Step by step

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, we oversee every aspect of the physical delivery of the business, from the specification of the components to assembly and packaging, all the way through to the moment the device arrives at a customer’s door. What makes us unique, however, is the fact that we don’t manage any of the product assembly in-house.

This has made it essential for us to find manufacturing, distribution and warehousing partners that we can trust implicitly, that can see the vision for the company and that can continue to service us as we grow.

Our product, the geko, 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 both hospital and home care settings, to address life-threatening blood clots, complications related to swelling after orthopaedic surgery and close hard-to-heal chronic wounds like leg ulcers.

When I joined 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 that is perfect for our current needs, and will support our continued growth.

Manual manufacturing works to a point; however, 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 system. 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. Because of the nature of our products 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 – much like component sourcing – it is considered sensible to have multiple partners to ensure a consistent supply chain. However, as you look to automation, this tends to swing the other way; therefore, you would choose to partner with a single supplier to fulfil all of your assembly needs.

This model 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. As a start-up, we didn’t have the cash for either of these. Now, however, we still manage every aspect of an automated manufacturing and assembly process. Moreover, we understand how to both scale this and the timelines associated with doing so, which will be essential as we expand into other markets. So, how did we do it?

How to approach automation

Overhauling an entire assembly process in one go would be a huge task, so our first action was to break it down into steps. 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.

Once we established the number of steps, we wanted to make sure we took the most costeffective 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 one, three 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.

From the outset, the manufacturing, quality assurance, and research and 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 research and development, we would have to make major changes further down the line. It was, therefore, essential for us to collaborate at every stage of the process.

Like us, most companies turn to automation because of an increase in demand for their products. As such, it’s essential that when you’re creating your automated assembly you make sure it’s scalable. Right now, the automated assembly system we have at Sky can produce one million devices per year, but with some small changes we can comfortably increase the capacity to four million. When we want to scale further, we can simply replicate our refined assembly process in other key markets to account for demand as we grow globally. And, because we own and understand every step of our automated assembly process, we have the knowledge in-house to replicate this without being tied to a single automation expert.

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 that the suppliers you choose – 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.

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 the point that the only constant thing is change. Instead of fearing it, you should aim to embrace it and plan for it.

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Automation in context

Alexander Nathaus, associate partner for medical devices and pharmaceuticals at Porsche Consulting, explains how OEMs should approach employing automation as part of a wider smart factory strategy. The gap between the status quo at many OEMs and the possibilities of smart factories seems daunting to bridge. But the need for bridges is getting more obvious with the increasing pressure caused by reimbursement changes and unprecedented events like the current pandemic. Successfully implemented smart factory solutions could reduce time-to-market, increase the robustness of the supply chain, and optimise manufacturing productivity.

One of the main levers for realising these potentials is increased automation, which relies on introducing data-gathering capabilities to production assets. This allows companies to implement advanced smart factory concepts like predictive maintenance in high-volume, regulation-compliant production. However, many OEMs encounter difficulties along their smart factory journey.

One typical early pitfall to avoid is a focus on single solutions inspired by impressive tech demos. Instead, OEMs should first design a smart factory vision. Derived from this, a holistic smart factory strategy – based on the corporate strategy and the future business model – is crucial to stay on track. Identifying the right use-cases, technologies and skill sets to achieve the required capabilities is another deployment step. In Porsche Consulting’s recent client projects, it has proved beneficial to unite all of this in a structured and aligned smart factory road map.

A second pitfall is the failure to keep people at the centre of the transformation. Even in a highly automated factory, staff remain the key contributors to success. Effective change management, strong and positive communication, and upskilling are essential. Often, a new way of working and leading has to be established, replacing routine tasks with more complex and technology-oriented ones. Adapted technical skills, such as automation management, data management and data analysis, are becoming increasingly important. At the same time, the workforce has to broaden its process understanding, since each individual’s focus area is expanding.

From a deployment perspective, lighthouse areas for prioritised process visions are helpful to more quickly identify and solve initial technical issues while creating acceptance for wider changes. By working within these controlled lighthouses, companies can limit investments and confirm estimated potentials while creating opportunities to familiarise the workforce with the new processes. In any case, lean processes should be established before they get automated.

Source: Porsche Consulting

The Covid-19 impact

Alexander Nathaus gives his assessment of how Covid-19 is impacting automation and smart factory strategies.

Covid-19 is changing the way we work and interact, and it shows how fragile complex supply chains are. The pandemic is currently catalysing three main paradigm shifts that could accelerate automation efforts and digital transformation in the medical device industry: the growth of remote work, the increase in digital literacy driven by the enforced reliance on digital technologies in personal contexts, and the collaboration and data-sharing mentality established by the need to fight the pandemic together. These paradigm shifts all increase acceptance and facilitate smart factory strategies.

For OEMs that want to adapt to rapidly changing market conditions like those caused by Covid-19, flexibility is key. However, automation is no guarantee of more flexibility – it could even lead to reduced flexibility if production systems are too rigid and not responsive enough. Finding the right balance based on customer and patient needs is the key to future success. Therefore, smart factories should be designed for modularity with self-managing assets. In this way, upgradeable machines can perform routine operations, and connect via standardised and adaptable interfaces that support plug-and-play capabilities. Planning and control processes should be set up so products are continually ‘negotiating’ their way through the fully connected supply chain – always identifying the most efficient manufacturing process, and broadcasting their status and location.

This approach means that data is captured, stored and analysed continuously, ensuring product quality and eliminating errors before they occur. Manufacturers can quickly adapt output volumes, increase efficiency and reduce changeover times for retooling during disruptions like Covid-19. In combination with a suite of early warning systems throughout the supply chain, this will help mitigate uncertainties in supply.

At the core of such a highly flexible system are strong planning and control algorithms, which provide options and solutions for unforeseen events, and changing market conditions. Think of it like utilising Google Maps – whenever a traffic jam occurs, the system seamlessly selects the new optimal route to reach the goal.

Source: Porsche Consulting