Digital Health Unit to be Created by the FDA

The Food and Drug Administration (FDA) has recently announced that they will be allocated funds and resources to a new centralized unit focusing on mostly on regulating medical devices. This unit will be a branch within the Center for Devices and Radiological Health.

The goal of this unit, in conjunction with its larger department, is to basically maintain a certain level of consistency when it comes to applying effective health policies. The functions of this digital health unit range has two main areas which are outlined below:

  • Creating software and developing assistance programs for software as medical devices or other digital health technologies before they reach the public.
  • Integrating useful metrics to track, evaluate and report pre-market health submissions.

In order to diversify the efficiency throughout this new centralized digital health unit, the FDA has confirmed that the agency will be hiring experts from the private sector instead of bringing in talent internally.

“The world of digital health has a lot of expertise that we need to supplement our organization with,” Bakul Patel, associate director of digital health in the FDA’s CDRH states. “If we had to do it all internally, then it would defeat the purpose.”

However, it will be quite difficult to hire professionals with particular expertise in complex areas such as artificial intelligence, cloud computing and cybersecurity. While the salaries for these types of positions are quite high, Patel is hesitant with regard to hiring fresh, young talent right of college.

In other words, retention an area of concern within the FDA recruitment process He is aware that this type of position at the FDA is an experience booster, making these young professionals even more marketable, leading them to leave within a few years for another opportunity.  

In this competitive market, it is possible that the above factors will make it hard for even new centralized health units to retain talent when there are a wide spectrum of incoming opportunities in the private and public sectors.

New Blood Test Could Prevent Lung Cancer Relapse

doctorWith blood tests becoming more common to detect breast cancer, it is no surprise that this type of test also has the potential of detecting the return of lung cancer after the disease has been removed from the body. Recently, researchers have reported that there is a good chance that unstable chromosomes increase the overall risk that the lung cancer will return.

This information was used by researchers at the New England Journal of Medicine and Nature to predict when the lung cancer would spread before signs were apparent in the patient.

A study conducted by the Cancer Research UK-funded TRACERx tracked the medical experiences of around one hundred patients through their diagnosis, lengthy surgeries and the post-surgery phase. The researchers paid close attention to the post-surgery phase as this could lead to either full recovery or a possible relapse with the return of cancer.

One highly important discovery from this study showed that patients with a high number of unstable chromosomes in their system had a 4x more chance of relapsing. Patients with a high number of unstable chromosomes unfortunately also had a stronger chance of dying within two years.

It is also important to note that genetically diverse tumors could become increasingly resistant to treatment in patients.

Mariam Jamal-Hanjani, the study’s lead author sheds light on why this study specifically is really important when it comes to guiding patients towards the end goal of beating lung cancer.” Jamal-Hanjani states that “Determining the relationship between diversity within tumors and patient survival is one of the primary goals of TRACERx, so to find evidence for this so early on in the study is really encouraging.

“We’ve also identified what causes lung cancer to advance, providing us with insight into the biological processes that shape the evolution of the disease,” Jamal-Hanjani also stated.


How the Digital World Is Constantly Transforming Health Care

There is no question that the merging of health care and technology continues to shape what it means to be a patient in this market. With national health expenditures, accounting for more around 18% of the country’s GDP in 2015, new healthcare focused technology can alleviate some of the fiscal burden of chronic diseases.

The rise of telemedicine
Along with offering everyone additional accessibility, telemedicine saves time/money while also providing healthcare to patients in remote areas that may or may not have a healthcare facility close by.

Basically, patients can now speak with a therapist, physician or any other medical professional on their smartphone to update prescriptions or ask a question about their latest visit. Since telemedicine lacks facetime, access to emotional therapy is through a smartphone is more cost-efficient than meeting with a healthcare professional in person.

Cloud Access
Cloud technology has also changed the way in which we interact with the health care system and more importantly, how patient specific medical records are stored. In the past few years, doctors have used their smartphones for day to day functions such as retrieving drug info, and patients are able to access test results with minimal wait time. As a result of this, there has been a new shift in focusing on data related protection when it comes to patients’ private medical records.

For many, the days of heading to your local grocery store and taking your blood pressure are long gone. Devices can perform DIY blood tests, or serve as a thermometer, which help patients regulate their day to day health without leaving their homes.

With some tools that have automation, individuals can measure their weight, pulse etc. and enter this information into their smartphones and transmit to medical professionals in minutes. If these details are submitted on a regular basis, this in turn can help predict one’s risk for heart disease and other illnesses that previously have not been so easily monitored and shared between both parties.


Recent Study Shows Nasal Swab Could Potentially Diagnose Lung Cancer

With regard to some patients who have a low risk of lung cancer during its early stages, a recent study shows that researchers have uncovered a less invasive and more cost-efficient way to screen at risk patients. Furthermore, this research suggests that a nasal swab could accurately detect lung cancer.

According to some findings published in the Journal of the National Cancer Institute, a research team from Boston University School of Medicine (BUSM) may have found a new way to discern whether lung lesions are malignant.

The key component is DNA-based “biomarkers” in the nasal passages which actually indicate whether a lung lesion is cancerous or not.

Marc Lenburg, co-author of the study states that “Nasal gene expression [production] contains information about the presence of cancer.” He believes the nasal swab “might aid in lung cancer detection.”

Moreover, the new study involved patients who were both current and former smokers across 28 different medical centers in North America and Europe. Through the nasal swab test, the Boston research team identified a distinct pattern of 30 genes that showed different activity from patients who have lung cancer from those who don’t.

One important outcome of this test was the ability to see cancer-associated gene expressions that were altered similarly through the two airway sites. This allowed to come to the conclusion that the brushings could be a biomarker or a scientific indicator of lung cancer.

After carefully evaluating 550 nasal samples, the research team concluded that they could actually detect lung cancer-associated genetic changes in both nose and lung cell samples. This in turn could help predict or detect if the patient had lung cancer.

While the nasal swab needs to undergo additional testing, there is no doubt that the nasal test has the potential of becoming a mass testing tool for patients across the country and even globally.

3 Digital Healthcare Trends That We Can Expect To See More Of In 2017

Last year, we saw a lot of disruption of the healthcare industry that improved the patient experience for the better. In 2017, we can expect a continuation of this as the industry shifts to a more value-based model. Many of the new technological advances used in hospitals have brought on a greater emphasis on preventative medicine, reduced costs and patient-centered and patient-powered care. Other aspects that have been making an impact are telemedicine, wearable remote monitoring and Electronic Health Records. Here are a few changes that we can expect to see in 2017:


1) Clinical Trials

Medical devices can be used to monitor the patients who are participants in clinical trials for new drugs and other therapies. Pharmaceutical companies rarely have the ability to monitor trial participants on a 24-hour basis. If electronic data can be sent via devices around the clock, researchers will be able to come to conclusions much sooner. According to a 2016 survey by digital device enterprise Validic, devices are being used more and more for clinical trial data collection. When data is generated by patients and streamed directly to clinical trial managers in real time, the information is much more accurate than it would be if patients visited periodically and relied on memories.


2) Digital Monitoring

Wearables are able to monitor aspects of a patient’s health like blood pressure, blood sugar levels, weight, mediation and levels of activity. When a patient uses any kind of wearable, whether it is a small device or a patch, a steady stream of data can be sent to healthcare providers and used to evaluate a patient. Recent research shows that in 2015, the medical device industry market totalled approximately $5.1 billion, and it will probably triple by 2020 and more healthcare providers will begin to take the concept on board.


3) Consumer Use of Digital Health

Consumers are gaining awareness of the need to monitor their own health to prevent future health conditions. Digital technology is being used in a much more abundant way than it was before. In 2016, a venture that invests in health-related startups called Rock Health released its annual survey about summer trends in healthcare. The survey found that 56 percent of respondents were utilizing at least three types of digital health, a huge increase from 19 percent in 2015.

Only 20 percent of respondents said they did not use any digital health technology. Of the respondents, 10 percent of them were considered avid users of digital health technologies such as telemedicine, wearables, electronic access to medical records and more. Unsurprisingly, millennials dominate the digital health market. In a constantly changing world, technology is truly altering the healthcare market for the better. Advances in digital healthcare changing the world, and we can expect this to continue in 2017.

Stanford Is Changing The Digital Health Sphere With Launch Of New Digital Health Center

stanfordOn January 17, 2017, the Stanford University School of Medicine announced the launch of the Center for Digital Health, which is dedicated to supporting collaborations between Stanford’s faculty and tech companies in Silicon Valley. These collaborations will have the potential to result in the development, testing and implementation of new digital health tools. The Center for Digital Health works to advance the field of digital health by conducting clinical research, promoting partnership and spreading education to the next generation.

Stanford has been working to improve patient care through precision health, and Lloyd Minor, MD, dean of the School of Medicine, feels that the Center for Digital Health will be able to further this mission. Because Stanford Medicine’s faculty are equipped with biomedical expertise and are located in Silicon Valley, Stanford Medicine has immense potential to become a leader in digital health. The Center for Digital Health uses the most advanced digital tools and technologies to tailor care to individual patients. For this reason, Minor states, the choice to open the Center aligns with the mission of the biomedical revolution in precision health at Stanford.

According to Sumbul Desai, MD, clinical associate professor of medicine and executive director of the center, the idea for the center came from the need to provide guidance and support to faculty who were being contacted by tech companies and startups with offers to collaborate. Stanford’s faculty wanted to give the faculty more opportunities by providing the resources and infrastructure necessary for these relationships to develop. The center will be able to help connect faculty with people in the tech industry, and vice versa.

There are currently a lot of digital health startups in existence. It’s important that doctors, hospitals, patients, insurers, investors and regulators are aware of which solutions will work. Mintu Turakhia, MD, assistant professor of cardiovascular medicine and senior director of research and innovation at the center, stated that high-quality evidence is necessary for making informed decisions.

He leads efforts to advance research in digital health. This can involve anything from implementation studies to technology assessments to multicenter trials. Turakhia is also the principal investigator for five trials in the field of digital health. Of these trials, the largest one is a randomized trial to test whether digital interventions combined with health coaches improve adherence to medication in people with atrial fibrillation. The trial involves 400 patients at 25 sites. This is an important trial since atrial fibrillation affects 4 million U.S. adults.

Turakhia says that even after evidence has been found, there are a number of questions that need to be answered. The faculty members need to figure out the best way to make new digital tools a part of health care. They need to determine if the new advances will actually make patient care better and whether they are worth the costs.

Lauren Cheung, MD, BMA, clinical assistant professor of medicine and senior director of strategy and operations for the center stated that there is not much evidence that can determine how to incorporate digital tools into practice. This is where Stanford’s faculty members come in. With their experience they can help design and implement digital health tools.

Training will be provided to physician in digital health medicine through the center’s fellowships, conferences, internship opportunities and traditional classroom material. Educational programs will also be offered to industry members.

It is clear that the center has the power to truly change the way medicine and tech collide. With the launching of this new center, Stanford will be able to make strides in digital health, which will have a large positive impact on patient care.

RoundTable Healthcare Partners Invest In Revision-Goodier

Earlier last month, operating-oriented private equity firm Roundtable Healthcare Partners announced some pretty big news. The firm, which focuses exclusively on the healthcare industry, has made a majority investment in Revision Skincare LLC  and Goodier Cosmetics LLC. Revision works to market physician direct dispensed products that are sold exclusively through specialists such as dermatologists and plastic surgeons. Goodier develops and manufactures niche topical personal care products, as well as over-the-counter pharmaceutical products for Revision and other third parties.

The owners and founders of Revision-Goodier, John and Rob Muller, will continue to serve in their respective current roles as CEO and COO, in addition to continuing their roles as members of the Board. They will also keep a significant ownership stake in the company.

RoundTable’s Senior Operating Partner, Pierre Fréchette, states that RoundTable is excited to partner with John and Rob Mullers. He went on to say that the Mullers have created a large presence in the physical direct dispense market and have worked hard to serve skincare professionals. Fréchette stated that RoundTable looks forward to using internal product development and product acquisitions to expand Revision’s product portfolio. He hopes this can be achieved for both over-the-counter skin care and products sold exclusively via the professional channel.

David Koo, Senior Partner at RoundTable, stated that Revision-Goodier is RoundTable’s third platform investment in the dermatology market within the past five years. RoundTable is familiar with the organizations that manufacture and develop topical products. This knowledge base will allow RoundTable to play a key role in facilitating the growth of Goodier and its clients.

John Muller stated that RoundTable is the ideal partner company for Revision-Goodier. He feels that this partnership will help Revision-Goodier continue its growth trajectory due to RoundTable’s extensive expereince in the pharmaceutical marketplace of dermatology.

Rob Muller is very thankful to Revision-Goodier’s employees for assisting in the development of a strategically valuable platform company. He shares John Muller’s sentiments of excitement about the partnership with RoundTable.

RoundTable chooses to partner with healthcare companies that fall within the experience and expertise of the firm’s principals of operation and transaction. RoundTable has made two investments from its $650 million Fund IV before investing in Revision-Goodier. In order to finance further growth opportunities for Revision-Goodier, RoundTable aided the completion of new senior credit facilities.

This partnership will be exciting for everyone involved. Revision-Goodier is a top notch skin care company, and the partnership it has made with RoundTable can only increase its success.

Online Pancreatic Cancer Community Keeps Patients In The Loop

In recent years, healthcare and social media have combined. This merging of industries has had a number of positive effects, but one of the best effects is that there are more and more patient-centered online communities. These groups help patients who are struggling with various diseases, common and rare, to connect with one another across the globe. Furthermore, they also make the patients and their family caregivers feel less confused and alone.

One of the many online communities like this is called Let’s Win. But Let’s Win isn’t just like any other patient-centered community. The group focuses on providing “science-driven” treatments for patients with pancreatic cancer. These treatments go beyond the standard level of care.

The community includes research scientists and oncologists. These professionals share information on drug development, clinical trials, and medical breakthroughs in order to give patients a more thorough understanding of what is available. It is quite possible that a group like this could lead pharma and biotech companies to make clinical trial recruitment better.

Let’s Win has a Scientific Advisory Board that ensures that the information shared in the community is scientifically based and that it offers a possible option outside of the existing standard of care treatments. The board vets crowdsourced pancreatic cancer treatments.

Anne Glauber, one of Let’s Win’s cofounders, was diagnosed with Stage 4 pancreatic cancer and was told that she had one year to live. She visited specialist oncologist and took an unconventional approach to her treatment. She founded Let’s Win because she wants other cancer patients to have these kinds of options.

Glauber started the online community alongside Dr. Allyson Ocean, one of the specialist oncologists who treated her. These two joined Willa Shalit, Kerri Kaplan and Cindy Prace Gavin to create Let’s Win.

On its website, Let’s Win provides links and summaries of new development, clinical trials, clinical research, and the use of FDA-approved drugs in different dosages. The website is written in a user-friendly way that can be understood if by someone without a medical degree. Glauber wants to keep patients in the know about compassionate use policies. She feels that most patients don’t get all of the information and they aren’t aware of all of the options available to them.

A large number of the pancreatic cancer patients are based in small towns. They are often treated by oncology generalists who do not have the specialty knowledge that clinicians possess. Allyson Ocean hopes that Let’s Win can empower patients, scientists and doctors in order to help them make more informed choices regarding treatment.

Alysson Ocean and an anonymous corporate donor have provided funding for the company. Let’s Win is affiliated with the Lustgarten Foundation, and welcomes donations from individuals through this affiliation.

From immunotherapy to precision medicine, great strides are being made in the field of cancer research. But for people who have recently received a cancer diagnosis, Let’s Win hopes to share information that can help cancer patients make more informed decisions with their doctors about treatment options.

Johnson & Johnson to Partner with HP in 3D Printing

Within the 3D printing industry, major developments that have been occurring over the last few years include advancements in bio-printing and customized medical implants. At first these developments had limited effects in the industry. Yet, with time these improvements have matured and expanded across the healthcare industry.

This rapid expansion is due to the increased developments of 3D printing in the medical field, along with the greater healthcare industry showing significant growth other health-related areas such as dental applications and medical implants.

Although medical equipment and applications that contain metal are often times more costly, this expense is expected to drop as this material becomes more commonly used in the field. With demand and supply both on the rise, we can expect metal to decrease in price in the industry’s future.

johnson and johnsonA major driving force within the medical 3D printing industry is the growing demand for patient-specific products in orthopedics and maxillofacial surgery. Similar to other industries, demand for certain products will create an environment where the cost can decrease while also making said product more common in the industry.

Due to government subsidy programs and medical bio-printing research grants, many healthcare professionals in the industry predict the cost of 3D printing will decrease significantly in the coming years.

Recently, a huge partnership between Johnson & Johnson and HP has revolutionized the various ways in which the healthcare industry has and will operate in the future.

This new partnership’s primary focus is to create what they have titled “more personal healthcare solutions” in terms of personalizing software and products so consumers can receive what they need from a health related perspective based on particular patient needs.

This business collaboration is just the beginning for building the bridge between healthcare and technology to service our everyday health needs with digital tools that already affect other areas of our lives.

This strategic partnership does not only change the future of the healthcare industry in terms of patient-service advancement, but it also underlines how the beginning of how the meaning of 3D printing will be associated with a different kind of advancement.

As this huge pharma and medical device manufacturer continues to improve how their brand approaches healthcare, this is truly only the beginning when it comes to a new, more beneficial way to strengthen the consumer and brand loyalty bond.

Highlights from the Healthcare Industry

Half of American Hospitals Fined for High Readmission Numbers 

Michelle Andrews from Kaiser Health News has reported that more than half of all American hospitals are being penalized due to high readmission rates. Nearly 2600 hospitals will forfeit a combined $420 million in the form of reduced payments for medicare patients. These measures, which will begin taking effect in October, are the result of having too high a number o patients returning within one month after being discharged. Hospitals have publicly stated that these penalties are unfair as the readmission levels and fines do not consider or reward improvement from year to year.

IBM to Purchase Merge

Jeremy Barbera - IBM HealthcareCrain’s New York recently reported that the tech behemoth, IBM, has reached a deal to acquire Merge Healthcare inc. for a price of around $1 billion. IBM has plans to utilize Merge’s medical imaging management platform within their Watson tool. This its the latest in a series of moves from IBM that has them strengthening their hold within health care.

Doctors Say Cancer Drug Prices are Unsustainable

In a recent article from the Mayo Clinic, a group of more than one hundred renowned doctors came together to draw attention to the unsustainable nature of cancer drugs prices in the United States. This article references data collected by CBS’ 60 Minutes that shows that the pharmaceutical companies set the price of these drugs as high as they can get away with. The prices of cancer drugs have gradually, and alarmingly, increased an average of $8000 each year over the last decade and a half. The report notes that about a third of Americans will someday develop cancer, in one form or another, and that these patients tend to pay for a fifth or more of the cost of these drugs. Citing data on the average income of an American household, this Mayo Clinic report points out that the majority of patients will have to either take out loans or sell their assets in order to make payments. To learn more about this report and possible solutions, visit the official Mayo Clinic website.