Boddingtons partners with Cytosystems at MTI EXPO May 15-16

Leading injection moulder, Boddingtons, will exhibit at MTI EXPO together with its customer, advanced diagnostics company Cytosystems.

For the first time the latter’s life saving medical device will be on show – a point of care collection device for fast and fail-safe testing/screening of cancer cells. Boddingtons has been involved in the design and development of this innovation from the outset.

Cytosystems is a new company, based in Aberdeen, Scotland, and specializing in advanced diagnostics systems for cancer detection.

The new device will be on show on the Boddingtons stand at the NEC, May 15-16 and is immediately available for licensing or purchasing. The simplicity and compactness of the device make for universal appeal. In theory every GP surgery could benefit from its features.

The new product from Cytosystems has been some eighteen months in development with Boddingtons and is now set to move to full production. It is comprised of a number of moulded components in different polymers, opaque and clear, as well as sharps inside the product.

The full manufacturing skill set of Boddingtons has been utilized in putting the various device components together – technical moulding, welding, assembly, and deployment of medical needles have all been factored into production.

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Boddingtons Managing Director, Andy Tibbs, says that ‘we are pleased and proud to next week be joined by our customer Cytosystems at MTI EXPO 2019. I urge all medical practitioners and healthcare specialists to visit our stand and take inspiration from what modern manufacturing methods can now achieve in the med-tech space.’

Since the launch of its £4.6m manufacturing facility in early 2017, Boddingtons has steadily expanded the scope and volume of its med-tech manufacturing services. The company is certified to ISO13485 and ISO9001 Quality Management Systems Requirements and is also compliant with FDA 21 CFR Part 820.

Expert Boddingtons personnel will be at hand throughout the MTI exhibition to give detail on the full scope of the company’s manufacturing services, including regulatory and quality assurance services.

Boddingtons is currently in the international MDSAP qualification for the medical industry– a commitment involving some £80,000 over the next three years resulting in a medical product standard that has no frontiers and is completely universal.

Boddingtons moves ahead with the Medical Device Single Audit Program

Boddingtons moves ahead with the Medical Device Single Audit Program (MDSAP) – learn more at MTI EXPO May 15-16!

Leading injection moulder and med-tech supplier, Boddingtons, has recently committed significant investment in order to transition to the Medical Device Single Audit Program (MDSAP). It is confirmed that this commitment will continue beyond the three-year certification cycle.

Boddingtons Quality Manager Jay Cheema says that ‘we are currently busy working on our Quality Management Systems and Regulatory Affairs processes in preparation for our MDSAP assessments scheduled to take place in May and July 2019.’

MDSAP is a global regulatory audit approach promoting alignment of Quality Management Systems and Regulatory approaches with the goal of improving medical device safety.

 

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An overview of the MDSAP system

 

The Regulatory Authorities in participation include the Therapeutic Goods Administration (TGA) of Australia, Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, Japan’s Ministry of Health and Labour and Welfare (MHLW), and the U.S. Food and Drug Administration (FDA).

Boddingtons CEO Andy Tibbs will include MDSAP material in his May 15th presentation at MTI EXPO on the afternoon of the first day of the show at Birmingham’s NEC, May 15th.

Tibbs says that ‘we welcome the MDSAP approach and see additional benefit in structuring our systems to comply with ISO13485:2016, MDR and the quality and regulatory requirements of five participating authorities. We understand that additional authorities will sign up to this program and Boddingtons expects to see additional benefit when this happens.’

Boddingtons returns to the MTI EXPO, May 15-16 for the fourth year running with its biggest and best exhibition offering yet.

The 8m x 4m stand will play host to Boddingtons’s leading edge in medical manufacturing services.

Since the launch of its £4.6m manufacturing facility in early 2017, Boddingtons has steadily expanded the scope and volume of its med-tech manufacturing services. Rewards, qualifications and awards have followed. The company is certified to ISO13485 and ISO9001 Quality Management Systems Requirements and is also compliant with FDA 21 CFR Part 820.

Expert Boddingtons personnel will be at hand throughout the MTI exhibition to give detail on the full scope of the company’s manufacturing services, including MDSAP matters.

Boddingtons to share best practice tips at MTI EXPO 2019

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Boddingtons CEO Andy Tibbs gives us a taste of the upcoming Boddingtons May 15th presentation at MTI EXPO 2019, NEC Birmingham  – addressing what it means to become the ‘finished article’ as a med-tech manufacturing supplier.

 

 

By Andy Tibbs

Boddingtons is looking forward immensely to this year’s MTI EXPO: Not only will we launching our biggest ever exhibition presence – an 8m x 4m med-tech technology space – I shall also be sharing Boddingtons views about industrial best practice in the med-tech industries.

In truth this is a sometimes subtle subject; a complex blend of commercial and technical factors and intelligence – and these factors and information are constantly changing according to legislation, economics and also the trends and fashions of the day.

However, our experience at Boddingtons has taught us that any successful supplier needs to keep renewing a commitment to certain non-optional activities.

I outline these few factors below and look forward to sharing them further at the NEC on May 15th.

 

Invest in facilities

In recent years Boddingtons took the decision to back our med-tech aspirations with hard investment. We undertook the design and build of a purpose built £4.6m facility, including a modular Class 7 cleanroom capable of making Class 1 and Class 2 medical devices. This was formally opened by Lord Digby Jones on November 1, 2016 and we have gone from strength to strength since.

Why did we do this? The medical world is one of the most highly regulated sectors on the planet and its demands are largely fixed. Production methods – and audits of the same – are highly structured, highly regulated and costly.  The price of admittance in time and money can be extremely high.

Put simply – your company might have all the creativity and ingenuity in the world but if you don’t have the equipment, the clean room, the certification(s), the compliance systems and documentation you won’t be making medical sales. It’s as simple as that. There is no alternative to making the investment.

 

Invest in creativity, innovation…and flexibility

Paradoxically, the rigidity of medical manufacturing protocols makes it all the more important for suppliers like ourselves to put a high premium on creativity, innovation and doing things a little differently. After all, when everyone else has invested in a similar fashion, what makes the difference? You will need to invest – but money alone will not win you business.

Remember that much of the medical sector is innovating and creating devices that have never been manufactured before. You therefore need engineering skills and creativity to make new products and you need production skills and a wealth of experience to create these products efficiently and at a profit.

Your business therefore needs to nurture talent in creating new production lines – assembling and disassembling these at speed and in-line with market needs.

In some ways this is the antithesis of capital intensive and fixed manufacturing lines. Our design-for-manufacturing ethos might have us create and build a six or seven workstation array within our Class 7 clean room. This cell might include injection moulding, automation, welding, hand assembly, QA Vision inspection systems; packaging and printing services before despatch.

And then this line might be relocated, disassembled and/or modified in order to accommodate further med-tech business or a changing order.  Production flexibility is therefore another mandatory requirement.

 

Make it easy for the client  – invest in systems

As a general rule, try to include all possible manufacturing, commercial and technical services for your client. Typically, your medical client needs to devote nearly all of their energies to needs of the marketplaces, letting you take care of all the manufacturing concerns.

And if you can also provide support with many of the regulatory and administrative services that the medical sector demands then you are likely to retain and increase your business.

Boddingtons offers these services; in many cases becoming the legal manufacturer in the supply chain in order to relieve clients of the burden.

Qualifications ISO 9001, BS 13485, FDA compliance and now, MDSAP, are all mandatory for the successful and global med-tech supplier. The client will invariably be new to such protocols, and will often view them as obstacles to success. The more you can remove them in your supply arrangements the better the overall business will be.

At Boddingtons we generally aim to take on the management of all regulatory, standards and ‘red tape’ work for our clients, together with all technical evolvement of designs and prototypes. Both processes generally combine in our company’s gated product introduction methods. Neither supplier nor customer should be so naïve as to assume that any and every new medical device will succeed in the market place. Gated product introduction methods are generally a good way to reducing client risk and maximising opportunity.

 

Treat all clients the same

It may sound strange to note – but treating all clients in the same way, regardless of size, scope or budget, is generally the best possible policy.

When med-tech solutions are right for their time this can be an extremely fast-moving and high volume world.  It therefore helps to view all of your inventors and your first-time projects as blue chip OEMs in the making.  This is sometimes not easy. Patience, good will and faith are needed in large measure. However, if all goes well, all types of clients will command a slice of your manufacturing operation for their devices.

 

Your main expertise – sharpen the saw

Our medical marketplace success is based upon our fundamental excellence as an injection moulder. In all that we do, day to day, we are mindful not to forget these fundamentals and to periodically renew our expertise and our facilities with the best-in-class options that we can find. We practice continuous improvement in our daily work practices and we keep ourselves informed about our every changing best technology options for modern manufacturing.

In terms of our shareholders and stakeholders our job at Boddingtons is to strategize and shaping our contract manufacturing services in order to deliver improved performance, unparalleled customer satisfaction resulting in expanded sales and profit margins.

 

See and be seen

In recent years – and coupled with our investment – Boddingtons has supported the med-tech manufacturing strategy with focussed marketing and with dedicated medical sales resources.

More than most sectors the med-tech world is truly international. At Boddingtons we therefore travel the world; looking to leverage those opportunities that are based on the competences and technology in our current portfolio.

Customer care and the nurture of manufacturing business

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