Artificial intelligence beating humans in detecting illness

    According to a recent report in Kurzweil Accelerating Intelligence, Samsung Medison has updated its RS80A ultrasound-imaging machine with a feature called S-Detect for Breast that analyzes breast lesions. The system uses big data collected from breast-exam cases and suggests whether the lesion is benign or malignant.

Source: QMED

     "We saw a high level of conformity from analyzing and detecting lesion in various cases by using the S-Detect," said professor Han Boo Kyung, a radiologist at Samsung Medical Center. "Users can reduce taking unnecessary biopsies and doctors-in-training will likely have more reliable support in accurately detecting malignant and suspicious lesions."

   Researchers at the Regenstrief Institute and Indiana University School of Informatics have also noticed that computers are better than humans in detecting cancer. According to their research, existing algorithms and open-source, machine-learning tools are as good or even better than human when detecting cancer cases using data from free-text pathology reports. The electronic approach was also faster and used fewer resources than people, according to Regenstreif.

    "We think that it’s no longer necessary for humans to spend time reviewing text reports to determine if cancer is present or not," said author Shaun Grannis, MD, interim center director. "We have come to the point in time that technology can handle this. A human's time is better spent helping other humans by providing them with better clinical care."

3D printed realistic brain model assisting complex brain surgery

In the past few years, we have seen 3D printing helping medical procedures and surgeries around the world.  Based on CT scans, printed bones to organs such as hearts have all been made to assist physicians. It can be applied to just about any medical field and Dr. Ivar Mendez, head of surgery at the University of Saskatchewan, proved that by 3D printing a brain replica for a complex deep brain stimulation procedure.

3ders.org

The procedure involves opening the skull and inserting electrodes into toe brain folds and a small error can do permanent damage. So Dr. Mendez always carefully prepares using computer simulations, but this time the technology failed him. The limitations of the software became apparent as it could not predict how the tissue would react. That’ why the Canadian physician contacted the University’s school of engineering and assembled a team of experts: engineers, a radiologist, MRI specialists and neuropsychologists. All with the purpose of translating complex brain MRI data into 3D printable files.

             After about seven months of work, they 3D printed an initial prototype in rubber, but that didn’t accurately display the necessary smaller features. Just now, Mendez and his team completed a larger, more detailed model he can work with. ‘You can actually do the surgery. You can actually put the needle in the brain,’ he said of the surgical model. ‘You can get really lost, because you really don’t know. But when you have the model it lets you see exactly where you want to go,’ he adds. 3D printed in transparent synthetic rubber, this brain replica even matches the consistency of an actual brain.

3D printing helps high-risk surgery in Brazil

China and the west have been constantly showing us how 3D printing makes life-threatening and complex procedures much safer. However, this is happening elsewhere too. A team of surgeons in Blumenau, South of Brazil, has used 3D printed medical models to increase the probability of success of a surgery on a six-year-old girl suffering from orbital hypertelorism.

3ders.org

It was a complex and high-risk operation because the doctors were forced to work in an area close to lots of vital organs and blood vessels. The team therefore decided to develop a 3D printed model of the girl’s skull in order to prepare for the surgery. The replica was also at hand during procedure and definitely contributed to the six-hour surgery’s success. One of the doctors explains. ‘After spending some hours studying the 3D printed skull, we practiced the crucial bone incisions on it and also used it as reference during the actual surgical procedure. Having a model to manipulate, as an addition to the imaging exams, was very important for the success of the final result.’

The surgeons were very satisfied with the 3D printing model and have already ordered the next one for a forthcoming spine reconstruction surgery, which will give the patient a few extra centimeters in height.

“MRI images and CT scans were used to make this medical model, which took 57 hours to 3D print. Finishing work to ensure complete accuracy took another 16 hours, and all the work was outsourced to the Brazilian-based 3D printing service bk3D. According to the company’s managing partner, this is just one of the ways in which 3D printing can be used to improve medical practices. ‘There are numerous possibilities for 3D printing to aid healthcare, from surgical procedure planning to the replacement of entire bioprinted organs. We still have a long way to go, but it is already possible to enjoy the benefits that engineering offers,’ he said.”

As 3D printing is already being used to save lives, we can only hope it will become common in every hospital around the globe.

Human Health Framework in the 21st Century

To understand the global framework of the 7 billion citizens’ health, the Harvard School of Public Health (HSPH) along with other institutions promoted a worldwide project called Global Burden of Disease. Described as “the largest study of its kind and the first such study since 1990”, the project intends to make a list of the main causes of death and disability, and brings together about 500 scientists from 50 nations.

One of the findings shows the decline in children’s mortality rate due to improvements  in infectious disease control with sanitation and vaccines. Another finding is the increase of life expectancy, but, unfortunately, people are spending their  later years in poor health as a result of chronic diseases (cancer, diabetes, etc). The leading causes of death are: Ischemic Heart Diseases, Lower Respiratory Infections, Stroke, Diarrheal Disease, HIV/AIDS.

To check the pdf version of the HSPH infographic, go to: http://www.hsph.harvard.edu/news/files/2013/05/HPHSPRING2013infographic.pdf

References: http://www.mddionline.com/blog/devicetalk/global-burden-disease

Cardiovascular Diseases: a Global Concern

Although the world of the new millennium has seen many improvements in the health sector, the path of healing diseases is far to be overcome. Cardiovascular diseases (CVD) are still huge challenges for the medical society.  More people die annually from this kind of illness than from any other cause and that is the reason why it has been given an especial attention worldwide.

According to the World Health Organization (WTO), an estimated 17.3 million people died from cardiovascular diseases in 2008, representing 30% of global deaths. Coronary heart diseases and stroke are the main causes of these deaths (almost 80%). It is well known worldwide the main factors that increase the probability of getting a stroke: unhealthy diet, physical inactivity, overweight, high blood pressure, tobacco use and harmful use of alcohol.

Besides, low and middle-income countries are the most affected, about 80% of world’s death from CVD. As reported by the WHO, “people in low and middle-income countries are more exposed to risk factors such as tobacco (…). At the same time they often do not have the benefit of prevention programs compared to people in high-income countries.” Meanwhile, at a macro-economic level, it represents a heavy burden on the economies of low and middle-income countries. Non-communicable diseases – including cardiovascular and diabetes – are estimated to reduce GDP by 6,77% in low and middle-income countries facing rapid economic development.

The programs to fight against cardiovascular diseases are highly expensive. Integrated actions at country level, led by governments, are the means to maintain the people away from risk factors and, hence, not allowing it to become a burden on national economies.

There is no difference in Brazil. Around 300 thousands of people die from cardiovascular diseases each year, according to the Brazilian government. Nevertheless, by the public healthcare system (SUS), the government provides many preventive actions programs, diagnosis and free treatments for CVD.

References: http://www.who.int/en/

http://portalsaude.saude.gov.br/portalsaude/

Medical Device Development: step-by-step

The development of medical devices requires rigorous regulatory requirements, careful planning and strategies for commercialization, pursuit for new technology and improvements.  While we see various commercially successful medical devices in the market, no comprehensive development model has been published.

Apart from the company size and the market they share, medical devices companies have a very similar strategy to develop and get their products to market. Scientific researches about medical device project and development process are very good references to the product development strategy of the companies and help them to improve and validated their models.

Stanford University’s researchers have studied the process of how medical technology is brought to market. The model developed by Researchers at the Stanford University Program in Biodesign divides the development in six phases:

“PREDEVELOPMENT, PHASE 0”

The clinical need must me identified and understood by the inventors and devices companies, this phase can be achieved, by direct observations, talking to patients or doctors. A large list of medical needs is made based on market size, clinical impact, and intellectual property.

“PHASE I: INITIATION, OPPORTUNITY AND RISK ANALYSIS”

When the need is identified, a review of all the perspectives is made. Market size, intellectual property, competitive structure, financial resources, regulatory requirements, likewise defining strategies.

“PHASE II: FORMULATION, CONCEPT AND FEASIBILTY”

Concept definition and feasibility take place in this phase, as well as strategies definitions. To accomplish the concept definition, both brainstorming sessions and 3D CAD occur. It is frequent to see the team’s marketing and the team’s R&D meeting with potential users (doctors, nurses, technicians, patients and others) to catch the clients’ attention. In addition, in Phase II we see the team of devices companies defining and analyzing the risks that can happen during the project.

“PHASE III: DESIGN AND DEVELOPMENT, VERIFICATION AND VALIDATION”

In this phase, the team creates a test to verify and validate the concept, although the tests only occur in Phase IV. These tests involve both engineering and quality tests. Many steps of this phase are conducted and reviewed by members of clinical regulatory departments, including FDA (in the USA). Likewise, the production of documentary records.

  

“PHASE IV: FINAL VALIDATION AND PRODUCT LAUNCH PREPARATION”

Final validation, final product design and regulatory approval take place in this part of the process that brings medical devices to market. Final product design must conform to ergonomics standards.  Quality system starts working to define, document and approve the business, which contains both product and administrative perspective.

“PHASE V: PRODUCT LAUNCH AND POST-LAUNCH ASSESSMENT”

Before the launch, doctors will have received training to use the new device. Once it has been approved that the medical device is successful, both launch and distribution will take place. With the new device been used widespread, literature and indications of use are made and approved by FDA (in the USA). R&D has a main role in this phase since the device requires continuing improvements.

         Stanford University Program in Biodesign research was based in more than 80 experts in the private and public sectors, including industry representatives and FDA officials.

         Biokyra follows its own product development process that is generically very similar to Stanford Model. Each country has its own regulatory system so that the product development process should adapt to those particularities.

          To develop a medical device is not an easy task but when it is done following a systematic method or model the process will be efficient, the results will be successfully accomplished and the market will have their needs met.

References: http://medicaldesign.com/mag/model_device_development_0908/

Innovation and medicine: a possible connection?

Life expectancy has risen significantly in the last decades throughout the world and medicine has played a key role in this change. However, the scenario for the healthcare industry has also substantially changed, what includes a more intense participation of emerging countries, the development of new technologies and devices, among others.

A challenge that is being faced by many countries is the limited budget for the healthcare system, and in what concerns to it, innovation can make an important contribution. Innovation, research, and  development of new devices, techniques, drugs, and procedures are fundamental for improving the quality of the healthcare sector while cutting its costs. By doing so, we believe that it is possible to make quality of life available to everyone, everywhere.

It’s clear that this goal is not easy to achieve, but if the many actors involved in the healthcare industry (such as policy makers, healthcare manufacturers, hospitals and healthcare professionals, just to mention some) do their best to accomplish it, the situation can improve significantly.

This blog was created driven by the cause of working towards a better and more efficient healthcare system. With that in mind, we will gather information about innovation and medicine, the healthcare industry in Latin American countries, especially in Brazil, the policies and programs pursued by different governments, and so on. We aim not only to provide information, but also to make people question themselves about how they are related to our cause.

Send your comments and contact us if you have any consideration about the subject. It would be great to hear from you!