With a half century in business behind it, medical product specialist Bespak’s focus on innovation, quality and meeting the needs of the market has made it one of the leading manufacturers of drug delivery devices for the world’s largest pharmaceutical companies.
A team of Bespak directors take Mark Young through the company's culture, its robust product development process and some recent innovations.
Founded in 1959, Bespak makes a range of complex drug delivery devices, specialising in self injection and respiratory products, with an output of half a billion assemblies each year.
The firm’s CFC free valves are believed to be used to deliver the widest range of formulations for COPD (Chronic Obstructive Pulmonary Disease) and Asthma and in more territories than any other company in the world. Asthma and COPD affect more than 300 million people worldwide. Impressively, more than 1,000 people use a Bespak product every second of any given day.
The company partners with the world’s very largest pharmaceutical companies who purchase its assemblies and use them in final product manufacture. In November last year it was saluted by GlaxoSmithKline for supplying the pharmaceutical giant with its 500 millionth Diskus, a dry powder inhaler device which GSK sells all over the world. The customer has been supplied by Bespak for the last 15-years.
Metered Dose Inhalers (MDI) – the most prominent device used by asthmatics – have historically been Bespak’s main focus. Here, Bespak supplies major medicine makers with the inhaler valve, which measures and delivers the correct dose of medicine, along with the actuator, which encases the canister that holds the medicine. The pharmaceutical company then buys in the canister, fills it with their formulation, attaches the valve and actuator and sells it on to the market. However, the company is now branching out into new areas through acquisition and organic growth.
Two years ago, it purchased of a Sheffield-based firm called The Medical House in a deal worth £16.9m. With it, Bespak garnered the capability to launch itself into large scale production of cutting edge auto injector devices – a market which is growing at approximately 15 per cent per annum. The new addition was renamed Bespak Injectables and became Bespak’s fourth UK site, after the main factory in King’s Lynn, Norfolk, a secondary manufacturing site in Nelson, Lancashire, and an innovation office in Cambridge. The 500 employees at the King’s Lynn site make the company one of the largest employers in North Norfolk, while the other sites employ around 100 more between them.
Says Bespak managing director Joe Barry: “We reviewed the whole medical device market to determine significant growth areas that could be aligned to the core competencies of the company and the auto injector segment fitted the criteria we were looking for. An increasing number of biologic drugs in the pipeline will need to be injected into the body. With our acquisition of The Medical House and our development work since, we now have auto injector platform technology that lends itself perfectly to deliver these sorts of drugs.
Along with the decades of experience and expertise that we have in putting together complex medical devices in high volumes, this means we are geared up nicely to take full advantage of this new opportunity.” Bespak accounts for around two thirds of the £119m turnover of parent company Consort Medical, which is listed on the London Stock Exchange and has its headquarters in Hemel Hempstead, Hertfordshire. Anaesthesia device specialist King Systems, based in Indiana, USA, chips in with the rest.
The group’s operating profit last year was £19m.
On site at King’s Lynn, Bespak has more than 100 moulding machines and 40 automated assembly platforms, running on 24/5 basis, and more than 13,000 square feet of manufacturing space of which approx 6,500 square metres is clean room. It injection moulds some 3bn parts each year, from 1 – 128 cavity tools.
|
GlaxoSmithKline Vice-President and Site Director – Graham Johnson “GlaxoSmithKline has worked with Bespak for several years on the Diskus device and I was pleased to visit the Kings Lynn site late last year to mark the production of their half billionth device. Given the complex nature of the device, it has required true partnership to deliver this medicine to the marketplace. Recent statistics suggest that the therapy area concerned – the treatment of asthma and chronic obstructive pulmonary disease (COPD) – is the fourth biggest killer in the world, so staff at Bespak should feel good about their contribution to improving the quality of life for millions of people every day.” |
Bespak introducing…
As well as contract manufacturing, Bespak provides full design, industrialisation and scale up in its core product areas. New product development follows a formalised process dubbed internally as the Bespak New Product Introduction Process. It starts with innovation director Ian Anderson’s growing team based at the St John’s Innovation Centre in Cambridge. The reason this team is based some fifty miles away from the main site in King’s Lynn is that it is far enough away that the industrialisation emphasis of the main site will not stifle creativity from the outset. Instead, the company wants to find the best fit solutions for market needs and then, being only an hour away, can quickly access industrialisation expertise which Bespak has built such proficiency in over the years to ensure it is manufacturable in mass volume. “We want to allow ideas that are slightly left of field the chance to germinate and build a substance and robustness to them,” says Anderson.
“Cambridge also has a network and innovation culture, with a lot of start up businesses and, of course, the university. So it’s a good place geographically to be based.” That isn’t to say that Ian and his team have a completely free reign when sat at the drawing board, though.
The innovation team is focussed not just on product development but also on how that product is to be realised and brought to market, and how it is going to go about being sold and who it will be sold to. Therefore, identification of needs – ascertained by working closely with all relevant stakeholders inside and outside of the business – is the primary concern while the ability to protect work, freedom to operate and, indeed, certain elements of industrialisation must stay at the forefront of considerations. In addition, to appease regulators and to ensure that the technology works exactly as it is expected to – a critical element of the philosophy upon which Bespak has set out its stall – the product development involves thorough checks and testing and fastidious documentation procedures.
Says Anderson: “We would generally begin with a detailed stakeholder validation involving everyone from the pharmaceutical company through to the patients, as the end user, focussing on how they are going to interact with the product. Based on the set of needs which we identify, we then build up a proof of principle demonstrator which demonstrates the technologies that we are trying to get manufactured and proves that they are robust and that we can control them.
“We do scrupulous sensitivity analysis of a product, including a lot of early stage maths and a lot of simulation to make sure it’s going to operate as expected. Once we are comfortable that we understand the technology and how it’s going to be implemented we start to transition it over to the product development team on site at King’s Lynn.”
|
Biography: Alan Paterson – Continuous Improvement Director 1992-96: Senior Scientist, Device Technology, 3M Healthcare 1997: Joined Bespak as the first dedicated Programme Manager 2003: Appointed Head of Advanced Services for Bespak’s Device Services Division 2007: Appointed Technical Services Director for Bespak leading all New Product Introduction 2009: Appointed Continuous Improvement Director for Consort Medical Alan Paterson is CI Director for Consort Medical with responsibilities spanning both Bespak and King Systems. Bespak are a leading global supplier of drug delivery devices for injectable and inhaled products. King Systems are a leading manufacturer and distributor of airway management, anesthesia and respiratory medical devices, products, equipment and supplies. Alan Paterson is a Mechanical Engineer who undertook pragmatic University research to PhD prior to joining the pharmaceutical and Medical Device industry in 1992. He became a six sigma Black Belt in 2007 and has been active in the field of CI for a number of years. He is married with 2 teenage daughters and his primary hobby is following Tottenham Hotspur who he has supported for more than 40 years. |
Here Lyndon Wild, as director of product development and operations, takes over the overseer role and prepares to take the product through to a single cavity prototype upon which consistency, performance and usability testing can be performed. Lyndon’s combined role means that he can manage the flow of products out of development and into manufacturing and he can ensure much closer, tighter, links so there is much less likelihood of issues when products leave development and move into operations.
He understands the challenges that the manufacturing operations are faced with and can feed these back into the product development stages.
“Getting a new product over to the development team from innovation takes somewhere in the region of six to nine months so it’s going to be quite a well considered thing by the time it reaches us in King’s Lynn,” says Wild.
“However, already by this stage the innovation and product development teams that are working on each project are often indistinct. The handover process is very considered; it’s a gradual transfer of ownership.
“We’ll usually go through a step-wise process from there on. The products we are developing usually end up being manufactured in their tens or even hundreds of millions through fully automated assembly but in order to go from a single cavity part where you’re making five to ten thousand, you have to scale up one stage at a time. We start with manual assembly, and then take it through a jigs and fixtures version. We then run some semi automatic assemblies before ending up with a fully automatic solution.
|
Biography: Joe Barry – Managing Director 1986: Manufacturing Engineer at Collins & Aikman 1989: Joined Dow Chemical and spent 7 years in various senior commercial roles 1996: Moved to The Netherlands when appointed European Product Manager at GE 1998: Transferred to Indiana, USA to become Product Manager- Americas at GE Plastics 2002: Joined US Can as European Commercial Director 2004: Joined Bespak as a divisional General Manager and appointed MD in 2009 Joe Barry is Managing Director of the Bespak Division of Consort Medical plc – a leading manufacturer of complex drug delivery devices, specialising in self injection and respiratory products. Joe is married with 2 children and his hobbies include rugby, cricket, tennis and skiing. |
“In the background of all of this is the regulatory environment which means we have to make sure we retain all of the design history files throughout the process, all the way from the original need right through to the finished product. This is important for the standards that we set for ourselves too, and that we have managed the whole process so that we’re talking to the right people – the regulatory body, our clients, the pharmaceutical companies to make sure the design for the system is something that can be manufactured to the quality levels we demand as well as fitting the original need. Of course, in the medical world, it is one thing being able to manufacture but it’s quite another thing being able to get it to market.” The Bespak directors are keen to stress the importance of staying in control and knowing exactly what will happen at each stage of the process.
Just as a barrister in a court of law knows the answer to every question before he submits it, the testing processes at Bespak are for proof, rather than for exploration. “What you can’t do is test your way out of a problem,” says Wild. “What you have to do is understand how your device works and carry out the testing that demonstrates that it works as you expect it to. First you do a round of verification testing and then you do a round of validation testing.” From the product development team through to volume production it depends on the drug and the device.
Usually it’s around another 12 months but it can be substantially longer.
To ensure quality of the product and that processes are laid out properly, the company is compliant with ISO13485 – a standard which is very much geared towards medical devices.
“The processes are well defined and there is no scope to rely on previous experience and skip a few steps. Increasingly it’s more about the process you go through and the value that process brings,” says Anderson. “We work with the world’s leading pharmaceutical companies and they expect us to have quality at the forefront and to continuously improve as well.”
|
Biography: Ian Anderson – Innovation Director 1987: Joined Vinten Ltd as a graduate engineer 1993: Joined Unicam, part of the Thermo group, managing the development of photo-spectrometers 1997: A move into consultancy with TTP, undertaking a range of development roles eventually heading up consumer products 2005: Sagentia Ltd – Director of Marketing and Drug Delivery 2010: Return to industry with Bespak Ian Anderson is Innovation Director of Bespak. The Cambridge office is responsible for identifying opportunities that will support the strategic aims of the business in drug delivery and POC diagnostics. He is married with two teenage children. His hobbies include football, golf and cycling. He has an Msc from Cranfield. |
Breakthoughs
The focus on innovation has paid off with many market changing breakthroughs over the years. Most recently, Bespak has developed a counter for inhalers which counts down every time a dose is administered.
This way, the user knows exactly how much medicine they have left in each device. The counter has been developed in response to new regulatory guidelines. The counter has a cost attached, of course, so it won’t be suitable for every market, but for the US, it cements Bespak’s position with existing customers and opens the door to new ones. And since the US is the world’s largest market for inhalers it was important that Bespak got in on the act quickly.
“Bespak is one of the few manufacturers in this emerging sector,” says Wild. “Ours has a patent protected mechanism focussed on ensuring absolute reliability in the product so that it cannot over or under count.” The second big innovation recently is in the field of auto injectors, propelled by the purchase of The Medical House.
Historically, medical devices are developed by working with a specific pharmaceutical company for use with a specific drug. The two are inextricably linked – one cannot function without the other. With its work on auto injectors, though, Bespak has developed a platform technology which can be used with a number of drugs and which it plans to license for a variety of therapies. Being a platform technology it is readily customisable to meet the needs of specific patient groups.
Explains Ian Anderson: “In developing this new technology we’ve taken a new approach and created an interesting business model around it. That’s really the innovation here. It’s a customisable platform which anyone can tap in to allowing smaller biosimilars and generic product manufacturers to offer a self injection system. From the patients’ perspective, it makes the experience of administering medicines a lot more comfortable as you do not have to physically insert the needle yourself.” In addition, Bespak has developed a new Easifill primeless valve which has a fast fill, fast drain characteristic and allows a metering chamber to refill just before actuation. It ensures the inhaler is always ready to deliver the correct dose. “We believe Easifill will be the first primeless valve available on the market in the US,” says Barry.
|
Employee Focus John Williams, Operations Manager
John Williams joined Bespak to earn some money over the summer before he went to university. However, he liked it so much that he never left. He’s now risen through the ranks at the company to become Operations Manager. What do you do in your role? What are the key skills you use? What do you consider to be your biggest personal success at the company so far? We have run two very successful projects within our Medical Check Valve product stream; leading the team to achieve our project goals was hugely satisfying. The success of these projects negated the need to procure an additional machine and thus saved a potential £1m plus capital outlay. In reality we delivered a 30% plus improvement in machine efficiency to average levels that are at world class performance levels of 85% plus. The next challenge is to maintain performance in the 90’s – we regularly achieve figures in the early to mid 90’s – we just need to keep the focus on raising the bar. What are the most rewarding parts of your job? What first attracted you to a career in manufacturing? What’s good about working for Bespak? |
|
CV in brief – John Williams Age: 43 Qualifications: Employment: Outside interests: |
Continuous Improvement (CI)
Over the last few years, Bespak has engendered an organisation wide culture of continuous improvement which has infiltrated all operations and processes, with the principle aims of supporting growth, improving competitiveness and value to its customers. The company appointed Alan Paterson two years ago as continuous improvement director for Consort Medical to harmonise and accelerate the approach.
“The function of continuous improvement is really to remove the barriers which prevent us achieving the performance levels we target,” says Paterson. “We identify the problem, define what success looks like and then come up with data driven solutions.
We look at driving out waste in all of its forms. In the new product introduction area, for instance, we make sure we don’t build waste into the process design. That’s not just the things you throw away, it’s about making sure that we do not do things that are non value added to our customers or the running of the business. In our industry there is a tendency to generate a lot of data from production which after a period of time is no longer routinely analysed.
We don’t do checks unless there’s a value attached, and we consider the workplace layout so that we don’t introduce unnecessary motion or unnecessary material movements.
“We are building continuous improvement into the very essence of our operating philosophy, the goal being that you could take it away as a function and it would continue to propagate naturally throughout the organisation driving the performance that matters.” As a recent example of CI in action, the company looked at how it could reduce the batch changeover time in a mature operation which had evolved over the years and found it could optimally reduce the downtime of the batch by 50 per cent. The project considered re-sequencing activities and concentrated on what tasks could be done while the machine was still running, rather than stopping it completely to perform the entire changeover process.
Paterson says the quantity and location of inventory is also integral to an optimised operation. “Overproduction is a big problem because if you make more than you need you have to transport it and store and administer it,” he says. “It’s important to make only what you need to satisfy the customer demand and locating what you need local to where you need it. It sounds obvious but it’s amazing how easy it is to slip into the habit of keeping the machine running and making five times the amount you need and then transport it into storage only to have to move it again when the customer requires it.” In most cases, Bespak operates on a make to order basis.
The personnel on the shop floor feed into continuous improvement through various means. Many of the ideas and suggestions for improvement come directly from the operators themselves and Paterson says it is critical that they have a good understanding of the efficiency concepts as well as the goals that the organisation is hoping to achieve.
“Then they are the best people to identify obstacles and opportunities,” he says. “You would be foolish if you didn’t engage with them for solutions and furnish them with the best tools and techniques for them to become effective in their analysis of their own day to day output and processes.” That doesn’t mean training for training’s sake though.
“You never see a true return on investment if you go down that route,” says Paterson. “If you train 100 people to green belt six sigma level but then you don’t allow them time to progress improvement opportunities that investment becomes wasted. So instead we look at where we have a need and then create a suitable team and provide them training on how to carry out a project and evaluate it afterwards. It’s a learn by doing approach.” In January, Bespak ran a week long practical workshop in which a cross functional team of participants were chosen not only for their skills but also their attitudes and behaviours in relation to CI and their potential for influencing others.
|
Bespak: At a glance
Based King’s Lynn, Sheffield, Nelson, Cambridge Formed 1959 Industry Complex medical device manufacturing Specialist areas Respiratory and auto injector technology Ownership Part of the Consort Medical Group Annual group Revenues £119m (of which Bespak accounts for two thirds) Output 500m complex medical devices per year Facilities 13,000 square metre factory, including 6,500 square metres of clean room, 100 moulding machines, 40 automated assembly platforms Trivia More than 1,000 people use a Bespak product every second |
The workshop was a live project which involved work on real processes and problems that needed solving around the factory with a focus on identifying challenging but achievable performance targets. The team comprised of five individuals from a range of operational disciplines as well as the operations manager from the area. After two blocks of training and three days on the job followed by a wrap up evaluation session at the end of the week, the outcome is that the company now knows that its aspirational targets are realistic and it has a plethora of ideas about how to achieve them. “We have a whole host of wastes to remove and we have ideas about how we want to structure the process of improvement in this area,” says Paterson. “The week was very successful and it has started something which we hope will become a lot bigger.” The CI philosophy extends all the way throughout the flow of processes from early product development, into manufacture and beyond into product life extension. As well as all of the way throughout the development stage and industrialisation, Bespak stays closely engaged with stakeholders in the management of mature products.
Anderson says “It’s very much about a full product life cycle management going through cost down journeys as drugs or devices become more generic or commoditised.
This is an increasing factor in the medical device manufacturing industry.” Paterson says his job has been made a lot easier because Bespak is blessed with a workforce which has a high amount of buy-in to the cause. “You’ll always have people who resist change and can’t see beyond the here and now but generally we have a very receptive, engaging and driven workforce which understands the motives and wants to get results,” he says.
|
Biography: Lyndon Wild – Product Development and Operations Director 1987: Joined BXL Plastics a subsidiary of BP Chemicals International as a Graduate Trainee 1989-92: Held various product development roles at SIMS Portex 1992-99: Rexam, senior product and business development roles within the pharmaceutical packaging division 1999-08: Jaycare, held various senior level roles; Product Development Director, Business Development Director and ultimately Commercial Director 2008-09: Joined Bespak as an interim programme manager 2009-10: Clondalkin Group, Managing Director of their UK multi-site labels business. 2010: Returned to Bespak as Product Development & Operations Director Wild is Product Development & Operations Director of the Bespak Division of Consort Medical plc – a leading manufacturer of complex drug delivery devices, specialising in self injection and respiratory products. He is married with two children and his hobbies include; fly fishing for trout & salmon and following Arsenal Football Club. |
New plant and machinery
To maintain its position at the top of its market in the ever advancing pharmaceutical industry, it’s critical that Bespak maintains the very latest technology. It has been steadily upgrading its moulding machines from hydraulic to electric which now accounts for more than fifty percent of the installed capacity at King’s Lynn. This brings all sorts of benefits in terms of an environmental and productivity standpoint.
“Fully electric presses bring a high level of energy efficiency and also give a high level of consistency,” says Lyndon Wild. “They are more precise in terms of their reproducibility in their cycle to cycle, they are smaller, quieter and in a clean room environment there tends to be less chance for contamination. It enables us to push on with development projects with a complexity of tightness of tolerance which is hard to envision being possible with older hydraulic machinery. The types of products we make need the combination of very precise tool making and all electric platforms. We’re asking some of these components to do many things and we need a high level of process capability to produce or reproduce the products.” Last year the company built 1,000 square metres of additional clean room on its freehold site and this facility is now up and running with a live project.
A similar sized expansion is currently under construction to support the industrialisation of a new product.
And, also in the last year, the company has added the ISO14001 environmental accreditation to its IS013485 for processes and quality in medical device manufacturing.
The future
Bespak has further diversified and expanded its product portfolio by entering the point of care diagnostic market through its investment in Atlas Genetics. Anderson says, “This is an exciting opportunity for Bespak to enter a fast growing market sector and leverage its core manufacturing and industrialisation skills. This technology will enable doctors to rapidly diagnose a number of medical conditions such as Chlamydia.” Says Lyndon Wild: “Bespak, with the backing of the parent company Consort Medical, is now very much geared towards growth through investment and there’s a number of ways we will look to do that through further acquisition, through in house development, by seeking partners who match our own ambitions and by investing in new technologies.” Overall, Joe Barry says Bespak’s holistic approach to excellence in all aspects of its operations and the expertise it has built up from over 50 years in the business make it the partner of choice for its clients.
He says: “I like to think our customers trust us because of our long history of constantly meeting expectations.
We endeavour to stay on the front foot from a quality, continuous improvement, innovation and technology standing. Our analytical approach to understanding how devices work and our focus on delivering to the needs of both the client and the end user while remaining competitive on cost sets us apart from our rivals.” Bespak is proud, says Barry, to be a world recognised company at the forefront of its industry.
