From manual assembly to automation: How to effectively plan for growth

5 mins read

Mark Whalley, head of manufacturing at Sky Medical Technology (Sky), has more than 30 years’ experience in pharmaceuticals and medical devices. After joining Sky seven and a half years ago he was tasked with creating a ‘best in class’ manufacturing process. Now he explains what makes Sky’s approach to manufacturing and automation unique and shares the advice he would give to anyone making the move to automated assembly from manual.

In 2013 many of Sky’s practices were manual, from the manufacture of the devices to the purchase-to-pay process. Since then we’ve created a robust and scalable automated assembly process which is perfect for our current needs and will support our continued growth.

As a medical devices company our number one priority is ensuring that every single device we produce is perfect - there is no room for error. Because of this, at Sky, we oversee every aspect of the physical delivery of the business from the specification of the components, to assembly, packaging, and right through to the moment the device arrives at a customer’s door. What makes us particularly unique is that we don’t manage any of the product assembly in-house. This has made it essential to find manufacturing, distribution and warehousing partners that we could trust implicitly, that can see the vision for the company and that can continue to service us as we grow.

Choosing partners

The device that we produce, the geko™ (pictured below), is an innovative medical device that uses neuromuscular electrostimulation technology to stimulate the common peroneal nerve in the lower leg to provide significant blood flow increase on-demand, in the hospital and homecare setting, to address life threatening blood clots, complications related to swelling after orthopaedic surgery and to close hard-to-heal chronic wounds (leg ulcers).

Not only are the elements of the device highly technical, but our vision is significant - our aim is to change clinical practice globally. Therefore we need to know that every partner we have can deliver its part to meet the high specification we require.

In terms of sourcing components, we work with partners across the globe to make sure each element is of the same high quality and that partners can deliver to our specific needs. For example, we required silver ink printing on one part of the device and this needed to be to a certain standard which few can provide. For each element we also look to second source, whereby we have multiple suppliers to ensure that should an issue occur with one supplier we are able to access the components from another for uninterrupted assembly and delivery to our customers.

After identifying companies that can supply the components we require at the expected quality and cost, the single most important aspect of picking a partner is the people involved. As a business we’re trying to make significant changes in healthcare, so it is important that we partner with people who understand and share our vision. We look for partners that appreciate the challenges that our market and proposition bring and can confidently stand alongside us as we look to tackle them. Having a partner that truly understands your business, and in Sky’s case our desire to own the assembly process, makes a huge difference when looking to make changes and scale up. It also means they’re more likely to work flexibly with you.

Why automate?

For the majority of companies there are three reasons they choose to automate the manufacturing process; product uniformity, capacity and cost.

Manual manufacturing works to a point, but as demand for a product begins to grow and you need to increase capacity a manual system will require more workers. More workers means more variation and therefore more room for error. It also means an increase in labour costs.

For Sky this was not a viable option, we needed to increase capacity while keeping risk low. We were also starting to look to the future and knew that in the long term we would need an assembly process that could be scaled very quickly, while keeping costs manageable.

The solution was automation – it reduces the risk of human error and the cost of human labour, while accounting for scalability. As such, in 2019 we began to move from a manual assembly model to an automated one.

The automation options

When looking to automate many companies opt for a black box solution, whereby an automation specialist creates an all-in-one purpose-built solution. In these cases the automation specialist carries all the risk, as they have designed the process, but they also own the process and understand it better than anyone else. Consequently, companies can find themselves tied to an automation partner for the long-term. Depending on what it is you are manufacturing and the level of control you need a black box solution may be perfect. However, because of the nature of the products we are producing and the level of control we want to ensure quality, this was never a suitable option.

Instead we decided to create our own automated assembly process in conjunction with one of our manual assembly partners. Normally, with manual assembly, like with component sourcing, it’s sensible to have multiple partners to ensure a consistent supply chain. However, as you look to automation this tends to swing the other way and you partner with a single supplier to fulfil your whole assembly needs.

Automation was also the right solution for us from a cost perspective. Increasing capacity on manual assembly means a higher cost of labour and black box solutions tend to bring a large cost up front, and as a start-up we didn’t have the cash to support this. Instead we’re now in a situation where we still manage every aspect of the manufacturing and assembly process and we understand how to scale this and the timelines associated with it, which will be essential as we expand into other markets.

How to approach automation

Break it down

Overhauling the entire assembly process all in one go would be a huge task. Our first action was to break the process into the individual steps that make up the assembly process. It may take some time, but it’s worth identifying each part of the assembly process and the technology involved individually so you can replace sections one-by-one in a controlled and predictable way.

Cost benefit analysis

Once we established the number of steps, we began to look at each element in terms of cost benefit analysis. As a start-up we wanted to make sure we took the most cost effective approach to automation and that any changes we made would save and make us money in the long run. A good place to start is to classify each step into different brackets - consider if it will pay for itself within the year, within three years or five years. From here you can go to your board and lay out a clear plan of action for automating with the appropriate cost benefit analysis to back it up.

Collaboration

From the offset, the manufacturing, quality assurance and research & development teams at Sky worked closely together to make sure that whichever solution we chose would work for everyone. Ultimately, if the quality of the product wasn’t right we would lose customers, and if our automated solution wasn’t able to adapt in line with R&D developments we would have to make major changes further down the line, so for us it was essential to collaborate at every stage of development.

Plan for the future

Most companies turn to automation because of an increase in demand for the products, this was the same for us. Given this it’s essential that when you’re creating your automated assembly you build in scalability. Right now the automation system we have at Sky can produce 1 million devices per year, but with some small changes we can comfortably increase the capacity to 4 million. From here, when we want to scale further, we will replicate our refined assembly process in other key markets to account for demand as we grow globally. And, because we own the process and understand every step of our automated assembly process, we have the knowledge in-house to replicate this without being tied to an automation expert.

Pick the right partners

When it comes to scalability, again, partners are important. If like us you’re looking to expand into markets across the globe you need to make sure the suppliers you chose, whether for components, machinery or something else are able to support you in every market you want to enter. All our automation partners have a global reach and they know and understand our future plans.

Don’t be scared to embrace change

The best piece of advice I can give to anyone looking to automate is to not be fearful of change. In the 30 years of my career in manufacturing we’ve had so much change, to such a point where the only constant thing is change, so instead of fearing it you should aim to embrace it and plan for it.