Want to reduce medical device development time?

The recent Covid-19 crisis generated a call for the Ventilator Challenge where consortium's of UK companies were approached by the UK government to urgently design, develop and manufacture ventilators. Thus, meeting the expected huge spike in demand from Covid-19 patients needing respiratory support.

At HD we offered our help, but to me it was instantly obvious that to meet the time frames involved that it would be much faster and safer to focus on accelerating output from existing medical device manufacturers. Or to piggy-back on technology or devices that were already proven or close to approval, not start from scratch. There was some amazing work done by the companies involved with new respirator development, but mercifully the spike in ITU/Ventilator demand was much lower than expected. These projects now seem to have been put on hold or have been cancelled. Hopefully, some proper research can be done into those projects, to identify which development processes and techniques were successful and which should become industry standard or avoided for rapid medical device development in the future.

In the meantime, what can be done to speed up the medical device development process?

I’ve done my own investigation and research by talking to a number of people at the coal face of device development, both at pharma and med dev companies. These are proven experts who run teams, do the actual work and take responsibility for creating a robustly designed and engineered device into verification, validation and through the approval process.

Everyone I have spoken to talks of time pressures, together with risks during the development process and gaining approval as their biggest concerns. Rarely, at established companies, do they cite cost as an issue which was a surprise to me. Their overriding concern is making sure development is on time – and it doesn’t go wrong! They understandably don’t want to risk delays or problems with devices out in the field. The device they create and are responsible for, must meet all regulatory requirements so the development work must be done thoroughly - and this inevitably takes time. So how can development time be reduced?

Projects are generally well planned and resourced, but the reality is that medical device development means lots of highly educated and highly skilled people are needed at various points in the project. These types of people aren’t easy to find, especially when you need them, so it is very difficult to balance the availability of this resource. Projects often hit technical or time related challenges and the recent Covid-19 crisis shows that even the very best of plans cannot be 100% controlled and people brought in when needed!

Traditional logic would be to keep building your own medical device development team. However, this is costly, takes time and it’s difficult to build then establish a great team with the systems and provide the facilities they require. This will become more difficult if full time remote working is going to be the norm, for the foreseeable future at least.

The traditional answer may be to use external companies or agency supplied on-site contractors to help with this process. However, the people I have spoken to are generally far too busy to manage or be involved with the outsourcing process. They often don’t want to lose control or take the risk of using unproven development companies. Or, they find it difficult to bring in contractors to the workplace, so people aren’t there to contribute, or they have to offer excessively long contracts to get them on board. They can then lose the knowledge/expertise they gain when the contract finishes.

I’m not talking of specific consultants and experts in the contracting element above. If you can build relationships with high quality people who know their stuff, they will save lots of time through their advice and experience. If you can hire them when you need them, then they can be crucial in planning and making decisions that can move projects forward very quickly.

It is now proven through recent events that people can work remotely in the short term, but quickly starting multiple people with remote work and building up their efficiency, is not easy for any team or manager to achieve.

A project or piece of development work may be estimated to require an average of 8 people for 6 months. However, the reality is that it may need 2-3 at the start 10 at the peak and 2-3 again at the end. This means that people often aren’t working effectively due to too much or too little resource during the project. This is not conducive to saving time and is not a good way to motivate people to work swiftly either.

The most effective solution, established from my research is to build up relationships with flexible external design teams, who you can trust. This means they become familiar with your in-house team, their development systems, and the technology you use for your devices. By their nature, external development teams have to be lean, effective and must deliver results in order to be paid and make money. If this resource is engaged and managed effectively, then a project’s overheads, risks and any downtime can be drastically reduced. All external teams will want to speed through the work and save time, so they can invoice ASAP. That commercial driver can be used by pharma and device companies to save lots of time!

HD has worked this way for many years, allowing us to create a fully ISO: 13485 compliant system that addresses the problems which device development team leaders often experience. I will explain more about this in my next article, please take a look at this video from someone who has first-hand experience of this approach.

In the meantime, please consider help is at hand to speed up development, if you are able to invest a little time up front to source a reliable development partner.