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It is time for you to design a device. You have a great idea. People support you in your idea. You have adequate funding to pursue your plan. It is time to get started.

You plan to create a medical device. Maybe it cleans teeth; maybe it pumps fluids into or out of the body. I don’t know. You haven’t told me yet, but you need to know whether to make a new dedicated device, or turn it into an application for a mobile device. Let’s look at the pros and cons of making dedicated devices and applications.

By making a dedicated device, you have complete control over the product. You decide how it looks, what it does, and when or if it is updated. You can pretty well guarantee that your device will continue to perform in the same way as or better than the day it is purchased. Making a dedicated device also means that you will have to deal with hardware development costs including time, as well as distribution costs that would not have been incurred with just software. Additionally, the burden is on you to ensure that your device passes FDA regulations.

Creating an application is easier up front. You were going to have to develop the software anyway. There is no hardware to be made or worried about or distributed. The lack of hardware is also the downside of this approach. Every time that any device you support gets an OS update, you must be sure that your application not only works, but also that the OS update didn’t open up any security flaws that could affect your device. With medical applications even more than regular ones, if it stops working for even one day, it could cause major problems at hospitals and if it doesn’t work, that may be enough to send users to a “more reliable” device.

Both routes are viable and products have successfully used both in the past. In the case of the applications, updates should come with plenty of warning, and should be testable. Both sides have risks as well. If there are hardware issues or the battery won’t last a whole day, then the manufacturer is the one in charge of fixing it or recalling it.


Who Regulates Mobile Health Apps?

by Patrick on December 27, 2011

When developing a product, it’s always a good idea to be on the lookout for laws that might cause problems for your creation. If you started building an apartment complex, you’d like to know in advance that they need to have electricity, right?

When your company decides to build something, it is important to make sure the product has been classified properly. If your new product is intended for use in medical applications, it will need to get the FDA’s approval. The FDA doesn’t regulate medical procedures, just products. Software’s ambiguous nature confuses whether it is a product or not, but since it is code written on a medium, it counts as a physical product.

To paraphrase the FDA’s own words, a medical device is a device intended for use in the diagnosis of disease or other conditions, or used in the cure or treatment of disease in man or other animals, or intended to affect any function of the body.

The FDA may also regulate accessories to medical devices. Dedicated devices used to monitor or control medical equipment are under the FDA’s jurisdiction. There are different levels of regulation depending on the risks associated with the parent product. A controller for an insulin pump would have to meet stricter requirements than a body mass index calculator. Smartphones may house applications and become medical devices, but smartphones have to go through a series of stringent tests already, and the FDA honors many of those tests, but may still do their own.

Applications on smartphones can be placed into three categories: standalone, accessories and components. Standalones do not connect to any other device, accessories are sold to users and connect to standalone devices, and components are sold to manufacturers and are used in the final product. These each have varying requirements for FDA approval. Accessories are regulated to the same degree as the products they connect with, and components are regulated for safety and reliability, as it is the safety and reliability of the end product that is most important.


CAN and Your Car

December 20, 2011

The Controller Area Network (CAN) had the honor of winning the race to be the OBDII standard and of being the best technology; something that doesn’t always happen with technology. This means that since 2008, the CAN system has been the only OBDII computer system installed in new vehicles. The CAN system can be visualized […]

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What makes OBDII so difficult?

December 13, 2011

The OBDII standard has done worlds for making vehicle diagnostics available to those who need them, but OBDII is still a fairly scary and confusing place for many developers. The most frequent use of a vehicle’s OBDII port is to provide emissions related diagnostics. This has been standardized by the SAE (Society of Automotive Engineers) […]

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OBDII: Scan Tool or OEM Tool?

December 6, 2011

When dealing with car troubles, a visit to the OBDII port under your steering wheel can clear up a lot of confusion really quickly. Unfortunately, we can’t just look at the port and tell what’s wrong, so we have to use a tool to read it. These tools come in two varieties: scan tools and […]

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OBD through the Ages

November 29, 2011

The OBD, or On Board Diagnostic computer is what ties all of the electrical and emissions systems together in a car, and it’s come a long way since its invention. You might have noticed the check engine light or low gas light turn on when you look at your car’s dashboard. Before the OBD computers, […]

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Paragon Innovations Nears Completion of AES ASTech

November 1, 2011

Paragon is wrapping up its work on the ASTech for Automotive Electronic Solutions. The ASTech is a device that solves a problem plaguing small auto repair shops across the country. Each parent company that manufactures cars has a different proprietary software system in their vehicles’ on board computer systems. This can control things like climate […]

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Dennis Ritchie, Software Trailblazer, Dies at 70

October 14, 2011

This week, the world of computing lost a hero. Dennis Ritchie, the creator of the C programming language as well as a key developer of the Unix operating system, passed away on October 8, 2011 at the age of 70. Dennis Ritchie was born in New York in September of 1941, and when the time […]

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“Let’s Talk iPhone” vs. the Royal Wedding

October 7, 2011

So, which impacted the economy more: everyone watching the British Royal Wedding, or everyone watching Apple’s “Let’s Talk iPhone” event? Both had their benefits, but both saw significant losses to their respective economies due to employees watching the presentations during work. Let’s look a bit deeper and see what the ups and downs were for […]

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Enjoying the Detours on the Road of Life

September 30, 2011

On this long winding road of life we see ups and downs, we have rough patches of unpaved road, and we are offered shortcuts. The best part of the road of life is the journey, but many people tend to choose the shortcuts because of how attractive they appear at the time. I’m not saying […]

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