Medical device development practices: empirical survey and legal implications

Safety concerns relating to medical devices have been raised through recent failures of heart valves, breast implants and pacemaker leads. Under common law in Australia, people who are engaged in the provision of medical care are under a duty to disclose, fully and frankly, the risks associated with any medical treatment, including those associated with new medical devices. A study via an anonymous questionnaire was undertaken to determine the engineering, testing and regulatory criteria and practices currently followed by developers of new medical technologies. While some good engineering practices, such as design specifications, design control and fail-safe tests, are normally adopted (86%, 64% and 64%, respectively), inadequate numbers had written functional specifications (18%), conducted a risk/benefit analysis (29%) or documentation control (47%). Only 45% of respondents indicated that they had any education or training in product development methodologies for medical devices. While low numbers engaged independent testers of their device (28-45%), a much higher number (80%) wanted independent safety reviews if they were the device recipients. These results raise concerns about the ethical standards being followed and suggest that current development and risk management practices may not meet statutory requirements or the common law standard of care to disclose risks