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?

The introduction of the 10% Patent Box is welcome news for companies such as mine who are investing heavily in R&D. It also supports the concept of keeping the innovation in the UK. The only real concern we have about this scheme is waiting until 2011, especially after the successful drive of the Office of Life Science and their recent launch to deliver the blueprint- what’s the rational and where’s the investment short term?

What about the small, innovative companies who struggle to have the resource to actually file patents? Couldn’t the Government also do something to support the patent application process, or is this only a bill for big industry?

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.

Shouldn't life sciences OEMs be sourcing components from companies like mine so that all the economic benefit stays in the UK?

Funding for start-up companies with innovations past the concept stage but some way from commercial reward, commonly called ‘the valley of death’, is still sparse. Funding for pure research is readily available. Funding for expansion of an established commercial entity with a sound business plan and track record is relatively easy to find but the bit in the middle is where we all are losing valuable initiatives. Even the VC community is loath to invest, or if they do, they will stifle the creative spark in their quest for a quick return.

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.

Has anyone else had experience of negotiating and agreeing a central price for a product or service (e.g. Drug Tariff) only to be then drawn in to attempts at a local PCT level to re-negotiate that price?

Is Medical Simulation Stimulating Users and Producers?

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.

Universities and higher education institutions have a lot of IP trapped in their empires which is potentially quite lucrative – how do we help them understand that by working with us clever SMEs who are skilled and experienced in the commercialisation process, we all will benefit?

I am still concerned by the discourse around the Medical Device Directive, and its possible recast, which may draw it closer to pharmaceutical regulation. Medical devices are significantly different than pharmaceutical products and deserve their own regulations without the added complications of pharmaceutical laws which could hinder innovative development and penalise small businesses. Such a change could also highlight further the current inconsistencies between Notified Bodies which appears to be on the increase.

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.

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?

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)

Given the financial status of the UK, one of the only arenas that has experienced growth is the Biotech market and it has been shown that investment in Biotech, gives much higher returns that other sectors. However this needs to stay as a focus as if the UK does not continue to invest and concentrate on new products, we risk this strong position. Continued development in UK innovation and NHS involvement with UK companies should be seen as a win-win situation and needs to be given increased focus and drive from all levels. The UK seems to get bogged down in red tape for implementing products and services that may make total common sense. All parties need to look at ways in which these can be used as they may increase patient outcomes and therefore overall costs in the long run. There are obviously areas in which we need stringent Regulation but there are also areas where if the product does not need to be regulated so thoroughly.

We contribute directly in the manufacturing chain to the safety of pharmaceutical industry. We are one of the gatekeepers for Quality, and as we are audited to do so (from MHRA) we ensure that the medication is what is supposed to be and is safe. This is a global market and as such, multiple outsourcing is occurring at a high level. This has mainly been dictated by ‘Big Pharma’ and the Generic manufacturers working in niche markets. Pharmaceutical product recalls are very expensive for companies, and the fact that they still happen is amazing. Even politically, the EU is dragging its feet on the way to go for legislation. Globally there are 22,000 API (Active Pharmaceutical Ingredient) manufacturers, and they are not all the same in standards of excellence. The good companies with cGMP (current Good Manufacturing Practice), actively show the quality certificates of the products made. The not so good ones, try to cut corners and save money, and creep into the drug chain. The consumers want cheaper drugs, but quality counts, and this has to be paid for. Currently the role of the ‘QC gatekeeper’ is one that has not been looked at as a key element by some. Just like Health & Safety it is integral to a company, and it only becomes important to everyone, when there is a problem. This is a burning issue to us, as we are the QC Gatekeeper, and as such, we are driving the Quality issues from the bottom up. People and companies are aware, however, cost is always a pressure for some with regards to QC Analysis. The UK leads the way for Quality, historically and currently. This needs to be put across to those that need services like this the most. In the global market our drum is small, but we are banging it harder than ever... so for 2010 onwards we hope to make sweet music

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.

Our experience from the BioEntrepreneur School is that overseas graduates in the UK are much more interested in setting up their own companies than our home grown graduates.

Why is it so difficult to get funding for early stage life science technology businesses? Does the classic model of VC funding and exit by floatation or trade sale still work?

We are routinely coming across pharma companies (small & large) who just don’t keep up with or monitor changes in packaging legislation that will have a major impact on their businesses. A good example is the impending Braille legislation which is now MANDATORY for ALL pharma packs sold in Europe and has to be in place within the next 7 MONTHS. As a consequence of non-compliance, an estimated 20% of pharma companies could have their products delisted. So why do companies ignore it?

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?

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?

It's been over a year since Gordon Brown guaranteed small businesses would be paid within 10 days for work done for the government, including the NHS. Is it happening?

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.

Click here to download the Voices of Industry Recommendation Letter & Supporting Evidence

The Proposal document is complete and ready for comment/feedback. Please feed any thoughts/edits directly back to me via email Michelle@MedilinkWM.co.uk or feel free to upload as a comment on this microsite.

Tony Davis will be delivering the final proposal document to Lord Drayson and the OLS on Tuesday, 30 June 2009. Thank you to everyone who has participated in our Voices of Industry campaign.

Click here to Download

We know there are grants available to support companies to export, but we have not applied for any recently because the forms are so cumbersome the return is not worth it. In the last two years alone we have spent hundreds of thousands of pounds on documentation and approvals in other countries, with no support from UKTI. With subsidy to expand my overseas business I would be able to employ more people and increase the overall wealth of the country.

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.

SME organisations within the pharmaceutical market are a prolific source of innovation and new ideas, fuelling the work of many large companies.
With varied levels of funding and resource they are not often recognised for the contribution they make as a well-spring of innovation.

The Voices of Industry campaign demonstrates the willingness for each of the areas within Life Sciences (pharmaceuticals, diagnostics, healthcare and medical device technologies) to work together to ensure this vital sector is recognised at all levels.

The ABPI is happy to support this campaign and would like to encourage all of its members to participate

(Principal Analyst - Healthcare Editor at Clinica-Scrip) The IVDs sector in the UK needs a long-term commitment to the early health model. A simply structured, well worded commitment to promoting, using and monitoring use of these technologies will result in benefits all round - to patients, to the healthcare system, and thus to the government. Too little is invested in this vital segment from the UK healthcare budget.
Click here for more

The BIA applauds this campaign. The chronic lack of access to capital is a challenge that unites all SMEs. These are particularly tough times for SMEs involved in crucial life sciences research, with viable enterprises still struggling to obtain the follow-on investment they need to be able to grow their businesses into the success stories of the future. Industry needs to send out a clear, united message on how to deal with this problem and get investment moving again. The package of work under discussion at the new Office for Life Sciences must be implemented to make a difference.

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.

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.