Mobile Medical Applications

Mobile applications are software programs that run on smartphones and other mobile communications devices. Development of mobile medical applications is opening new and innovative ways for technology to improve health and health care.

Consumers use mobile medical applications to manage their own health and wellness. Health care professionals are using these applications to improve and facilitate patient care. These applications include a wide range of functions from allowing individuals to monitor their calorie intake for healthy weight maintenance, to allowing doctors to view a patient's X-rays on their mobile communications device.

The FDA encourages further development of mobile medical apps that improve health care and provide consumers and health care professionals with valuable health information very quickly.

The FDA has a public health responsibility to oversee the safety and effectiveness of a small subset of mobile medical applications that present a potential risk to patients if they do not work as intended. In order to balance patient safety with innovation, it is important for the FDA to provide manufacturers and developers of mobile medical applications with a clear and predictable outlines of our expectations.

Through draft guidance release on July 19, 2011 the FDA defined a small subset of mobile medical apps that may impact on the performance or functionality of currently regulated medical devices and as such, will require FDA oversight.

The FDA encourages feedback from manufacturers, health care providers and others on how its proposal may support the balance between promoting innovation and assuring safety and effectiveness.

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 19, 2011.

Mobile applications are software programs that run on smartphones and other mobile communications devices. Development of mobile medical applications is opening new and innovative ways for technology to improve health and health care.

Consumers use mobile medical applications to manage their own health and wellness. Health care professionals are using these applications to improve and facilitate patient care. These applications include a wide range of functions from allowing individuals to monitor their calorie intake for healthy weight maintenance, to allowing doctors to view a patient's X-rays on their mobile communications device.

The FDA encourages further development of mobile medical apps that improve health care and provide consumers and health care professionals with valuable health information very quickly.

The FDA has a public health responsibility to oversee the safety and effectiveness of a small subset of mobile medical applications that present a potential risk to patients if they do not work as intended. In order to balance patient safety with innovation, it is important for the FDA to provide manufacturers and developers of mobile medical applications with a clear and predictable outlines of our expectations.

Through draft guidance release on July 19, 2011 the FDA defined a small subset of mobile medical apps that may impact on the performance or functionality of currently regulated medical devices and as such, will require FDA oversight.

The FDA encourages feedback from manufacturers, health care providers and others on how its proposal may support the balance between promoting innovation and assuring safety and effectiveness.

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 19, 2011.

Robotic suit developed to enable paraplegic walk again

A new Robotic suit has been invented by the scientists which will allow the Paraplegic walk again. This suit enables a person walk with the help of Sensing movements which are later translated with the help of a computer brain.

Esko, which look like an exoskeleton, allows the person wearing it to walk on their own accord by sensing the small movements of the upper body and convert them into strides. Amanda Boxtel, which got her waist down portion of the body paralyzed, has described the suit as ‘life changing’.

“The first time I walked in them I went back to my hotel room and cried hard,” the Telegraph quoted her as saying.

According to the chief executive officer of Ekso Bionics, Eythor Bender said that the project was initially financed by American military interested in providing soldiers extraordinarystrength and potential on the battlefield.

Describing the device Bender said, “It has sensors, that pretty much mimic your nerves, that sense your movements.”

Opinion: This new invention is really a ‘life changing’ one as the paraplegics will now be able to walk again and look forward for the well being of their lives.

A new Robotic suit has been invented by the scientists which will allow the Paraplegic walk again. This suit enables a person walk with the help of Sensing movements which are later translated with the help of a computer brain.

Esko, which look like an exoskeleton, allows the person wearing it to walk on their own accord by sensing the small movements of the upper body and convert them into strides. Amanda Boxtel, which got her waist down portion of the body paralyzed, has described the suit as ‘life changing’.

“The first time I walked in them I went back to my hotel room and cried hard,” the Telegraph quoted her as saying.

According to the chief executive officer of Ekso Bionics, Eythor Bender said that the project was initially financed by American military interested in providing soldiers extraordinarystrength and potential on the battlefield.

Describing the device Bender said, “It has sensors, that pretty much mimic your nerves, that sense your movements.”

Opinion: This new invention is really a ‘life changing’ one as the paraplegics will now be able to walk again and look forward for the well being of their lives.

Medical Devices and Medical Equipment

The process of bringing a new medical device to market has a number of important milestones. In addition to product design, it is important to anticipate many of the obstacles that will need to be overcome to achieve success. The medical device industry is a rapidly growing, competitive and regulatory landscape, with shorter product lifecycles, increased regulatory scrutiny, and the need to manage complex partnerships across the value chain.

Our Approach

Thomas Group is a business process-improvement consulting firm; thus, our general approach is to look at processes and sub processes in-depth and then evaluate the effectiveness of each one. We examine how the processes interrelate with one another and find improvements and linkages that will result in enhanced business results.

For a company developing a new medical device, the ultimate goal is to ensure the safety, reliability, and quality of the product. Medical device companies work with Thomas Group to manage R&D, device design and control processes, and vendor selection and retention, as well as the intellectual property generated by innovation. We provide specific industry solutions that reduce the complexity of regulated business processes while reducing costs associated with production, design, and customer service.

How Thomas Group Can Help

Thomas Group can help ease the regulatory, clinical trial, and quality assurance burdens, allowing you to focus your time and resources on achieving your business goals. Thomas Group can also help overcome challenges associated with:

  • Inefficient systems
  • Contract manufacturing
  • The high cost of validation

At Thomas Group, we are focused on assisting medical device, pharmaceutical, and equipment manufacturers across the globe with services that help them achieve efficiency in process improvement. We provide our clients with professionals who are armed with a proven and flexible consulting methodology. This approach enables us to provide clients a customized service that meets your specific needs.

Among the benefits realized by Thomas Group clients:

  • Faster time-to-market
  • Reduced costs
  • Lower cost of regulatory compliance
  • Lower costs due to poor quality
  • Improved product quality
  • Reduced noncompliance risk

Whether you need to define your regulatory pathway, support your product with a well designed clinical trial, prepare your team for an FDA or ISO audit, or ensure ongoing compliance, Thomas Group has the experience and knowledge that will help you achieve success.

thomasgroup.com

The process of bringing a new medical device to market has a number of important milestones. In addition to product design, it is important to anticipate many of the obstacles that will need to be overcome to achieve success. The medical device industry is a rapidly growing, competitive and regulatory landscape, with shorter product lifecycles, increased regulatory scrutiny, and the need to manage complex partnerships across the value chain.

Our Approach

Thomas Group is a business process-improvement consulting firm; thus, our general approach is to look at processes and sub processes in-depth and then evaluate the effectiveness of each one. We examine how the processes interrelate with one another and find improvements and linkages that will result in enhanced business results.

For a company developing a new medical device, the ultimate goal is to ensure the safety, reliability, and quality of the product. Medical device companies work with Thomas Group to manage R&D, device design and control processes, and vendor selection and retention, as well as the intellectual property generated by innovation. We provide specific industry solutions that reduce the complexity of regulated business processes while reducing costs associated with production, design, and customer service.

How Thomas Group Can Help

Thomas Group can help ease the regulatory, clinical trial, and quality assurance burdens, allowing you to focus your time and resources on achieving your business goals. Thomas Group can also help overcome challenges associated with:

  • Inefficient systems
  • Contract manufacturing
  • The high cost of validation

At Thomas Group, we are focused on assisting medical device, pharmaceutical, and equipment manufacturers across the globe with services that help them achieve efficiency in process improvement. We provide our clients with professionals who are armed with a proven and flexible consulting methodology. This approach enables us to provide clients a customized service that meets your specific needs.

Among the benefits realized by Thomas Group clients:

  • Faster time-to-market
  • Reduced costs
  • Lower cost of regulatory compliance
  • Lower costs due to poor quality
  • Improved product quality
  • Reduced noncompliance risk

Whether you need to define your regulatory pathway, support your product with a well designed clinical trial, prepare your team for an FDA or ISO audit, or ensure ongoing compliance, Thomas Group has the experience and knowledge that will help you achieve success.

thomasgroup.com

Advanced Therapies

New technologies, therapies and medicines are emerging; this includes regenerative medicine, more personalised treatments, as well as the development of nanomedicines. The Commission is committed to monitoring scientific progress and to constantly review Community legislation in the light of new developments so as to make safe, novel treatments available to patients as early as possible.

Advanced therapy medicinal products are new medical products based on genes (gene therapy), cells (cell therapy) and tissues (tissue engineering). These advanced therapies herald revolutionary treatments of a number of diseases or injuries, such as skin in burns victims, Alzheimer's, cancer or muscular dystrophy. They have huge potential for patients and industry.

The lack of an EU-wide regulatory framework in the past led to divergent national approaches which hindered patients' access to products, hampered the growth of this emerging industry and ultimately affected EU competitiveness in a key biotechnology area.

The EU institutions agreed on a Regulation on advanced therapies (Regulation (EC) 1394/2007 , designed to ensure the free movement of advanced therapy products within Europe, to facilitate access to the EU market and to foster the competitiveness of European companies in the field, while guaranteeing the highest level of health protection for patients.

The main elements of the Regulation are:

  • A centralised marketing authorisation procedure, to benefit from the pooling of expertise at European level and direct access to the EU market.
  • A new and multidisciplinary expert Committee (Committee for Advanced Therapies), within the European Medicines Agency (EMA), to assess advanced therapy products and follow scientific developments in the field.
  • Technical requirements adapted to the particular characteristics of these products.
  • Special incentives for small and medium-sized enterprises.

This new Regulation also marks the recognition that a number of advanced therapy products actually combine biological materials, such as tissues or cells, and chemical structures such as metal implants or polymer scaffolds. These combination products lie at the border of the traditional pharmaceutical area and other fields (e.g. medical devices). They therefore cannot be regulated as 'conventional' drugs and need adapted requirements. In addition, it should be borne in mind that a significant share of economic operators involved in this field are not large pharmaceutical companies, but rather small and medium-sized enterprises or hospitals.

'-Omics' and Personalised Medicine

New genetic technologies such as pharmacogenomics enable scientists to use patients' genetic information in order to better determine the right drug, at the right dose and at the right time. With the emergence of such technologies, personalised medicine is now on the horizon. This field is already affecting the business strategy of pharmaceutical companies, the industry structure (with the creation of highly innovative and specialised small and medium-sized enterprises), the design of clinical trials and the way medicines are prescribed.

Although it is at the moment too early to tell whether pharmacogenomics and other '-omics' technologies will indeed revolutionise the way medicines are developed and prescribed, it is important that the Commission closely monitor this trend towards personalised treatments and reflect on how it can support its development, by regulatory and non-regulatory means.

ec.europa.eu

New technologies, therapies and medicines are emerging; this includes regenerative medicine, more personalised treatments, as well as the development of nanomedicines. The Commission is committed to monitoring scientific progress and to constantly review Community legislation in the light of new developments so as to make safe, novel treatments available to patients as early as possible.

Advanced therapy medicinal products are new medical products based on genes (gene therapy), cells (cell therapy) and tissues (tissue engineering). These advanced therapies herald revolutionary treatments of a number of diseases or injuries, such as skin in burns victims, Alzheimer's, cancer or muscular dystrophy. They have huge potential for patients and industry.

The lack of an EU-wide regulatory framework in the past led to divergent national approaches which hindered patients' access to products, hampered the growth of this emerging industry and ultimately affected EU competitiveness in a key biotechnology area.

The EU institutions agreed on a Regulation on advanced therapies (Regulation (EC) 1394/2007 , designed to ensure the free movement of advanced therapy products within Europe, to facilitate access to the EU market and to foster the competitiveness of European companies in the field, while guaranteeing the highest level of health protection for patients.

The main elements of the Regulation are:

  • A centralised marketing authorisation procedure, to benefit from the pooling of expertise at European level and direct access to the EU market.
  • A new and multidisciplinary expert Committee (Committee for Advanced Therapies), within the European Medicines Agency (EMA), to assess advanced therapy products and follow scientific developments in the field.
  • Technical requirements adapted to the particular characteristics of these products.
  • Special incentives for small and medium-sized enterprises.

This new Regulation also marks the recognition that a number of advanced therapy products actually combine biological materials, such as tissues or cells, and chemical structures such as metal implants or polymer scaffolds. These combination products lie at the border of the traditional pharmaceutical area and other fields (e.g. medical devices). They therefore cannot be regulated as 'conventional' drugs and need adapted requirements. In addition, it should be borne in mind that a significant share of economic operators involved in this field are not large pharmaceutical companies, but rather small and medium-sized enterprises or hospitals.

'-Omics' and Personalised Medicine

New genetic technologies such as pharmacogenomics enable scientists to use patients' genetic information in order to better determine the right drug, at the right dose and at the right time. With the emergence of such technologies, personalised medicine is now on the horizon. This field is already affecting the business strategy of pharmaceutical companies, the industry structure (with the creation of highly innovative and specialised small and medium-sized enterprises), the design of clinical trials and the way medicines are prescribed.

Although it is at the moment too early to tell whether pharmacogenomics and other '-omics' technologies will indeed revolutionise the way medicines are developed and prescribed, it is important that the Commission closely monitor this trend towards personalised treatments and reflect on how it can support its development, by regulatory and non-regulatory means.

ec.europa.eu

Evolution 201/220 UV-Visible Spectrophotometers

Empower your analysis and bring versatility and productivity to your lab with the new Thermo Scientific Evolution 201 and 220 UV-Vis systems. With next-generation INSIGHT software for on-board and computer control, your instrument is always up to date and ready for the next challenge. Take your routine measurements to the next level with our Customized User Environment (CUE) software which allows you to completely customize both the logical measurement steps and the output environment.

For routine to research analysis, this instrument series offers real innovations that provide enhanced superior usability and performance – without added complexity. With straightforward software, cutting-edge instrumentation and a wide selection of accessories, the Evolution 201 and 220 systems work with you to perform experiments the way you want - for the results you need.

Resources

  • Thermo Scientific Evolution 201 and 220 UV-Visible Spectrophotometers Brochure
  • Thermo Scientific CUE Software

INSIGHT Software – Sophistication Simplified

  • Personalize your home screen for easy navigation and convenience
  • Workbook tools save time and ensure accurate results
  • CUE scripting allows creation of customized interface and simplified workflow

Optimized Engineering Delivers Ultimate Performance

  • Double-beam geometry with 1 nm spectral bandwidth for precision measurements
  • Application Focused Beam Geometry (AFBG) technology enables the best performance from microcells, solid samples, and fiber optic probes
  • Xenon flash lamp requires no warm-up time allowing instant measurements
  • Electronic triggering provides the highest level of accuracy for rapid-mixing kinetics measurements
  • Precision monochromator drive delivers fast scanning data collection and wavelength accuracy

Powerful Convenience at your Fingertips

  • Color, touch screen provides instrument control using built-in computer
  • Integrated keypad allows communication with INSIGHT software
  • Choice of Local or PC configurations provides flexibility and convenience

Accessories for all your Sampling Needs

  • Wide accessory selection with various temperature control options, sample changers, sippers and solid sampling devices complete your analysis
  • Choice of Peltier Single Cell Holder or a Smart 8-Cell Peltier system for temperature control and sample monitoring from 0 to 100 °C
  • Easy software integration gives you complete control of your measurements

Assurance of System Performance

  • The Thermo Scientific UV Validator package provides support for system qualification and validation activities
  • Documentation facilitates compliance of your system with the requirements of FDA, GxP, ISO 9001:2000 and ISPE 2001 guidelines and regulations
  • Mercury Lamp accessory is available to perform instrument calibration
  • Thermo Scientific INSIGHTsecurity software provides complete tools to meet 21 CFR Part 11 requirements
thermoscientific.com
Empower your analysis and bring versatility and productivity to your lab with the new Thermo Scientific Evolution 201 and 220 UV-Vis systems. With next-generation INSIGHT software for on-board and computer control, your instrument is always up to date and ready for the next challenge. Take your routine measurements to the next level with our Customized User Environment (CUE) software which allows you to completely customize both the logical measurement steps and the output environment.

For routine to research analysis, this instrument series offers real innovations that provide enhanced superior usability and performance – without added complexity. With straightforward software, cutting-edge instrumentation and a wide selection of accessories, the Evolution 201 and 220 systems work with you to perform experiments the way you want - for the results you need.

Resources

  • Thermo Scientific Evolution 201 and 220 UV-Visible Spectrophotometers Brochure
  • Thermo Scientific CUE Software

INSIGHT Software – Sophistication Simplified

  • Personalize your home screen for easy navigation and convenience
  • Workbook tools save time and ensure accurate results
  • CUE scripting allows creation of customized interface and simplified workflow

Optimized Engineering Delivers Ultimate Performance

  • Double-beam geometry with 1 nm spectral bandwidth for precision measurements
  • Application Focused Beam Geometry (AFBG) technology enables the best performance from microcells, solid samples, and fiber optic probes
  • Xenon flash lamp requires no warm-up time allowing instant measurements
  • Electronic triggering provides the highest level of accuracy for rapid-mixing kinetics measurements
  • Precision monochromator drive delivers fast scanning data collection and wavelength accuracy

Powerful Convenience at your Fingertips

  • Color, touch screen provides instrument control using built-in computer
  • Integrated keypad allows communication with INSIGHT software
  • Choice of Local or PC configurations provides flexibility and convenience

Accessories for all your Sampling Needs

  • Wide accessory selection with various temperature control options, sample changers, sippers and solid sampling devices complete your analysis
  • Choice of Peltier Single Cell Holder or a Smart 8-Cell Peltier system for temperature control and sample monitoring from 0 to 100 °C
  • Easy software integration gives you complete control of your measurements

Assurance of System Performance

  • The Thermo Scientific UV Validator package provides support for system qualification and validation activities
  • Documentation facilitates compliance of your system with the requirements of FDA, GxP, ISO 9001:2000 and ISPE 2001 guidelines and regulations
  • Mercury Lamp accessory is available to perform instrument calibration
  • Thermo Scientific INSIGHTsecurity software provides complete tools to meet 21 CFR Part 11 requirements
thermoscientific.com

Top trends for healthcare to 2012

As medical technology advances faster than ever, 2012 promises to be a landmark year for patients and caregivers alike. Elly Earls investigates new legislation, issues of sustainability and innovative uses of squeezed budgets to single out five trends likely to have the biggest impact on the healthcare industry in the next 12 months.

Almost every morning the world is greeted with news of a groundbreaking new medical invention, a pioneering piece of pharmaceutical research or an innovative but untested treatment technique.

However, healthcare trends are not solely driven by scientific progress; the industry is equally influenced by bigger issues, from global concerns about sustainability and cost-cutting to regulatory changes designed to protect the world's most vulnerable patients.

The technologies and initiatives set to impact the healthcare industry in 2012 demonstrate the many forces at work across this complex sector.

Out with the old: innovative home care solutions

"Wireless infrastructure is increasingly being used to connect medical devices to patients' electronic medical records (EMRs)."

The population is ageing fast, particularly in Western Europe. In the UK, ten million people are aged 65 and over, a figure that is rapidly rising. With the NHS already spending 70% of its budget on caring for people over the age of 65 (according to research and analysis firm Ovum), it's an issue that clearly needs to be addressed.

By using innovative home care technologies, healthcare commissioners could significantly reduce the frequency of elderly patients' hospital visits, saving a huge amount of money, as the Birmingham East and North NHS Trust, Honeywell HomMed and NHS Direct have discovered.

They implemented the 'OwnHealth' telehealth programme in 2006, which monitors elderly patients' vital signs at home and transmits data back to medical professionals. For 74 patients who have been on the programme for 12 months, the savings were substantial. In the 12 months before the monitors were installed the NHS spent £348,000 on these patients and in the year after the technology was fitted, NHS spending fell to £72,000.

For Mark Ayton, managing director of Honeywell HomMed, this is only the beginning. "The domestic environment is becoming subject to greater technological innovation with wireless technologies being combined to provide an integrated, easy-to-control environment for users in new 'smart homes'," he said.

"With trials already underway, in the not too-distant future, assisted technologies such as telehealth are likely to be integrated to bring greater control and support for patients, carers and family members."

Going green: sustainability initiatives

Sustainability in the healthcare sector extends far beyond 'green' medical devices; energy generation and environmental purchasing in hospitals are two issues that are increasingly coming under the spotlight as we move into 2012.

The UK's renewable heat incentive (RHI), a government initiative formed to revolutionise the way heat is generated and used, will provide an additional incentive to hospitals already considering an investment in alternative resources. From 2012 it will provide a fixed, index-linked income paid to organisations for every unit of heat generated from renewable sources over a 20-year period.

Wood Energy, a biomass boiler supplier that has already supplied the United Lincolnshire Hospitals NHS Trust's Pilgrim Hospital with a heating project expected to save £210,000 a year, has launched a new product called the Green Heat Module, specifically designed for maximising benefits of the RHI.

"The scheme will revolutionise the way buildings are heated," said Neil Turner, business development manager of the on-site division of leading renewable energy developer, the RES Group. "Biomass heating is the preferred choice for NHS buildings."

Meanwhile in the USA, Practice GreenHealth, a non-profit membership organisation providing environmental solutions for the healthcare sector, announced the formation of the 'Greening the Supply Chain Initiative' in August 2011. The programme aims to help hospitals meet emerging demands for more environmentally preferable purchasing (EPP) practices for products within healthcare facilities, GPOs and in the business marketplace.

An injection of change: safety-engineered devices

EU legislation aiming to reduce the occurrence of needlestick injuries and subsequent infections among healthcare workers was ratified in the summer of 2010 and must be transposed into national legislation by all EU members by 2013.

"Almost every morning the world is greeted with news of a groundbreaking new medical invention."

A key part of achieving compliance to this new legislation will involve using safety-engineered medical devices such as needles and intravenous catheters. "It is estimated that one million needlestick injuries occur in the EU each year and studies demonstrate that the adoption of safety-engineered devices radically reduces injury levels," said Johnny Lundgren, VP/GM, North West Europe, Becton Dickinson (BD).

Although adoption of these devices does incur additional costs, Lundgren feels they provide a viable return on investment.

"Needlestick injury costs can be substantial when treatment, lost working time and staff turnover are taken into account," he explained.

BD, which offers products including the Eclipse needle and SafetyGlide needle, is already working with forward-thinking hospitals that have converted to safety-engineered devices and Lundgren expects to see the trend gathering momentum in the next year.

Tailor-made: the growth of personalised medicine

The mapping of the human genome, which was completed in 2003, marked the beginning of a new approach to medicine; it made it possible to envisage disease treatment based on the personal DNA sequence of each patient. Personalised medicine now has the potential to transform the way healthcare is offered, but only if scientific researchers, big pharma and policymakers work together to make it happen.

The UK-based Stratified Medicine Innovation Platform (SMIP) is one initiative bringing together three parties to advance the development of personalised medicine. £7m has just been pumped into the programme to be used across seven new research projects, three of which will be directed by GlaxoSmithKline , with AstraZeneca, Ig Innovations, Janssen UK and Randox Laboratories leading one each.

Four of these new projects aim to develop the use of biomarkers to predict how groups of patients will respond to inflammation and immunology therapies in rheumatoid arthritis, among other conditions.

Across the pond, the US-based Multiple Myeloma Research Foundation (MMRF) recently announced it had entered into a collaboration with Millennium: The Takeda Oncology Company, to advance its personalised medicine programme. The initiative hopes to enable the biological segmentation of patients and accelerate the development of targeted treatments for multiple myeloma.

Second skin: wearable technologies

"BD, which offers products including the Eclipse needle and SafetyGlide needle, is already working with forward-thinking hospitals."

Wireless infrastructure is increasingly being used to connect medical devices to patients' electronic medical records (EMRs).

Although comprehensive medical-grade wireless networks are still far from commonplace, a few pioneering individuals are already taking the technology to the next level with wearable wireless devices.

Toumaz, for example, has recently introduced the Sensium Digital Plaster, an ultra-small, ultra-low power, wireless, body-worn monitor that continuously acquires high-quality vital sign data, including temperature, heart rate and respiration rate.

Researchers at the University of Illinois have gone still further, blurring the boundary between electronics and biology with their wearable 'electronic tattoo'. The device, which is thinner than a human hair, attaches to human skin like a temporary tattoo and can monitor the heart and brain.

According to lead researcher John Rogers, the Lee J. Flory-Founder professor of engineering at the University of Illinois, the team behind the electronic tattoo is now thinking about commercialisation. "Start-up company MC10 hopes to launch a product in sports medicine / monitoring with Reebok in mid-late 2012," he said. "That device will establish a roadmap to true epidermal electronics."

medicaldevice-network.com

As medical technology advances faster than ever, 2012 promises to be a landmark year for patients and caregivers alike. Elly Earls investigates new legislation, issues of sustainability and innovative uses of squeezed budgets to single out five trends likely to have the biggest impact on the healthcare industry in the next 12 months.

Almost every morning the world is greeted with news of a groundbreaking new medical invention, a pioneering piece of pharmaceutical research or an innovative but untested treatment technique.

However, healthcare trends are not solely driven by scientific progress; the industry is equally influenced by bigger issues, from global concerns about sustainability and cost-cutting to regulatory changes designed to protect the world's most vulnerable patients.

The technologies and initiatives set to impact the healthcare industry in 2012 demonstrate the many forces at work across this complex sector.

Out with the old: innovative home care solutions

"Wireless infrastructure is increasingly being used to connect medical devices to patients' electronic medical records (EMRs)."

The population is ageing fast, particularly in Western Europe. In the UK, ten million people are aged 65 and over, a figure that is rapidly rising. With the NHS already spending 70% of its budget on caring for people over the age of 65 (according to research and analysis firm Ovum), it's an issue that clearly needs to be addressed.

By using innovative home care technologies, healthcare commissioners could significantly reduce the frequency of elderly patients' hospital visits, saving a huge amount of money, as the Birmingham East and North NHS Trust, Honeywell HomMed and NHS Direct have discovered.

They implemented the 'OwnHealth' telehealth programme in 2006, which monitors elderly patients' vital signs at home and transmits data back to medical professionals. For 74 patients who have been on the programme for 12 months, the savings were substantial. In the 12 months before the monitors were installed the NHS spent £348,000 on these patients and in the year after the technology was fitted, NHS spending fell to £72,000.

For Mark Ayton, managing director of Honeywell HomMed, this is only the beginning. "The domestic environment is becoming subject to greater technological innovation with wireless technologies being combined to provide an integrated, easy-to-control environment for users in new 'smart homes'," he said.

"With trials already underway, in the not too-distant future, assisted technologies such as telehealth are likely to be integrated to bring greater control and support for patients, carers and family members."

Going green: sustainability initiatives

Sustainability in the healthcare sector extends far beyond 'green' medical devices; energy generation and environmental purchasing in hospitals are two issues that are increasingly coming under the spotlight as we move into 2012.

The UK's renewable heat incentive (RHI), a government initiative formed to revolutionise the way heat is generated and used, will provide an additional incentive to hospitals already considering an investment in alternative resources. From 2012 it will provide a fixed, index-linked income paid to organisations for every unit of heat generated from renewable sources over a 20-year period.

Wood Energy, a biomass boiler supplier that has already supplied the United Lincolnshire Hospitals NHS Trust's Pilgrim Hospital with a heating project expected to save £210,000 a year, has launched a new product called the Green Heat Module, specifically designed for maximising benefits of the RHI.

"The scheme will revolutionise the way buildings are heated," said Neil Turner, business development manager of the on-site division of leading renewable energy developer, the RES Group. "Biomass heating is the preferred choice for NHS buildings."

Meanwhile in the USA, Practice GreenHealth, a non-profit membership organisation providing environmental solutions for the healthcare sector, announced the formation of the 'Greening the Supply Chain Initiative' in August 2011. The programme aims to help hospitals meet emerging demands for more environmentally preferable purchasing (EPP) practices for products within healthcare facilities, GPOs and in the business marketplace.

An injection of change: safety-engineered devices

EU legislation aiming to reduce the occurrence of needlestick injuries and subsequent infections among healthcare workers was ratified in the summer of 2010 and must be transposed into national legislation by all EU members by 2013.

"Almost every morning the world is greeted with news of a groundbreaking new medical invention."

A key part of achieving compliance to this new legislation will involve using safety-engineered medical devices such as needles and intravenous catheters. "It is estimated that one million needlestick injuries occur in the EU each year and studies demonstrate that the adoption of safety-engineered devices radically reduces injury levels," said Johnny Lundgren, VP/GM, North West Europe, Becton Dickinson (BD).

Although adoption of these devices does incur additional costs, Lundgren feels they provide a viable return on investment.

"Needlestick injury costs can be substantial when treatment, lost working time and staff turnover are taken into account," he explained.

BD, which offers products including the Eclipse needle and SafetyGlide needle, is already working with forward-thinking hospitals that have converted to safety-engineered devices and Lundgren expects to see the trend gathering momentum in the next year.

Tailor-made: the growth of personalised medicine

The mapping of the human genome, which was completed in 2003, marked the beginning of a new approach to medicine; it made it possible to envisage disease treatment based on the personal DNA sequence of each patient. Personalised medicine now has the potential to transform the way healthcare is offered, but only if scientific researchers, big pharma and policymakers work together to make it happen.

The UK-based Stratified Medicine Innovation Platform (SMIP) is one initiative bringing together three parties to advance the development of personalised medicine. £7m has just been pumped into the programme to be used across seven new research projects, three of which will be directed by GlaxoSmithKline , with AstraZeneca, Ig Innovations, Janssen UK and Randox Laboratories leading one each.

Four of these new projects aim to develop the use of biomarkers to predict how groups of patients will respond to inflammation and immunology therapies in rheumatoid arthritis, among other conditions.

Across the pond, the US-based Multiple Myeloma Research Foundation (MMRF) recently announced it had entered into a collaboration with Millennium: The Takeda Oncology Company, to advance its personalised medicine programme. The initiative hopes to enable the biological segmentation of patients and accelerate the development of targeted treatments for multiple myeloma.

Second skin: wearable technologies

"BD, which offers products including the Eclipse needle and SafetyGlide needle, is already working with forward-thinking hospitals."

Wireless infrastructure is increasingly being used to connect medical devices to patients' electronic medical records (EMRs).

Although comprehensive medical-grade wireless networks are still far from commonplace, a few pioneering individuals are already taking the technology to the next level with wearable wireless devices.

Toumaz, for example, has recently introduced the Sensium Digital Plaster, an ultra-small, ultra-low power, wireless, body-worn monitor that continuously acquires high-quality vital sign data, including temperature, heart rate and respiration rate.

Researchers at the University of Illinois have gone still further, blurring the boundary between electronics and biology with their wearable 'electronic tattoo'. The device, which is thinner than a human hair, attaches to human skin like a temporary tattoo and can monitor the heart and brain.

According to lead researcher John Rogers, the Lee J. Flory-Founder professor of engineering at the University of Illinois, the team behind the electronic tattoo is now thinking about commercialisation. "Start-up company MC10 hopes to launch a product in sports medicine / monitoring with Reebok in mid-late 2012," he said. "That device will establish a roadmap to true epidermal electronics."

medicaldevice-network.com

 
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