalHelped introduce an evidence-based, patient care guidelines and prior authorization SaaS solution for a $3.3B Healthcare IT Solutions vendor.- Nationwide travel, presented cloud - technical solutions/merits and operational benefits to executive decision makers- Presented to, interacted with all levels of stakeholders on workflow automation to reduce burden and costs- Helped win contract with 48-hospital healthcare system & health plan

Los Angeles, Ca, Us

Elected to a 2-year, Vice President position on HIMSS Southern California Chapter's Board of Directors where I chaired the chapter's public policy and advocacy committee and efforts.HIMSS is a global, cause-based, not-for-profit organization focused on better health and outcomes through healthcare information, technology, and informatics.

Chicago, Il, Us

Recruited by founder and CEO of DR Systems for a multi-faceted, leadership position to run new business unit. Responsible for strategy and day-to-day operations that supported strategic growth plans to expand customer segments and top line revenue. Focused on scaling product development and sales-business development as leader of newly formed Cardiology business unit. Also led/performed in marketing, partnerships, and client support efforts.- Managed 'start-up' and grew product and customer base to earn $3M initial revenue within 2 years- Led ~30 direct and cross-functional staff that created 2 solutions using MVP and agile processes- Market analysis, product roadmap, requirements, and sales projections for CVIS and ECG solutions- Identified new features, advocated UX design principles that enhanced product’s capability, usability- Worked intimately with SW Engineering team to ensure understanding and goal alignment - Introduced 6 solution partners that accelerated product feature development- Trained sales, support, and marketing organizations on new products and launch- Evaluated 2 potential acquisitions to expand business unit’s product portfolio- Promoted 'umbrella' marketing strategy for company's suite of products- Developed marketing plans, collateral, and executed with marketing team and PR firm- Created BOMs, price lists, quoting tool, margin analysis and sales reports- Presented annually to hundreds of conference attendees, led trade show planning and presenceBefore DR Systems was acquired by Watson Health, the team commercialized a technically complex and competitive product into a $210M segment of the Digital Health/HIT marketplace.

Chicago, Il, Us

3 Leadership and 1 IC position in R&D, Software Development, Technical Sales, Technical Product Management at Camtronics Medical Systems, a Class II software solutions company:DIRECTOR TECHNICAL SOLUTIONS (’07-’09)SR R&D MANAGER - SOLUTION PLATFORM (’04 – ’07)SW ARCHITECT, SW TEAM LEAD, TECH PRODUCT MANAGER - HL7 INTERFACE ENGINE (’01 -’04)SR SW ENGINEER - Medical Device Solutions (’99 -’01)- Introduced transformational development processes that revived flagship solution to earn #1 KLAS- Designed/wrote critical uptime, data handling SW for 7+ yrs before leading 40+ direct/cross functional- Directed company-wide initiative that reinvigorated company's world-class quality commitment- Worked with global teams of technical and non-technical individuals to develop new products- Resolved critical business and technical matters with all levels of clients as customer-facing product expert- Analyzed historic sales data and created new price book that improved overall product margins- Secured new business and certifications with VA and HCA organizations that resulted in 25% revenues- Led cross-functional team of 20+ that delivered healthcare's earliest, GUI-based HL7 Interface Engine- Created scalable, multi-threaded and multi-service IoT/MQTT-like event-driven data exchange solution- Sold and implemented 20+ HL7 interfaces into Epic, Cerner, Meditech EHRs in 3 years- Performed in Software Engineering positions before moving into various management roles - Camtronics was acquired in 2010 by Merge Healthcare, a division of IBM Watson Health

Bs, Mathematics; Computer Science - Systems Emphasis

Finance Skills For Technical Leaders, Dept Of Business And Management

Managing Technical People, Dept Of Business And Management