Medical Technology

Jujhar Singh of - MedilinkWM - 19:02:56pm Mar-2nd

I was interested to hear about the HMO system from Sweden that Trevor Lewis mentioned in your first webcast, and I'd like to know more. What did they do and how did it bail them out? What are the lessons learned that we could implement over here in the UK?

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Trevor Lewis of - Medical Device Consultancy - 13:40:03pm Mar-4th

During the webinar I (TL) did refer to Switzerland, although Sweden’s model is also very interesting and may be even more relevant to “socialised medicine” than Switzerland.
A good starting place for understanding the interest in Switzerland’s healthcare system, especially from America is “Swiping Ideas from the Swiss”, an article was published on 1Mar10 http://healthcare.change.org/blog/view/swiping_ideas_from_the_swiss
For further detailed background please see the WHO site that provides really helpful information on all countries. For Switzerland go to: 'Health Care Systems in Transition - Switzerland' published by the European Observatory on Health Care Systems This was published in 2000 and does provide some historical background p5-7 and you will see that Switzerland has been struggling with an adequate and appropriately funded health care system since around 1890; this is not a new problem. The Health Care Reforms and Conclusions (p71-78) provide more insights but this is a very different model to the UK. It is a managed care type approach implemented in a very European way. It has been relatively successful.
Another useful article is The Swiss Healthcare System (2002) by Civitas that includes Swiss Lessons for UK Policy-Makers
Please see an American view on Switzerland that is cited by many interested parties: Inside the World's Finest Heath Care System

Tony Davis of - Medilink WM - 13:14:25pm Feb-17th

Would others agree that The NHS procurement organisation rules, regulations and general bureaucracy are a hindrance to the UK industry base which is 98% SME and unable to invest the amount of time and energy required to comply.

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Andrew Ives of - Advanced Therapeutic Materials - 14:57:33pm Feb-22nd

I see the main difficulty faced by any small company, be it start up or established SME, lies in the barriers which discourage adoption of new technologies within the NHS. Yes, a level of patient protection is needed, but many innovations fall foul of the full range of defenses even when there is little or no risk and great benefits. Despite a number of well sounding bodies and initiatives, I am yet to be convinced that a simple route exists through the labyrinth.

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chris of - medilinkwm - 17:20:39pm Feb-1st

Is Medical Simulation Stimulating Users and Producers?

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Peter Dines of - Surgi-C - 15:00:34pm Feb-1st

I think the pressure on the NHS to save 5% each year for the next three years will increase pricing pressures on its suppliers. We are reacting to this by working with our customers to source generic products with significant cost savings. I believe this strategy of building a UK company focused on delivering quality products with significant cost savings will enhance our opportunity and break down the barriers to entry that currently exist where the market leaders are largely International healthcare organizations.

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Ewart Woolley of - CMPR - 14:58:09pm Feb-1st

In its report on catheters, the Rapid Review Panel refers to a recent report by the international Cochrane Collaborative which highlighted that ‘the results suggest that the use of BARDEX(R) I.C. silver alloy indwelling catheters for hospitalised adults short-term reduces the risk of catheter acquired urinary tract infection. The relative risk of symptomatic urinary tract infection was 40% lower than if a standard catheter had been used.’ Therefore, I concluded that the RRP is a necessary step in the device evaluation process, but now I’m finding that’s not necessarily the case. And just because a product is ‘approved’ by the RRP it does not guarantee the NHS will adopt it. So what is the point of the Rapid Review Panel?

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Alan Press of - Kimal - 15:51:34pm Jan-28th

The single thing that really concerns me is the capability (actually the lack of it) of the NHS to rapidly implement best practice, productivity reforms, movement to community and home, and all the other things they know they have to do before the 15 and 20 billion black hole hits in a couple of years. They currently seem incapable of getting out comparatively simple tenders. Where is the inspirational leadership delivering the change and innovation needed? Many people at the top know what is needed (I have just been with Lord Darzi at Arab Health) but the delivery mechanisms seem so disparate. All I can foresee are pockets of change and innovation, but huge areas where waiting lists grow and cuts occur.

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Adam Maclean of - The Good Birth Company - 7:52:25am Jan-28th

There seems to have been a lot of announcements recently about the importance of being able to trial medical devices and as a manufacturer we have seen an increase in demand for evidence of efficacy. But is the NHS really going to be industry-friendly or will all products quickly become as highly regulated as the pharma industry?

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Steve May-Russell of - Smallfry - 7:48:53am Jan-28th

We saw in the local press recently an announcement on a Health Innovation and Education Cluster (HIEC) being awarded in our region. We normally pay no attention to these NHS Quango announcements, but this one mentioned collaboration with industry. Does anyone know how these things will work? And what will they do?

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Tony Davis of - MedilinkUK - 10:23:55am Feb-2nd

MedilinkUK has long campaigned for better recruitment and reduction of cost by not applying the full economic cost of the NHS overhead and through its Clinical Trials Industry Special Interest Group which it runs on behalf of the medical Technologies and medicines Knowledge Transfer Network

Tony Davis of - MedilinkWM - 12:07:26pm Oct-20th

The European Commission has asked us to become advisors on a future of medical devices EU parliament process. We are representing on behalf of UK industry on Trade and Innovation.
Please let me know your thoughts on the following four issues:

- Is the European regulatory framework appropriate?
- What are the main market access challenges and how would you reduce the technical barriers to trade between member states?
- Is it necessary to improve international regulatory coordination?
- Is counterfeiting a significant issue for medical devices?

However any observations on selling into Europe would be more than welcome.

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Mike Edwards of - Kimal - 19:45:07pm Nov-1st

The Medical Devices Directive is an adequate tool for ensuring safety and performance of medical devices placed on the European market. The problems have been in its correct implementation by European Member States. Much can still be achieved by all stakeholders to ensure we have a common approach to its correct implementation.

Rod Palmer of - Performance Health Products - 15:03:12pm Oct-30th

Individual countries have additional approval regimes ranging from the understandable technical (Germany, TUV approval, etc.) to the opaque and impenetrable (France). These are trade barriers in disguise, barriers that CE marking was supposed to eliminate. And is there a danger that endless, needless refinement and complexity will result in an expensive and debilitating burden for SMEs? Yes!

Trevor Lewis of - Medical Device Consultancy - 10:40:51am Oct-28th

There is a need for the methods of paying for all types of devices to be better understood throughout Europe and it made easier for manufacturers to access the requirements, especially as evidence-based purchasing and e-procurement become more commonplace throughout the Community.
The European regulatory framework for most medical devices works very well and is a flexible system that allows manufacturers some choice in the conformity assessment route chosen to achieve CE marketing, this is good for both large and small companies, especially startups. The recent Revision of the New Approach brings the processes for CE marking closer to those established and used to good effect in the medical device sector.

Andrew Davidson of - DTR Medical - 18:22:53pm Oct-27th

Areas of concern for us are 1) Development of local registrations - here I know at least one country has created non tariff barriers that do not seem to take CE marking as it should be. This seems wrong and makes it harder to operate as a new SME with export intentions; 2)Poor payment record - I hear horror stories about some public hospitals in certain countries taking up to two years to pay, this contrasts markedly with the current UK government policy where payments are now often within 2 weeks from the NHS.

Peter McGuinness of - Chromogenex Technologies Ltd - 16:22:58pm Oct-27th

The biggest challenge we face in Europe is competition from non EU imports which do not comply with medical device regulation, and in some cases have fake CE marks. Despite this they are being sold openly and cheaply across Europe.

Kirk Buller of - Binding Site - 14:30:48pm Oct-27th

A big issue for us is Vigilance reporting. Whilst the Competent Authorities do talk to each other, a company can end up having separate correspondence on the same issue with the CA in each country where the product is sold. The eventual adopting of the Eudamed database might improve this, but for political reasons it is likely to remain.

Trevor Lewis of - Medical Device Consultancy - 16:30:16pm Oct-22nd

The differences between pharmaceutical and device regulation has been discussed at length by ABHI and Eucomed, the need is to keep the regulatory frameworks independent of each other and not attempt to merge them or absorb their management completely into the pharmaceutical regime.

Peter Ellingworth of - ABHI - 15:05:06pm Feb-4th

It is vitally important for the SME voice within the medical technology and healthcare market, and the life sciences sector as a whole, to be heard and appreciated. This is a strong theme from the report which industry and government has recently published and for which an action plan is now getting underway. As a majority stakeholder in medical manufacturing, the UK SME community plays a vital role in the growth and prosperity of larger businesses with its quick response times, competitive pricing and entrepreneurial spirit.

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Richard Stone of - MedilinkWM - 16:30:00pm Jun-18th

If there were a mechanism for easily identifying the procurement route within the NHS for a particular product, more companies would be able to achieve UK sales and not have to spend so much resource targeting overseas markets.

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Christina Keey-Andersen of - Advantage West Midlands - 14:57:50pm Feb-22nd

The Medical Technologies industry is one of the strongest performing industry sectors currently, but there is still much that could be done to improve the conditions for SMEs in this area. The Voices of Industry campaign is a great initiative by Medilink West Midlands to try to capture the issues facing SMEs today. The campaign will be used to make decision makers and policy shapers in central government listen to what industry has to say, so I hope as many companies as possible will take the time to share their views.

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