For over 10 years Single Use Surgical have been taking ideas and transforming
them to sterile products used in the operating theatre. Many aspects of problem
definition and development are common to any product development,
but there are particular challenges relating to the operating theatre environment
and the regulatory framework. This seminar details some of the practical
issues encountered in this journey.
Often the problem and potential solution has arisen in theatres, and so interest
and access is facilitated. There are guidelines and protocol for these theatre
visits and involving the correct people can ensure fewer blocks later on. Sometimes
it is possible to produce proof of concept non-sterile prototypes that can
be used in a non-clinical situation but still in theatres (eg at end of case). These
visits result in much higher quality feedback than meetings with the same
people in an office environment.
A sterile prototype is actually medical device, and requires full CE marking,
together with technical file, risk analysis, sterilisatin validation and product
liability insurance. This can be less of a challenge where reference can be
made to similar product families. Production of the prototype has to be in the
same controlled environment as volume production, and so we invested in a
cleanroom for prototype s at SUS. (This cleanroom is also available for daily
hire at £100/day). Final feedback from prototypes can give confidence for final
tooling and volume production.
Selling a finished surgical product generally takes around 10 times the effort
and cost of developing it. SUS now sell to over 450 UK hospitals and export
30% to over 20 countries. Understanding the challenges of the different markets
also influences product design. Post market surveillance and customer
feedback provide further opportunities for product improvements, sometimes
many years after initial launch.
www.susl.co.uk
D4H2013
them to sterile products used in the operating theatre. Many aspects of problem
definition and development are common to any product development,
but there are particular challenges relating to the operating theatre environment
and the regulatory framework. This seminar details some of the practical
issues encountered in this journey.
Often the problem and potential solution has arisen in theatres, and so interest
and access is facilitated. There are guidelines and protocol for these theatre
visits and involving the correct people can ensure fewer blocks later on. Sometimes
it is possible to produce proof of concept non-sterile prototypes that can
be used in a non-clinical situation but still in theatres (eg at end of case). These
visits result in much higher quality feedback than meetings with the same
people in an office environment.
A sterile prototype is actually medical device, and requires full CE marking,
together with technical file, risk analysis, sterilisatin validation and product
liability insurance. This can be less of a challenge where reference can be
made to similar product families. Production of the prototype has to be in the
same controlled environment as volume production, and so we invested in a
cleanroom for prototype s at SUS. (This cleanroom is also available for daily
hire at £100/day). Final feedback from prototypes can give confidence for final
tooling and volume production.
Selling a finished surgical product generally takes around 10 times the effort
and cost of developing it. SUS now sell to over 450 UK hospitals and export
30% to over 20 countries. Understanding the challenges of the different markets
also influences product design. Post market surveillance and customer
feedback provide further opportunities for product improvements, sometimes
many years after initial launch.
www.susl.co.uk
D4H2013
