President & CEO
Kris leads client-facing operations and business development for Advantu. Prior to Advantu, Kris consulted on SDLC Process Improvement and SQA Engineering. In 2000, Kris founded Qualsoftest, San Diego’s first Independent Software Testing Lab, and the mission critical solutions they provided directly contribute to Advantu’s solution capabilities. Kris was interviewed about how to prevent problems with the FDA if you’re a Medical Device Manufacturer – check it out.
Mr. Reynal joined our Advisory Board in 2014 and serves as our Program Management expert. Today, Mr. Reynal is Advantu’s General Manager, directing the company’s business operations. He has more than 25 years of senior management experience in the Defense, Transportation, Communications and Medical Device industries. He has managed and led teams to develop medical devices for our clients; cloud-based, Software Defined Networking solutions at AT&T; Data Warehousing and Business Intelligence projects at Cricket; Logistics applications for the US Army, and many other game changing programs. He is especially talented at taking problem projects and turning them into successes by building structure, discipline and collaborative teams for our programs. He states, ‘My goal is to ensure that each person understands the vision and has clear direction needed to deliver high quality products that delight the end user.’
As news of Advantu’s regulatory successes continue to spread within the medical device industry, one of our Advisory members, Tim Reynal, recently expanded his role at Advantu to be the Lead Program/Project Manager. Tim will be providing program and project management oversight for our expanding client base. Time-to-market competition is fierce. Capital funds for development are scrutinized at every company. Product quality is of prime importance. Program and project management provides the structure, oversight, and early warnings when any of these three things are at risk of slipping.
Project management is the glue that keeps engineers and stakeholders aligned and focused on the project’s highest priorities throughout the development lifecycle.
As Advantu’s General Counsel, Cindy brings a wealth of experience in helping businesses formulate and achieve goals while mitigating risk.
For over 35 years, Cindy has served as in-house legal counsel for companies in a range of industries including energy, commercial real estate and telecommunications.
Patrick A. Ward
Chief Technology Officer
As our Advisory Board Member and Virtual CTO, Patrick has focused his professional career on multi-national enterprise wide software data integrated connectivity solutions for the past 20+ years.
Having been formally trained as a computer scientist with a BS in Computer Science from the University of Southern California obtaining expertise in more than a half dozen software languages, he spent his initial formative years at Andersen Consulting LLP (Now Accenture) programming software at numerous clients in both the financial services (capital markets) and telecommunications industries with engagements acting as both a delivery consultant as well as a technical architect.
Upon departure from Andersen Consulting LLP, he spent a more than decade in the startup/entrepreneur space helping to build and expand consulting divisions for two unique profitable software companies. (Cardiff Software, Inc. which later through acquisition became a part of HP and Alignent Software, Inc. which later was acquired by Sopheon). This enabled Patrick to bring his acumen and energy to traditional software development as a software leader in larger corporate entities such as Hospira Inc. (Now Pfizer) and CareFusion, Inc. (Now BD) focusing on medication delivery management systems in the acute care segment of the medical industry. These roles deepened his software delivery skills and Cybersecurity intelligence in a highly regulated environment while allowing him to bring innovation and new approaches to augmenting capacity, aptitude and efficiency through strengthening internal teams and complementing with external geographically disperse software development and testing partners.
Vice President of Engineering
Richard has 20+ years of experience in software testing and process, including automation & simulation, outsourcing and process development. Richard is a well-organized skilled and creative problem-solver with a talent for strategic planning and an ability to understand and resolve difficult technical issues.
He is results and customer oriented with effective mentoring and people skills.
Richard has extensive experience in regulated environments (FDA & FAA) in addition to experience in small startups, mid-size as well as large corporations and consulting and SAAS organizations.
Vice President, Compliance Engineering
John brings over 35 years of medical device product development design, compliance, and manufacturing experience. With his formal education in manufacturing engineering and executive management experience, John has led and supported development and manufacturing of single use consumable product and electro-mechanical devices used in the cell therapy and pharmaceutical industries.
John’s experience includes years at both larger and smaller medical device companies including Medtronic, Johnson & Johnson’s Ethicon Inc., Ethicon Endo Surgery, CardioVations, Advanced Sterilization Product and smaller companies like EndoQuest Robotics, USGI Medical and Inovio Pharmaceuticals. His vast knowledge in product design, development, manufacturing, and compliance related activities is an asset to Advantu’s continued growth.
Director, Operations/Software Engineering
Ronald leads the Software Engineering team at Advantu.
With 20+ years of experience in designing high performance software systems, Ronald has a proven record of success in providing strategic direction in the management and execution of projects that drive revenue. For over 12 years, Ronald has designed and led the implementation of system improvements in regulated environments for large medical device companies such as Hospira (Now Pfizer) and CareFusion, Inc. (Now BD).
As a founding member of SaaS startups such as Corio (bought by IBM) and Velosel (bought by Tibco), Ronald helped provide the foundation for large scale growth in data-centric services.
Consulting Process Quality Expert
Charlie has been facilitating companies in achieving sustainable quality process improvement for the past 31 years. He applies invaluable teamwork and accountability life lessons from his twenty years active duty service as a submarine commander and Joint Chiefs of Staff Advisor. His approach centers around open and honest support of all stakeholders, working hand in hand developing, implementing and delivering increased and sustainable customer focused solutions exceeding their expectations.
Charlie graduated with a BS in Manufacturing Engineering from Miami University in Oxford, OH and a MS in Management Systems from USC in Los Angeles, CA.
Employing a “Common Sense Approach” in developing and implementing solutions, organizations move beyond just being “Compliant to the Letter” to being “Complaint to the Intent” by harmonizing guidance, regulations, policies, procedures and work instructions into a continuous improvement framework that provides real cost/benefit value.
Organizations that have and continue to benefit from Charlie’s techniques and guidance include: IRS (Tax Systems Modernization), DynCorp (Ft Rucker, Aircraft Automated Maintenance Management System), Hospira (R&D Quality Systems), Fresenius Medical Care (Automated Software Build and Validation), Johnson and Johnson (Development and Implementation of Quality Metrics), Zimmer-Biomet (QMS Process Improvements including Manufacturing Inspection Techniques), Baxter Hospital Products (Continuous Build/Automated Test Framework for New Product Development and Design Control Tools Evaluation and Consolidation), Obalon Therapeutics (Process and Procedure Improvements supporting compliance to ISO changes) and Medtronic (Updated and Enhanced Procedures and Process for Risk Management and various other Design Control documents).
Charlie served as an Adjunct Professor at California State University San Marcos from 2002- 2009 developing and presenting Graduate and Undergraduate level courses in Systems Analysis and Design and Management Information Systems (MBA Program) for the School of Business Administration, High Technology Management.
Additionally, he is called and frequently presents at Quality Conferences across the US.
Consulting Process Quality Expert
Quality and Regulatory executive with expertise in global manufacturing, multiple site management, medical device regulations, quality management systems, and team development.
A strategic thinker that delivers sustainable continuous improvement utilizing a data driven approach.
Here are Jim’s areas of expertise:
- Quality System development and management
- ISO 13485, ISO 9001, Quality System Regulations
- Budget development and management
- Establishment and management of department and personnel goals and objectives
- QA due diligence assessments for potential acquisitions
- Regulatory management for FDA, Health Canada, and Latin America
- System auditing
- Corrective Action and Preventive Action Systems
- Supplier management of domestic and overseas manufacturers
- Complaint handling management
- Document control management
- Inspection systems and controls
- Calibration systems
- Process improvement utilizing tools such as Lean, Value Stream Mapping, and Kaizen
- Failure analysis / Investigation / Troubleshooting
- Continuous improvement using Statistical Analyses and Six Sigma
- Medical Device manufacturing including CPAP, Ventilators, and mask systems
- Electronic component manufacturing including DC motors and blowers, trimmers, potentiometers, and resistor networks
Consulting Process Quality Expert
Steve Babb has almost 40 years experience as a Software Engineer with decades of experience in Process Improvement for both Regulatory and Software Development Processes. He has a solid track record of Project and Client Success and Advantu’s Clients are lucky to benefit from his experience.
Here are some of his Specialties:
International Conference on Software Quality – ICSQ Technical Program Chair 2014-15
ICSQ Track Chair 2011-2013
American Society for Quality – Senior Member
ASQ San Diego Section 703 Chairman 2009-2011
ASQ Certified Software Quality Engineer (CSQE) June 2008
Adjunct Professor- National University ASQ (Certified Software Quality Engineer) CSQE Refresher Course
More than 34 years experience in roles ranging from electronics test technician, digital electronics design, software design and development, software verification and validation, software performance testing, software quality management, to Director of Quality
Expert knowledge of FDA and other regulated environments best practices, standards and guidelines for System and Software Requirements and Design, Software Development Lifecycle Processes, Software Design Verification and Validation, Software Quality Assurance, and Software Program Management.
Contributor to the Certified Software Quality Engineer Body of Knowledge (CSQEBOK).
Certified Lead Auditor and Audit Team Leader for Internal and External audits with experience interacting with FDA, NRC, DOE auditors.
Rhona Lopez, Sales Development Specialist
Rhona is a member of Advantu’s Sales Development team.
Rhona’s path to being a highly adaptive & credible IoT (Internet of Things) evangelist began in her native Philippines, where right after she earned her Bachelor’s in Development Studies (Sociology and Economics concentration, w/ Environmental Studies electives), she became a Resource Development Manager for the Philippine Network Foundation/PHNET, eventually connecting over 50 colleges and universities to reliable, high-speed Internet access.
Throughout her US career as a lead generation professional, Paid Programming TV Producer (CNBC, ION/PAXTV, WE/OWN, DirecTV), and an Ogilvy Action-trained experiential marketing professional, she also helped successfully launch other IoT products and services in the US market, such as Nortel Networks’ IVR solutions and Lenovo IdeaPads.
In recent years, Rhona has aided IoT leaders in other industries with her account development and market research analysis skills, such as: OnePlus Systems (now Waste Harmonics) in waste/recycling/renewables, Phone.com in UCaaS/VoIP, the Doorway to College Foundation in online test prep/study skills management, Assertive Industries in physical asset auditing/M&A due diligence, and Sensitel in transport logistics.
A US Army veteran and former American Legion Post Vice-Commander, Rhona joins Advantu to help essential medical device/biotech/biopharma companies bring new products to market and through the FDA approval process.
Timothy Reynal, PMP, CSM
Tim brings a vast and diverse portfolio of program experience to the table, each one worth millions of dollars in increased revenues, cost savings and operational efficiencies. With more than 25 years of Information Technology experience, most recently as a Senior Technical Project Manager and Program Manager at AT&T, he masterfully executes transformational technologies which are changing the way the world communicates, socializes and entertains.
Tim has proven success in the defense, transportation and telecommunications industries on army logistics, RFID technologies, big data initiatives, event management systems and software-driven, cloud technologies. He is passionate about the Internet of Things and the expansion of network infrastructure to support it. He is an expert on Agile Scrum and is a long term member of PMI & Scrum Alliance.
Larry Pollack brings over 30 years of management and practitioner experience in software development, software quality, and quality systems. Larry has been responsible for software development, testing, and quality engineering in enterprise, defense, and communications markets, including Fortune 500 companies Intel and L-3 Communications, as well as several successful (and some not-so-successful) startups.
At FP Complete, he recently managed testing an oncology clinical decision support tool for patient care. He has developed test and support strategies for products supporting enterprise businesses in banking, healthcare, and other markets. With a focus on practical implementation, he integrates software quality engineering into the product life cycle. He has also been responsible for key products and systems leading to company acquisitions.
Larry attained his degree in Computer Science from the University of California, San Diego.
Eric Januszko’s mission is to demystify technology for business stakeholders and clarify business goals for product and technology teams through his virtual CIO consulting service www.januszkostudios.com, which he founded in 2012.
Eric is a former CIO and CTO with 25+ years of IT management experience. His expertise in business processes and technology systems, technology assessment, and roadmap strategy has helped organizations drive growth, enhance customer satisfaction, and leverage company IP. When combined with his extensive skills in risk management, cyber security, system integration, and governance, Eric has successfully transformed cost center IT organizations into strategic assets.
Eric served as the C-level technology leader four times in his career, and recently served as CEO of a tech start-up, taking the stalled company to profitability in 18 months. His breadth of experience ranges from pre-funded start-ups to large global enterprises spanning the US, Europe, and APAC, such as Science Applications International Corp (now Leidos), Profitline (acquired by Tangoe), and Pharmacopeia (now Ligand Pharmaceuticals).