Q&A's
Q. Were there any intellectual property challenges for this project?
A. The ethos was to create a novel design avoiding supply chain conflict which minimized the commonality with existing designs. In this emergency situation there was less emphasis on designing around existing IP.
Q. Have any patients been ventilated on the Sagentia Ventilator?
A. No patient has currently been ventilated on the Sagentia Ventilator design. Efficacy studies were conducted using an artificial lung at the government assigned test house. The feedback from the studies was extremely positive. Life testing was also performed, and the final test model was switched off after 4.5 weeks -756 hours. Over 900,000 artificial breaths were produced on the life test and it was still going strong when it was switched off.
Q. What’s next for the Sagentia Ventilator?
A. The UK government owns the design, so future use is at their discretion. We have transferred the design files to the UK government and future clinical need will determine whether the UK government takes the project further.
Q. Given the continued change in requirements during this project, in hindsight, would you have preferred to include software in the ventilator?
A. No, although hardware changes were perhaps more time-consuming than software changes, the timesaving in development and verification was still the driving factor in our hardware approach and helped us ultimately deliver a manufacture ready medical product within 7 weeks.
Q. Given the simplicity of the finished design, are modern designs too complicated?
A. While we achieved core functionality with a more simplistic approach, the intended use was in an emergency situation. Modern designs enable a smaller form factor, enhanced use experience and sophistication of control in treating a wide range of patients in different use cases.
Q. What was special in applying agile development principles into the development of a hardware predominant product?
A. We used more flexible processes within the development as we iterated the design, working in 2-day sprints of activity across multiple parallel workstreams. In so doing we used some of the philosophy of agile development, used frequently in software projects, and applied it to this hardware only product development. In hardware developments we normally follow a more serial process of designing, reviewing, prototyping and testing each design iteration.
Q. Was it a let-down for your staff when the ventilator wasn't needed?
A. No. The system not being needed due to reduced clinical need was definitely the best outcome. The team’s satisfaction came from designing a medical device in unprecedented timescales and getting good clinical feedback of the system, confirming that it met the government’s stated requirements.
Q. Have all the competing designs been successful and adopted as well?
A. Throughout the project we were aware that parallel designs were being slowly filtered down to the most likely candidates for success. Other designs were stopped based on factors such as functionality versus the evolving government specification. We are proud that our design was favoured right until our pillar of new designs was deemed unnecessary due to reduced clinical demand.
Q. Would you attribute part of your speed to the avoidance of design loop backs or design tear ups?
A. The latter has most bearing on the speed of our work as the foundation work in defining the context and question being asked avoided the need for wholesale design tears ups. Design loopback featured strongly and was indeed a part of successful performance definition and refinement.
The Poll review
During the webinar we asked the audience ‘Comparing product development in an emergency situation with normal conditions; where are the greatest opportunities for shortening timescales?’
Not surprisingly the leading answer, from 34% of the audience, was ‘regulatory review’ and we wholeheartedly agree. In many ways this was the most different part of the process, normally we would expect a pre-determined, unbending schedule with specific, and spread out, milestones. With the regulatory authority able to operate in this more flexible way and push through at the speed they did made a huge difference to the time saving.
24% of the audience voted for ‘supply chain’. Indeed, in this scenario the supply chain was often on the critical path of the project; the components needed to be localized, plentiful, and timely to minimize critical lead times. It may not always be the cost-efficient approach but certainly the most reliable.
‘Design, Development and Validation & Verification’ was selected by 21% of attendees. Working with so many of the usual design and development roadblocks stripped away certainly gained time. In this scenario decisions had to be made, and fast. Design freezes had to be implemented on a design that was only days/weeks from inception. One observation was that to successfully save time in design and development, high levels of integration and trust need to be present within the team. The Sagentia team, across all disciplines, had to work closely and intensively together. Highly effective communication and project management were fundamental to taking time out of the development. As discussed, V & V was streamlined due to our avoidance of software, but our stripped-down verification protocols were also a reflection of the simple functionality of the device. Working hard to succinctly define product requirements paid dividends in verification timelines.
13% of the audience felt ‘project definition’ was one of the greatest opportunities for shortening timescales. Having the context and requirements fixed by the emergency situation, the situation and task was crystal clear which did save time when compared to ‘normal’ conditions. Any normal product development would certainly have to spend a great deal of time defining the requirements in the early phases of development in order to meet clinical and commercial goals.
8% thought ‘transfer to manufacture’ had the potential to offer the greatest time gains. With our strategy being to initially manufacture in-house, this saved on the transfer time as the system’s designers were readily available to support, train and troubleshoot. Once production was stabilized the transfer to an additional manufacture would have been systematically approached in such a way that would have not slowed the production.
Rob Morgan concludes “Developing a product in an emergency situation allowed for time savings which wouldn’t normally be available, but many learnings and improvements can be taken forward into normal developments in the future. Most importantly we’ve seen how much the timescales on a development can be compressed, allowing us to challenge conventional thinking and reset our beliefs in what is possible in a product development”.
If you have any further questions Rob and Carl would be happy to answer them. Please contact them through [email protected]
