Darzi the Next Steps Review (NSR)

August 18th, 2008

The NHS is beginning to look at how it takes Lord Darzi’s vision forward through the next steps review process.

The part of this process that is of most interest to industry is the section covering innovation in medical devices and diagnostics. The following is a direct quote from the NSR…

The NSR statement on innovation and medical devices and diagnostics:

“Ensuring that clinically and cost effective innovation in [medicines and] medical technologies are adopted. For new medical technologies, we will simplify the pathway, by which they pass from development into wider use, and develop ways to benchmark and monitor uptake.”

The process to deliver this seems to break down into four main work streams, to be developed jointly between government and industry.

(i) Evaluation – a single pathway, fed by horizon scanning, via NICE & CEP, with outputs transmitted to the Evidence Centre [‘NHS Evidence’ in the NSR].

Government will need guidance from Industry to judge how far it needs to look ahead to spot new medical technology applications, as well as to find out which potential existing technologies in other global markets might benefit from evaluation or evidence gathering. But it’s clear that a streamlined evaluation pathway that could assist disruptive innovations would be welcomed by industry.

(ii) Create a “pull effect” within the system to help draw innovative technology into use - this is probably the most difficult strand as it goes to the core of the ‘culture’ of the NHS as an organisation. Potentially, this will challenge NHS organisations such as the Strategic Health Authorities to increase clinical engagement through periodic clinical conferences, designed specifically to diffuse knowledge of, or create an appetite for, innovative technologies.

Developing a focus through technology demonstrators, with organisations such as the Technology Strategy Board showcases healthcare innovations and develops stronger links between Industry and the research communities.

(iii) Make NHS Procurement more receptive to the value of innovative technologies - this is the bringing together of the recent review of the procurement hubs and the OGC review of NHS procurement along with the growth of emphasis on world class commissioning. Industry obviously has an interest in ensuring procurement functions make purchase decisions based on value and not cost.

(iv) Establish metrics to benchmark and monitor uptake and spread of innovative technologies - the intention is to develop an indicator using industry sales figures to the NHS in England. Industry will be supportive of this approach as long as there is adequate protection for commercially sensitive product data.

The first steps will be to agree which products should be captured and tracked under the “innovation” label, then to identify appropriate sources of data, for example, companies’ unit sales figures or NHS expenditure figures.

It is envisaged that there will be joint Industry and Government groups on each work stream, so watch this space if you want to get involved.

UK R&D is “world class”

August 11th, 2008

But the translation of research is still patchy
A report this week on academic research output has benchmarked the UK against the world’s 25 leading R&D economies, revealing that “the UK continues to punch above its weight in world class research”.
The report’s findings, which show that the UK is second only to the US in these terms, should act as an incentive to government to maximise this endeavour by investing in mechanisms to support the translation and application of current research.
According to the report by the Department for Innovation, Universities and Skills (DIUS), the UK has increased its share of published research in the world’s most influential scientific journals and “offers the best return globally for R&D investment”. The UK contributes 9% of papers and 12% of citations – second only to the US – according to an analysis of 17 million papers and 22.5 million citations in 8,000 scientific journals.
As an industry association, MedilinkWM has witnessed at first hand the amazing research capacity of our region; with many academic institutions undertaking ground breaking pieces of work in all the major healthcare and medical disciplines. The challenge remains for the region’s Science City and Innovation and Technology Council initiatives to buck the national trend of being good at “R” but no good at “D”.

We would then begin to see the West Midlands establish itself as a place where great science is undertaken and then translated into meaningful economic activity.

Over the next few years MedilinkWM will be working with all its colleagues in the knowledge economy to understand and articulate applied and academic research opportunities to the medical technologies industry in the West Midlands. The aim is to make sure that as much of the region’s intellectual property as possible is commercialised within its own industrial base.

Awaiting Feedback

August 1st, 2008

For those of you who read Tony’s post last week, titled “Is Government Listening?  It Appears So” we are anxiously awaiting your feedback, anecdotes or challenges.  Please forward these directly to Tony@MedilinkWM.co.uk or feel free to call if you’d prefer to not put the information in writing, 0121 452 5630.

Thank you!

Is Government Listening? It Appears So.

July 17th, 2008

Tony Davis, CEO, MedilinkWM

The recent Engineering Employers Federation survey stated that many manufacturing firms are out-performing the rest of the economy at present and are well placed to weather the current economic down turn.

This confirms what many of us in the manufacturing sector have known for a long time: UK manufacturing in the 21^st century is lean, dynamic, and above all innovative - delivering high value to the economy.

In a recent Business Enterprise and Regulatory Reform (BERR) department meeting in London, the Medilink UK networks and other healthcare trade associations were requested by senior civil servants at the department to canvas their members for feedback on how medical technology SMEs are coping with the current economic climate and the credit crunch.

Has there been a reduction in orders?

Have expansion or relocation plans been shelved?

Has R&D activity been suspended?

Concurrent with asking UK medical technology companies for their feedback on trading conditions, BERR have been engaging with industry as a result of the previous industry taskforce on how best to organize and reform the existing support / funding available, and to best advantage a sector which government has identified as being a significant contributor to the nation’s GDP. 

With the split up of the old DTI, many industry pundits predicted there would be a long hiatus in any sort of intelligent response from government in assisting the MedTech industry’s growth. In reality though, many of us have been surprised by a willingness from BERR (and DIUS) to look at many of the old DTI mechanisms and consult with industry on how to make them fit for purpose for the coming economic challenges.

So please email (Tony@MedilinkWM.co.uk) any comments or answers to the above questions or general comments you think the government should hear. Also keep a look out for an event later in the year where you can give your feedback directly to BERR.

High Quality Care for All

July 3rd, 2008

Most of us in industry have lived through many “New Dawns” for the NHS with many a government expert delivering their diagnosis on what ails the NHS and how government should react to provide potential solutions. Previous reports have majored on how the NHS had suffered from underinvestment and the current government reacted accordingly and increased the investment considerably. But were these investments made wisely? And did the NHS leadership along with the politicians have a robust strategy which informed the investment decisions?

 

In the same week as the report was published, the Confederation of British Industry (CBI) has urged the government to increase the pace of reform by embracing the independent sector. It advocates maximising competition and patient choice as the basis for tackling “failing provision and poor standards” in the NHS. “One thing recent years have shown us is that extra money alone has a limited effect on service outcomes,” said CBI Director-General Richard Lambert, in reference to the NHS’ £111bn budget. Richard Lambert is not alone in his assessment of the lack of impact the extra investment has had, many industry pundits are already talking in terms of the “Missed Opportunity” in truly reforming the 60 year old NHS post the Wanless review.

 

Many of those who participated in Lord Darzis’ review would share my view that he showed thoroughness and openness to all views and opinions, and perhaps for the first time we in the medical technology industry detected a true interest in innovation and technology and a willingness to include industry in the agenda of reform.

 

In the report and many of his recent statements I believe he understands the potential of new technologies to deliver part of the solution in creating a 21^st century healthcare system. However I am not convinced that his political masters or the leadership in the DOH &NHS share his vision or have the desire to carry it out.

 

The Secretary of State’s announcement to the house articulated the vision presented within the document, however the measures he proposed in my opinion stopped well short of being radical, it seemed to be a mixture of announcements of increased layers of bureaucracy at both regional and national levels, more panels, more boards etc and re-announcements of measures that the government introduced when they came to power, for example speeding up NICE.

 

On a more positive note we see the announcement from the Secretary of State on relationships with industry to be a positive move “We will create an environment in which excellence and innovation can flourish. That is why the report heralds new partnerships between the NHS, universities and industry to achieve the very best care for patients” Also in the report there is mention of “Innovation Clusters” where the NHS, Academia and Industry collaborate.

 

So do we believe Lord Darzi is sincere in his reform of the NHS? Largely yes!

Do we believe Government and the Civil Servants will carry it through? The jury’s out on that one I’m afraid!

 

 

 

The growing importance of overseas markets

June 23rd, 2008

The increasing emphasis on driving down price in the NHS potentially means that the procurement and adoption climate in the UK has never been more hostile.

That’s why new product entries and the adoption of disruptive technologies are becoming much harder, causing many UK companies to choose to supply a larger percentage of their products to export markets year on year. It’s therefore crucial that the UK Government provides a world-class export service to industry that will be fit for purpose.

The government organisation responsible for overseas trade is UK Trade and Investment (UKTI) and the section responsible for Medical and Healthcare markets is the Life Science Unit. This consists of two market disciplines – Biotechnology & Pharmaceuticals and Healthcare & Medical.

UKTI is driven by many factors, but not necessarily by what’s best for the SME industry base. As international trade promoters, MedilinkWM and My M-link are mindful that priority markets are often chosen because they are eye catching and politically significant. However, many of these large emerging global markets, including China and India, simply represent too much of a challenge for SMEs. The cost, time and commitment required to break such markets are investments that only the largest of Medtech companies can afford.

Many of the SMEs we talk to about international trade have told us that they are interested in markets closer to home, such as Germany, France and Scandinavia. Many of these smaller companies are seeking low-cost, well-targeted approaches to European markets.

So is UKTI missing the mark for SMEs? And what does it hope to achieve? Well, the recent UK Life Science Marketing Strategy focuses on large global markets and seems to be somewhat overly emphasised on the UK’s biotechnology sector – which is strange, because as the export strategy itself identifies in 2006, pharmaceutical exports were £12 billion, healthcare exports were over £14 billion, while UKTI forgot to include the export figure for biotechnology!

With the exception of Roy Johnson, the medical device and healthcare entrepreneur and Chris Francis, director of the UK India Business Council Chair of the UKTI Healthcare Sector Advisory Group, the recently formed UK Life Science Marketing Board is extremely light on members representing or even understanding the needs of SME’s in the medical and healthcare technology sector.

But be assured that as ambassadors for the sector, MedilinkWM and My M-link are working closely with colleagues from UKTI in the region to promote trade in the most effective way and to make sure that all our export efforts are industry-led and driven by the needs of West Midlands’ SMEs.

The Medical Devices Directive – Commission Consultation May 2008

June 15th, 2008

Posted by Tony Davis, CEO, MedilinkWM

In general it’s agreed that the system of regulating medical devices in Europe works well. The legislation was recently reviewed and improvements proposed. These improvements are in the process of being implemented, but the Commission has now embarked on a consultation containing proposals which would undermine the current system. This will stifle innovation and increase product costs without any consequent improvement in patient care or safety.

The three Medical Devices Directives and six modifying or implementing Directives form the framework for the regulation of medical devices. These directives come under the umbrella of the New Approach and classify devices into four categories according to risk. They were developed and implemented in the early to mid nineteen nineties. The main Directive (93/43 EC which covers the widest number of products) was reviewed in 2001 resulting in a report published in 2002. This report concluded that the regulatory regime created by the directive generally worked well but that various improvements could be made. Work on these improvements has been carried out by the Commission, Member State Competent Authorities and industry over the last several years. These changes were extensively scrutinised by the European Parliament and the process was completed with the publication of Directive 2007/47 /EC which comes into force in September 2010. It was indicated at this time that there would be a need for some further review because of the on-going review of the New Approach. It was also suggested that a process of ‘simplification’ (merging all the existing directives in to a single legislative instrument) might bring further improvement and this would be considered at the same time.

The Commission recently (May 2008) issued a consultation to a wide range of stakeholders, one of the most important being the medical technology industry. However the consultation, while covering the aspects described above, goes a great deal further in that it also proposes moving the regulation of higher risk devices into a regime similar to that of medicines using EMEA. Industry has serious concerns about these proposals. Were they to be implemented, there would be a significant increase in the cost of medical technology (the difference between notified body fees and those of EMEA is a factor of ten) and a decline in the number of innovative technologies coming to market with a consequent adverse effect on patient care. Many of these innovative technologies are coming from SMEs, which will be disproportionately affected by a more costly regulatory regime. On the other hand, if special fees are created for SMEs, then bigger Companies will see their competitiveness seriously eroded. Furthermore, the burden has to be spread over a few thousand units compared to several millions in the case of medicinal products

The document itself is flawed, is highly inconsistent, and makes claims not supported by any evidence:

· There is a clear statement at the outset that medical devices should remain under the New Approach. However the proposal to use EMEA would in itself move a large number of devices away from the New Approach
· The suggestion, both stated in the consultative document and implicit in the proposal to use EMEA, that there is a need for a new radical approach to device regulation is totally at odds with the recent Commission report that the current system requires only minor modification.
· The switching from NB to EMEA in terms of evaluation of the products will for the first time require the direct involvement of Competent Authorities officials, who have never had experience in evaluating medical devices: does this match with improving patient safety?
· There is a constantly repeated claim that the system does not work well. This is not only in contradiction of the earlier report but is completely unsupported by any evidence. In addition, this fails to acknowledge that the recent revision of the MDD will enter into force in 2010. We believe that the modified MDD should be allowed to demonstrate its effectiveness before embarking in a new revision of this kind.
· A claim is made that there is underreporting of device incidents in the EU. Again this is not supported with any evidence.
· The efforts made by the Global Harmonisation Task Force to harmonise device regulation globally is supported in the document but it is clear that the proposals concerning high risk devices would be incompatible with GHTF.

Industry is happy to engage in the debate prompted by many of the proposals in the consultation. However we are of the opinion that further improvements in the regulation of devices can be made without recourse to a costly and prescriptive regulatory model which will only increase cost and stifle innovation.

The Trials and Tribulations of the NHS Rapid Review Panel

June 9th, 2008

By Tony Davis, CEO, MedilinkWM

That the history of the NHS Rapid Review Panel is somewhat chequered is a great example of how even when politicians, clinicians and the public want something to happen quickly in the NHS, it’s still almost impossible to achieve.

The Rapid Review Panel was established in 2004 by the then secretary of state for health, John Reid, as a reaction to the rising ground-swell of public outrage at the increase in MRSA and other “Super Bugs” seemingly spreading throughout the whole of the NHS (primarily acute trusts) in the UK.

John Reid made the following observations at the time:

“Cleanliness remains a major patient concern and MRSA is a growing problem. The NHS is open about this. A clean environment provides the right setting for good patient care practice and good infection control. It is important for efficient and effective healthcare”.

“Patients rightly expect hospitals to be clean. Just like a clean hotel, a clean hospital gives a good first impression and can make a difference to how patients feel about the NHS and how they feel they have been treated. It is a physical manifestation of the health of the NHS”.

“Our new approach is to empower patients with more knowledge and encourage them to demand the highest standards of hygiene.  It is to give matrons and nurses at ward level the practical advice and power to ensure high standards are maintained. It puts cleanliness and the control of infection at the heart of inspection regimes, and it is to learn from the best at home and abroad to tackle the increasing problem of infection.”

His information came from a number of reports published by the DoH at the time, such as:
Winning Ways: working together to reduce healthcare associated infection in England. Report from the Chief Medical Officer <http://www.dh.gov.uk/PublicationsAndStatistics/Publications/PublicationsPolicyAndGuidance/PublicationsPolicyAndGuidanceArticle/fs/en?CONTENT_ID=4064682&chk=Vqjhyn>

New technologies, products and services were seen as potential solutions to the situation the NHS found itself in. However, when the politicians wished to push through “Silver Bullet” solutions such as alcohol gels and deep cleaning bombs, they discovered what we in the medtech industry had known for years. The time it would take to get such products evaluated, tested and trialed in a clinical setting, then procured, would equate to a full term in office of constant lambasting by the media – hence the Rapid Review Panel for Hospital Acquired Infection Products was born.

As is the way with knee jerk, short term political solutions, the Panel was given an almost impossible task: a colossal work load due to the amount of profile it received in the press and hardly any resources. The members of the Panel were exactly the right mix of experience and expertise, however it is largely done on a voluntary basis with a small secretariat resource. This means it can only be reactive not proactive in its relationships with industry, resulting in a trail of bad experiences and dashed expectations, and an undeserved reputation as a blocker rather than an enabler of technology.

We are now seeing, at long last, an increased investment by the Department of Health in the process aligning its activity with the Centre for Evidence-based Procurement (CEP) and the NHS National Innovation Centre which should result in a better quality of interaction with industry and potentially increased take-up of product.

So, for the time being the jury’s out on whether the RRP will make the difference that is required in using new technologies to reduce infections; but we all have an interest as companies and as patients in their endeavors.

Lessons Learnt from the American Association of Orthopeadic Surgeons Congress

June 2nd, 2008

Tony Davis CEO of Medilink West Midlands recently attended the American Association of Orthopedic Surgeons Congress in California.  The following observations highlight the industry trends and challenges emerging from the American market.

The rise of the ‘weekend warrior’
Orthopedics trends are being driven by our more-active lifestyles, less-invasive surgery, and increasingly personal care options. Patient benefits will include shorter recovery times, less pain, and better prognoses. Patients now expect to be given the option of products that are making these benefits possible, including artificial spinal disks, artificial bone and skin grafts, joint replacements, and advanced equipment in computer-guided and minimally invasive surgery.
All of these elements working together should make orthopedics a $94 billion industry by 2019, said Anthony Viscogliosi, founder of venture capital firm Viscogliosi Bros. LLC at the recent AAOS UKTI mission meetings in New York.

The patients of the future
In the future, patients will be more involved with their care, but who will those patients be?   “The traditional orthopedics patient base is changing,” says Greg Aurand, senior medical devices analyst at Zacks Investments Research Inc. “ People under the age of 65 now spend more on orthopedics care than they did in the early 1990s. The rise of the weekend warrior and the injuries that come with activities like mountain climbing will continue to spur demand. Increased competition is also driving the growth of the orthopedics industry.”
“People want a better mp3 player or a better PC—it’s a need for better performance,” says Aurand. “Partly it has to do with the aging population, but it also has to do with younger people who need orthopedic care because they wrecked their knees on the slopes or the basketball court.”

Questions over physician relationships with orthopedics industry
Orthopedics manufacturers are coming under increasing fire in the US. At a recent senate Special Committee on Aging hearing, legislation focused on manufacturers’ conduct, including accusations of ‘kickbacks’ for surgeons due to their relationships with orthopedic manufacturers.  But lawmakers and enforcement agencies recently expressed concern about doctors’ potential conflicts of interest as well.
The American Medical Association (AMA) is trying to modify some language in the bill, called the Physician Payments Sunshine Act. AMA ethical guidelines prohibit doctors from accepting gifts of substantial value, or with conditions attached, from medical device companies.
At the hearing, the Health and Human Services’ Office of Inspector General (OIG) offered several examples of conflicts of interest between the medical device industry and physicians. For example, between 2002 and 2006, the top four manufacturers of artificial hips and knees paid physicians more than $800 million in 6,500 consulting agreements.
While some of these payments were for legitimate services, the federal government found evidence of kickbacks disguised as consulting contracts, royalty agreements or gifts designed to influence the physicians’ medical decisions. In September 2007, the four companies entered into a settlement with the federal government for $311 million to resolve allegations that some payments were improper.
The OIG is concerned about the growing trend of physician ownership of medical device manufacturers. Due to the potential for improper inducements between and among the physician investors, the entities, device vendors and device purchasers.
Criticism at the hearing was not limited to device makers. Doctors who accept improper payments are equally culpable, Kohl said. “Physicians signaled to the industry that their loyalties are for sale to the highest bidder. So there are two groups here: companies and doctors.”

Doctors’ role affirmed
Physicians often invent new devices and move innovative ideas to reality, said Christopher White, executive vice president, general counsel and secretary of the Advanced Medical Technology Assn., which represents manufacturers making almost 90% of health care technology purchased in the US.
Practicing doctors give valuable data on improving medical devices, he said. “Physician expertise, feedback and experience are critical to a robust and innovative medical technology industry.”
The industry’s use of physician consultants may have been excessive, testified Chad F. Phipps, senior vice president, general counsel and secretary of Zimmer Holdings Inc.
Zimmer for instance now bans its sales team from involvement with physician consultants and is reviewing its royalty agreements for hip and knee products to ensure that they are at fair market value.
In another example of clinical and industry collaboration, surgeons helped medical device company Stryker develop a hip implant system designed to secure initial fixation when implanted and a orthopedic surgeon helped the company design a knee implant system.

In conclusion
The factors determining orthopedic trends in the U.S are varied and complex. New surgical techniques, increasingly active lifestyles, and consumer awareness will all play a role in changing expectations. The patient benefits will be measured in less pain, faster recovery times, and better prognoses. Advances in materials, CAS, and bone and skin grafts will contribute to these improvements.
To compete, UK companies will need to learn new manufacturing techniques to lower costs and speed up production. The orthopedics companies that survive will be those that know their customers, adapt to complementary technologies, and innovate.

Government Trade Support?

May 27th, 2008

Posted by Tony Davis, CEO, MedilinkWM

Lord Jones’s recent failure to fulfil his commitment to attend MACH 2008 is the most recent manifestation of a trend that those of us in industry have been witnessing over the past couple of years.

Industry associations and trade promoters in all sectors of manufacturing have been getting, at best, a lukewarm reception to our overtures to government asking for ministerial support for many of the excellent trade shows and forums we organise each year.

Manufacturing especially seems to have fallen down the gap when the DTI was recently split in to BERR (Business, Enterprise and Regulatory Reform) DIUS (Department of Innovation University and Science) Logic would seem to dictate that manufacturing would sit squarely in the realm of BERR, although so far nothing is coming out of the department, which leads us to believe there is even tacit support for the effort of UK manufacturers to drive the economy forward. Indeed the last BERR minister that had manufacturing in his portfolio, Steven Timms, recently lost his position in a reshuffle only to be replaced by Baroness Vadera who principally made her name in the city of London money markets. We in industry are not expecting a great deal of empathy for the plight of Britain’s manufacturer’s from the new minister any time soon.

Industry would however expect support from the Ex Director General of the CBI Lord Jones, and we probably believe that he is sincerely flying the flag for British Industry.  However, he may be thwarted in his efforts by working for an administration that seems to feel that producing a manufacturing strategy in 2002, seven years ago, was sufficient support for manufacturing in the UK.

So, if Government truly believes the sound bites coming from BERR, it should be prepared to “front” industry initiatives and “promote” British manufacturing in person at the coal face where it matters.