InfoNovus Technologies, LLC (Portland, OR)

A method and system of studying a design for software includes receiving the specifications that contain some or all design elements. Some design elements are not listed in the specifications. One or more design elements not included in one or more specifications is generated. The generated design elements are then added to the one or more specifications.

The development of software applications is time intensive and resource intensive. Companies often hire software developers to develop and maintain applications that are used within their environment. For instance, a supervisor at a medical facility might want to make use of an application that can automatize the scheduling of medical procedures in order to cut down on time and expense. However, the manager might realize that no commercial software is available. To acquire a suitable application,the manager and the medical facility might be required to design their own application, by having software engineers develop the application.

Software such as an application that helps automate the scheduling of medical procedures could be part of a wider design definition that includes the actions of patients, doctors, and medical staff. Although non-application software elements or variables can have an impact on the layout of software, these are generally not part of the requirements for software applications. A design definition may not contain measurements of the operational processes that are required to analyze or evaluate.

Software development will typically include at a minimum an initial specification capture phase, which collects requirements for software as well as a development stage to develop the software, and a test phase to test the software. The process is time-consuming and costly, especially when the company requires numerous custom-designed software or modifications to an existing software. The end result of the process is likely to be a customized software application that is that is tailored to meet specific requirements however, it will not be one that can be reused or flexible The company will need spend additional time and resources to make changes to the custom application, or even to develop a new one.

A system and method to analyze the design definition which has been reduced to data, find the measurements of operational processes contained in the design definition and modify the definition of the design to include these measurements in order that the design definition could be used to develop application software that includes the measurements identified could speed up the development cycle and require fewer resources to produce more adaptable, reuseable results.

A method of analyzing a product design involves: receiving one to more specifications that contain one or several design elements; identifying one, more or all design elements not included in the specifications; creating one or multiple design elements, so defining one, more or all of the created design elements; and finally to add one, more, or all of the design elements.

You may add one or more of these options. One or more specifications can be saved. Analyzing event triggers that are related to process actions could be used to find design elements not contained within the specifications. This can include analyzing the data gathered by process actions, producing metrics from the data gathered through process actions as well as generating metrics associated with design elements contained in the specification. A determination may be maderegarding whether the one or more of the generated design elements are included in the specification. Determining whether the one or more of the generated design elements are included in the specification could involve determining whether data from the one or more generateddesign elements are included in the specification; determining whether a process action of the one or more generated design elements exists within the specification; determining whether a user interface definition of the design elements that were generated exists within the specification; and determining if the rules for the one or more generated design elements are contained in the specification. The procedure of creating one or several generated design elements can include the creation of one, several, or all of the following: data definitions; data definitions user interface definitions rules generation; and more data definitions.

In another embodiment the computer program resides on a computer readable medium, containing a variety of instructions stored on it that, when executed by a processor cause the processor to perform operations including: receiving one or more specifications that contain one or more design elements; identifying one or more design elements that aren’t included in the one or more specifications; and generating one or more design elements not included in specified specifications, thereby the processor is defining one or more of the generated design elements; and then adding the one or more created design elements to one or more specifications.

You could include any or all of these features. One or more specifications can be saved. Examining event triggers connected to process actions can be used to identify design elements that aren’t included in the specification. This could include analyzing data captured through process actions, generating metrics from the data gathered by process actions, and generating metrics related to design elements within this specification. It is possible to determine if one or more generated design elements is present within the specifications. In determining whether one or more created design elements are included in the specification could involve determining whether the information of the one or more generateddesign elements exists within the specification; determining whether a process action of one or more created design elements are included in the specification; determining whether the user interface definition for the one or more design elements generated exists within the specification; and determining if rules of the one or more of the generated design elements are included in the specification. The procedure of making one or more of the design elements that are generated can comprise the creation of one, several, or all of these: data definitions, data definitions, user interface definitions; rules generation, and other data definitions.

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What is a software medical device?

The FDA may refer to software functions that include ” Software As a Medical Device” and “Software in a Medical Device(SiMD)” which are functions of software that are integral to (embedded within) a medical device.

Section 201(h),?21 U.S.C. 321(h)(1) defines a medical device as ?an instrument, apparatus, implement an instrument, device, implant an in vitro reagent or any similar or similar item, which includes accessories or components that is . . . (b) intended for use for the diagnosis of diseases or other conditions, or for the treatment or treatment or prevention of disease, in man or other animals, or (c) intended to affect the structure or function of the body of man or other animals.? Thus, to be considered a medical device, and thus subject to FDA regulations, your software must meet one of two requirements:

  • It should be used for diagnosing and treating patients.
  • It must be designed to affect the structure or purpose of the body.

Therefore, if your program is designed specifically for health professionals to diagnose and treat patients, or is used in hospitals for the management of patient records The FDA will likely consider such software as medical devices subject to regulatory review.

Is Your Software a Medical Device?

In accordance with FDA’s current approach to oversight which examines the capabilities of the software more than its platform, FDA will apply its regulation only to devices for medical use that possess functionality that could be a risk to the safety of patients. Examples of Device Software and Mobile Medical Apps that FDA is looking at includes

  • Software functions to help patients with diagnosed psychiatric conditions (e.g., post-traumatic stress disorder (PTSD) depression, anxiety, or obsessive compulsive disorder) maintain their behavioral strategies for coping by offering the “Skill of the day” behavioral technique or audio messages that the user may access during times of increased anxiety;
  • Software functions that offer periodic reminders, motivational guidance and information on education to those recovering from addiction or who are trying to quit.
  • Software functions that make use of GPS location data to warn asthmatics of environmental conditions which could trigger asthma symptoms or warn an addict (substance abusers) whenever they are near a designated high-risk or high-risk area.
  • Software functions that employ games and videos to motivate patients to do their exercises in their own homes;
  • Software functions that prompt users to select the drug and herb they wish to take in conjunction and offer information on whether interactions have been observed in the literature, as well as an overview of the type of interaction was described;
  • Software functions that use the characteristics of the patient such as age, gender and risk factors for behavioral health to offer specific screening for patients as well as preventive counseling from well-known and established authorities;
  • Software functions that use a checklist to determine common symptoms and provide advice about when to see an acupuncturist.
  • Software functions that lead users through a list of symptoms and signs in order to give a recommendation on the kind of health facility that is most suitable to their requirements;
  • Mobile apps that are intended to let users initiate a pre-specified nurse call or emergency call using broadband or cellular phone technology.
  • Mobile apps that enable a patient or caregiver to design and send an alarm or general emergency alert to first responders;
  • Software functions keep track of medications and provide user-configured reminders for better compliance with medication;
  • Software functions that provide patients with a way to access their personal health records including access to the information gathered during a prior visit to a doctor or historical trending and comparison of vital signs (e.g., body temperature and heart rate, blood pressure or respiratory rate);
  • Software features that combine and display trends in personal health events (e.g. rate of hospitalization or alert notification);
  • Software functions allow the user to collect (electronically or manually entered) blood pressure information and share this data through email, monitor and track it, or add it into a personal or electronic health record.
  • Mobile apps that allow for tracking and reminders of oral health. They also provide tools to track users who suffer from gum disease.
  • Mobile applications that offer patients with prediabetes guidance or tools to assist them improve their eating habits, or to increase physical activity;
  • Mobile apps that display at the right time, images or other messages to a substance abuser who wants to stop addictive behavior;
  • Software functions that offer interactions between drugs as well as relevant safety information (side effects and drug interactions, active ingredient) in a form of a report, that is based on demographic information (age, gender) and medical information (current diagnosis) and the current medication; and
  • Software functions enable the surgeon to determine the best intraocular lens powers for the patient, and the optimum axis of implant based on the data given by the surgeon (e.g. anticipated surgically induced astigmatism and length of the patient’s axial axis, preoperative corneal astigmatism etc.).
  • Mobile apps, typically software that converts a mobile device into a medical device.
  • Software that can be connected to a mobile platform with a sensor or lead that measures and displays the electrical signals produced by the heart (electrocardiograph, ECG).
  • Software that attaches a sensor or other device to the mobile device to monitor eye movements to diagnose balance issues.
  • Software that inquires about their history with donors and records and/or transmits those answers to an institution for blood collection. The software helps determine if a potential donor is eligible before collecting blood or other components.
  • Software that is connected to an existing device in order to control the device’s operation, function or power source.
  • Software that changes the settings or function of an infusion pump
  • Software that controls the inflation or deflation of a blood pressure Cuff
  • Software is used to calibrate hearing aids and to evaluate the electroacoustic frequencyand the characteristics of sound intensity, and emanating from hearing aids master hearing aids group hearing aids, or group auditory trainers.

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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