Biomedical R&D Consultant, Implantable Device Experience

A specialist biomedical engineering consultant approached us to place cover for their sole-trader R&D advisory business. The consultant has extensive prior senior experience inside the implantable medical device manufacturing sector and runs their advisory work on a solo basis.

The work is narrow and highly technical. They provide biocompatibility and materials advice used in the design and development of implantable devices. This is exactly the kind of advice that standard insurers struggle to price, because the downstream exposure (an implantable device ultimately used in a patient) sits at the far end of the risk curve.

Professional Indemnity combined with Public Liability was the sensible structure, but from the outset we knew this wasn't going to be a tick-and-flick placement.

The issue here is never really about the individual consultant. It's about how the occupation reads in an underwriter's system. "Implantable medical device consulting" will trigger an automatic referral or decline in most standard markets, regardless of who is doing the work.

We built the submission around the right framing from day one, focusing on:

• The client's depth of experience inside regulated Australian device manufacturing
• The advisory nature of the work (R&D guidance, not design sign-off or regulatory certification)
• The controls around documentation, scope of work and client selection

When we took the risk to market, a handful of insurers declined on occupation alone before we reached an underwriting agency that understood technical medical and life sciences risks.

The first challenge was the occupation itself. "Implantable medical device" is one of the more difficult occupation descriptions to place in the Australian market, so we knew a few declines were likely before landing with the right underwriter.

The second challenge was limit adequacy. A $1M Professional Indemnity limit is the floor for this type of work, and the client wanted Public Liability sitting above it to respond to any physical exposure at client sites. Not every specialist market will bind both layers in one placement for a sole trader.

The third was budget. The client is a sole operator with realistic turnover expectations. A premium that consumed a meaningful slice of annual revenue would have been a dealbreaker.

We placed combined Professional Indemnity ($1M) and Public Liability ($5M) cover through a specialist underwriter at an annual premium of around $1,900.

The broader lesson for anyone working in biomedical R&D: a decline or two on occupation doesn't mean you're uninsurable. It usually means the submission needs to reach a specialist market. The specialist Professional Indemnity and Public Liability markets are there. Reaching them is the broker's job.

This is the kind of placement we built our life sciences insurance capability around.