Automation transforms the manufacture of electronic medical devices

How-automation-is-transforming-medical-manufacturing

OEMs servicing the healthcare and medical sector are feeling the squeeze as new technologies introduce as many new challenges as they provide opportunities and solutions.

Let’s take a look at the role of automation – and how it is answering old problems as it creates a fresh set of challenges – to those researching, developing and producing medical devices and products.

Automation, manufacturing and the medical sector

In a recent McKinsey Report manufacturing was found to be one of the sectors where automation can most easily be introduced.

478 billion of the 749 billion working hours (64%) spent on manufacturing-related activities globally are automatable with currently demonstrated technology.

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Specifically, in relation to medical device manufacture it was found that 60% of the hours spent on activities performed by production workers are automatable.

There are compelling reasons for OEMs to capitalise on the accuracy, efficiency, connected communication and agility that automation can bring.

OEMs of medical devices are experiencing increasing challenges in terms of price and margin pressure, speed to market expectations, increased product (and manufacturing) complexity and more stringent regulatory compliance.

  • There is intense pressure to produce and distribute medical products within ever-decreasing timeframes.
  • Simultaneously, the products are increasingly complex and regulatory requirements are more stringent and labyrinthine than in the past.
  • The trend toward personalisation and miniaturisation of medical products simply compounds these challenges further.

In many ways, it’s the case of a perfect storm hitting the sector – tighter regulation, more product variants, complex designs and sophisticated manufacturing processes are all coinciding with an expectation that development and distribution will be faster than ever before.

But, in other ways, it is a perfect opportunity for those who are positioned correctly to take advantage.

So, how has automation helped cause this situation? And how can medical OEMs position themselves to benefit from it?

The automated future of healthcare

It’s not just in the manufacturing process itself that automation is affecting healthcare. It’s also affecting the products developed and the services delivered.

Five years ago the medical device connectivity market was largely insignificant but it is now expected to grow 38% over the next five years.

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The biochip market is estimated to be worth around USD17 billion by 2020.

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  • A new area of bioelectronic medicine is emerging, thanks to the miniaturisation of electronics – tiny devices implanted in the body may help treat arthritis, diabetes and asthma by influencing electric signals in nerve pathways.

Other areas of innovation include robotic-assisted surgery, next generation smart inhalers that can track use and the ability to produce personalised products in small batches for specific patient requirements.

Juki

Automation and the healthcare supply chain

Automation and machine learning are set to radically improve the supply chain for the healthcare sector.

‘When we have visibility of product from manufacture to finished goods to the use on the patient, and we actually capture consumption activity rather than purchasing activity, we significantly reduce waste and variation in the supply chain.’

Steve Kiewiet, Vice President of Supply Chain Operations, BJC HealthCare

Automated tools can help organisations increase price transparency and streamline healthcare professional’s orders.  Meanwhile, Radio Frequency Identification (RFID) technology can capture volumes of data from a product’s barcode.

More effective healthcare supply chain management could help check the $5 billion that the American healthcare sector loses annually to pilferage and waste.

Source

And data from devices collected during use can be continuously looped back to the manufacturer – for automatic ordering, performance feedback and even AI-initiated product improvements.

Automation: OEMs, EMS and the medical manufacturing processes

For OEMs, this data-connected supply chain will inevitably cause a shift from using many EMS suppliers to partnering with a select few. Inevitably, it will be those who are already intelligently automating and using smart technology to track and control production that will benefit.

Let’s look at the benefits that automation in the EMS sector can bring to OEMs.

From applying conformal coatings to protect circuitry and components in hazardous environments, to exclusive JUKI-automated kitting processes in our surface mount lines, we use smart, data driven techniques to not only increase the speed of production but also to eliminate errors and inconsistencies.

Stewart Gadd, Technical Director, Chemigraphic

Eliminating error and delivering flawless performance

The Internet of Things (IoT) is located at the point where physical objects with embedded electronics, software, sensors and network connectivity can automatically collect and exchange data with each other. For electrical manufacturing, this means smart machines that can accurately capture real-time data as they communicate with each other and the products they process.

This not only increases productivity, but it also identifies any inefficiency, increases quality consistency and avoids errors.

Many electronic components used in surface mount technologies are – to the naked eye – identical. But fitting the wrong part in the wrong place could be catastrophic for the product, and for the OEM’s reputation.

Control processes can be automated to avoid this. In relation to PCB, for example, each printed circuit board is given an individual barcode that enables manufacturing machines to access its production data. Enterprise Resource Planning (ERP) systems will only allow the movement of components and materials between each stage of the manufacturing process once the necessary criteria are fulfilled.

The ERP allocates a unique serial number per product which is automatically placed on it to avoid any possibility of duplication, lack of serialisation or inconsistency. All surface mount stock is managed by a fully automated kitting and storage system that avoids the risk and cost of human error.

In addition, RFID-enabled processing equipment tracks the movement of materials through the factory. Every operator, and operation performed, is tracked and measured against estimated figures and then monitored on site-wide dashboards. This means that we have the fully archived traceability of process necessary for regulatory compliance, and also live management data which is critical to driving truly effective improvement.

Our business relies on the strength and insight provided by the data network that runs throughout it. Automation is key to us – but, for us automation is about more than highly technical machinery.  Automation is about using the tools and information we have around us to implement the best and most consistent methods of delivering the best results for us and our customers.’

Stewart Gadd, Technical Director, Chemigraphic

Reducing speed to market

Regulatory approval for new products

The rate at which OEMs can get a new product to market is determined often by the time taken to gain regulatory approval. Such approval requires the collection of vast amounts of data through every stage of the product lifecycle.

The IoT provides a pathway for the efficient production of increasingly complex products, while capturing and analysing data flows to assist with regulatory compliance and process improvement.

Miniaturisation and personalisation

Advanced sensor technologies are increasingly enabling robots to take on tasks, like cutting gemstones, that had previously been reserved for highly-skilled craftspeople. The same technologies may even permit activities such as ‘painting’ electronic circuits on the surface of structures.

The role of automation is switching from high-speed and high-volume production applications to agile systems that can adjust on the fly, switching seamlessly between product types without the need to stop the line. Many emerging production technologies, from computerized-numerical-control (CNC) cutting to 3-D printing, bypass the need for tool changes, making it possible to produce batches of one.

Medical device manufacturers must remain competitive by responding quickly to changes in patient treatments. Customisation – and increasingly personalisation – of patient-specific devices will require high quality, high mix production that is perfectly suited to machine learning and automation.

‘One of the main areas of benefit the decentralised, smart manufacturing model offers is the ability to efficiently individualise products with high quality results — something that will be critical to success in the patient-specific devices market.’

Francisco Almada Lobo,  CEO, Critical Manufacturing

Technology is only as effective as the way it is used

Of course, in the medical sector, it is critical that this automated production is vertically integrated so that corporate processes cannot be avoided: quality processes may demand that a device requires additional verification steps before the production process can continue.

The implementation of automation will, as a result, always be tempered throughout the medical device production process by compliance requirements and the need for quality control.

And, this is just one way that automation will only ever be as effective as the skill, knowledge and experience of those who use it. This is something that our team at Chemigraphic has always firmly believed.

 The most successful EMS operations are those which combine the mass delivery and rigidity of automation with the intelligence and flexibility of those programming the machines.  

Stewart Gadd, Technical Director, Chemigraphic

Read about how we recently supported the market introduction of Elekta Unity, a ground-breaking cancer treatment technology.

Chemigraphic donates handmade teddy bear to local charity auction

A Chemigraphic employee has donated a unique, handmade teddy bear for a charity auction in order to raise money during a family fun day at CAE. CAE is a manufacturer of flight simulation technologies and Chemigraphic’s neighbour in Manor Royal and holds an annual event in support for local charity, St Catherine’s Hospice.

The bear was made in-house by Michele Simmonds, one of Chemigraphic’s factory team, whose PCB assembly talents clearly extend to sewing and other art & crafts!

Chemigraphic directly supports St Catherine’s Hospice, but is always looking for new and fun ways to become more involved in their work, and so it was an easy decision to become involved in the fund-raiser at CAE.

John Johnston, Sales and NPI Director at Chemigraphic comments, “As a company that believes in partnership, we are delighted to be able to support both CAE during its fundraising day, and St Catherine’s Hospice. The Hospice does fantastic work and we are proud to be one of its long term supporters. We hope that our bear, made by Michele, is a winner at its auction!”

An eye for Design: Why a DfM approach is critical for OEMs

Design for manufacturing (DfM) is (perhaps self-evidently) the practice of designing products with the manufacturing process in mind, choosing the best processes, materials and components. This approach ensures manufacturing costs are lower but no corners are cut, so the best results are achieved without compromising on quality or performance.

  • DfM allows cost-effective solutions to be found prior to production.
  • And it allows potential production problems to be fixed while the design is still fluid and changes will be less expensive and less disruptive to the manufacturing process.

Could design vs should design

Perhaps the simplest expression of the principles of DfM came, obscurely enough, in the blockbuster dinosaurs-brought-to-life-by-unthinking-scientists movie, Jurassic Park.

At the end of the film, having witnessed what happens when scientists simply concentrate what can be done (rather than on what is actually needed), Ian Malcolm (Jeff Goldblum) comments to Park boss Mr. Hammond (Richard Attenborough):

‘Your scientists were so preoccupied with whether they could, they didn’t stop to think if they should.’

And, in a nutshell, it is this tendency to work in a silo devoid from the real world of manufacturing that DfM aims to address.

  • It asks them to consider how they should
  • And not think about what they could

DfM: never too early

The designer’s objective under DfM is to optimise product design with whatever production eco-system is available: including suppliers, material handling systems, manufacturing processes, labour force capabilities and distribution systems.

In this sense, it’s never too early to start implementing a DfM-led approach. At the concept stage of product development, it can add value, avoid cul-de-sacs and point toward ways to keep unit costs as low as possible.

DfM can prevent design considerations being overlooked – or design decisions being made – that will lead to costly components, materials or production methods.

  • Research reveals that decisions made during the design period determine 70% of the product’s final costs.
  • And that decisions made during production account for just 20%.
  • It also reveals that decisions made in the first 5% of product design can determine the vast majority of the product’s cost and its quality and readiness for production.

This is why DfM is such an essential best practice for OEMs when considering an EMS manufacturer to partner with. It can optimise everything from the design stage to the project development stage and on into the manufacturing process itself.

Three Chemigraphic DfM principles for cost-effective manufacturing for OEMs

  1. Fewer active parts should be used through standardisation, simplification and the practice of maintaining records of existing and preferred products and processes.The design of a new part is – in the vast majority of cases – only the best option from a purely design point of view. Minimising active parts through standardisation simplifies product design and leads to operational efficiencies through lower inventories. Group technology (GT) and Component Supplier Management (CSM) systems can facilitate standardisation by basing new designs on similar, existing ones.

  2. Design alternatives should always be evaluated and design tools used to develop a more producible design before release into production.

    Traditionally, designers develop initial concepts that are translated into a product design, making small changes as they do so to meet the specification. We advocate early engagement with our customers’ design teams to make key decisions early that will positively influence and impact the overall manufacturing process.The DfM tools and principles that we use provide a structured way to achieve simplification of product design through practices such as a modular building block approach to assembly.

  3. Product and process design should take place within a framework that considers and balances product quality against design effort and product robustness.

    All guidelines that we use are based on our changing manufacturing environment and increased use of automation. Our designers constantly update their understanding of our production system and all activity and process data is recorded, monitored and acted upon as a matter of continuous improvement.

DfM: The Chemigraphic difference

Let’s put all this into a workflow so you can see how it works in reality at Chemigraphic.

 

Through early engagement with your design team, we identify design alternatives for your product and develop these using the latest design technology

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We evaluate these alternatives against DfM principles

We establish standardised designs based on our DfM principles. These designs can be easily retrieved for your future products

We regularly hold design reviews with the participation of our manufacturing team to continually refresh and improve our approach

And that’s how we can lower your costs without compromising your product’s quality or performance. That’s the Chemigraphic difference.

Why a service-led EMS approach is ideal for modern manufacturing

Advances in technology are ushering in a new era of manufacturing.

The ground rules are changing, possibilities are expanding and relationships between suppliers, manufacturers, retailers and consumers are being rewritten at pace.

  • OEMs are researching and developing increasingly complex products.
  • These products are also reaching markets with vastly reduced lead times.
  • They can be monitored as they are used in the market in real-time.
  • To capitalise on this, OEMs need to achieve agility and efficiencies across their supply chain.
  • And, as a result, they are looking for EMS manufacturers who can become not just a supplier but a critical partner to whom the entire manufacturing process can be outsourced.

Electronic Manufacturing Services (EMS) are now as much about the services provided as the products supplied.

This service-led approach is crucial in the modern manufacturing landscape, supporting increasing demands in the context of ever-decreasing timescales.

The changing face of products within Industry 4.0

The fourth industrial revolution, or Industry 4.0, is upon us, and it’s affecting how we work, how we live and how we interact with people and products around us. New technology is changing the products that we make, the way we make them and the way we test and develop them.

Let’s take a look at just one way that – in the next few years – technology may radically alter the things we make.

Here’s where we are:

It is predicted that electronic devices embedded into plastic materials will have grown into a $25.9 billion market by the end of 2018 in The United States alone.

Here’s where we’re going:

These devices are currently limited by battery life and size. But, advanced battery technology is currently being heavily invested in due to the growing consumer demand for eco-friendly transport and it’s only a matter of time before solutions will be available.

The Advanced Materials market is predicted to grow from $195B in 2016 to $283B in 2021

Exponential Technologies in Manufacturing
Deloitte in collaboration with the Council on Competitiveness and Singularity University

Innovative and ground-breaking medical devices, such as robotic capsules, could be developed as soon as engineers can design suitable nanomaterials for reliable, implanted devices.

Which will mean:

OEMs developing such products will want to work with trusted EMS partners who are able to build and test Printed Circuit Boards (PCBs) made from nanomaterials, such as printed graphene ink, as well as being skilled in the assembly of traditional PCBs.

New materials will enable new devices – and these will provide new service opportunities throughout the supply chain for those in a position to capitalise on them.

The changing role of the end user in Industry 4.0

‘It’s easy to get obsessed with technology – it is the key enabler of today’s revolution – but the harder part of the transformation is cultural. It’s about putting the customer experience and their business outcomes at the centre of everything. That means realigning engineering, manufacturing and the supply chain around delivering a world-class sales and service experience.’
Professor Tim Baines, Aston Business School

At the heart of many new technologies, including the much-talked about Internet of Things (IoT), is the ability to share and analyse data from many sources in real-time. This is causing a sea-change in manufacturing.

 Investment in the Internet of Things (IoT) is predicted to grow from $737B in 2016 to $1.521B in 2021

Exponential Technologies in Manufacturing

For OEMs, their customers – product end-users – can now truly be placed at the heart of everything they do thanks to the interactive technology at their fingertips.

By using connected technologies and the crunch-capacity of the cloud, data from the manufacturing plant can be integrated with data created by customer activities to form a virtual data loop that enables manufacturers to achieve unprecedented levels of customer service.

And OEMs are expecting the same from their EMS partners.

Lean manufacturing processes and practices such as Kanban, Just in Time, VIM: this is all just the tip of the iceberg. OEMs need suppliers who fulfil products in exactly the way they require and who can manage the quality testing and stock for them. They want an EMS manufacturer who can be involved in the early stages of R&D and help overcome problems with solutions.

OEMs want fantastic service as well as excellent products. That’s why supply chains are changing – gone are the days of multiple suppliers and in come the days where partners who offer service alongside products are winning the contracts. Fewer suppliers will compete on service, quality and responsiveness (and, of course, price).

The collaborative nature of Industry 4.0

 86% of the top 100 companies in R&D spending worldwide are from the manufacturing industry

Exponential Technologies in Manufacturing

Technological advances are also revolutionising the way products can be developed.

New tools are allowing companies to collaborate on the creation and testing of products in the virtual world, simulating the design process and the assembly line before an actual product is created.

service-led EMS approach is ideal for modern manufacturing

EMS partners who can help early in the design process while plans are still fluid and malleable can reduce risk and cost at the later stages of manufacturing. Augmented reality can allow remote assistance from people in different locations around the world to connect in a live view and trouble-shoot product development problems very early in its life cycle.

Similarly, 3-D printing and automation can help reduce waste and create efficiencies throughout the manufacturing process.

 

By 2020, 75% of manufacturing operations worldwide could use 3D-printed tools, jigs, and fixtures for the production of finished goods

Exponential Technologies in Manufacturing

 

Data from augmented and virtual reality, as well as increased customer feedback, will allow collaborative research and development (R&D) to give consumers more of what they want, getting products to them faster and cutting down on costs.

EMS: Electronic manufacturing for the future

The technological impact of Industry 4.0 for the EMS industry will see OEMs working much more closely with suppliers that can offer services as well as products. As they look to shrink their supply chains into more consolidated networks of multi-skilled partners, it’s a huge opportunity for EMS businesses to step up.

There will be fewer EMS suppliers – and those who will benefit will be those who have invested wisely in new technology and who place their customers – the OEMs – at the heart of all they do.

And Chemigraphic has always been happy to serve.

Why choosing the right plastic casing is a crucial EMS decision

Why choosing the right plastic casing is crucial in Electronic Manufacturing Services

John Johnston, NPI and Sales Director, Chemigraphic

Plastics have become an essential component of many electronic products, in both consumer and industry markets. Most products rely on using plastics for lightweight structures, electrical isolation, and designed-for-use enclosures and human interfaces.

There are many different kinds of plastics and polymers being used in all aspects of technology, with each having individual user properties that are suitable for very different applications and environments.

It is crucial that the correct type of plastic or polymer is sourced for the product, as different plastics may not have the structural integrity, consistent function in changing environments, or acceptable long term wear characteristics required. Selecting and vetting a supplier is another vital step in ensuring that the assembled product is not compromised.

Selecting suitable plastic properties

Selecting the correct plastic or polymer for electronic products is a crucial task within the early stages of product design and development. Subsequent changes can be costly to correct once a product’s manufacturing processes have been established.

On the whole, plastic enclosures are used to provide protection for the electrical components within. It is easy to focus on the validation of the electronic function and overlook the need for a sustainable and effective enclosure design solution until later stages. Selecting the correct plastic compound and enclosure is crucial to get right early on in the design stage in order for the product to be fit for purpose.

We support customers in selecting the most effective and suitable plastic components, based on the application and operational environment specified.

For example, Acrylonitrile Butadiene Styrene (ABS) is a two-phase polymer that provides good all-round performance for electronic enclosures. However, it is only suited for indoor use as it becomes compromised when exposed to sunlight for prolonged periods. Conversely, a blend of Acrylonitrile Styrene Acrylester and Polycarbonate (ASA+PC) enhances plastic performance at high temperatures, is flame resistant, increases product impact strength, and is therefore more suitable for harsher environments

Plastics in EMS

Plastic sourcing and supplier quality issues

It is of vital importance to select a capable, vetted supplier, especially when importing plastics or polymers from offshore locations. Less tangible quality aspects, such as cosmetic appearance, and long term resilience to tool wear can be difficult to fully communicate and standardise due to the complication of geographical and language barriers. Simply validating samples is often not enough.

Electronics designers can often be unaware of some of the very latest additive plastics manufacturing process options such as new multi-shot multi-materials injection moulding (MS-MMM) techniques which can incorporate soft-touch textures and colour, rather than relying on subsequent distinct operations which may demand the use of  different suppliers.

Even apparently trivial things like incorporating soft rubber feet into the enclosure moulding can accumulate significant benefits.  Such improvements might harvest relatively modest gains on an outright single unit cost basis, but multiplied by annual volumes over the entire lifecycle and, merged with multiple other similar cost-down initiatives, the accumulated savings can be very worthwhile. Of course the objective is not to cut corners, but achieve savings though efficiency and empirically improving the underlying performance and reliability of the product in its entirety.

Chemigraphic’s solution: A customer case study

We are specialists in design-led electronics manufacturing, and work directly with OEM customers to migrate projects from concept, through validation and into volume manufacturing fulfilment, as efficiently as possible. Engaging with customers early in their product design phase, allows for our input into part selection, materials and processes to both meet customer requirements and to optimise long-term manufacture, while the design is still fluid.

Chemigraphic has direct links with diverse specialist global suppliers, and we adopt a highly proactive supplier management approach. For example, our sourcing office in Shenzhen, China, has built up a network of reliable made-to-drawing plastic component supply partners, receptive to UK volumes, which we have personally audited. Having a local Chemigraphic resource allows for effective selection, tooling and monitoring of such supply chains, and we can even co-host customer visits.

This reduces the risks to our customers of partnering with new international suppliers and creates a tier of very capable and cost-competitive supply options, which we can then make conveniently available to our UK customer base.

There can be also opportunities for retrospective process improvement. For example, we have just completed a successful project with a customer with a premium product that used well established plastics supply chains, who then entered the Japanese sales market.

Japan has exceptionally demanding cosmetic standards and expects near-perfection, which the customer’s existing mandated enclosure moulding and coatings process (with tooling which was becoming worn) was simply not able to achieve. It was time for a new, more sophisticated solution.

Chemigraphic’s Shenzhen site was able to identify a highly capable, in-region, specialist supplier who was receptive to the low-volume and high-mix project.

Chemigraphic helped establish and document firm design and appearance criteria (which did not exist previously), achieve exact colour-match values by using the latest high-accuracy sample measurement equipment, define a robust documented process, arrange supply of samples, then facilitated introductions and a joint supplier site visit to give our customer full confidence that this was a superior supply option.

The outcome was a vastly improved cosmetic appearance, reduced turn-around times and a more cost-effective solution, even taking shipping and tooling costs into consideration.

Although much of our historic expertise has been in electronics manufacturing, particularly PCBAs, our customers need to consolidate supply chains and benefit from economies of scale, often with limited design resources. Therefore we are constantly extending our capabilities to include various associated services, dealing with plastics, mouldings, metalwork, component selection, coatings and supply chain management.

Our EMS expertise brings Elekta’s cancer treatment tech to market

Chemigraphic expertise supports market introduction of Elekta Unity, a ground-breaking cancer treatment technology

The manufacturing and product development division of Electronics Manufacturing Services (EMS) provider Chemigraphic was part of a year-long process in supporting Elekta, a leading innovator in radiotherapy treatment and software, with bringing their newest cancer treatment system to market. Elekta Unity received CE mark in June and is the first of its kind, a high-field MRI-guided linear accelerator (linac) system that enables magnetic resonance radiation therapy (MR/RT), a new approach to cancer treatment.

Chemigraphic has been involved in the development of the product since 2014, conducting complex mechanical and bespoke PCB assemblies, and developing test and installation kits.

Chemigraphic’s focus on precision and early engagement, plus its ability to handle multiple assemblies from concept to production, has been a vital contributing factor in progressing the product’s route to market. Additional support throughout the testing and ongoing development stages, incorporating a number of engineering changes whilst maintaining consistency has further enabled the product to succeed in validation tests, resulting in the clinical introduction of Unity.

Barney Sheppard, Sales Operations Manager at Chemigraphic, comments: “Having been involved in this project since 2014, it is very gratifying to see the product launched onto the commercial and clinical market. It is humbling to be able to play a part in the development of a machine which will genuinely change and save lives, and we are very proud that our focus on seamless delivery and the highest quality assemblies has been a contributing factor in this project.”

The Elekta Unity MR-linac, which has been installed in MR/RT Consortium sites globally for research purposes, can now be used by and sold to hospitals throughout the UK and the EU.