Medicine in the Age of Predictive Biometrics
Last March, Apple released ResearchKit, an open-source platform that allows developers to create apps that collect data for health research. From the start, results were pretty well astonishing: researchers from Stanford University who partnered with ResearchKit to create a heart health study reported that 11,000 users signed up within 24 hours.
Generally, they said, getting 10,000 study participants would take a year—and that’s if you were working with a large number of medical centers.
What that means is that health researchers could soon have access to a veritable avalanche of data, which, when organized and interpreted, could offer major insight into when and why various health crises occur.
According to some, ResearchKit and other apps like it could predict the next major outbreak of a disease like Ebola. Hence the term, “predictive biometrics.”
From tracking your sleep cycles to predicting a heart attack
Biometrics in health applications have been growing in popularity for years—the Fitbit, which measures the number of steps you take among other biometrics, is probably the one that many of us are most familiar with. But the Fitbit is just one of many devices and apps that are designed to measure our biometric data, from sleep cycles and heart rate to blood glucose levels.
Predictive biometrics are, essentially, the next step. They can be used in all kinds of settings and scenarios—aging, for example. One app, Agewell Biometrics’ Equilibrium, can accurately test and predict an individual’s risk of falling.
Other possibilities for predictive biometrics are what panelists at a SXSW event on the topic call “invisible” —in other words, the capability to gather data when we do something as simple as open an email on our phones. At random intervals, the phone could perform a quick facial scan to measure heart rate or blood pressure.
The potential amount of data that scans like that could produce is truly staggering. Already, the individual data that users of products like the Fitbit, Jawbone, and Garmin’s Vivofit are producing is being hailed as the sign of a new chapter in health.
For instance, if a person feels ill, or has a chronic condition that requires regular doctor visits, they can go to their physician armed with data on their heart rate, or glucose levels, or sleep cycles. Then the physician could potentially use those data points to aid a diagnosis or treatment plan.
When you think about what all that individual data could tell us about ourselves as a population—if it was aggregated and organized—you get a basic idea of what ResearchKit and other predictive biometric apps might be able to offer us in the near future.
That “if” is key, for as far as we currently know, there’s no standard method of organizing or aggregating the data that could come from thousands of individuals (as the author of this Fortune magazine article asks, “how is a researcher supposed to compare what the Fitbit algorithm calls a step to what the Jawbone algorithm calls a step?”). There’s also the issue of where to store all this hypothetical data, once it starts rolling in.
Think you might have an idea that will help solve these problems? Pivot International works with software and mobile app entrepreneurs all the time. We’ve even got our own team of software specialists who can work with you to make your idea a reality. Contact us today!
The Amazing Features of Biomedical Polymers
Biomedical polymers are a special class of materials that are designed to work in harmony with the body, and for the basis of a growing number of artificial organs and replacement parts intended for fitting into the human body.
Biomedical Polymer Features
Next to deep space, the human body is the most aggressive environment that materials can be subject to, with changes in PH value, the need for complex movements, and inbuilt aggressive defense mechanisms. Developing new polymers that are able to exist safely within living organisms is a huge business.
Biomedical polymers can actually be divided into two distinct sub-sections; those that remain inert to the complex chemistry and operations of the body, and those that gradually break down in place by intention.
Types of BioMedical Polymers
The first group of materials is the basis of many long-term fitments already in use, such as artificial hearts and replacement trachea. The lack of suitable donor replacements has led to research and development into artificial replacements that can be produced as required, meaning that recipients no longer need to wait months or years to receive a real organ. Materials such as these must be designed to work in combination with the body’s complex systems, otherwise they are liable to fail. In the case of hip replacement components, the medical device is working under stress, which, when combined with chemical attack from the body, can lead to the production of metal ions with metal replacement parts. This can then lead to a condition called metallosis, whereas polymeric materials – typically polyethylene — can lead to small polymer fragments being present and a condition called osteolysis. Both of these can create discomfort and joint pain, joint looseness, and bone deterioration, and can lead to complications if the foreign material is not successfully flushed from the body.
The second group of materials is composed of sutures and other temporary fixings that are used to support the body’s infrastructure as full healing occurs in structure and tissue. The basic reason behind wanting a biodegradable polymer is that there is no requirement for a second surgical event to remove whatever structure has been put in place. Biodegradation offers other advantages too; if a polymer support can be made to degrade and weaken at the same rate as the bone it is supporting strengthens, then the patient does not suffer from a condition known as “stress shielding,” and experiences no difference in the applied stress that the structure feels. While structural materials are generally metallic, there are a number of developments in using initially stiff polymers that dissipate over time, again removing the need for a second operation.
This second class of polymers is also becoming increasingly important in the field of drug delivery and for the measured release of medications according to how fast they decompose under the actions of the body. By encasing a medication in a material that can be made to decompose at a regular and reliable rate means that a drug — such as a painkiller — can be administered to a patient in an orderly way and away from a hospital environment.
Importance of Biomedical Polymers
Biomedical polymers are an increasingly important subfield of polymer chemistry, and significant research is being carried out on how these and other materials interact with living tissue. As our bodies wear out, there is a good case to replacing parts with other materials that can extend life or movement by many years, and possibly even decades. While there is still much more research to do and many biological mechanisms that need to be fully understood to be translated into devices for production, the groundbreaking work in this important field has shown the extent to which these materials can be used to aid health care.
Pivot International is a product design, development, and manufacturing firm with extensive experience in the medtech industry. If you are interested in engineering a new product or updating an existing product, contact us at 1-877-206-5001 or request your free consultation today.
Medical Device Tax Endures in the Face of Political Scorn
Though its supporters in Congress are few and far between, the tariff imposed on medical manufacturers as part of Obama’s 2010 healthcare initiative doesn’t seem to be going anywhere any time soon.
Medical Device Manufacturing Service Companies cope with Increased Taxes
No appeal is in sight for the tax, despite calls for repeal by Congress members on both sides. This is partly because the tax is set to help fund Obamacare by $30 billion, and if stricken, has no source of replacement funding to help curb the enormous cost of the program.
The tax looks to disrupt an otherwise robust medical device industry that has been on a consistent upturn for decades. Major players in the sector such as Medtronic, Stryker Corp. and St. Jude Medical have even seen net margins doubling across some years. Medtronic, for instance, saw a profit margin breach 20 percent, a figure so lofty that it’s comparable to the renowned earnings of top pharmaceutical firms.
The tariff is an excise tax, meaning it considers companies’ profits, not just sales. Ergo, it causes a much larger problem for small companies with thinner margins. In some cases, it’s possible to be taxed even in situations where the affected company loses money.
“We’re actually borrowing money to pay the excise tax,” said Tom Allen, who serves as chief executive of the company Iconacy Orthopedic Patients, an orthopedic device startup with only 13 employees.
Allen’s company is based in Warsaw, Indiana, a small town just outside of Fort Wayne. Warsaw has become a hub for dozens of medical device makers, as well as a handful of more expansive med tech companies such as the privately held Biomet Inc.
Economists share the concerns of Allen and other med tech startups, largely agreeing that the tax will suppress innovation among those who would otherwise enter and prosper in the med tech arena. Critics also point to the fact that med tech was unfairly singled out among many medical-centric industries in what’s being called a sloppy, inelegant method of forcing companies in the sector to contribute to Obamacare.
The battle isn’t over yet, however. Congress still has time to stop the bill in its tracks, but it will take stalwart effort from legislators on both sides. Despite being weaved into the bill itself, it looks like the tariff won’t become crystallized without a fight.
ObamaCare Set to Reinvent Medical Device Industry
The Affordable Care Act, or ObamaCare, has been the legislation on everyone’s lips since it went live on the first of this year. Although the bill is commonly regarded as rife with new legislation, loopholes, problems and solutions, the bill may actually have a hidden silver lining for the medtech industry. Specifically, the new taxes mounted by ObamaCare may actually be a blessing in disguise for medical device manufacturers.
Industry insiders are pointing out that the constraints and barriers created by the Affordable Care Act are driving progress from a design perspective and an innovation perspective. Those up in arms over the new health care system may be dwelling on short-term trends rather than long-term manifestations. As the medical device industry adapts to the Affordable Care Act in years to come, newer products will be able to build the price of the tax hit into their products. Further, as more people come under coverage thanks to ObamaCare’s mandates, sales will inevitably incline.
The benefits aren’t confined to helping big business. ObamaCare also makes doctors responsible all the way through their patients’ outcomes rather than limiting their liability to only the procedures they perform, encouraging a transition from “sick care” to real health care. Such an evolution opens the door for patients, too, to be more responsible for their own recovery.
Several of Pivot International’s recent products illustrate this bridge, including a home sleep recorder that provides patients with a convenient and accurate alternative to sleep lab testing. With more concern on both sides, experts believe, a more careful, conscious healthcare climate will materialize.
For more information on medical device design and manufacturing, contact Pivot International at 1-877-206-5001.
