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The NHS Technology Adoption Centre (NTAC) has launched a new online system to help NHS and private health providers adopt proven medical technologies more quickly and effectively.

The new Generic Adoption Process (GAP) provides a detailed roadmap of the adoption process and access to the tools and resources needed.

GAP builds on the experience of NTAC’s Technology Implementation Projects over the past four years in improving the diffusion of proven medical technologies across the NHS.

Users of the GAP website are encouraged to navigate through each of its sections in order, thereby building relevant knowledge – however, they are free to navigate between sections as they wish.

The site is designed for use by health providers at all stages of the technology implementation process.

Sally Chisholm, CEO of NTAC, commented: “GAP has been tested by a number of key stakeholders from the NHS and industry. We believe this is a vital tool which will help drive widespread adoption of proven technologies, as GAP can provide unrivalled knowledge and information to those who do not choose to directly engage with NTAC on an implementation project, for example.

“The idea for GAP came from our recognition that there is a clear need for something which can equip clinicians, managers and other key stakeholders crucial to service development with the tools and resources they need to be able to drive change and innovation throughout the NHS.”

NTAC takes the view that the NHS often fails to adopt innovative medical technologies whose clinical and economic value is proven due to a lack of well-resourced and coordinated adoption pathways.

GAP is available at http://www.ntac.nhs.uk/GAP/GAP_Home.aspx

Medtronic has launched its T2 Altitude expandable corpectomy device for spinal stabilisation and correction worldwide.

The expandable vertebral body replacement cage features a self-locking mechanism that removes the need for placing a set screw during surgery, using bone graft to create contact to encourage fusion with the device.

Doug King, Senior Vice President and President of Medtronic Spinal, said that the new product demonstrates the company’s “long-term commitment to therapies for complex spine disorders for spinal tumour, trauma and deformity patients”.

Cancer patients can also benefit from the product. If the cancer has spread to the spine, the surgeon may replace the affected vertebrae with the T2 Altitude device.

More than 150,000 spinal fractures occur in North America every year, of which approximately 11,000 are spinal cord injuries.

Based in Memphis, Medtronic Spinal provides advanced treatment through the collaboration with surgeons and researchers to offer affordable, minimally-invasive products and medical technologies for neurological, orthopaedic and spinal conditions.

Healthcare corporation 3M has lost its dispute with representatives of the British Government over the company’s failure to market a diagnostic for MRSA developed within the Ministry of Defence.

The complainants have won $1.3 million in damages, whereas they were seeking $40 million – an outcome claimed by both sides as a success.

The BacLite medical device, which uses photoluminescence to detect MRSA bacteria, was purchased by 3M in 2007 and then abandoned as having failed the necessary clinical trials to support its marketing in the EU and the US.

The MoD, its spin-out company Ploughshare Innovations and private equity firm the Porton Group together claimed that 3M had deliberately mismanaged the BacLite trials in order to protect its rival (and more expensive) Fastman device.

The High Court in London found that 3M was in material breach of its obligation “actively to market” BacLite in the EU, the US, Canada and Australia, including its obligation to seek regulatory approval in the US.

However, it did not find that 3M had “intended” a breach of contract and thereby conducted the clinical trials dishonestly.

3M has announced its intention to pursue charges in the US against the Porton Group for alleged attempts to “extort” an out-of-court settlement by threatening to use political influence.

While the arguments rage on, the question of whether BacLite has the potential to improve worldwide treatment of MRSA remains unresolved.

A new report by the FDA highlights weaknesses in medical device quality in the US over the past decade.

The FDA’s report, Understanding Barriers to Medical Device Quality, stated that while revenues in the medical technology industry have grown over the last ten years, “serious adverse events” have outpaced this growth by 8% each year.

Failures in medical device design and manufacturing process control were found to account for more than half of all product recalls.

“While medical device flaws may vary by device, some sources of error are pervasive throughout the field,” the report reads.

“Identifying and addressing systemic barriers may yield improvements in medical device quality on a large scale.”

The report was launched by the FDA’s Center for Devices and Radiological Health in order to understand and improve gaps in device quality, and outlines recommendations for both industry and federal regulators.

The analysis found that “nearly 60% of the adverse event reports” involved cardiovascular, in vitro diagnostics and general hospital/surgical equipment.

“Our efforts revealed that there are systemic gaps within the medical device industry's quality approach that result in these issues,” said the report. “Attempts to improve quality are hindered by challenges within the industry as well as specific aspects of the agency's regulatory approach.”

According to the FDA, medtech manufacturers are facing a series of challenges which are impeding device quality, such as the increasing complexity of devices, time to market competition, and cost pressures.

Identified opportunities for improvement include postproduction monitoring and feedback, creating quality incentives, and improving design and engineering.

The report also cited steps for the FDA to incorporate, such as clarifying Agency requirements and learning from regulators of similar high-tech industries.

A similar initiative is underway in Europe to improve medical device regulatory assessment processes, with support from Eucomed.

John Wilkinson (pictured), Chief Executive of Eucomed, has received a special Career award from the International Vascular and Endovascular Course (IVEC) in Milan.

The award recognises the medtech industry’s contribution to the development of vascular and endovascular surgery.

IVEC Chairman Giorgio Biasi presented the award to John Wilkinson to “honour the excellence of a distinguished scientist and eminent colleague who has contributed enormously in promoting, divulging and spreading culture, development and achievements in the field of vascular and endovascular techniques.”

Following the award presentation, Wilkinson gave the Edmondo Malan Lecture on ‘Development and Achievements in Endovascular Procedures as a Result of a Continuous and Ingenious Co-operation between Physicians and Industry’.

He discussed the long history of collaborative working between clinicians and industry over 200 years, with ideas from doctors and surgeons being developed by companies, culminating in such revolutionary devices as the drug-eluting stent.

Wilkinson also emphasised the need for innovation to be built on a platform of ethical interaction and transparency, and for industry to support education and training in the delivery of new therapies.

Finally, he drew attention to the demographic and economic challenges facing Europe’s health systems, and called for a collaborative approach between all stakeholders to support innovative solutions to these urgent problems.

Eucomed is the leading European medical technology industry association. It represents 4,500 designers, manufacturers and suppliers of medical technologies.

Final NICE diagnostic guidance on the EOS 2D/3D X-ray imaging system calls for the system’s health benefits to be further investigated in clinical research settings.

The new system (pictured) from US company EOS Imaging uses low-dose radiation imaging to produce 2D X-ray images and 3D reconstructions for bones.

Its innovative slot-scan technology, scanning a line at a time rather than taking the entire image at once, enables it to produce upright and weight-bearing whole-body images.

By showing relationships between the spine, hip, pelvis and knees, the EOS system could particularly benefit the monitoring and treatment of patients with spinal deformities or alignment problems.

The system’s reduced dose also offers potential safety advantages in the repeated imaging of patients with spinal deformities, especially children.

The new guidance encourages the use of the 2D/3D imaging system in specialist research settings to collect evidence about clinical benefits associated with weight-bearing whole-body imaging and 3D reconstruction.

Professor Carole Longson, Director of the NICE Health Technology Evaluation Centre, said: “The EOS 2D/3D imaging system was identified by the Diagnostics Advisory Committee as an important emerging technology. There is evidence showing comparable or better images and radiation dose reduction associated with using the EOS system to image patients with spinal deformities.”

However, she said, there is currently no evidence that compares the diagnostic accuracy of the EOS system with that of conventional radiological examinations. “NICE will follow up the Diagnostics Advisory Committee’s research recommendations on the EOS 2D/3D system and will assess the feasibility of this research with a view to facilitating the development of further relevant evidence.”

Full data sets evaluating the system’s benefits will trace the outcome of its use from planning through to complex surgeries such as hip replacements.

Marie Meynadier, CEO of EOS Imaging, said: “The EOS 2D/3D imaging system is subject to an extensive programme of research associating radiologists and orthopaedic surgeons. We will provide data to NICE as they are established to determine when a cost-effectiveness review based on this evidence would be appropriate.”

The new external assessment centres recently announced by NICE will help to develop and facilitate research products to assist suppliers when NICE medical technology or diagnostics guidance recommends it.

Medical device outsourcing company Vention Medical has acquired ATEK Medical Group, a leader in medical device assembly, packaging and injection moulding.

Dan Croteau, CEO of Vention Medical, said, “Our partnership with the ATEK Medical Group management team will allow Vention to provide an enhanced customer experience. Like Vention, ATEK Medical Group aspires to continually satisfy customers through intense focus on services that improve quality, innovation, and cost.”

The acquisition will incur a variety of combined capabilities and services, including product design and development, innovative component technologies, along with the manufacturing space of 175,000 square feet at its Costa Rica campus.

ATEK recently opened a second facility in Grand Rapids, Michigan, to support customer demands in the US.

Chris Oleksy, President of ATEK Medical, and Tom Houdeshell of ATEK Plastics, said that Vention’s experience and capabilities in design, components and assembly makes Vention “a very appealing partner for us”.

Vention Medical specialises in components and services used in interventional and minimally-invasive products, including medical balloons, advanced extrusions and heat shrink tubing, clean room injection moulding, assembly and packaging services.

New funding for medical technology research by companies, clinicians and academics aims to promote innovative approaches to the prevention, diagnosis and treatment of diseases in the NHS.

The National Institute for Health Research (NIHR) Invention for Innovation (i4i) programme has allocated up to £13m for research projects, and has launched a call for proposals.

The NIHR i4i programme funds projects through prototype and commercial development until a technology is ready for clinical testing, bringing together academic or clinical researchers and technical experts from industry.

The programme has been updated in two ways:

• Research projects in Wales, as well as in England, are now eligible for i4i.
• Instead of being divided between early- and late-stage product development awards, applications will all be submitted through a single route.

As well as looking for technologies that will benefit NHS patients, the NIHR i4i programme supports collaboration between researchers in industry, the NHS and the academic field. Each approved proposal will bring together researchers from at least two of these sectors.

NIHR particularly welcomes proposals from SMEs and from teams that have previously succeeded in developing and commercialising new technologies.

Martin Hunt, NIHR i4i Programme Director, said: “In the present economic climate, it is becoming increasingly difficult for medtech companies to secure funding for new, innovative technologies. The NIHR i4i programme provides a valuable funding opportunity for the medtech sector.”

This year’s i4i funding covers a “much broader” range of projects than last year’s, he noted. “The amount of funding awarded is determined by the nature and scale of the proposed research activity and we are considering projects seeking larger funding amounts than before.”

Outline research proposals must be submitted by 5pm on Wednesday 7 December 2011. Further details are available at www.i4i.nihr.ac.uk.

The FDA has approved Abbott’s next-generation Xience Prime drug eluting stent to treat patients with complex coronary artery disease.

The Xience Prime Everolimus Eluting Coronary Stent System is based on the company’s cobalt-chromium stent technology and is designed to enhance deliverability, flexibility, and more accurate stent placement in patients with symptomatic heart disease due to de novo native coronary artery lesions.

The approval was based on results from the SPIRIT PRIME clinical trial, a prospective, multi-centre, open-label trial involving 500 patients with coronary artery disease at more than 60 centres in the US and Australia. Clinical results show that the trial met its primary endpoint of low rates of target lesion failure (TLF) at one year.

Dr Marco Costa, principal investigator of the SPIRIT PRIME trial, said: “Drug-eluting stent technology continues to advance, leading to improved outcomes for patients with coronary artery disease.”

He said that the medical device “will improve our ability to access challenging, complex lesions, and thereby improve care for our patients”.

Robert Hance, Senior Vice President at Abbott Vascular, said that the FDA’s approval “expands the range of treatment options that we can offer physicians for the benefit of their patients with coronary artery disease”.

Xience Prime received CE Mark Approval in 2009.

Abbott recently split into two companies, one concentrating on research-based pharmaceuticals and the other (Abbott) on medical products.