“Regulated Software and Medical Device Expert”
I have worked at HAEMONETICS for 20+ years and have launched five FDA 510(k) approved software during my tenure, took a software business from 10% to 80% market share, hold five provisional patents, and recognized throughout the plasma industry as a key opinion leader on digital innovation. I am a technologist that combinemy passion for entrepreneurship, product development, interpersonal relationships, and people leadership to bring commercial success to my organization and the health care industry.•
Managed $8M P&L and 85+cross–functional staffin Edmonton AB.•Directed the product development of 14 plasma software products, including their vision, roadmap, technology,architecture, regulatory submission, marketing, commercialization, sales operations,SaaSoperations, maintenance, and support.•Prepared and obtained FDA 510(k) approval for NexLynk DMS, thethird–generationelectronic health record system for the plasma industry.•Increased the plasma software market share from 10% to 80%within3 years.•Led the digital innovation agenda covering plasma, blood, and hospital businesses.•Self–prepared and filed for 5 USApatents for software and hardwareinnovation.•Delivered acloud–based,SaaSmobile solutioninunder 3 months in response to the COVID–19 pandemic.•As stretch assignments, took over and successfully recovered 4 failing software projects fromthe bloodand hospital businessunits.
University of Alberta (Canada)
BSc Computing Science
Minor in Mathematics
- FDA 510(k) Submissions
- Health Canada Registrations
- ISO, IEC, FDA, & Health Canada Regulations
- Software Medical Devices
- Inventions in Digital Innovation
- IP & Patent Protection
- Software as a Service
- Enterprise, Mobile, and Cloud Applications
- Up/Downstream Marketing
- P&L Management
- Contract Management
- Strategic Sourcing
- Public Speaking
My career at HAEMONETICS has been an incredible journey, covering the entire spectrum of product development life cycle from cradle-to-grave and encompassing multiple roles with increasing responsibilities as follows:
Director of Product Development & General Manager (R&D)
Senior Global Product Manager (Marketing)
Solutions Manager (R&D)
Product Manager (Marketing)
Software Development Manager (R&D)
Systems Implementation Team Leader (Sales)
Software Developer (R&D)
- Ran an entire division of up to 85 staff members spanning across 8 different software products.
- Created and executed a strategic plan to grow the software business from 10% to 80% market share.
- Led a multimillion-dollar software program from inception to FDA 510(k) clearance, to on-time production go-live with the largest pharmaceutical player in the industry.
- In addition to the plasma business, I also held responsibilities in blood banking software, blood storage medical devices, thromboelastography (TEG) diagnostic devices, hospital transfusion software, and financial software.
- Hold 5 provisional software and hardware patents.
- Became a trusted subject-matter expert in the plasma collection industry.
- Managed the software division P&L to within 5% of AOP.
- Established a strong track record of delivery, never missing deadlines, and coming under budget.
- Remained technical by writing code, designing software solutions, and defining methodologies to keep the innovation pipeline flowing.
Director of Product Development & General Manager
HAEMONETICS / 2014-Present
Responsible for leading the plasma software division, which is the largest of three business units at Haemonetics.
- Managed $8M P&L and 85+cross-functional staff in Edmonton AB.
- Directed the product development of 14 plasma software products, including their vision, roadmap, technology, architecture, regulatory submission, marketing, commercialization, sales operations, SaaS operations, maintenance, and support.
- Prepared and obtained FDA 510(k) approval for NexLynk DMS, the third-generation electronic health record system for the plasma industry.
- Increased the plasma software market share from 10% to 80%within3 years.
- Led the digital innovation agenda covering plasma, blood, and hospital businesses.
- Self-prepared and filed for 5 USA patents for software and hardware innovation.
- Delivered a cloud-based, SaaS mobile solution in under 3 months in response to the COVID-19 pandemic.
- As stretch assignments, took over and successfully recovered 4 failing software projects fromthe bloodand hospital businessunits.
Senior Global Product Manager
HAEMONETICS / 2013-2014
Responsible for software strategy, competitive analysis, upstream marketing, and disciplined“cradle to grave”product lifecycle management.
- Developed a 10-year roadmap for our flagship product, including an innovation roadmap that spans multiple new product opportunities and core competencies.
- Won the RFP for a Cross-Donation Check System (CDCS) and commercialized the product ahead of schedule, including FDA 510(k) clearance.
- Prepared and obtained FDA 510(k) approval for NextGen DMS 2, the second-generation electronic health record system for the plasma industry.
- Translated market intelligence and voice of customers into clear product vision for the product team.
- Provided pricing strategy and customer value proposition for product sales.
HAEMONETICS / 2012-2013
Responsible for customer success by being the voice of the customer and feeding customer-facing functions with disciplined input mechanism for making smarter business decisions.
- Managed the roadmap of 5 software products from the plasma and hospital business units.
- Simplified the flagship blood product, which included consolidating roadmaps for 5 different markets(US, UK, Ireland, Italy, and Australia).
- Managed all phases of software development, implementation, and operations by coordinating cross-functional departments and ensuring that project objectives complied with specifications for scope, budget, schedule, quality, and compliance.
HAEMONETICS / 2006-2012
Responsible for identifying customer needs and larger business objectives that a product would fulfill and articulating a product roadmap to take the vision into reality.
- Concurrently managed 6 different plasma software products, both medical and non-medical products.
- Established key partnerships with financial institutions to introduce the first electronic payment system for the US plasma industry.
- Prepared and obtained FDA 510(k) approval for NextGen DMS1, an electronic health record system for the plasma industry.
- Prepared and obtained FDA 510(k) approval for LOGIC 3, the first warehouse and logistics system to be classified as a medical device in the US.
- Articulated the software roadmaps for the electronic health records system, electronic payments system, shipping & logistics system, business intelligence system, data integration system, and customer service system.
Software Development Manager
HAEMONETICS / 2004-2006
Responsible for leading a software development team to execute the plasma software roadmap.
- Managed a 25-person software development team to create NextGen DMS, the next generation electronic health record system for the plasma industry.
- Worked with the product manager to win an RFP for developing the third-generation medical warehouse and logistics system for European export.
- Developed short 6-12 month roadmaps for all products in the plasma portfolio.
Systems Implementation Team Leader
HAEMONETICS / 2003-2004
Responsible for working closely with customers to plan and rollout software.
- Prepared and obtained two (2) FDA 510(k) approvals for LOGIC, the first warehouse and logistics system to be classified as a medical device.
- Organized a cross-functional team to setup a SaaS infrastructure for commercializing LOGIC.
- Worked closely with the American Red Cross and United ParcelService (UPS) to rollout LOGIC on the new SaaS infrastructure.
Software Developer (Internship)
HAEMONETICS / 2001-2002
Responsible for designing and developing medical software for plasma warehouses.
- Developed SaaS products based on Java and Oracle technologies.
- Performed all phases of software testing in accordance with FDA regulations.
- Created training materials and conducted in-person product training classes.