PROJECTS

The only way to describe what Starke Consulting is all about is to showcase past work and projects - through a Case Study
Company: Aksys Ltd.
Company Type: Healthcare - Medical Device
Product: Home Hemodialysis Machine
Project: Developer of world’s first fully integrated Home Hemodialysis System
 

Summary:  As systems engineer for provider of home hemodialysis products and services, took FDA approved home use hemodialysis machine from design, through production, to clinical trials. Consistently met all project goals and deliverables within scheduled time.

 

Outcomes:

  • Developed functional requirements from business requirements based on direct interaction with clinical staff and patients

  • Designed machine automated processes based on established requirements, clinical needs, and manufacturing needs. 

  • As Systems Lead in initial stage software integration, developed coding standard and template for mode development integration into production ready software.

  • Worked closely with Field Service department and coordinated effort to define and develop requirements used to design software for field service engineers. 

  • Trained and supported field service engineers on the serviceability of the machine. Wrote Service Software Manual for field service engineers. 

  • Worked closely with patients and clinical group during clinical trials to develop requirements for phase II of device.

Company: Centrifusion 
Company Type: IT Systems Integrator
Project: Systems Integration for B2B Websites and Content Management Systems
 

Summary:  Implemented process reengineering plans and progression/platform strategies for client companies, focusing on B2B web sites, personalization and content management systems. 

 

Outcomes:

  • Project Manager for major gum/confectionary manufacturer.  Project consisted of analyzing company’s current Idea to Product lifecycle and working with the process owners to turn business needs and requirements into technology solutions. 

  • Project Manager for major writing instrument manufacturer.  Project consisted of analyzing company’s current digital asset management process.

  • Project Manager for leading outfitter for outdoor activities. Project involved working with other partners as the lead coordinator in the following areas: Enterprise Architecture, Content Management, System Integration and Testing, Education, and Deployment.

Company: Baxter Healthcare 
Company Type: Healthcare
Project: Global IT Implementations and Software Product Development
 

Summary Project Manager for Baxter Clintec Nutrition and Global R&D/QA Portfolio.  Responsibilities include management of the project schedule, scope and budget, customer interfacing, and integration of multidisciplinary team members under an immovable deadline, released based schedule.  Responsibilities also include direct reports responsible for project deliverables.

 

Outcomes:

  • Project / Program Manager for Clintec Nutrition Logix Software product applications.  Software medical device application being created through .NET technology, used for interface with multiple compound devices.  21CFR 820.  Executed through the use of Baxter’s Product Development Process (PDP).

  • Project Manager for Global Product Surveillance Application (Complaint Management System) for Baxter’s Global IT R&D / Quality Organization

  • All Global IT projects executed under the direction of 21CFR Part 11, Government Procedures for Software Validation (GPSV) and common SDLC approach for software validation.

  • Project Manager for Extreme Programming projects for Baxter’s Global IT PDM/EDM Organization

  • Design and setup of the Baxter PDM/EDM Project Management Office (PMO).  

  • Lead team to successful release of product upgrades and divisional migrations under the direction of 21CFR Part 11, Government Procedures for Software Validation (GPSV) and a 2-tier hierarchy approach for software validation.

Company: Solucient, LLC
Company Type: Healthcare Analytics
Project: Build World Class PMO Function From Scratch
 

Summary:  Design, build, and estabilsh Program Management Office (PMO) for Solucient, LLC.     Worked to establish and deploy consistent, best in breed Project Management practices for Healthcare Analytics product development projects.

 

Outcomes:

  • Creator and owner of the Product Development Lifecycle.  Ownership included creation and enforcement of all templates associated with the development process.  Ownership also included establishing clear roles and responsibilities (RACI) across all groups involved in the Product Development Lifecycle process.

  • Creator and owner of the Project Management Lifecycle.  This includes standardized project documentation and methodology and project tracking and reporting procedures.

  • Resource Manager for entire Products Engineering staff.  Ensuring that resources were being utilized and projects were properly staffed with correct skill set to be successful.  

  • Developed and mentored 6 direct reports which included training 4 to become PMP certified.

  • Developed and maintained relationships with all members of the senior leadership team, reporting on project status and any impacts on delivering against corporate goals.   

  • Developed and maintained a collaborative relationship with all functional team members across the entire Product Development Lifecycle.

Company: Thomson Reuters - Healthcare Division
Company Type: Healthcare Analytics
Project: Manage Product Management Team for $30M product line in the Operational and Financial Healthcare space
 

Summary:  Responsible for leadership of cross-organizational team that drove successful solutions, top line revenue growth, bottom line profitability, increased client renewals and improved operational delivery of its offerings into the healthcare acute care marketplace from a product management and development perspective.

 

Outcomes:

 Platform expansion initiative to move organization from a retrospective data solution offering to more near real-time solutions specializing in clinical data. Responsible for leadership of cross-organizational team that built plan to drive change and top line revenue by 50% over 5 years.

Company: Thomson Reuters - Healthcare Division
Company Type: Healthcare Analytics
Project: Develop and Lead Program Management and Business Analysis Functions 
 

Summary:  

Head of Program Management Office (PMO) for Thomson Reuters Healthcare.   

 

 

Outcomes:

 

  • Creation and execution of the PMO.  The PMO encompassed three different business units across Thomson Reuters Healthcare -  worked to establish and deploy consistent, best in breed Project Management practices across three completely different cultures. 

  • Further development and expansion of the Business Analysis function.  

  • Responsibilities also include vendor relationship management of the off-shoring initiative for Thomson Reuters Healthcare and Process Engineering (process improvement) across the entire Product Development Lifecycle.

  • Creator and owner of the Project Management Lifecycle.  This includes standardized project documentation and methodology and project tracking and reporting procedures.

  • Developed and mentored 12 direct reports and 30 indirect reports which included program managers and business analyts

  • Developed and maintained relationships with all members of the senior leadership team, reporting on project status and any impacts on delivering against corporate goals.   

  • Developed and maintained a collaborative relationship with all functional team members across the entire Product Development Lifecycle.

Company: Actuation Consulting
Company Type: Product Management Training/Consulting
Project: Develop World Class Training Material for Product Managers and Product Teams 
 

Summary:  

Advance the profession of Product Management by developing training courses, material, contributing time and effort to Actuation Consultings consulting engagements.

 

Outcomes:

 

  • Co-developed Training - Creating Value Through Collaboration

  • Co-developed Training - Take Charge Product Management for Product Teams

  • Contributed regularly to Actuation Consultings Blog - "Take Charge Product Management"

  • Worked on consulting assignments/delivered training with American Hospital Association
     

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