This Week's Poll

Are mobile apps the 'holy grail' to assist GPs in their new commissioning role?

Supported by Medilink UK
Medical Technology

Support for Export - Federico Loterijman of - Anders Associates - 13:56:19pm Jul-29th

Our recent work with a couple of clients has meant we are more aware of the potential opportunities in India, especially for UK pharmaceutical consultancy & design expertise. Many global conglomerates have facilities in India and we’ve found making contact with the local Embassy is a good way of arranging relevant introductions. But accessing a market this geographically distant requires a financial investment, one that is often out of the reach of SMEs without some level of government support. The abolishment of the RDAs makes this a very concerning time for companies and their export strategies.

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Simon Checkley of - e-Medix - 14:25:09pm Jul-29th

Historically we’ve not considered India a commercially viable market because of their unwillingness to pay market rates, but we’ve recently started conversations with a company who may change our mind. Hopefully PM Cameron’s visit will be able to shift the focus from immigration and have some meaningful conversations about trade.

Sharing best practice in telehealth - Sharon Ross of - NHS Telford and Wrekin - 8:37:55am Jul-28th

As one of the first strategic health authorities to use Alvolution’s telehealth product comparison site, NHS Telford and Wrekin has been involved in its expansion, providing significant user input. As the population ages, Telehealth will expand rapidly. Our teams already dedicate a considerable number of hours to sourcing technology that supports members of our community who wish to live independently. By using this single repository, we can refer products on to commissioning teams, clinicians and community workers with real confidence. How do we encourage more widespread use, to share this as an example of best practice?

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medical mobile apps - Prof Ian Wells of - Royal Surrey County Hospital - 9:39:03am Jul-27th

One of the key advantages of mobile technology for clinical staff is getting the real-time information they need when and where a medical decision has to be taken about a patient.

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Chris Dyke of - MedilinkWM - 12:33:46pm Jul-22nd

I agree with all of the comments here. Yesterday's event really highlighted the immense opportunity healthcare Apps can be for companies, but that there are several issues to be aware of. But mobile Apps are no different than other healthcare products, they need to start with the end-user in mind.

George MacGinnis of - PA Consulting - 12:02:10pm Jul-22nd

With the personalisation agenda rarely out of the news and NHS efficiency savings of 20% required over the next 3-5 years to meet demands of an ageing population, the healthcare system is under pressure to change. This provides a massive opportunity for industry and the development of mobile technology in what is still a heavily paper-based world. The NHS is complex and this means change is slow. There is a strong case for mobile Apps at point of care in hospitals, in community settings and for patient self care (for patient ID and safety, e-prescribing, referrals and ordering, decision support, location/presence and logistics). However, developers should consider some key questions: Who is the target audience? What does the user really need the App for? Can the App be integrated into the current healthcare system? And what is the longevity of the App for the user?

Nick Hunn of - Mobile Data Association - 11:05:17am Jul-22nd

I agree, but it is vital that developers of Apps consider their market carefully. The number of smart phone / iPhone users is still very small in comparison to the number of mobile phones in use today, and purchasers of them tend to be those with more disposable income and the less critical medical need. Therefore, think carefully about who are you writing your App for.

Sharing Information on Assistive Technologies - Jim Ellam of - Staffordshire County Council - 14:47:16pm Jul-6th

I believe it’s essential that those of us in the public sector set new standards of best practice and promote new healthcare technologies internally and externally. Healthcare devices now range from mobility to memory aid to medicines compliance, and a single device can perform many functions, potentially helping the NHS and councils improve care while saving costs. I’m using Alvolution’s assisted living product comparison website to demonstrate that just as there are a range of issues, there can be a range of solutions. But here, knowledge is the most important factor. This application means that we can inform the public, share our product expertise with our colleagues and fellow professionals and recommend solutions. So how are others sharing product knowledge between departments?

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Mobile Apps for Healthcare - Trevor Lewis of - Medical Device Consultancy - 15:17:04pm Jul-5th

There seems to be a plethora of events taking place in the field of mobile apps for healthcare. Most of these events seem to be skipping over the complicated discussion about regulation and getting apps approved for medical and/or personal use. The exception is MedilinkWM. MedilinkWM is hosting an event on 21st July which I have agreed to speak at. It is the only event addressing the needs of the app developers and key regulatory compliance issues that must be met to get to market legally. There will be some innovative clinicians in the room with whom we'll be able to debate this issue with. This technology is important for more efficient and more personalised healthcare, we all need it to happen. However the regulations matter, and are there to protect the public health. Everyone wants to know who looked after the safety and risk compliance issues when something goes wrong when using an app! And yes innovative product development and regulatory compliance can be achieved, the use of well developed technology can benefit us all.

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Collaboration to reduce costs - Sue Wilde of - myM-link - 11:29:22am Jun-30th

I've been noticing that in these tough economic times many more companies are working together to get new products to market. myM-link, the membership arm of MedilinkWM, has had a hand in directly assisting a number of companies to increase their bottom line, most recently putting Kimal and Openhouse together for the nationally-recognised launch of the UK’s first mobile pack for people reliant on infusion for nutrition or pain relief. Is this because partnership can be a way to share the cost, shorten development times and reduce risk?

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NHS adoption of innovation - Kevin Wilson of - Innova Partnerships Ltd - 9:14:00am Jun-30th

I’ve been to three innovation events this month and am concerned there is still a lot of talk and not enough adoption taking place of new technologies. At each event companies expressed the same challenge: the NHS, as the largest purchaser of products and services, is not being adequately incentivised to explore new technologies and instead the procurement officers are just beating down the costs of the current suppliers. How can this be addressed with the cuts and efficiencies being driven down from the top which still seem incapable of looking at the overall cost savings as opposed to individual budget savings?

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SME fund for innovation - Rod Davidson of - Dyecor - 12:39:04pm Jun-29th

We recently received an Advantage Proof of Concept Fund award through AWM which allowed us to get an idea to market. These types of funds are valuable to small businesses wanting to develop new ideas and realise commercial value.

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West Midlands Task and Finish Group - Dr David Gleaves of - MidTECH - 8:20:43am Jun-24th

The Regional Task and Finish Group has made the following recommendations for medical technologies in the West Midlands: 1)create a specialist tendering and sales support service; 2)integrate regional support mechanisms; 3)articulate clear, consistent messages describing the region's capabilities and support mechanisms to promote the region. Is there anything we've missed which you would like to see included?

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Budget impact on medical simulation - Michelle Dalton of - MedilinkWM - 13:23:15pm Jun-22nd

The budget announcement is good news for Herefordshire cider makers, bad news for Birmingham video game developers...and several of those companies are leading the country in medical simulation.

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Graham Green of - Socialmark - 17:53:46pm Jun-22nd

Good news for start-ups in the regions though, including those who have great ideas for new medical products or services - with an entrepreneurs' relief rate of capital gains tax and national insurance payment exemptions.

The NHS and Innovation - Yvonne Robertson of - at the Medical Innovation Forum - 11:41:50am Jun-22nd

Is there any reason the NHS can't be an early adopter?

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NHS Direct effectiveness - BBC News of - BBC - 16:12:30pm Jun-10th

According to the BBC (http://news.bbc.co.uk/1/hi/health/10285950.stm), the British Medical Association is questioning the effectiveness of NHS Direct, claiming it delayed patients getting healthcare. Is this where cuts could be made?

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Economic growth projections lowered - Lisa Jones of - Reeves Green - 12:47:17pm Jun-9th

So the new independent fiscal watchdog has downgraded the economic growth projections for the UK economy. Is this bad news for business?

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Assisted Living technology funding - Rob Chesters of - Alvolution - 11:19:49am Jun-7th

More than €50million of EU funding and £10million of UK funding is available for firms researching Assisted Living technology. Mike Biddle, the Technology Strategy Board (TSB) team leader for the Assisted Living Innovation Platform, will be at two MedilinkWM workshops to explain how firms can improve their chances to access the £10 million funding to be invested by the Technology Strategy Board, the Economic and Social Research Council and the Department of Health’s National Institute for Health Research. He'll also focus on the call from Ambient Assisted Living (AAL) for ICT-based Solutions for Advancement of Older Persons’ Independence and Participation in the “Self-Serve Society”. This European competition for funding of more than €50million, seeks proposals from firms developing innovative Assisted Living technology. This is an amazing opportunity for companies to receive free funding for their research and development, but what more can be done to help companies take advantage of these opportunities?

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Coalition government policies for life science - Tony Davis of - Medilinkwm - 15:26:35pm Jun-2nd

Two important messages seem to be emerging from the new coalition government that relate to our industry. The first being the continuing importance of life science's to the economy, with distinct life science responsibility being given to two senior ministers in Vince Cables BIS ministry. The second is the jettisoning of the notion that all regions of the UK should receive economic assistance of equal measure in order to support and encourage growth within industry. There seems to be an emerging policy in targeted public sector economic support being given to those parts of the country that still have, challenging conditions, significant market failures and rising unemployment. Is my perception of the current climate correct and if it is are the approaches being taken the best for UK PLC??

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MDD changes - Michelle Dalton of - MedilinkWM - 15:33:25pm May-17th

The recast of the Medical Devices Directive 2007/47/EC will see medical device manufacturers facing, among other things, more stringent clinical trials. How do you think these changes will affect our industry?

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Les Farrington of - Binding Site - 18:39:42pm May-19th

I believe that companies should be pre-planning for regulation, both in the design phase and significently before a UK launch. Most devices will be launched internationally eventually, so this sort of trial should be a consideration in any case.

Peter Dines of - Surgi C - 12:17:38pm May-18th

We're currently using a patient outcome system, GPOS, which analyses patient outcomes for spinal disorders and we allow that data to be used for post-market clinical follow-ups. Patient safety is paramount in developing and using any new medical device, so increasing transparency is clearly a positive step that both SMEs and multinationals can achieve. As a distributer, we at Surgi C (www.surgi-c.com) have one concern, that there is no transitional period as the guidelines change, so every manufacturer has to adhere to the revised regulations instantly.

Trevor Lewis of - Medical Device Consultancy - 11:39:15am May-18th

Many small manufacturers now often feel overwhelmed by regulations, and it will definitely add some costs. But overall the changes are there to protect public health and many of the changes could have been avoided if companies had applied the original directives more rigorously. If manufacturers do not follow both the letter and spirit of the revision and recast, it is likely the industry will end up with a more prescriptive and inappropriate pharmaceutical-type regulation. All medical device manufacturers should be clear that demonstrating the system isn't broken and works well is definitely in their best interest - the alternatives are much worse!

Political party manifesto summaries - Michelle Dalton of - MedilinkUK.com - 9:15:15am Apr-30th

MedilinkUK.com has asked each of the three major political parties for a summary of their policies that will affect, enhance and support the life science market. This is your chance to share your thoughts and comments too, or take part in our independent poll.

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Summary of the Labour party policy (The Labour party were unable to respond) - - 9:17:55am Apr-30th

Over a decade of sustained investment by Labour has rescued science and research in the UK. The UK research base ranks as among the best in the world, supporting business development and inward investment, and is second only to the US on research citations. We are the most productive nation in the G8, per researcher and per public pound spent. By 2010-11, Labour investment in science and research will have doubled from its 1997 level, to over £6 billion.

Supporting curiosity driven research creates knowledge. This in turn generates innovation and creates employment in emerging new sectors.It is clear that a business led recovery, underpinned by excellent science and ground-breaking technologies, will enable the UK to secure strong economic growth. As the economy recovers, we will build on our strengths at creating knowledge in the UK and become even more effective at transforming that knowledge into economic growth. We need more young people to undertake STEM degrees. To enable this to happen we will recruit 20,000 extra undergraduates on courses starting in September 2010.

We are already taking action to make sure that innovative new businesses succeed. For example, we have started to invest in centres of excellence in emerging technologies. Facilities such as the recently launched Stevenage Bioscience Park, the Composites Centre, the Printable Electronics Technology Centre (PETEC) and the European Space Agency’s investment in a new space technology centre at Harwell will play a critical role in commercialising the outputs of our world leading research and developing the platform technologies and industries of the future.

Labour’s Innovation Investment Fund will back entrepreneurs who need capital for their businesses to grow. Financed by £325m of government investment and private venture capital, the fund will support the next generation of technology-based businesses. The fund will be invested in important growth sectors, such as low carbon, digital, life sciences and advanced manufacturing. We have simplified the research and development (R&D) tax credit scheme to further support small and medium-sized enterprises (SMEs). SMEs will no longer have to own any intellectual property attributable to their R&D expenditure as a condition of being able to claim under the R&D tax credit SME scheme. The change will apply to any expenditure incurred in accounting periods ending on or after 9 December 2009.

We will continue helping businesses to fully exploit the commercial potential of their intellectual property. The Intellectual Property Office has introduced a raft of measures to improve the granting of patents and trademarks. These include a fast track procedure for green patents to support the rapid growth of climate-friendly industries. Building on the Hauser Review, which is looking into the role of science in the UK economy, we will ensure that the UK’s Technology and Innovation Centres achieve their potential to commercialise new British discoveries. We will encourage businesses from all sectors to benefit from the introduction of the 'Patent Box'. From April 2013, the Patent Box will apply a 10 per cent rate of corporation tax to income received from UK patents to ensure the UK that remains an attractive location for innovation.

The process of transforming knowledge developed in the UK into economic benefits for the UK must be a key focus of policy in the years ahead. This is reflected in a new commitment to increase our focus on the economic and social impact of research. Through changes in the new Research Excellence Framework, we will do more to incentivise universities to broaden and deepen their links with business and users of research and to think further about the impact they generate. We will provide further incentives for universities to commercialise their research. We will invest up to £25 million in a University Enterprise Capital Fund, which will provide crucial early stage funding for the commercialisation of some of the most promising university innovations.

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anon of - anon - 12:14:30pm May-10th

i agree

Response from the Conservative party - Response from the Conservative party - 9:19:36am Apr-30th

We will implement key recommendations from Sir James Dyson’s Review into how to achieve our goal of making Britain Europe’s leading hi-tech exporter, including: encouraging the establishment of joint university-business research and development institutes; initiating a multi-year Science and Research Budget to provide a stable investment climate for Research Councils; creating a better focus on Science, Technology, Engineering and Maths (STEM) subjects in schools; and establishing a new prize for engineering.
 
Research and development tax credits will be improved and refocused on hi-tech companies, small businesses and new start-ups. At the same time, we will give strong backing to the growth industries that generate high-quality jobs around the country. We will improve the performance of UK Trade and Investment with a renewed focus on high priority sectors and markets where the return on taxpayers’ money is highest. We will regularly compare government support for exporters and inward investment against the services provided by our competitors. We will work for the successful conclusion of the Doha trade round and support bilateral free trade negotiations between the European Union and other countries.
 
Thirteen years ago, Britain’s tax system was one of the most competitive in the developed world. Over the last decade, other countries have cut their tax rates while our tax system has become one of the most complex in the world. Our competitiveness rating has fallen, while the burden of regulation and the impact of taxation have risen. We can only make a sustainable economic recovery if we send a clear signal that Britain is open for business again. That means stopping Labour’s jobs tax, lowering corporate tax rates, reducing the regulatory burden, and supporting innovation and sustainable development – changes that will benefit businesses of all sizes and boost employment.
 
The Conservative Party believes in lower and simpler taxation. That is why we will ensure that by far the largest part of the burden of dealing with the deficit falls on lower spending rather than higher taxes. Cutting the deficit is the most urgent task we need to undertake if we are to get the economy moving, but it is not enough. So, initially, we will cut the headline rate of corporation tax to 25p and the small companies’ rate to 20p, funded by reducing complex reliefs and allowances. To boost small businesses and life sciences start-ups, we aim to deliver 25 per cent of government research and procurement contracts through SMEs by cutting the administrative costs of bidding.

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Lisa Jones of - Socialmark - 13:08:26pm May-5th

Good to see the role of small businesses has been recognised in this market - and that the administrative burden could be lifted. But reducing regulation? Could that be true for those competing in an international healthcare technologies market?

Response from the Liberal Democrats - Response from the Liberal Democrats - 9:21:45am Apr-30th

It is critical that the education system provides young children with properly funded, high quality science education.  This initial enthusiasm must then be cultivated by ensuring that science is viewed as an attractive career choice. Alongside setting out our vision, practical action is needed as well.  That’s why we will:

• Invest a further £2.5bn a year in the education system directed at the most disadvantaged pupils in the form of a ‘pupil premium’.  This will improve the quality of maths and science education by reducing class sizes. 
• Expand the TeachFirst programme to get more top graduates in our classrooms, particularly in shortage subjects like maths and physics.
• Scrap university tuition fees so that access to higher education is based on an individual’s ability, not their bank balance
• Reform the existing bursary system for university students so that bursaries are awarded on the basis of studying strategic subjects (such as sciences and mathematics) as well as financial hardship.  This will promote the supply of skilled scientists that we need.
 
The current career structure in science is not letting talented young researchers make the most of their education, and this is a waste of resources. We would explore with stakeholders across the sector how these concerns could be addressed, by measures such as expanding the number of postdoctoral places, as well as making PhDs more industry-friendly, funded by reducing the surplus of under-utilised PhD places.
 
Liberal Democrats recognise that UK science needs long-term planning in order to be structurally viable and internationally competitive. We are therefore committed to not cutting science spending in the first year of the new Parliament. In the current economic climate it is not possible to commit to growth in spending and, as a matter of principle, the Liberal Democrats have ruled out guaranteeing spending commitments to any individual department until a full spending review has been undertaken and we are clearer about the scale of the reductions needed.  However, we are clear that rebalancing the economy is a key objective and the Liberal Democrats recognise the importance of science investment to economic recovery.  We also acknowledge the important contribution being made by the Technology Strategy Board and will seek to ensure that this continues. The honest reality is that public spending will be tight even for priority areas as we seek to rebuild the public finances onto a sustainable footing.  In this context, we need to make better use of the resources that we do have and introduce new mechanisms that support private sector funding. 
 
The UK has an excellent track record of generating innovative new ideas but frequently this knowledge is trapped within a university or other higher education institution.  We must develop more of these ideas to the point of commercial production.  We will encourage universities to work more closely with businesses, particularly SMEs, to combine the technical knowledge of academics with the business experience of local entrepreneurs. Commercialisation of new ideas is a risky business, more suited to being financed by equity than debt.  Sources of UK equity for small innovative manufacturers are scarce as existing UK markets do not serve smaller business well.  We will therefore support the creation of new mechanisms to provide smaller businesses with access to equity by connecting investors with businesses in their own region:

• Local Enterprise Funds - tax efficient investment vehicles to provide seed capital to start-up/early stage businesses as they commercialise their ideas
• Regional Stock Exchanges - regional platforms matching local investors with growing SMEs.   They will provide SMEs with cost effective access to equity through a simple operating model that meets the needs of smaller companies

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Combating silo thinking in life science - Dr Naomi Hubber of - Medilink WM - 14:13:36pm Apr-6th

Business leaders in the life sciences sector have criticised the NHS for 'silo thinking' - especially in respect of departmental savings vs enterprise-wide benefits. Attitudinal change typically takes years to achieve. Any suggestions for how the new Life Sciences minister should address this problem?

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David Missenden of - HealthVision Consulting - 12:14:30pm Apr-7th

The problem is evidently with the managers / executives rather than clinicians. The new minister should work with the Sec of State for Health on finally deconstructing the old monolithic power structures, even if it means job losses, and streamline the NHS to run more like a modern business, with a shared vision and less 'empire building'. It will be painful and prolonged but would save money, add to efficiency and help life sciences businesses to get over the procurement barriers.This is, of course, if the LS minister does have sufficient influence over Andy Burnham!

Minister for Life Science promised - Tony Davis (CEO) of - MedilinkWM - 16:54:36pm Mar-22nd

Medilink UK welcomes Gordon Browns announcment following the budget that there will be a minister for life sciences if labour win the election but what would we want him or her to achieve on behalf of our industry

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HMO system - Jujhar Singh of - MedilinkWM - 10:04:36am Mar-3rd

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

NHS procurement a hindrance - Tony Davis of - Medilink WM - 6:49:48am Feb-15th

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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Katy Draper of - Maketing Medicine - 18:24:57pm Apr-17th

I would agree with Tony Davis. Procurement is overly complex, time consuming and bureaucratic. Succesful companies must be good at constructing tenders in addition to actually developing and producing excellent products. Consequently products making it to market are those which have performed well in the tender exercise and are not necessarily those which are the best. However, in balance, the NHS needs to ensure that it is working with robust, safe and reliable businesses so measures to evaluate this are required. Perhaps a good place would be some compromise and understanding on both sides - i.e. industry improving tendering skills and the public sector being more open to reducing the red tape.

Barriers to adoption - Andrew Ives of - Advanced Therapeutic Materials - 9:13:48am Feb-10th

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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Simulation challenge - chris of - medilinkwm - 9:34:48am Feb-1st

Is Medical Simulation Stimulating Users and Producers?

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Regulation for export - John Adcock of - Advena Medical - 8:56:49am Jan-28th

UK SMEs operating in the medical diagnostics industry want to compete with the global companies yet often need a reminder about the importance of regulatory issues. A word of advice: appropriate risk management approval processes may protect you from future liability issues, so make sure your documentation is detailed and conforms to the European standards.

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NHS cuts and pricing for products - Peter Dines of - Surgi-C - 15:31:49pm Jan-18th

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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Rapid Review Panel - Ewart Woolley of - CMPR - 14:41:04pm Jan-14th

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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Unique device identification - Trevor Lewis of - MDC - 19:02:04pm Jan-13th

There are several issues I feel are hot right now: - Differing registration requirements in EU Member States affects the ability to gain reimbursement - Clinical trial reporting requirements for trials started prior to 21Mar10 - Unique Device Identification (UDI) is coming and companies should get involved now to understand it as it affects the whole supply chain - Software classification of all kinds (patient records/data handling, and more importantly when s/w is used in the diagnosis of the patient and involves some form of processing/interpretation)

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NHS implementation - Alan Press of - Kimal - 14:57:04pm Jan-5th

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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Medical device trails - Adam Maclean of - The Good Birth Company - 13:13:35pm Dec-10th

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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Health Innovation and Education Cluster launch - Steve May-Russell of - Smallfry - 7:25:47am Dec-5th

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

European regulations - Tony Davis of - MedilinkWM - 12:22:05pm Oct-21st

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.

SME voice in market - Peter Ellingworth of - ABHI - 14:15:51pm Jun-16th

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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NHS procurements routes - Richard Stone of - MedilinkWM - 9:19:56am Sep-12th

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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Matthew Harte of - Protomed - 9:36:41am Mar-23rd

This is an age old argument with no satisfactory outcome. Given the huge nature of the NHS and the lack of purchasing structure, I'm not sure that this is possible. It would be nice though but may result in huge job savings of trust based purchasing teams.

AWM supports voices of industry - Christina Keey-Andersen of - Advantage West Midlands - 16:36:36pm Jun-6th

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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