Guidance Interactive Technologies, Inc. (Delano, MN)
What is a Software Medical Device for Handheld controller for monitoring/using medical parameters
Is Your Software a Medical Device for Handheld controller for monitoring/using medical parameters
A little more than 15,000 children aged under 20 suffer from Juvenile Diabetes each year. At present in the United States has over 200,000 of these kids who battle with the disease. To avoid long-term damage to their kidneys, eyes, and feet, diabetes sufferers must monitor their blood glucose levels frequently. There are no blood glucose testing devices currently in use that contain any reward or motivational mechanisms to encourage the individualto maintain this test regimen. Because the majority of the people who are diabetics are adults, the majority of commercially available glucose testing meters are designed in a way that isn’t user-friendly nor socially acceptable to children. Children might be reluctant to test their blood glucose when they are in social settings. This social phobia could expose them to instances of hyperglycemia, hypoglycemia or an insulin shock.
Any reason for abstinence from routine glucose tests could have a significant impact on the long-term wellbeing of the teenager with diabetes. This can lead to significant increase in health care costs. There have been many articleswritten and scientific studies conducted about incorporating motivational stimuli into the medical testing process, however no major improvements have been made to these devices. Numerous positive results have been realized and the greater compliance with testing has been achieved. (Lieberman Debra Games for Children and Adolescents: Theory Design, Designs, and Research Findings)
Researchers in the field of diabetes are exploring methods and technologies to carry out non-invasive glucose blood level monitoring for Type I and Type II diabetics. There are currently two types of technology that can be used to determine the levels of blood glucose. Both are available in the majority of glucose monitors for home use. One is the differential device, the second is the reagent model. A small amount of blood must be placed on a strip that has been chemically treated to determine if the reagent strip is the one using the chemically reactant strip method. The color of the chemically treated strips will change depending on how much glucose is in the blood. After the blood sample has been taken, a measurement of the differential is obtained from the test strips. The results are then compared with the color of strips. The enzyme/current differential method is used to determine the correct glucose level by measuring the current change that occurs when you place the blood sample of a patient with glucose on the test strip. The electrical resistance of test strips is directly affected by coating of enzymes. Both methods can be used to determine the glucose level. This is accomplished by looking at the change in electrical current and the color properties.
One of the biggest issues in the market for glucose testing devices has been to develop a glucose-testing device that doesn’t require the use of a tiny capillary blood sample. The “non-invasive” technique could become a huge commercial successbecause it will eliminate the discomfort associated the process of obtaining the blood sample, and also increase the rate of testing blood glucose.
It is public knowledge that one of the less invasive techniques that could soon become commercially accessible is utilizing the EKG/EEG readings, associated with a host of sophisticated algorithms that determine blood glucose levels. However, it is not known that there are not any commercially available products that incorporate these methods or technologies, even though an EKG/EEG glucose monitoring device could be available soon. It is possible that, due to the research, new devices, that incorporate additional sensors, could be made available to detect epileptic seizures and asthma attacks.
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What is a software medical device?
Is Your Software a Medical Device?
What does it mean if your software/SaaS is classified as a medical device?
SaaS founders need to be aware of the compliance risks that medical devices pose. Data breaches are one of the biggest risks. Medical devices often contain sensitive patient data, which is why they are subject to strict regulations. This data could lead to devastating consequences if it were to become unprotected. SaaS companies who develop medical devices need to take extra precautions to ensure their products are safe.
So who needs to apply for FDA clearance? The FDA defines a ?mobile medical app manufacturer? is any person or entity who initiates specifications, designs, labels, or creates a software system or application for a regulated medical device in whole or from multiple software components. This term does not include persons who exclusively distribute mobile medical apps without engaging in manufacturing functions; examples of such distributors may include the app stores.
Software As Medical Device Patenting Considerations
The good news is that investors like medical device companies which have double exclusivity obtained through FDA and US Patent and Trademark Office (USPTO) approvals. As such, the exit point for many medical device companies is an acquisition by cash rich medical public companies. This approach enables medical devices to skip the large and risky go-to-market (GTM) spend and work required to put products in the hands of consumers.
Now that we have discussed the FDA review process, we will discuss IP issues for software medical device companies. Typically, IP includes Patents, Trademarks, Copyrights, and Trade secrets. All of these topics matter and should be considered carefully. However, we will concentrate on patents to demonstrate how careless drafting and lack of planning can lead to problems, namely unplanned disclosures of your design that can then be used as prior art against your patent application.
In general, you should file patent application(s) as soon as practicable to get the earliest priority dates. This will help you when you talk to investors, FDA consultants, prototyping firms, and government agencies, among others. Compliance or other documents filed with any government agency may be considered disclosure to third parties and could make the document public. In general, disclosures to third parties or public availability of an invention trigger a one year statutory bar during which you must file your patent application. Failure to file your application within the required time frame could result in you losing your right to protect your invention.
The information from your FDA application may find its way into FDA databases, including DeNovo, PMA and 510k databases and FDA summaries of orders, decisions, and other documents on products and devices currently being evaluated by the FDA. Your detailed information may be gleaned from Freedom of Information Act requests on your application. This risk mandates that you patent your invention quickly.
When you patent your medical device invention, have a global picture of FDA regulatory framework when you draft your patent application. Be mindful of whether your software/SaaS application discusses the diagnosing and treating patients or affecting the structure or function of the body and add language to indicate that such description in the patent application relates to only one embodiment and not to other embodiments. That way you have flexibility in subsequent discussions with the FDA if you want to avoid classification of your software/SaaS/software as a medical device. In this way, if you wish to avoid FDA registration and oversight, you have the flexibility to do so.
An experienced attorney can assist you in navigating the regulatory landscape and ensure that you comply with all applicable laws. This area of law is complex and constantly changing. It is important that you seek legal advice if you have any questions about whether or not your software should be registered with FDA.
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