I am a biomedical engineer, systems engineer, and design quality assurance consultant. For over 25 years I have worked on a wide variety of medical device development projects at large and small companies (>50 devices and >30 quality systems). These include surgical robotics systems, laser eye surgery systems, a wearable device for drug adherence, a digital x-ray fluoroscopy system, a heart-lung bypass machine, and multiple IOT and SaMD products. From this broad experience I know what works and doesn’t for different types of medical devices and different organizations. My goal is to find and share ways to make it faster and cheaper to bring medical devices to market.

Sunstone Pilot, Inc. (sunstonepilot.com) is my consulting company to deliver services to my clients. These services fall into four categories:

– Hands-on assistance with DHF documentation, especially software documentation, to help a product team complete a current development project

– Improving quality system procedures to improve every development project at the company- Documentation automation: implementing software tools for requirements mgmt / test mgmt (ALM systems) and related tools to streamline DHF documentation and manage increasingly complex product data

– Training engineers in risk management and design controls

I believe that design control procedures should support best practices for product development, based on lean and agile principles, and need to be tailored to the unique needs of each company and its products. Mismatched procedures are one of the most frequent problems I encounter and correct. After revising risk management and design control procedures at dozens of medical device companies, I have learned how to develop the procedures best suited to a particular client and their products.

Specialties:

• medical device software development and compliance to the IEC 62304 standard (SDLC)
• risk management and compliance to the ISO 14971 standard
• design verification and validation (V&V)
• medical capital equipment, SaMD, and other software-intensive, connected medical devices
• Adaptive Design Controls package for managing development of complex, software-intensive medical devices

These are typical issues and challenges that I help clients resolve:

• Problems writing and managing DHF documentation, especially for software
• Audit findings with design controls or risk management
• Multiple delays in achieving product development milestones (need to accelerate without sacrificing compliance)
• Struggling to incorporate agile methods into software development