About Us

Bob Duffy, President

Bob Duffy

BDA is led by Bob Duffy who has over 25 years product development, Standards compliance and regulatory experience combined with 15 years manufacturing experience. His manufacturing experience includes electronic assembly, mechanical part manufacturing and materials management in California’s Silicon Valley. His product development experience includes a wide range of devices including pulse oximeters, anesthetic gas monitors, infusion pumps, cardiovascular devices, multi-parameter monitors, nerve and muscle stimulators, and other devices. He was an inventor on (13) medical device patents. He was the original project leader for one of the most successful medical devices in the past decade, providing in excess of $1.0 billion in revenues.

Our integrated team provides solid World Class Product Development services in a wide range of disciplines and products. We provide the experience, expertise and excellence you expect in product development. Most importantly, we provide leadership, integrity and a passion for excellence that permeates everything we do.

Learn About Our Team

The BDA Team is a group of top notch professionals providing the full range of services to overcome hurdles in product development, manufacturing and Regulatory and Standards compliance. Our professionals have years of experience in a wide range of disciplines and products, integrating Customer, technology and business elements to solve problems that allow our Customers to be successful. Here’s a partial list of the challenges we overcome:

Design and Development challenges

  • Design and development planning including, project, software, risk management, usability engineering, verification and validation.
  • Product, software, usability, electronics, mechanical and process requirements and specifications.
  • Root causes analysis and solving problems in system, electronics, software and mechanical designs.
  • System, electronics, software, mechanical, User Interface and process design documentation.
  • Risk Analysis including Hazard Analysis and Failure Modes Effects Analysis (FMEA).
  • Design and Process Verification including creating verification protocols, conducting design verification and process verification, and creating verification reports.
  • Design and Process Validation including creating validation protocols, conducting design validation and process validation, and creating validation reports.
  • Establishing traceability among risk analysis, requirements, specifications, designs, verification and validation.
  • Creating, organizing or updating Design History Files.
  • Transferring designs from engineering design into production.

Manufacturing challenges

  • Creating, updating or documenting manufacturing process flow.
  • Process Failure Modes Effects Analysis (PFMEA).
  • Specifying, qualifying and validating manufacturing equipment (IQ, OQ and PQ).
  • Process validation including creating process validation protocols, conducting process validation, and creating process validation reports.
  • Solving component obsolescence issues.
  • Solving non-conforming material challenge.

Standards Compliance and Regulatory challenges

  • Quality Management System development, implementation and improvement.
  • Labeling review and Regulatory compliance review.
  • 510(k) preparation, submission and clearance.
  • CE Mark Technical File preparation, submission and approval.
  • FDA 483 issue resolution.

Achieving international Standards compliance

  • General Standards such as IEC 60601-1.
  • EMC Standards such as IEC 60601-1-2.
  • Alarms Standards such as IEC 60601-1-8.
  • Usability Engineering Standards such as IEC 60601-1-6 and IEC 62366.
  • Software Engineering Standards such as IEC 60601-1-4 and IEC 62304.
  • Risk Management Standards such as ISO 14971.
  • Biocompatibility Standards such as ISO 10993-x.
  • Packaging Standards such as ASTM D4169, F88, F2096, F1929 and F2054.
  • Sterilization Standards such as ISO 11137 and ISO 11737.