Andrew Parton, Hugo Technology

Guest blogger Andrew Parton, Joint Managing Director, Hugo Technology (Bromsgrove, UK), writes:

I used to be an electro-biomedical engineer, so I know what it’s like trying to keep track of biomedical equipment in the field. Let me share some horror stories about poorly maintained medical equipment.

There was the gas analyser bandaged together with Micropore tape that we found in the operating theatre. How about the machine that was still in use, even though it had been recalled years ago. Or the syringe driver that hadn’t been calibrated for six years and was still being used to deliver prescribed drugs?

Then there are the stories of engineers turning up to service seven machines—each worth £50,000—three of which are missing. “Now, where did I leave my car?”

Funny? Not really. How would you feel if the life of one of your loved ones relied upon one of those machines?  That’s what we ask our engineers to keep in mind, no matter how boring or challenging their assignment.

Who’s in charge?

Last year at Hugo, we polled medtech OEMs to see what sorts of regimes they followed in maintaining, repairing and calibrating their biomedical devices. We didn’t share the results as they weren’t statistically significant, but there were some interesting findings.

There is often no named individual responsible for a piece of kit at a medical establishment. That not only creates issues when you annually audit the kits (which explains why many establishments don’t audit or at least not annually), but it also often means that the kit sometimes is not fully charged when it’s needed.

There is also a training issue—no one is quite sure how to use it, because the person who was trained has now left.

There are many machines that have reached the end of their lives but everyone just accepts that they are old, so procurement isn’t even aware of the matter.

Then there’s the equipment that came free when you ordered the associated consumables. You can now fashion quite a stockpile out of those consumables.

Mark my words—this is all changing.

Outsourcing of medical manufacturing soars

Market research publisher Global Industry Analysts predicts that the outsourcing of medical devices will rise to a US$42.6 billion (£27 billion) industry by 2015. As this trend continues, the management of medical device maintenance will become increasingly important.

Many of the world’s leading biomedical manufacturers—Philips, Moog, GE, Intel, Kimal, Teleflex—are already outsourcing the maintenance and repair of their medical devices, and that trend is set to continue. Here’s why:

• The drive for value. NHS restructuring and the call to lower costs means doing more with less, while improving care and reducing risk.
• The importance of compliance with standards such as ISO 13485 and ISO 9001, in which organisations such as ours are well versed.
• Society’s readiness to sue the NHS and other health services has made the focus on standards and the audit trail paramount.
• We expect more of engineers these days. You can train an engineer to carry out the most complex procedure on any OEM’s equipment, but it’s their mindset that makes all the difference. For that reason, you need to be as careful in identifying a candidate’s attitudes and values as you are their qualifications when recruiting. OEMs seem happy to delegate this aspect to outsourced providers, who focus their culture around that exact mindset.

NHS will hold medical device manufacturers accountable

In a conversation with Ian Cohen, medical negligence expert solicitor and director at Goodmans Law in Liverpool, I discovered that the NHS is set to get smarter in its risk management practices.

His warning was stark.  The NHS is becoming more organised in identifying issues of product liability across the service so that, where it can, it will attempt to offset some of its liabilities and seek to recover damages from manufacturers.

“Previously, the NHS found it very difficult to pick up on similar issues that may have occurred in hospitals in different parts of the country,” Ian said.  “While the manufacturer would have collated all of the information and possibly identified trends, the individual Trusts will not have told each other, so the significance would not have been spotted. The NHS would have dealt with the problem in isolation without considering a root-cause analysis.

“The whole manner of risk management has changed and continues to change; with the NHS Litigation Authority, the NHS is better prepared to mitigate against future potential claims.

“If and when patterns and trends do emerge, the NHS will be better placed to identify them and this could have considerable impact on manufacturers’ product liability,” Ian warns.

Andrew Parton is Joint Managing Director at medtech repair and maintenance specialist Hugo Technology (www.hugotechnology.co.uk).

The effort by hospitals to phase out PVC in IV bags and tubing is a waste of resources and energy, says Len Czuba, President of Czuba Enterprises Inc. and former president of the Society of Plastics Engineers.
Sounding off on PVC bans, biomaterials’ pricing and antimicrobials (PlasticsToday)

AlpVision and Nolato Medical have announced a new partnership to protect pharmaceuticals and medical devices from counterfeiting.
Nolato Medical and AlpVision Announce Joint Collaboration to Protect Pharmaceutical Primary Packaging and Medical Devices (PMPNews)

Last week, an associate professor of Harvard School of Public Health announced his decision to resign as an associate editor of Genomics, because he thinks the system “provides solid profits for the publisher while effectively denying colleagues in developing countries access to research findings.” The announcement is the latest development in the Academic Spring movement.
I can no longer work for a system that puts profit over access to research (The Guardian)

Recently, hospitals group asked IRS to make sure that medical device makers don’t raise prices to cover the cost of the 2.3% tax on revenue that will start in 2013. This is a “manufactured issue” and makes no sense, says the Medical Imaging & Technology Alliance.
MITA: Windfall rhetoric about med-tech tax makes no sense at all (MassDevice)

A prosthetic retina made of thin silicone

A new type of prosthetic retina could restore vision to patients with age-related macular degeneration (AMD), the most common cause of blindness in the developed world, according to a press release from University of Strathclyde. The device is wireless and less bulky than existing devices. Current prosthetic devices require complicated surgery, and the new device could result in much simpler procedures, according to the press release.

The device is being developed by researchers at the University of Strathclyde and Stanford University. A study on the implant was recently published in the journal Nature Photonics.

The retina implant is made of thin silicone. It converts pulsed near infrared light into electrical current that stimulates the retina and elicits visual perception. (Conventional prosthetic retinas are powered by coils.) Video goggles deliver energy and images directly to the eye.

Part of the inspiration for the device was the cochlear implants, devices for people with hearing loss. The retina implant is similar to these implants, but has a camera instead of a microphone and is designed to deal with millions of light-sensitive nerve cells.

AMD affects one in 500 patients aged between 55 and 64, and one in eight aged over 85, according to the press release from University of Strathclyde. As the aging population increases, AMD is expected to continue to grow.

HAnano Surface is based on nanothin coatings of the substance hydroxyapatite (HA). The company has developed a wet chemical method of producting nanoparticles of HA. The technique creates a surface with high wettability, a proven factor to improve osseointegration. Because of the material’s small pores, even complex materials can be coated.

The coating can be used with various implant materials, including metals, ceramics and polymers, to enhance the anchoring strength and accelerate bone integration. Several in-vivo studies have demonstrated that the coating serves these purpose. Implants coated with the material are up to four times harder anchored just after four weeks of healing, according to the company.

Promimic recently obtained a US patent for the material. It already holds patents for the product in several countries, including Sweden, Israel, China and Russia. The company was founded in 2004 by two researchers from Chalmers University of Technology (Gothenburg, Sweden).

The aim of the treaty is to support “sustainable growth, employment, competitiveness and social cohesion” in Europe through budgetary rules. Only countries that have ratified the treaty will be able to receive funds from the European Stability Mechanism, a new rescue fund. Supporters say that a yes vote will encourage businesses to continue to invest in Ireland.

The medtech sector in Ireland employs 25,000 people. About half of the med-tech companies in Ireland are indigenous. Executives at several medical technology companies have expressed their support for the treaty. In an IMDA press release, both Donal Balfe, Vice President of Covidien, and John O’Dea, founder and CEO of Crospon, speak out in support of the treaty.

“The medical technology sector is playing a vital role in Ireland’s export-led recovery and creating jobs in the process,” says O’Dea. “While major challenges remain, it is crucial that we build on this success. It is important that we don’t jeopardise the progress already made by isolating ourselves in Europe.”

“We operate in a global environment where there is enormous competition for future research and development investments,” says Balfe. “Financial stability in Ireland is critical for companies to be able to plan for future innovation in the country.”

To learn more about the objectives of the renewed MoU, which was signed on 26 April 2012, Helen Zhang, Associate Editor of China Medical Device Manufacturer (CMDM), spoke with Dr. J. Zhou, Associate Professor, Department of Biomechanical Engineering and Faculty of Mechanical, Maritime & Materials Engineering at TU Delft.

CMDM: Can you tell me under what circumstances the collaboration was initiated, and why your university selected SIC as your partner in China?

Dr. J. Zhou: The cooperation in research on biomaterials was initiated in September 2008 during the China Medical Technology Tour, headed by Dr J.W.A. van Dijk, former Vice Governor of the Netherland’s South Holland province, and Prof. J.T. Fokkema, former Rector-Magnificus of TU Delft. The main reason for choosing SIC as our partner is quite simple: complementary expertise.

The Biomaterials and Tissue Engineering Research Center of CIS, led by Prof. Jiang Chang, is particularly strong in developing bioactive ceramics and ceramic-matrix biocomposites. In addition, it has expertise in understanding cell-biomaterials interactions (including the effect of biomaterials on cell adhesion, proliferation, differentiation and gene expression) and is capable of characterising the physical and chemical properties of biomaterials. Its research covers the fields of bioactive materials, tissue engineering scaffolds, nano-biomaterials for controlled drug release, biolabelling, diagnostics, inorganic bioactive coatings for medical implants, and fibre-optic materials for medical devices.

The Biomaterials Technology Group of TU Delft is particularly strong in developing biometals and metal-matrix biocomposites and adding multiple biomedical functionalities to the surfaces of these biomaterials. Its unique expertise lies in metallic and composite biomaterials processing and surface biofunctionalisation. It is equipped with a full range of facilities, including a bio-safe lab, for biomaterials processing, characterisation and surface biofunctionalisation. This research covers the whole chain of biomaterials research for advanced multifunctional combination devices and instruments.

CMDM: The updated MoU will contribute to a joint research project with ZonMw (The Netherlands Organisation for Health Research and Development) and CIS. Can you tell us more about this?

Dr J. Zhou: We strongly believe that the MoU contributed to the approval of a four-year joint research project titled, “Bioactive and biodegradable composites for new-generation bone fixation devices.”

Our joint proposal was submitted in April 2011 in response to a call for proposals under the China-Netherlands Joint Scientific Thematic Research Program 2011 (JSTP) with a thematic focus on “Medical Devices for an Ageing Society.” It was assessed by three international experts appointed by the JSTP assessment committee. (Sino-Dutch cooperation was one of the four criteria for the assessment.) It was then assessed in China.

The Chinese-Dutch Assessment Committee ranked our proposal as one of the six top proposals out of 29 applications and approved funding for our project in November 2011.

In its first term (2009-2011), the MoU provided a formal framework under which many joint research efforts were conducted and a joint research proposal was rewritten.

Satisfied with the outcome of the collaboration, both institutions agreed to a renewal of the MoU for five years (2012-2016). The execution of the approved joint research project will certainly be part of the new MoU.

CMDM: What are the goals for the project mentioned above? Specifically, how might this benefit the medical technology industry?

Dr. J. Zhou: The project intends to make the best use of the expertise of the individual institutions in biomaterials research. It aims to develop composite materials for new-generation bone fixation devices that are both biodegradable and bioactive. Their clinical applications will eliminate the medical problems of current bone fixation devices, which are left permanently in the body after the bones have healed. These problems include stress shielding, physical irritation and [the devices'] inability to adapt to changes in the human body, and, thus, the need for a second surgical procedure to remove them.

Bioactive, biodegradable bone-fixation devices that are being developed in this project will be welcome additions to existing orthopaedic devices and further drive market growth in Europe and China. The research will generate know how and intellectual property and provide the medical device industry with an opportunity to develop innovative products.

The report found that the agency started to receive reports related to the Pip implant scandal as early as 2002. In 2006, surgeons contacted the agency, concerned that the implants were breaking more frequently than other brands. MHRA brought these concerns to the attention of the notified body TUV Rheinland, which was responsible for assessing the implants, and continued to analyse Pip incident data afterwards. Ultimately, the blame “lies squarely with the fraudulent manufacturer”, the report found.

While the review found that the MHRA acted reasonably, it also calls for several improvements to the agency. MHRA needs to improve its procedures for gathering evidence related to device safety and analysing reported problems, according to the report. It also needs to find better ways of communicating with the public. In addition, the report calls for changes to the European regulatory system, stating that EU countries must work more closely together and become better at sharing information on medical devices.

However, the report rejects the need for a premarket authorisation system, something the European Parliament called for in its Pip resolution. “Nothing about this case provides evidence to suggest the system for regulating medical devices is fundamentally unsound and that there needs to be a shift to a system like that used to regulate pharmaceuticals in the EU, or the system used to regulate higher risk devices in the United States…Putting in place even the most exhaustive testing regime before market authorisation would not have prevented this deliberate fraud taking place once the product was on the market,” the report says.

Chomerics Europe uses advanced manufacturing techniques to achieve a combination of shielding effectiveness, optical transmission and mechanical and environmental performance, notes the company in a press release announcing the completion of the new specialist cell. The Grantham facility has been producing optical windows for more than 10 years, during which time the company has developed expertise in the design and manufacture of these specialised products.

Commenting on the commissioning of the new cast window production cell, Billy Sheedy, General Manager, Parker Chomerics Division Europe, said: “With an increasing demand for equipment to be designed for portability and use in uncontrolled environments, along with more stringent regulations in terms of EMC, we are seeing greater demand for the shielded optical products designed and manufactured at our facility in Grantham. The establishment of an advanced, dedicated cell for cast windows will enable us to further advance the quality of our products for this important market.”

Last week, US FDA approved the first surgical device that can be assembled and disassembled inside a patient. However, Ethicon Endo-Surgery, the manufacturer of the device, might never launch the product, MedCity News says.
A look (kind of) at the first ever, FDA-approved surgical device that can be assembled inside a patient’s body (MedCity News)

Open access publishing often shifts the cost from subscribers to authors because of processing fees. Universities should encourage the growth of journals that don’t charge readers or authors, two UK professors argue in this blog post from The Guardian.
Open access publishing should not favour those with deep pockets (The Guardian)

In this video, device inventor Thomas Fogarty discusses how medical device companies can overcome hurdles such as difficulties getting funding and regulatory challenges.
Thomas Fogarty, MD on Overcoming Barriers to Innovation in Medtech (MD+DI)

The global minimally invasive surgical market will see an estimated annual growth rate of 8% during the next five years, according to a report by global market research and consulting company MarketsandMarkets.
Minimally Invasive Device Market Poised for Continued Growth (Medtech Pulse)

Last week, the author of the article, BMJ Investigations Editor Deborah Cohen, responded to DePuy’s comments, accusing DePuy of sidestepping the issue of metal hip safety. Cohen claims that the article “provided a necessarily alarming portrait of the state of medical device regulation today.” Cohen also said that the main point of her article was to point out “the laxity of medical device regulation in Europe as a whole and some aspects of the US system.”

As the European Commission drafts its proposal for the revision of the Medical Device Directives, the controversy is likely to impact the outcome. The Pip resolution, which was passed in April, already included references to the controversy, using it as an example of the failure of the European regulatory system. The resolution is not binding and only expresses the views of the European Parliament, but it demonstrates the prevailing view in the Parliament that Europe’s medtech regulations are not strict enough to prevent similar incidents (see this medtechinsider post for more information and for Eucomed’s response to this argument).