Assessing your manufacturing operations – from the customer perspective

assessing manufacturing operationsA lot of consultants will audit your company and come up with a long list of opportunities for improvements, and if you follow their advice you will conceivably make your manufacturing operations very much more efficient. You might also end up with a white elephant. What matters most is to improve your performance in ways your customers think are important and which will influence their future purchasing decisions.

Typical of the sort of performance improvements your customers might want most are:

  • Shorter lead times
  • More reliable delivery services
  • Improved design (e.g. packaging, features, appearance)
  • Increased quality product/service (e.g. fewer defects on delivery, lifetime reliability)
  • Enhanced after-sales support and service
  • Reduced operating costs
  • Lower initial price

Read more ›

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Customer Supplier Partnerships – a collaborative relationship

customer supplier partnershipsOnce upon a time I was asked to set out a strategy for improving supply chain management with the objective to reduce our reliance on some key suppliers whose products were considered to be of such a specialised nature as to warrant them as “threateningly” strategic to the future of the company. Read more ›

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New product start ups: deciding between employing full resources or working with a manufacturing, engineering and design specialist

start up manufacturersI have worked closely with start up companies for a number of years. There are really only three vital elements to a successful start up.

One is access to funding by either using your own money or cash sought through a variety of providers, or both.

You need to have the right mentality from the very start of your journey. This means a complete focus on cost, delivery and customer experience.

The third element you need is a delivery plan. You need access to the right skills, management, commercial and technical, because investors and potential investors will want to make sure that there is adequate ability within the start up to get the product into the hands of your customers. Don’t expect investors to be as excited about your product as you are; they will want to see a return on their investment. Start ups that are able to demonstrate a credible delivery plan will instil a sense of confidence in their investors, who will then be far more likely to invest. Read more ›

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Notified Bodies: Choice or Controversy?

notified bodies choiceThis jumble of names in the adjacent picture is a bit how one feels when first looking for a Notified Body. Who to pick?  How to discern one from the other? To a new company who is just starting down the road of the Quality Management System, this is a bit daunting and I think my first assumption, when I started in this field many years ago, was that as regulatory bodies they would all be pretty much the same.


To give a bit of background – I first worked with the old BS5750 standard, which grew and changed into 9001. When the medical devices company I was working for needed 13485, I registered them to that standard as well, and have worked extensively with it ever since.  These two standards are very different, as anyone working with the two will know, even though they both ostensibly address the same issues.  Read more ›

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Is the patent process still worth it?
Protecting your IP – Part 1

patent process worth itInvent something clever and potentially lucrative then protect it via a patent.
This was the time honoured way, and is still usually the only way to safeguard your idea, to stop someone else from benefiting from it.

But things are not all well in Patentland, with many now questioning if it is worth getting a patent. Read more ›

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How to justify optimism in your medical device invention

inventor optimism“If you really want to do it then go for it.” That’s a statement I have heard more than a few times from my teenage children or from one of their friends.  The ensuing ‘ can do’ optimism followed by trial and error are to be applauded in the young, providing of course it’s legal and the bank of dad isn’t in peril! The stakes are generally lower, life skills are being learnt and time is, after all, on their side. That same unqualified optimism can be a train-crash waiting to happen for inventors, though. Read more ›

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The Perception of Quality Management Standards: ISO 13485 – a good way of looking at it

quality assurance adviceTo a small business, just starting out, it does always seem a very daunting thing to install a Quality Management system to ISO 13485 or ISO 9001. As I am generally more involved with medical device manufacturers and those businesses associated with medical devices, I will discuss the merits of that particular standard, ISO 13485, rather than the more general one of ISO 9001.

The whole process often begins when a company has just invented a medical device and jumped through all the hoops required to have a product that will stun and intrigue the medical world. At that time, the next step is usually to climb the regulatory mountain to the top to make sure all the distributors across the world will be able to buy it, register it and sell it!! Read more ›

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How to build manufacturing into your medical device designs

manufacturing and medical device designs“If medical companies want to continue to make money as prices face continued pressure , their only option is to take cost out.’’ This comment is from the head of procurement of a major UK healthcare provider.

Everywhere in the world, there is a serious effort to contain healthcare costs. This has had the effect of rewiring the system. Yes, outcome based or value based reimbursement is increasingly the normal expectation, but so are lower unit costs – and an early appreciation of this at the design stage will help you stay ahead of the curve. Read more ›

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Welcome to the Open Water blog

Thanks for stopping by. This blog will be regularly updated with our thoughts relating to the medical devices industry, manufacturing and devices consultancy in general. Check back for more later!

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Who we are:

OpenWater is Nick Shelley and Liz Streeter. With a combined experience of over 50 years in medical device manufacture, we help companies succeed by offering specialist knowledge and expertise to get their products to market. Working hands on with our clients, we get actively involved in the manufacturing process for the best possible results. Very aware of changing markets and world medical device price pressures, we understand the need to combine innovation with responsible manufacturing, regulatory costs and long-term efficiency.

Nick Shelley

medical device consultantManufacturing Consultant Nick Shelley advises on all aspects of design, materials, machinery, tooling, processes, factory layout, work flow, and value engineering. He has been working in these areas for over 30 years.

Tel: 0044 (0)7704 426371
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Liz Streeter

quality assurance consultantQuality Assurance/ Regulatory Affairs Consultant Liz Streeter builds operational systems and frameworks, and advises on manufacturing, testing and streamlining - all with a mind to meeting business goals. She has extensive experience installing quality systems to ISO 13485 and ISO 9001, working with both European CE marking regulations and FDA requirements.

Tel: 0044 (0) 7778 317806
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