Your sterile Single-use solution without compromise
19th October 2017
by Andrew Davidson

Single-use surgical instruments have relied on low labour costs and sweatshops in Pakistan and China for many years. Healthcare providers, like the NHS have recognised the benefits of this and procurement teams have forced prices down to contain the well-known budgetary pressures they face.

But is this approach the answer for the future?

Is it sustainable as volumes increase yet the number of highly skilled workers remains relatively stable?

At DTR Medical, we have recognised that Far East manufacturing is not always the right approach. As a result, 50% of our sales are derived from the UK or other Western countries.

Can the Far East Deliver Sustainable Quality?

The simple answer based on many years’ experience is no.

There are a select few producers who get close to this, but even they are inconsistent and 100% checks are common to ensure customers do not end up with poor quality instruments such as scissors that don’t cut or forceps that don’t grip.

Mass produced lines like Mosquito Forceps or Needle Holders are easier to assure a level of quality. When instruments are finer, like Straight Tying or Epilation Forceps and Vannas or Westcott Scissors, the ability to source consistently high quality declines dramatically to the extent that all supplies have to be 100% inspected to achieve the highest level of quality.

When a new product is being developed the quality of samples is often misleading. Far East producers are adept at making a handful of top quality product and the thought “Act in haste, repent at leisure” so frequently applies.

How Can Innovation Happen?

To guarantee reliable supply requires careful attention to the specification that is developed between the Far East instrument producer and the surgeon. Tolerances are vital together with particular features requested by the customer. This often takes several months to fine tune and usually involves more than one potential provider.

To overcome the “shiny ten samples” scenario, once the specification is agreed and signed, the first order will be in the hundreds to check the consistency of the quality, but also to determine the ability to service growing demand.

For products like our Desjardins Forceps, the exceptionally tight specification for Gynaecology use in Colposcopy, is an example of where innovation with a Far East manufacturer can be made to work successfully. This product gives the Colposcopist good visibility but it has been modified carefully to ensure it is atraumatic for the patient, proving the relationship can be strong and innovation driven by customer need works.

When Does UK Production Become The Answer?

There is a point in the innovation cycle where it becomes clear that Far East instrument suppliers simply cannot get close to what the surgeon wants. The specification is out of reach, however, the needs of the customer remain. In these circumstances, what should a Single-use surgical instrument manufacturer do?

Compromise is an option, but the customer will not be satisfied with the instrument and regular supply is likely to fail. Stopping the development may be an easy choice, but the surgeon and healthcare provider will still seek a Single-use device for reasons of Time, Life or Cost saving, so others will pick up this challenge.

The alternative is to evaluate UK manufacturing and to use innovation to re-design the device to use high technology solutions such as automation and materials to neutralise the Far East benefit of low production costs. To achieve this requires a network of open minded British companies, which can be surprisingly difficult to find. Do they possess the vision or creativity to come up with effective solutions and to do this quickly?

University Schools of Engineering are an excellent source of support for a MedTech SME like DTR Medical and they can point the way to the latest material and process developments to trial and test.

How Successful Can UK Production Be?

Providing the right partners are chosen for each instrument, the answer must be an emphatic yes.

At DTR Medical, we have invested in UK production that can deliver products in appropriate volumes and with consistent quality that requires a much lower burden of checks to provide the necessary customer assurance. Consequently nearly 50% of our sales are produced in the UK by British manufacturers, which probably makes us unique in the specialist Single-use surgical instrument market.

This result is spread across a wide range of devices from our Cervical Biopsy Punch to our Frazier Suction Handles and Ear Specula and we have invested heavily in production tooling to deliver the patient and clinical value the customer wants to see.

The most recent product made in the UK is our NEW Double Ended Punctum Dilator used for opening the tear duct in dry eye cases, which is an ever-increasing clinical task as the population ages. Far Eastern samples were sought but after repeated attempts it was obvious this was destined to be unproductive. UK production was always a possibility but cost was an issue until a combination of skill sets at two engineering providers gave us an innovative solution. The result is a high quality instrument with polished tapered tips, more comfortable for the patient and much less likely to cause trauma than some of the earlier samples we received.

How will UK Production Develop?

The advent of new technology like 3D printing and new materials that provide greater sustainability combined with the strength of stainless steel are much more likely to be generated in more sophisticated markets where allied industries like aerospace and automotive are predominant. With environmental pressure and disruptive development from the likes of Tesla and Google, these are exciting times for medical device manufacturers, who can utilise innovations in their own field.

The Far East will still have a place, for instance in the production of many forged instruments which are very difficult to replicate at present. However, hand finishing with risks of increased bioburden or protein residue may encourage more use of automation and non-contact production, which could accelerate change.

With success of UK Single-use instrumentation, more companies will see the opportunity to adapt their skills to meet the needs of this market and bring new techniques that will enable companies like DTR Medical to convert these into successful new devices for surgeons to use safely and effectively.

 

DTR Medical Ltd is registered in England & Wales. Company No. 4394278. Registered office: 17 Clarion Court, Enterprise Park, Swansea, SA6 8RF. VAT No. 800410205. DTR Medical is a registered trademark of DTR Medical Ltd.

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