Dundon; Michael J. (Coppell, TX)
What is a Software Medical Device for Interactive body suit and interactive limb covers
Is Your Software a Medical Device for Interactive body suit and interactive limb covers
The Internet has produced an explosive expansion in a variety of markets, including gaming, online chat, videoconferencing, adult entertainment, and medical procedures and information dissemination. The number of internet users has also increased with the introduction of numerous new technologies. Because wireless service providers offer broadband internet access to mobile phone, fixed line, and cable providers are required to offer broadband services or risk being left out. Broadband services are now accessible to homes and individuals. This has resulted in a desire to make use of the massively increased bandwidth offered by broadband.
As applications on wireless communication networks move closer to Internet, products are being developed that use both firmware and software (e.g. microcode). Developers of computer systems attempt to recreate better the virtual environment that computer programs create to replicate the real world in the virtual world. Software, firmware, and hardware devices all work together to trigger the senses and produce a sensory illusion that is akin to the interactions in the virtual world that are created through computer programs.
Vision and sound have been well-integrated into computer systems. There are many development avenues for virtual reality helmets. These helmets provide realistic visual representations to the wearer and include headphones that give both audio and visual illusions of real-world reality to the computer interface. Simpler computer screens and speakers do not deliver as effective illusions of reality. While hearing and vision are integrated into computers but it’s impossible to simulate the three other senses of the human body – touch as well as smell and taste to create a virtual reality.
The invention makes use of the existing technologies and platforms within 3D (“3D”) virtual reality, and connects those applications over the Internet with broadband services provided via wire-line or wireless communications networks to provide a physical feeling of touch that is a reflection of the user’s actions and interactions in an Internet or computer-driven virtual world or as a response to a computer program or device protocol. This allows the user to engage in a virtual, computer-generated environment by imparting emotions or sensations of impact as well as touches to the actions that users perform within the virtual realm.
This invention is applicable to three different vertical markets for adult entertainment, gaming and medical. Each of these markets possesses a well-established presence on the Internet and established computer-driven applications.Numerous companies offer products that a touch of feeling can enhance the experience provided by the computer-generated frame of reality.
Touch feedback can benefit in the field of gaming by incorporating players in the game. The sensations of hearing, sight, and hearing are already stimulated by monitors, virtual reality helmets and speakers. Touchsensation allows the player to get feedback that is related to any physical contact made in the game.
The invention can also be utilized in the medical industry. Researchers are working to offer virtual medical care by using computer connections. Methods like videoconferencing are being utilized along with the transmission of vital physical data from patients who live located in remote areas to medical professionals. Due to the rising costs of medical treatments and the reduction of medical professionals due to the high price of insurance, the medical field is boldly seeking innovative ways to lower costs and to provide experts in areas that require them. This research focuses on virtual doctors and medical care. Virtual systems for computers are in use or being researched and developed for medical education. physicians,medical students, other medical professionals, treat patients, and train non-medical patients.
Trainers and trainees can use feedback via touch to determine the correctness of instructions. Massage therapy is available to the leg or arm peripheral device that is connected to a computer or hand-held mobile device. Other treatment options may be considered, including medication therapy, and perhaps in the future surgery or other procedures with remote treatment units or modules. This could be particularly beneficial in remote areas that have few doctors and limited facilities for treatment. Emergency situations, injured military personnel in remote locations, or small ocean craft operating in isolated locations–all far removed from medical help but capable of Internet connections over satellitecommunication systems–are examples of possible applications.
This kind of feedback training simulation can also be used for non-medical purposes. Simulations for military training could also be augmented with virtual reality programming software. Infantry training, pilot training, armor training, or simulators for training of ship crews could benefit from incorporating tactile feedback.
The technology can also be used to provide adult entertainment. The Internet along with the changing sexual and social norms as well as an increase in the desire of certain to opt for “virtual relationships” over riskier real-life liaisons have led to an explosion of adult content available over the Internet. Within the adult entertainment vertical Touch feedback is one of the most evident enhancements to the virtual world provided by the Internet or computer programming.
The Internet has made adult entertainment possible, and it has a significant economic impact on the world economy. AT&T Wireless and Match.com both provide adult community services and the wireless adult service is expected to make one billion dollars by 2008. As more people embrace adult entertainment, it is recognized that broadband service expansion across Europe will be driven by the growth of adult entertainment.
This invention provides a force feedback sensation of touching between an object located in an online virtual world Internet or computer, and an individual who wears an interactive bodysuit, peripherals associated to the interactive bodysuit or interactive limb covering. The body suit that is interactive is a suit that is worn over the arms, torso, and legs, providing a feeling of touch. The body suit that is interactive will also provide the same sensation of touching through peripheral devices, such as socks, gloves, and entertainment devices for both males and female.
The sensation of touch is created by small motors that oscillate inside the body suit as well as in peripherals. The motors that are embedded in the body suit are activated through a computer connection. The interactive bodysuit, limb covers, and peripherals are driven by a software and firmware set operating through a chip set control interface that converts contact with objects in the virtual world of an application or computer program into tactile sensations that are simulated by the selectively activated motors.
Motors are organized in accordance with body parts that are linked to a particular logic address. Due to the increased demand for sensing, there will be one the logical address for both adultentertainment devices and medical interactive devices. Gaming apps can utilize coarser sensations. Instead of focusing only on certain locations, you are able to activate the entire body suit.Click here to view the patent on USPTO website.
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What is a software medical device?
The FDA is referring to the functions of software that can include ” Software as a Medical Device” (SaMD) as well as “Software in a Medical Device (SiMD) ), which is software that is integrated into (embedded within) an medical device.
Section 201(h) of the Federal Food Drug and Cosmetic Act, 21 U.S.C. 321(h),(1) defines a medical device to be?an apparatus, device such as a machine, device, implant, in vitro-reagent, or other similar or related items comprising a component or accessory. . . (b) is intended to be used for the diagnosis of illnesses or other conditions or in the cure, mitigation, treatment, or prevention of disease for humans or other animals, or (c) is designed to alter the structure or any function of the body of man or any other animal.? So, to be considered a medical device and therefore subject to FDA regulations, your software must meet one of two requirements:
- It is essential to use it in diagnosing and treating patients.
- It must be designed to modify the structure or function of the body
So, if your application is designed specifically for health professionals to diagnose and treat patients or used in hospitals to handle patient information, the FDA will likely consider such software as medical devices subject to review by the regulatory authorities.
Is Your Software a Medical Device?
According to FDA’s current oversight strategy which takes into account the capabilities of the software higher than the platform, FDA will apply its regulation only to medical devices that have capabilities that cause harm to the safety of patients. Examples of Device Software and Mobile Medical Apps that FDA is looking at include
- Software functions to aid patients suffering from diagnosed mental disorders (e.g., depression, anxiety, post-traumatic stress disorder (PTSD) for instance.) by offering “Skill of the Day” an approach to behavior or audio-based messages that the user can access when suffering from anxiety.
- Software functions that provide regular reminders, motivational guidance, and educational information to patients recovering from addiction, or who are who are trying to quit.
- Software functions that utilize GPS location information to notify asthmatics when they’re close to high-risk areas (substance users) and to inform asthmatics to possible environmental conditions that may trigger symptoms.
- Software functions that employ video and games in order to encourage patients to do their exercises in their own homes;
- Software functions which let users choose the medicine or substance they want to use simultaneously. They also provide details on interactions and provide a summary of the type of interaction reported.
- Software functions that use the characteristics of the patient such as age, sex and other risk factors for behavior to offer specific screening for patients, counseling and preventive recommendations from well-known and established authorities;
- Software functions that utilize an inventory of the most common symptoms and signs to give an overview of medical conditions and advice on when it is appropriate to speak with a health care provider;
- Software functions help patients to answer a survey about symptoms and to make a recommendation on the most appropriate healthcare facility for their needs.
- Mobile apps that are intended to let users initiate a pre-specified emergency or nurse call by using broadband or cell phone technology;
- Mobile applications that permit a patient or caregiver to design and send an alert or general emergency message to first responders;
- Software that tracks medications and offers user-defined reminders that help improve the medication’s adherence.
- Software functions allow users access to their health records. This can include historical trending as well as comparisons of vital signs (e.g. body temperature heart rate, blood pressure).
- Software features that combine and show trends in personal health events (e.g., hospitalization rates or alert notification rates);
- Software tools let users electronically or manually enter data on blood pressure, to send it to e-mail, track it and trend it, and then upload it into an electronic or personal health record.
- Apps that offer mobile apps to monitor and remind you about oral health , as well as tools to track users suffering from gum disease.
- Apps that give mobile users access to information and aids for prediabetes patients;
- Mobile applications that display when appropriate pictures or other messages for a substance abuser who wants to stop addictive behavior;
- Software functions that report drug-drug interactions as well as pertinent safety data (side effects and drug interactions and active ingredient) as a report based on demographic data (age, gender), clinical data (current diagnosis), and current medications as well as
- Software functions that give the surgeon an inventory of intraocular lens power and suggested axis of implantation based on information provided by the surgeon (e.g., predicted surgically induced astigmatism patient’s axial length , cornea astigmatism before surgery, etc.)
- Applications, mostly mobile, that transforms mobile platforms into an approved medical device.
- Software that is connected to a mobile platform using a sensor or a lead that measures and displays the electrical signals produced by the heart (electrocardiograph, ECG).
- Software that attaches a sensor to the mobile platform, or other tools in the platform, in order to monitor, record, and analyze the eye movements to diagnose balance disorders
- Software that collects data about potential donors and transmits it to a blood collection facility. The software will determine whether a person is eligible to receive blood or any other component.
- Software that connects with an existing device type to regulate its operation, function, or energy source.
- Software that changes the settings or function of an infusion pump.
- Software that regulates the inflation and deflation of the blood pressure cuff
- Software that is used to calibrate hearing devices and evaluate the electroacoustic frequency, sound intensity characteristics, and sound quality of hearing aids, master hearing aids, group hearing aids or auditory trainers for groups.
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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