Cardiac Pacemakers, Inc. (St. Paul, MN)
What is a Software Medical Device for Modular patient portable communicator to be used in life critical network
Is Your Software a Medical Device for Modular patient portable communicator to be used in life critical network
Implantable pulse generators (IPGs) are medical devices commonly used to treat irregular heartbeats also known as arrhythmias. Bradycardia is an abnormally fast or irregular heart beat. Cardiac pacemakers are utilized to treat it. Leftuntreated, bradycardia can cause symptoms such as dizziness, fatigue and fainting. Cardiac resynchronizers are a particular class of pacemaker that provide cardiac resynchronization therapy, such bi-ventricular pacing, which is for those suffering from heart failure. Implantable cardioverter defibrillators (ICDs), by way of an additional example, are designed to treat tachycardia, heart rhythms that are abnormally quick and potentially life-threatening. Certain forms of tachycardia may result in sudden cardiac death, ifleft untreated.
Implantable pulse generators are now being fitted with on-board volatile memory where telemetered signals can be stored to be later analysed and retrieved. Telemetered signals provide information on various patient devices, including atrial electrical activity as well as the electrical activity of the ventricular. They can also show time of day, activity level, cardiac output, and any interventions that were made in response to a heartbeat or binned. In addition, a growing class of cardiac medical devices, such as implantable heart failure monitors, implantable event monitors, cardiovascular monitors as well as therapy devices are being used to provide similar device information. Telemetered signals are also stored in a wider range of therapeutic devices, monitors, and other medical areas, like endocrinology, metabolism and neurology, metabolic, the genital-urology field, and ocular.
A proprietary interrogator/programmer is used to retrieve information stored on implantable medical devices. It can be performed during a visit to a clinic, or following a device event. The volume of data retrieved from a single device interrogationprocedure can be large and proper interpretation and analysis can require significant physician time and detailed subspecialty knowledge, particularly by cardiologists and cardiac electrophysiologists. These analyses are impossible due to the present techniques for data interpretation and understanding as well as the limitations of time and physician availability.
Conventional methods for analyzing and collecting pacemaker and ICD signal telemetered in a clinic or office environment can be used to retrieve data, such as patient electrocardiograms and other physiological signals, collected by the IPG to record, display and printing. The retrieved data may be displayed chronologically and then analyzed by a doctor. Traditional systems typically lack remote communications facilities and are operated with patients present. They provide a limited analysis of data based on a single device.
The invention described hereinafter is generally directed towards devices, systems techniques, software, and methods that provide for transportation of medical data over a network. Embodiments of the invention are directed to a modular PPC having an input/outputinterface to which detachable modules having disparate functionality can be connected. A number of modules may connect to the PPC’s input/output interface for enhanced functionality and external communication.
A portable, modular patient communicator, according to embodiments of this invention, is designed to be able to communicate via an implantable medical device. It also allows for connection to a central authority via an unsecurednetwork. A modular PPC conforming to the specific embodiments of the invention comprise a housing configured for portability by an ambulatory patient, a processor, an interface for users that is coupled to the processor and a radio that is configured to communicate only using the PIMD in accordance with program instructions from medical firmware which can be run by the processor. The modular PPC features a universal communication port supported by the housing and coupled to the processor. The universalcommunications port includes a connector configured to detachably engage and establish signal connectivity with at least one module of a multiplicity of disparate modules.
It is recommended that the modular PPC doesn’t have any other means of external communication other than radio or the universal communication port. At least some of the disparate modules are configured to provide the PPC with an externalcommunications facility and have disparate communication protocols. The housing houses the memory and is linked to the processor. The memory is set up to store the medical firmware as well as the life critical network (LCN) software comprising programinstructions which, when executed by the processor will cause the processor to work with the attached module to send the request to a network access facility for an access to the unsecure network, authenticate the PPC to the CA, and facilitatesecured communications between the PPC and CA after the successful PPC authentication. The modular PPC comes with a power source configured to provide power to parts of the PPC.
Based on various embodiments, techniques of the present invention allow for communicating with an PIMD and facilitating connectivity with the CA through an unsecure network. The present invention provides medicalfirmware as well as a life-critical network (LCN), within a portable patient communicator (PPC) which wirelessly interacts with the PIMD, and acquiring data using the radio and medical firmware. Methods further involvemechanically attaching at least one detachable unit of a multiplicity of disparate detachable modules to the universal communications port of the PPC. At least some of the detachable modules are configured to provide the PPC with an externalcommunications facility and have disparate communication protocols.
The invention provides signals connection between the PPC, the detachable that is mechanically connected, and the PPC. Preferably, the PPC does not have any other way of communicating with other parties other than radio or universal communications port. The LCN software is executed in cooperation with an additional module that will allow the PPC to send a request to an access facility on the network for an access to the unsecure network, authenticate the PPC tothe CA and allow secure communication between the PPC and CA after successful PPC authentication.
According to other embodiments, the computer-readable medium of the present invention contains instructions that can be executed by a computer system for data processing disposed in the form of a modular PCC. The instructions for program execution stored on the medium cause the arrangement for data processing to establish signals connectivity between a universal communications port of the PPC and at least one detachable component comprising a variety of detachable modules that are mechanically connected to the universal communications port. At least some of the detachable modules are configured to connect the PPC with an external communication facility. They also have different communications protocols. The PPC is preferably devoid of a facility to effect externalcommunications other than by way of a radio and the universal communications port of the PPC. The data processing arrangement runs the life critical network software (LCN), which is stored on the medium. This allows the PPC together with at least one module to transmit a request for an access to network facility that allows it to connect to an unsecured network. It also facilitates the authentication of the PPC (CA) and securecommunication between the PPC (CA) and CA following successful PPC authentication. These methods can be used to establish methods and equipment that are in accordance with the invention.
The above summary of the present invention isn’t meant to be a comprehensive description of every aspect or each implementation of the invention. The detailed description that follows and claims will allow you understand and appreciate the benefits and achievements of the invention.
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What is a software medical device?
The FDA is referring to the functions of software that may comprise ” Software as a Medical Device” (SaMD), and “Software in a Medical Device (SiMD) ), which is software that is integrated into (embedded within) the medical device.
Section 201(h) of the?Federal Food Drug and Cosmetic Act, 21 U.S.C. 321(h)(1), defines a medical device as ?an instrument, apparatus, instrument, machine, contrivance implant an in vitro reagent or any other similar or related article, including accessories or components that is . . . (b) is intended to detect the presence of disease or other ailments or treat, ameliorate, treat, or prevent them. (c) has the possibility of altering the body’s structure or function. body of animals. Thus, to be classified as a medical device and therefore subject to FDA regulation, your program must satisfy one of two criteria:
- It must be used in the diagnosis and treatment of patients.
- It is not intended to change the structure or function of the body.
If the software you use is designed to be used by health professionals to diagnose, treat or manage patient records in hospitals, the FDA is likely to consider the software as medical devices subject to review by the regulatory authorities.
Is Your Software a Medical Device?
The FDA’s oversight currently, which considers functional capabilities more than platforms and will ensure that FDA applies its regulatory oversight to medical devices that have functionality that could present a risk to patient safety. Some examples of Device Software and Mobile Medical Apps FDA is focusing on
- Software functions that help patients with diagnosed mental disorders (e.g., depression, anxiety, post-traumatic stress disorder (PTSD), etc.) by providing the “Skill of the Day” behavior technique or audio-based messages which the user can access when they are feeling anxious.
- Software functions provide periodic reminders, motivational guidance, and educational information to patients who are recovering from addiction, or who wish to quit.
- Software functions that use GPS information about location to notify asthmatics of conditions in the environment that could trigger asthma symptoms or notify an addict (substance abusers) in proximity to a specified, high-risk location;
- Software that makes use of games and video to help people to do their take part in exercise at home.
- Software functions which allow users to select which medication or herb they would like to take at the same time. They also give information on interactions and provide an overview of the kind of interaction reported.
- Software functions that use factors that affect the health of a patient, such as age, sex and risk factors for behavioral health to provide patient-specific screening and counseling, as well as preventive advice from well-known, established experts;
- Software functions that utilize a list of common symptoms and symptoms to provide guidance on when it is appropriate to visit an ophthalmologist and what next.
- Software functions help patients to answer a survey about symptoms and to make a recommendation on the most appropriate health care facility for the patient.
- These mobile apps allow users to make pre-specified nurse calls or emergency calls using the internet or cell phone technology.
- Mobile apps that allow patients or their caregivers to create and transmit an alarm or general emergency alert to first responders.
- Software functions keep track of medications and provide the user with a customized reminder system to help improve compliance with medication;
- Software functions that give patients with a way to access their own health data for example, access to information captured at a previous visit to the doctor or historical trending and comparison of vital sign (e.g., body temperature and blood pressure, heart rate, or respiratory rate);
- Software features that combine and show patterns of personal health events (e.g. rate of hospitalization or alert notification);
- Software features let users electronically or manually enter blood pressure information, to share it via e-mail, track it and trend it, then upload it into an electronic or personal health record.
- Apps that provide mobile applications for tracking and reminders about oral health or instruments to track people who suffer from gum disease.
- Mobile apps that provide prediabetes patients with guidance or tools to help them improve their eating habits or increase physical exercise;
- Apps that allow users to display images and other messages on their smartphones, which can be used by users of drugs who wish to end their addiction.
- Software functions that report information about safety and interactions with drugs (side effects and interactions between drugs, active ingredient active ingredient) in reports based on demographic data (age and gender) as well as current diagnoses (current medication), and clinical information (current treatment).
- Software functions that allow the surgeon to have an inventory of intraocular lens power and suggested axis of implantation based on information supplied by the surgeon (e.g. an expected surgically-induced astigmatism that is likely to occur, patient’s axial length and preoperative corneal astigmatism, etc.)
- Software, typically mobile apps that converts a mobile platform to an approved medical device.
- Software that connects with a mobile platform via an instrument or lead to display and measure electrical signals coming from the heart (electrocardiograph; ECG).
- Software that attaches an eye sensor to the mobile platform or other tools within the platform, in order to monitor, record, and analyze eye movements to identify balance issues
- Software that gathers data about potential donors and transmits the information to an institution for blood collection. This software determines if a donor is eligible to receive blood or other components.
- Software that is connected to an existing device type to control its operation, function, or energy source.
- Software that alters or disables the functions of an infusion pump.
- Software that regulates inflation or deflation of a blood pressure cuff
- Software is used to calibrate hearing devices and evaluate the electroacoustic frequencyand audio intensity characteristics, as well as sound quality of hearing aids master hearing aids, hearing aids for groups, 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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