The Champion Within

When I lived in the States, I competed in triathlons. My coach had always told us that there is a champion within each one of us and the search was enough to find it. I have never finished first in a triathlon, but I have always enjoyed training and racing. My crowning glory was when I beat my very good friend who introduced me to triathlons. He was an experienced and accomplished triathlete, my benchmark of success and a motivator in my healthy competition. The victory was a small satisfaction that for me was proof enough. I found the champion inside me the day I proved to myself that I could also win, and my coach was the key.

So if it is true, as my old coach Jim says, there is a champion within each of us. Now the question is, have you found your inner champion? If the answer is no, maybe you don’t have the right coach. I was lucky enough to work for one of the best companies in the world, General Electric, and thanks to their brutal, but natural way to create leaders, I always received excellent coaching from my managers. I assure you it was never easy to sit and listen when they would tell me all my shortcomings (that I already knew) and where I should commit more to improve. Perhaps this contributed to my success, and there is definitely a personal component, let’s call it the “Luca” factor, but surely it was my coach, very hard like myself, to help me release my inner champion and thrive in my fertile work environment. My advice is that if you do not have the right coach and are not growing in your current position, this may be a time to search opportunity at another company. Your worst nightmare could be the regret of never reaching your full potential, is it time to change coach and/or company?

 

Luca Leone

CEO Albelissa

The value of a thank you

Thank you as the end of the year has always been a moment of festivities and exchange of greetings, and is also the time of reflection and closure.
This applies to families, associations, institutions and of course to companies, whether large or small.
It is the time to evaluate and understand what has worked and what has worked less, and is also the time to set new goals for the year that awaits.
And looking further, with a keen eye, you’ll find that every goal has been achieved as a team. Alone, one would not have gone far. And those who have contributed to these successes are from the highest ranking in the company to the base of the company hierarchy, and vice versa.
And therefore it becomes natural to express to all, sincere thanks for the dedication of effort, for the trust, for the energy put in every day, and for the hours stolen from sleep and family.
A thank you, because the nature of our team is directly evident in the details and results.
A thank you because with this spirit, one can start again with new enthusiasm towards new challenges that only yesterday seemed impossible, but are not anymore because it’s learned that rowing together in the same direction is the only solution.
A thank you to our customers and partners encountered along the way who have trusted us and continue to grow with us, and that have been and are part of our great history.
Thank you as this year marks 10 years that Albelissa has been in business and we will continue grow and succeed thanks to all of you!
Luca Leone
CEO, Albelissa

Cornaglia S.P.A. and Albelissa S.r.l. to establish an Engineering Tech Center in Hyderabad, India

Cornaglia S.P.A. and Albelissa S.r.l. have signed an international agreement for the establishment of an Engineering Tech Center in Hyderabad, India, from which Albelissa already has an active joint venture offering its customers Information Technology (IT) services and multidisciplinary engineering. Cornaglia also has a longstanding presence in Hyderabad with two joint ventures since 2007. The agreement between Cornaglia and Albelissa will create new synergies which will enable both companies to focus on issues of internationalization in the automotive sector.

With the new Engineering Tech Center in Hyderabad, Cornaglia will be able to support its many Asian clients by creating an extension of their existing R&D center in Brassicarda, Italy, allowing them to operate 16X5 (16 hour coverage, 5 days/week). Albelissa will furnish the Center’s technical manpower of highly specialized personnel in a quick ramp up to serve the ever-increasing demands of Cornaglia’s international customer base.

Cornaglia has served the automotive industry in Turin for over 100 years and has over 1000 employees across EMEA, North and South America, North Europe and Asia. It is a global company strongly rooted in Italy, with 8 sites between HQ, R&D and production plants. Albelissa has been in the business of engineering, IT and Business Process Outsourcing for 10 years and is located in Italy, Romania and India, with a workforce of 450 employees.

Start-up Academy – Medtec UK

Medtech UK, aka the UK’s leading event for medical device manufacturers, will soon take place in London. The event this year will be part of the “Healthcare Technologies”, a business event for companies in all areas of medical and healthcare technology, becoming part of the London Life Science Week. The event’s organizer, UBM EMEA, connects people and creates opportunites for companies across five continents and more than 20 industry sectors to develop new business, meet customers and following the introduction of the new products.

http://www.emdt.co.uk/daily-buzz/uk-start-academy-here-are-finalists

A major trend for 2015 in the medical field is the rise of many start-ups in the medical field. To encourage this trend and the many young entrepreneurs, UBM has launched the Start-Up Academy, a contest whose aim is to find the most innovative medtech start-ups in Europe.

Next Generation TAVR

Source: University College London

Among the finalists we find some really revolutionary ideas, such as the one developed by some researchers from University College London who have devised a new a transcatheter heart valve that might overcome limitations of current TAVI/TAVR devices.
This devices in fact allows surgical cardiac valve replacement by delivering a substitute valve into the anatomical site through the vascular system, avoiding open heart surgery and associated risks such as cardiac arrest. Since this procedure is less invasive, it can be performed on weaker or ill patients as well. However, clinical experience with first generation TAVI/TAVR devices has indicated that this approach still requires substantial design improvements to overcome problems such as the inability to extract or reposition misplaced valves or the common recurrence of paravalvular leakage.

Thanks to recent developments in transcatheter aortic valve implantation and replacement (TAVI or TAVR), it is now possible to deliver a valve substitute into the anatomical site through the vascular system, avoiding the need of open heart surgery and its associated risks, such as cardiac arrest. This allowed surgical valve replacement for patients who were before considered as too ill or weak to withstand the stress of invasive treatments.

However, clinical experience with first generation TAVI/TAVR devices has indicated that this approach still requires substantial design improvements. Common complications were the inability to extract or reposition misplaced valves, common recurrence of paravalvular leakage, and high incidence of atrio-ventricular blocks deriving from the excessive anchoring forces, according to Gaetano Burriesci, reader in biomedical engineering at University College London.

The new transcatheter heart valve, consisting of three polymeric flexible leaflets supported and secured through a self-expanding frame, is named TRISKELE and it should be able to mitigate this limitations. A member of the research team, named Gaetano Burriesci, says that “the valve is designed to be retrievable and repositionable, ensuring enhanced anchoring and sealing, without applying excessive pressure on the annulus”.

Another start- up is the London-based Cupris, which has developed a solution that enables the remote diagnosis of Ear Nose and Throat (ENT) conditions without the patient seeing the doctor in person.

Cupris developed a system that consists of a low-cost medical device to clip up on a smartphone and an app. The patent-pending smartphone-connected otoscope can capture clinical images of the ear. Patient information can be entered into the app, combined with the captured images and securely sent to the cloud where it can be shared between clinicians. This data provides specialists with enough information to make a diagnosis or provide advice on further treatment, according to the company.

This simple device could help in reducing medical expenses as well: in fact, the British NHS spends £250m every year on 3 million outpatient ENT consultations, £70m of which could be avoided by reducing unnecessary referrals to ENT specialists.

The company, founded by the consultant and NHS surgeon Julian Hamann and the designer Paul Thomas, was initially funded by an angel investor, the InnovationRCA business incubator, and InnovateU and it is currently raising a larger seed funding round to finance production tooling, trials and generating initial sales. “Getting the NHS to adopt an innovative technology that changes the patient pathway, understanding and effectively targeting the correct people who make buying decisions, and in India, finding a trusted partner that has in-depth knowledge of the local market,” Pallett describes the major challenges the company faces currently.

To see the other finalist to the Start-Up Academy, visit http://www.emdt.co.uk/daily-buzz/uk-start-academy-here-are-finalists

French start-up developes a fibre optic tumor detecting device without Markers

Source: Nodea Medical

 

Nodea Medical, a new startup located in Villejuif Biopark Cancer Campus, Paris, has developed a new technology to detect a breast tumor by measuring the natural fluorescence of tumor tissue. The new medical device helps to diagnose the suspect nodule by measuring the natural fluorescence of tumor tissue.
This new method could help reducing the number of unnecessary biopsies, which are painful and intrusive, and be a new way of monitoring tumor cells and benign lesions, explains Florian Chatellier, engineering graduate of ParisTech Optics Institute and Nodea Medical’s CEO and co-founder.

logo nodea medicalNodea Medical is the result of the collaboration between by René Farcy, the other cofounder of Nodea Medical and researcher professor at Paris-Sud University, with Gustave Roussy, one of the first center for fighting against cancer. The medical instrumentation research he led brought to the creation of Probea, a medical device consisting of a fine needle containing optical fiber, polished to a 15° angleto improve needle tissue penetration. The fluorescent blue light, due to endogenous fluorophores whose expression is modified in cancerous tissues, is emitted by a laser diode; it goes through the fiber needle and excites cells in penetrated tissues. The emission of fluorescence by excited cells is caught by the same optical fiber and immediately processed by the system.

Chatellier says that since the device does not need markers such as as fluorophores to be injected, it presents no toxicological risk to patients. The diagnose provided by Probea is immediate, giving additional information wether the nature of the nodules. The technology has gained excellent preclinical result on surgical specimens and will be validated by a clinical trial on 350 patients in many French hospitals. The contribute of this technology could really be significant: every year in France 49000 new cases are detected and 11000 people die of breast cancer.

 

 

Source: 
http://www.emdt.co.uk/daily-buzz/fibre-optic-needle-detects-cancerous-tissue-without-markers?cid=nl.emdt03.20150120

10 Dos and Don’ts for Developing Medical Devices

Whether it involves focusing on ways to reduce heathcare waste or trying to make your product “invisible”, Qmed has come across plenty of helpful tips for medtech industry experts.

Do: understand the Way the Equipment Is Intended to Be Used

Understanding the way in which users or clinicians interactions can be made simple and efficient while also encouraging correct data entry.

Do: Try to reduce healthcare waste with technology

Fact: about one third of all health care spending in the United States is waste. This is an incredible number which technology can help to reduce in the development of a medical device. Device developers can rely on technologies like Big Data in order to create device in a more scientific, evidence based way, getting past tradition.

Do: Learn from Consumer Technologies

Many technologies that apparently are totally disconnected with the medical environment could in fact be used as a starting point for developing health care devices. Let’s think of flight simulator technology, which is used to reboot surgery, for instance. Also, being surgery basically a “navigation problem”, as Alan Greene, MD, chief medical officer of Scanadu, says, technologies like Google Maps can in fact be the future of medical healthcare devices. ).

As Greene explains, technology has thoroughly changed the experience of navigation. Google Maps strength is the contextualization of information: with a smartphone we can instantly calculate how much a Uber ride will cost or have live traffic information. Meanwhile, much of medical practice is stuck at the MapQuest stage, Greene said, where patients are given context-less paper printouts of lab results.

Do: Research When it Comes to Materials

The amount of materials traditionally used in the medical device sector is fairly limited, and this trend has to stop. As Michael Drues, PhD, says, developers must try to find materials which are more customized and not just biocompatible, but at the same time keeping the price affordable. “More custom blends can also have an impact on availability, which could depend on how much of that grade the raw material supplier sells,” says Phil Katen, the president of injection molding firm Plastikos (Erie, PA).

Do: Take Advantage of the Technology Out There

A great example of this is Ativa Medical, a St. Paul, MN based company, has just developed a new product called Scotch Tape, which consists of a business card-size test cards for blood samples. Researchers figured out how to laser-etch micro channels on sheets of 3M co adhesive polymer, or more commonly tape, allowing for a single drop of blood to flow through the channels on a test card as the company’s clock radio-sized MicroLAB device performs a variety of tests, including not only electrochemistry but also flow cytometry, imaging, and colorimetric analysis. The result is a complete blood count and a host of other tests that could be conducted within 5 minutes at a doctor’s office, or any other place a blood test is being done, versus being shipped off to a central laboratory.

Do: aim to Make Your Products ‘Invisible’

The most useful technologies are those that can be integrated into our everyday living in such a good way yhat we are not even aware of them anymore. Smartphone are a perfect example of this: we always bring it with us but we kind of forget it’s there when we are not using it. The BAM Labs sensor, which goes under a mattress and monitors whether someone is in the bed, sleep pattern, heart rate, and breathing rate (all with minimal human intervention) is a good example of this, as consultant Mark DiPerri says.

Do: Seek Out Inspired Patients and Innovators to Collaborate With

Inspired patients and their loved ones can come up with some pretty innovative ideas for medical technology for two reasons: they have considerable insights and they are uniquely driven to relieve suffering. Engeneer John Costik, for example, has developed a cluod-based glucose monitoring system to keep his young son under control; despite challenging involved in such project, they are more and more frequent.

Do Not: underestimate hackers

Even if medical device companies are not in the hacker’s radar, it is always better not to let the guard down. Reuters in a private notice from FBI in 2014 said that even if the industry is quite hacker-risk free compared to financial and retail sectors, a ciber intrusion may still be likely and  there has already been an infiltration in Medtronic company’s computers, and that two other medical device companies faced similar incidents.

Do Not: Think Humans Always Have a Better Solution Than Mother Nature

From geckos to silk, scientists continue to draw inspiration from Mother Nature. In the medical device field, recent examples of this trend include a squid-inspired injection system and a bioadhesive inspired by barnacles. Simply put: you can’t go wrong in studying the intricacies of biology—especially when it relates to the human organism.

Do Not: Ignore the Expertise of Your Contract Manufacturers

Take full advantage of the expertise offered by contract manufacturers: try to involve them early and often, from design process up to final production.

Do not: confuse Customer with Target User

In the consumer sector the final users are the potential customer; however in the medical device sector this is often not true. Ad Andy Schaudt, director of usability services at MedStar’s National Center for Human Factors in Healthcare , explains, the person buying the end product is often different from the user. In addition, much of the design feedback given to medical device engineers comes from the company’s own sales and marketing, which, of course, is also not the user demographic you ultimately want to target. Also, there might be many target users, like nurses, who might use the device: the product is often used by a team of people and this must be taken into account.

Do not: Assume That You (or Your Client) Are the Expert

Always involve key stakeholders in your development, whether it be manufacturers, distributors, nurses, clinicians, and especially the patient, says Adam Bilney, manager, medical division at Outerspace Design. “Understanding their needs and involving them in the design process will lead to a much more successful product.”

Do not; Let Your Company’s Culture Shackle You

Ask not what your company’s culture can do for you, ask what you can do for your company’s culture”. Even companies that have a history of embracing quality principles can lose ground. After establishing itself as a manufacturing leader, which helped formulate lean principles, Toyota let its high standards slide in recent years and to this day is dealing with the the ramifications of quality issues from nearly a decade ago. So don’t let “because that’s the way it is” hold you back. If you’re in a company that gives you blowback for that type of attitude, then maybe it’s time to find a better employer – or even try to start a company on your own.

http://www.qmed.com/mpmn/gallery/dos-and-donts-developing-medical-devices

Why X-ray Screening Might Never Be the Same Again

X-rays were discovered in 1895 by Wilhelm Röntgen: electrons generated in a cathode and accelerated to high energies collide with a fixed anode and thereby release X-rays that can penetrate body tissue and make bone structures visible.
Still today over 90% of all medical imaging examinations worldwide relies on X-rays, since technology hasn’t changed during the last 120 years. However, X-rays have some disadvantages: their formation needs a lot of energy, they can damage tissue and, when used in examinations of cardiovascular diseases, need contrast agents to make blood vessels visible which can cause allergic reactions in 1 case every ten patients.
Siemens is trying to develop a new technology to overcome all this problems. The new ring-shaped “cold cathode” of nanostructured carbon cathode will have some really interesting features: it will no longer be 2,000-degree Celsius filaments to emit electrons but instead it will operate at high voltage and room temperature and the new X-ray tube will require less than half the electricity and cooling of conventional systems.ytng
Also, the focus of the new X-ray beam is 400 times smaller than in today’s systems. “At the focal point, this X-ray radiation is four billion times brighter than the sun on the surface of the earth,” says Oliver Heid, head of the Global Technology Field of Healthcare Technology and Concepts at Siemens Corporate Technology. This higher resolution is key to operate phase-contrast X-ray imaging, a new imaging technique which can show the effect the penetration has on the wave phase.
Thanks to the new LiMA technology, developed by Siemens researchers, the electrons no longer collide with a fixed target of tungsten, but with a liquid metal jet as thin as a human hair, consisting of 95 percent lithium and 5 percent heavy elements such as bismuth or lanthanum. The latter elements produce short wavelength X-rays while lithium is the coolant. Siemens researchers also plan to feed back the electrons leaving the liquid-metal-jet anode into the energy cycle.
The new technology could be very helpful for minimally invasive surgery too since it will allow catheters navigation using magnetic fields. “If everything goes well with our next-generation X-ray system”, says Heinrich Kolem, CEO for Angiography and Interventional X-Ray Systems at Siemens Healthcare, “it will be another revolution in medical diagnostics.”

 

 

Why X-ray Screening Might Never Be the Same Again
Posted in Medical Imaging by Thomas Klein on February 25, 2015

The Uberization of Healthcare

Medical device developers should take notice of a huge trend that could drastically change the medical sector. The continuous rise of startups, focused on designing health products for patients and their caregivers and not for clinicians only, is shifting the healthcare model from hospital-centric to patient-centric.
More and more companies are trying to disrupt this existing healthcare model by bringing solutions which are more efficient and, most of all, most user friendly: just as Uber changed transportation in positive and sometimes controversial ways, the healthcare system will undergo a similar process.
Like modern healthcare systems, the taxicab model was inefficient, not mobile, and often unpleasant for the consumer. The old model was built around the needs of taxi drivers and their companies, and not on the consumer. Uber instead, taking advantage of the mobile technology, has developed a mobile platform which allows the consumer to get the nearest cab around, rate the driver and paying him cashless via credit card. This efficiency has been appreciated by more than 8 million users, despite regulatory pushback has verified in many countries.

ImmagineHealthcare hasn’t yet seen its version of Uber. But the signs are there: within the next decade, Uber-like medical companies will emerge.
But is the socioeconomic and cultural environment ready for a change in this direction in this sector? It seems likely. The population is aging, chronic conditions that require management during patients’ daily lives are on the rise and we are seeing widespread connectivity emerge across all economic classes. Portio Research estimates some 6.9 billion cell phones are currently in use worldwide. That’s up from 2 billion in 2005, according to Wireless Intelligence.
Transformation in the man-machine relationship are also occurring: internet of things and smart objects are regular these days and body implantation of devices seems not so far from reality. Also, patients these days wants to be informed. They want to make their own diagnosis, to research their doctors, they want their own health data and caregivers want to be part of the loop. In 2009, about 42.1 million family caregivers in the United States provided care to an adult with limitations in daily activities at any given point in time. The estimated economic value of their unpaid contributions was approximately $450 billion. Caregivers want to use connectivity tools to keep track of loved ones.
It all starts now. Healthcare must shift its focus toward the patient. Successful medical products will put the patient’s needs first and foremost. Just as Uber has demonstrated with putting the passenger first, ignoring the patient will be fatal for health solutions companies: they will be the new taxi drivers, baffled by how the world has passed them by.

Posted in Design Services by Qmed Staff on February 12, 2015
The Uber business model will soon come to healthcare. Medical device developers should take notice.
Stuart Karten

Using Apple Tech to Improve Diabetes Tech

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The Apple Watch showing a heartbeat. (Image courtesy of Apple)

Good news for type 1 diabetes patients and their families: Dexcom will launch an app this April which will display readings on Apple’s smartwatch. According to a report appeared in the Wall Street Journal, the readings from the wearable glucose monitor will be as an easy-to-read graph on the Apple Watch, and the Californian Company has announced in November that it is making tools available to developers to design apps for the watch.
This is a great device particularly for parents with diabetes affected children, since one of the biggest problems is in facts monitoring their glucose levels particularly overnight. This personal experience had already brought in 2013 a group of frustrated software engineers, identified by the name NightScout and using the hashtag #wearenotwaiting, to develop an online glucose monitoring system. Then they challenged the slow pace of diabetes technology innovation and approval, while highlighting the growing role of continuous health monitoring by medtech companies and software developers, the Journal report said.
The Apple Watch includes four rings built into its backside, which are not at all just styling elements, but are sensors that the Apple Watch uses to measure its wearer’s pulse. The sensors include infrared and visible-light LEDS in addition to photosensors, which all work together to detect heart rate. Using that information, Apple says that it can begin to put together a comprehensive look at a person’s daily activity. In addition to the four rear heart-rate sensors, the Apple Watch will also include an accelerometer, which will likely be used for tracking movement and eventually help the user to achieve its fitness goals thanks to the suit of health features built in as well, giving wearer’s fitness goals and telling them how many calories they’ve burned.
Dexcom is benefiting from FDA’s recent loosening of regulation over software. While the agency still considers glucose monitors (including the recently approved G4 PLATINUM Continuous Glucose Monitoring System) Class III devices, it now requires medtech companies to register apps for mobile devices rather than seeking PMAs.
In the diabetes world, Dexcom intends to introduce a “stead stream” of sensor-related products but competition is high: Johnson & Johnson, Abbott Laboratories, and Medtronic are all productors of continuous glucose monitors.

 

 

Posted in Mobile Health by Nancy Crotti on February 10, 2015
http://www.qmed.com/news/using-apple-tech-improve-diabetes-tech

Google Is Redefining Healthcare, Literally

Some people believe Google is trying to redefine healthcare. In more than one aspect, they would be right.

media-partnership-helps-heal-health-case-firms-conversions_case-studies_lg

Google is up to some changings in its healthcare strategy. First, on Tuesday 17th of February Google will update the definitions of the 400 most frequently sought health-related terms on its search engine, including details about each entry such as the frequency rate of the disease and how it’s treated. Some definitions will come with an attached illustration or drawing, like an old-fashioned dictionary. Rabies, for example, will be represented by a raccoon next to a human arm with a biting mark and the comment “very rare”, according to a statement by Google.
This achievement has been made in collaboration with the help of the Mayo Clinic (Rochester, MN), whose choice has fallen upon Google’s technology for providing quick, reliable, useful information, as stated by dr. Phil Hagen, medical director for healthy living.
This will be a huge innovation, since one every 20 words searched in Google are health related, as Google product manager Prem Ramaswami wrote in a blog post this week. The aim of this innovation is to help people to find the basic information they need of what the disease is on Google and to make it easier for the user to search for more information and to know what to ask the doctor. However, both Google and Mayo were careful to say that the new Google definitions should not be considered medical advice.
The definitions will be available in English only, but Google is planning to extend the program to other languages.
This is another step in Google’s strategy to become a healthcare company: the group in the past six months has acquired technology for Parkinson’s patients and has started some projects involving disease detecting nanoparticles. The firm also has a division known as Calico, which as Bill Gates recently put it, is trying to help rich people live forever.

 

 

 

Posted in Mobile Health by Nancy Crotti on February 12, 2015
http://www.qmed.com/news/google-redefining-healthcare-literally