Consulting

ENGINEERING CONSULTING SERVICES FOR MEDICAL DEVICE DEVELOPMENT

Although I have full-time commitment to my job, I am pleased to offer consulting services to nascent medical device companies. I have developed Class II and III medical devices that have resulted in successful 510K, PMA and CE submissions. My consulting services include product feasibility analysis, budgeting, product definition, specialized R&D, vendor selection, design and execution of preclinical testing (bench and animal), preparing technical dossiers for submission to FDA and European Notified Bodies, as well as on the planning of clinical trials.

I bill my work as a consultant based on the time spent engaged on project-related activities. Please contact me for current hourly and daily rates.

Technological Feasibility

A proper feasibility analysis is critical to investigate the viability of a potential business venture. My experience spans a very wide range of technologies, so I can help you evaluate the feasibility of a concept and assess its technological risks before embarking on a costly adventure.

Development Budgeting

The cost of development and testing of medical devices, especially of those that require clinical studies, is commonly underestimated by even seasoned entrepreneurs. I have managed the development of a large number of medical devices, including several implantable systems, so I can help you estimate realistic costs and scheduling for the various phases of medical product development.

Medical Product Definition

Product definition is a critical starting point in the development of any new product. I have been involved in medical product design for decades, and can help you translate your clinical needs into a comprehensive set of product requirements that can be acted upon by an Engineering Design House or Original Equipment Manufacturer (OEM).

Vendor Selection

In the medical device field, the design and components of a product cannot be changed without costly retesting and regulatory resubmissions. For this reason, it is extremely important to select vendors wisely, making sure that they embody minimal downside risk. I have over 25 years of interacting with vendors (medical-grade components, design houses, software developers, and OEMs), and can help you make safe, solid choices, with no unpleasant hidden surprises.

Specialized R&D

Most medical start-up companies base their value on recent intellectual property that may not be mature enough for product development. I have an extensive background in applied R&D. My core competencies include biomedical signal acquisition and processing, excitable tissue stimulation, biomechanics, biosensors and biomaterials, transcutaneous energy transfer, long-range RF telemetry, and implantable electronics. I can help your R&D efforts by developing technologies for integration within your product platforms.

Medical Product Qualification Testing

The trick to proper testing of a medical device is to clearly and unambiguously identify test requirements and methods. I have the ability to reduce complex issues to unambiguous test requirements, develop test protocols and write final reports in acceptable format for FDA/CENELEC regulatory submission. In addition, I have the know-how and contacts required to develop and conduct product qualification tests. The device qualification protocols and methods that I have developed have passed strict scrutiny by US and European regulatory agencies. I work with test facilities that are certified to meet US and European norms, and which possess the state-of-the-art equipment necessary to conduct medical device qualification testing per the latest international standards.

I can help you identify relevant test requirements, develop test protocols, develop custom test jigs and execute testing. My consulting services include the most demanding aspects of implantable-device qualification, including:

• Identifying Applicable Standards
• Device Safety Testing
• EMI/EMC Testing
• Mechanical Leads Testing
• Electrode Durability Testing
• Environmental Testing
• Component Qualification

Post-Engineering Consulting

Many entrants in the medical devices business severely underestimate the effort required to put a newly developed product through preclinical and clinical testing to satisfy regulatory requirements necessary to bring the product into the market. I can help you with the design and execution of animal preclinical testing, preparing technical dossiers for submission to FDA and European Notified Bodies, as well as in the development, implementation, and execution of world-wide clinical trials.

If interested, please contact me to discuss your project proposal.