Welcome to our website
Device Design Solutions specializes in ensuring the timely and cost-effective completion of medical device systems, facilitating their approval by regulatory agencies and market release.
Our extensive experience in project rescue/recovery and product development and realization drives successful outcomes.
Our mission is to enhance human health by expediting the delivery of innovative products to customers and patients.
We also offer comprehensive organizational improvement and growth strategies across various industries.
Partner with us to achieve your medical device goals!
Our Services
Leadership - Management - Organizational Health/Culture
Executive Leadership - Working with Executive Leadership Teams and Boards of Directors on company leadership, operations, strategy, and goals
Management - Developing, mentoring, and training new and existing managers to develop leadership and management skills to ensure successful teams
Financial Planning/Budgeting - Defining, developing, implementing budgets
Strategy - Defining strategic goals at corporate, departmental, and team levels
Culture - Organizational improvements driving better and more cohesive cultures
Team Engagement and Accountability - Working vertically and cross functionally to get teams better engaged leading to best in company engagement scores
Change Management - Defining, implementing, and managing change to ensure successful outcomes
Risk Management - Identification and mitigation
Global Staffing/Team Engagement and Management- Selection, engagement, integration, and management of teams globally
Global Vendor/Partner Relationships - Analysis, selection, engagement, management
Mergers and Acquisitions (M&A) and Due Diligence - Evaluating potential partners for mergers and acquisitions, including due diligence analysis
Intellectual Property (IP) - Setting up and managing IP portfolios and local/global patent strategies
Product Management - Development - Realization
Project Rescue/Recovery - Diagnosing and fixing project issues covering - schedules, costs, resourcing, definition, process issues
Product and Project Management - Setting up and managing product and project management organization, optimizing processes and methodologies for project and portfolio management, including setting up and defining Product Roadmap strategies and planning sessions
Research & Development (R&D) - Setting up R&D organizations to help drive innovation from concept to product realization
Software Engineering - Setting up, organizing, scaling, and driving engineering teams for all types of development - embedded, application, cloud, etc. using the best tools and processes for the task
Hardware Engineering - Setting up, organizing, scaling and driving engineering teams of all disciplines - electrical, mechanical, systems, biomedical engineering
Manufacturing - Working with internal and external manufacturing teams to improve processes, quality, yield, testing, and training
Quality Assurance - Setting up and working through regulated QA requirements to ensure proper compliance to standards like FDA QSR and ISO 13485, experienced in Quality Management Systems and setting up processes and procedures; experience in QMS tool selection, engagement, implementation, and management
Verification/Validation - Setting up systems for both regulated and non-regulated products/projects
Regulatory Affairs - FDA, QSR, GMP, ISO/IEC 62304, 14971, 13485, 62366, 60601
Our team
David Shanes, President
David has over 20 years of medical device experience, over 30 years of software development experience, and over 35 years of leadership experience.
He is a U.S. Navy Veteran and has worked on many medical devices and has been involved in all aspects of product development.
David has been brought in to help get companies, teams, and projects back on track and drive success (rescue/recovery).
David holds a BS in Computer Science from the United States Naval Academy in Annapolis, Maryland and a MS in Computer Science from San Diego State University in San Diego, California.