TelePack Pill Packet Dispenser for Personal Use – FDA funded
Film your elevator pitch.
What specific problem are you solving?
TelePack Pill Packet Dispenser for Personal Use – FDA funded
The outbreak of the COVID-19 has exposed shortages in capacity and capability in the healthcare system.
What is your solution?
Our award winning, patented Ai enabled TelePack Pill Packet Dispenser uses image and speech recognition to identify pill-packet contents and respond to spoken requests (Alexa). Our dispenser uses pre-packaged medications and vitamins from online pharmacies: Amazon PillPack, CVS, Walmart, Walgreens, Nurish, Persona. Our One-Touch Video call feature (zoom) is a dedicated Video conferencing device which allows people to received remote care and medication monitoring at lowest cost to under-serviced populations.
Our Web Portal admin dashboard provides quick real-time monitoring of 50+ remote dispensing units, with One-Touch Video Calling. Our conversational Avatar Assistant provides a friendly voice interactive conversation asking and answering questions while dispensing medications. Personalized Avatars can log spoken “key” words such as: headache, pain, nausea, anger, sadness, PTSD symptoms and suicide ideation. All data is securely encrypted and compliant with HIPAA and the 2013 Drug Security Act. (Track/Trace/Authenticate).
Who does your solution serve, and in what ways will the solution impact their lives?
Telepack is video conferencing is covered by Medicare Advantage Part D subscribers for: Medication Adherence automatic logging, telemedicine, telehealth, telemental health, teleoncology, telepsychology, telephysical therapy, tele occupational therapy, sleep therapy, wellness health check.
How are you and your team well-positioned to deliver this solution?
David Prokop
Founder / CEOFounder / CEO TruMedicines · Full-timeTruMedicines · Full-time Jan 2017 - Present · 5 yrs 2 mosJan 2017 - Present · 5 yrs 2 mos Sammamish, waSammamish, wa Ex-Microsoft Researcher CEO of TruMedicines - NIH FDA Grant for Drug tracking patented technology. International award & grant winner for innovative Ai hardware design for TelePack Pill Packet Dispenser. TelePack dispenses medications and uses remote video monitoring of Medicare Advantage users. Using Ai image recognition to read contents of pill packets and interact with patients using conversational Ai Avatar to answer health questions and provide feedback on fitness and health questionnaires.
UW Comotion TruMedicines Ai Hardware Research LabUW Comotion TruMedicines Ai Hardware Research Lab University of Washington College of Engineering · Self-employed University of Washington College of Engineering · Self-employed Nov 2020 - Present · 1 yr 4 mos Nov 2020 - Present · 1 yr 4 mos Seattle, Washington, United States Seattle, Washington, United States
Ex-Microsoft Researcher CEO of TruMedicines UW Comotion Hardware Lab at University of Washington College of Engineering building Vitamin and pill packet dispensers using image recognition to identify pill packet contents, speech recognition, and text to speech to animate a photo realistic, synthetic talking medication assistant.
Ex-Microsoft Researcher and NIH Grant Technical Reviewer Computer Science Ai Image Recognition Ex-Microsoft Researcher and NIH Grant Technical Reviewer Computer Science Ai Image Recognition >span class="visually-hidden">span class="t-14 t-normal t-black--light">Nov 2020 - Dec 2020 · 2 mos Nov 2020 - Dec 2020 · 2 mos
Ex-Microsoft Researcher Computer Science reviewer for SBIR/STTR Grant Reviewer for NIH As an ad hoc reviewer, I provide expertise on computer systems, Ai image recognition for medical applications, identification of pharmaceuticals, tracking, anti-diversion systems, use of Ai in patient care for SBIR grant review study sections. In this capacity, I provide written critiques and participate in person on review panels for SBIR/STTR grants submitted to NIH.
TruMedicines CEO and Research Scientist - Funded by NIH- FDA GrantTruMedicines CEO and Research Scientist - Funded by NIH- FDA Grant NIH Clinical Center (CC) · ContractNIH Clinical Center (CC) · ContractSep 2018 - Feb 2020 · 1 yr 6 mosSep 2018 - Feb 2020 · 1 yr 6 mosSammamish, WASammamish, WA
NIH - FDA Grant recipient Principal Computer Research Scientist, founder of TruMedicines pill scanning process to identify pharmaceuticals and tracking them through the supply chain to patient's hand, using micro-image recognition neural networks.NIH - FDA Grant recipient Principal Computer Research Scientist, founder of TruMedicines pill scanning process to identify pharmaceuticals and tracking them through the supply chain to patient's hand, using micro-image recognition neural networks.
XBOX Kinect (Optical image/voice recognition sensor) Dev Program Manager Kinect uses cameras to track motion of objects in a room Sustaining Engineering management of product changes, updates, deviations, special builds.XBOX Kinect (Optical image/voice recognition sensor) Dev Program Manager Kinect uses cameras to track motion of objects in a room Sustaining Engineering management of product changes, updates, deviations, special builds.
Which dimension of the Challenge does your solution most closely address?
Build fundamental, resilient, and people-centered health infrastructure that makes essential services, equipment, and medicines more accessible and affordable for communities that are currently underserved;
Where our solution team is headquartered or located:
Seattle, WA, USA
Our solution's stage of development:
Prototype
How many people does your solution currently serve?
prototype phase - not released to public
Why are you applying to Solve?
Business Model – Medicare Part D Coverage Reimbursement
The product offerings that will be developed by TruMedicines is a Hardware and software service that tracks/traces/authenticates drug doses to monitor patient drug regime compliance. Insurance & Medicare coverage, the Current Procedural Terminology (CPT®) codes offer doctors and health care professionals a uniform language for coding medical services and procedures to streamline reporting, increase accuracy and efficiency. CPT codes are also used for administrative management purposes such as claims processing and developing guidelines for medical care review. The TelePack device is covered TruMedicines A2314-052- A2D-0519 and can expect reimbursement payments from healthcare insurance providers participating in Medicare Part D coverage by the following CPT codes 99453, 99454, 99457, 99458, 99473, 99474, 99607, 99490. Descriptions of Telemedicine CPT codes developed from the American Medication Association (AMA) Reference link https://www.ama-assn.org/pract...
In which of the following areas do you most need partners or support?
Financial (e.g. improving accounting practices, pitching to investors)
Who is the Team Lead for your solution?
David Prokop
More About Your Solution
What makes your solution innovative?
TelePack Project Overview
The proposed TelePack system with mobile web app (Fig. 0) will allow H2F measures to be input from any device which can run an internet browser (google chrome, Microsoft explorer, Apple safari) and the TelePack device, which includes video technology that allows patients and supervisors to record fitness measurements at any remote location with an internet connection, the TelePack has the potential to transform delivery of multidisciplinary care for patient and fitness measurements. TelePack will help fill these gaps in solder readiness profiles. Demo Video link TruMedicines A2314-052- A2D-0519 Objective: The TelePack (Fig 1) solution is a scalable and convenient web browser user interface that is functional on many device types and can link to wearable technologies, collects data across all H2F five domains, provides individualized performance plans, and is capable of interfacing with the COVID Patients, allowing for the creation of leader data dashboards for individuals or across multiple unit configurations. This will allow data-informed interventions to occur sooner, improve performance and readiness across the unit, allow for a more persistent repository of patient data, and provide leaders who have different roles and requirements (command structure, different H2F practitioners, and others) with the tools to understand the individual and collective readiness of patient across the formation. The TelePack Ai fitness-health device dispenses packets of nutritional supplements and collection of H2F fitness measures via speech recognition, touch display or connected wearable devices. The TelePack Ai uses trained neural networks to identify pill packet image feature descriptors to verify data against a central data. Using novel bi-directional communications text, voice, and speech recognition (like Alexa) or via 7 inch touch sensitive input display screen. TelePack Ai will automatically log time/date of consumed oral dose (external camera can take video recording) and logs user answers to fitness measurement questions; sleep, nutrition, mental and spiritual mood. The external camera and touch display screen allows real-time bi-directional video conferencing (like Zoom) to communicate with team supervisor.
A secure web based administrative portal (fig.2) tiered supervisor interface, will provide a cloud database repository with multi-modal tabular and graphical display (like Excel) to display the real-time status of critical fitness measures for each user. The TSI admin portal will allow individualized survey questions with instructional videos, and scripted avatar coaching advice, to be delivered to the target user on a periodic basis. TelePack Ai device data capture can be expanded by Bluetooth pairing with off the shelf measurement devices for additional data capture including: wearables (like fitbit) or fitness test measurement devices like MVO2 -maximal ventilated oxygen masks (like cosmed). All user data is stored locally until an internet connection is established, then all data is uploaded and
What are your impact goals for the next year and the next five years, and how will you achieve them?
Business Model – Medicare Part D Coverage Reimbursement
The product offerings that will be developed by TruMedicines is a Hardware and software service that tracks/traces/authenticates drug doses to monitor patient drug regime compliance. Insurance & Medicare coverage, the Current Procedural Terminology (CPT®) codes offer doctors and health care professionals a uniform language for coding medical services and procedures to streamline reporting, increase accuracy and efficiency. CPT codes are also used for administrative management purposes such as claims processing and developing guidelines for medical care review. The TelePack device is covered TruMedicines A2314-052- A2D-0519 and can expect reimbursement payments from healthcare insurance providers participating in Medicare Part D coverage by the following CPT codes 99453, 99454, 99457, 99458, 99473, 99474, 99607, 99490. Descriptions of Telemedicine CPT codes developed from the American Medication Association (AMA) Reference link https://www.ama-assn.org/pract... 99358 Prolonged physician services without direct patient contact; first hour Note: This code is no longer an “add-on” service and can be reported alone. 99359 each additional 30 min. (use in conjunction with 99358) 99421: Online digital evaluation and management service, for an established patient, for up to 7 days, cumulative time during the 7 days; 5–10 minutes 99422: Online digital evaluation and management service, for an established patient, for up to 7 days cumulative time during the 7 days; 11– 20 minutes 99423: Online digital evaluation and management service, for an established patient, for up to 7 days, cumulative time during the 7 days; 21 or more minutes. Clinicians who may not independently bill for evaluation and management visits (for example – physical therapists, occupational therapists, speech language pathologists, clinical psychologists) can also provide these e-visits and bill the following codes: G2061: Qualified non-physician healthcare professional online assessment and management, for an established patient, for up to seven days, cumulative time during the 7 days; 5–10 minutes G2062: Qualified non-physician healthcare professional online assessment and management service, for an established patient, for up to seven days, cumulative time during the 7 days; 11–20 minutes G2063: Qualified non-physician qualified healthcare professional assessment and management service, for an established patient, for up to seven days, cumulative time during the 7 days; 21 or more minutes. G2012: Brief communication technology-based service, e.g. virtual check-in, by a physician or other qualified health care professional who can report evaluation and management services, provided to an established patient, not originating from a related e/m service provided within the previous 7 days nor leading to an e/m service or procedure within the next 24 hours or soonest available appointment; 5-10 minutes of medical discussion. G2010: Remote evaluation of recorded video and/or images submitted by an established patient (e.g., store and forward), including interpretation with follow-up with the patient within 24 business hours, not originating from a related e/m service provided within the previous 7 days nor leading to an e/m service or procedure within the next 24 hours or soonest available appointment. Virtual check-ins can be conducted with a broader range of communication methods, unlike Medicare telehealth visits, which require audio and visual capabilities for real-time communication. 99444: Online evaluation and management service provided by a physician or other qualified healthcare professional to an established patient, guardian or health care provider no originating from a related E/M service provided within the previous 7 days, using the internet or similar electronic communications network 99451 Interprofessional telephone/internet/electronic health record assessment and management service provided by a consultative physician, including a written report to the patient's treating/requesting physician or other qualified health care professional, 5 minutes or more of medical consultative time. TruMedicines A2314-052- A2D-0519 99451 is reported by the consultant, allowing him/her to access data/information through the electronic health record (EHR), in addition to telephone or internet. 99452 is reported by the requesting/treating physician/QHP (e.g., the primary care physician). 99453: “Remote monitoring of physiologic parameter(s) (e.g, weight, blood pressure, pulse oximetry, respiratory flow rate), initial; set-up and patient education on use of equipment.” 99454: “Device(s) supply with daily recording(s) or programmed alert(s) transmission, each 30 days.” What to know: CPT 99454 offers reimbursement for providing the patient with a RPM device for a 30-day period. Note that 99454 can be billed each 30 days. 99455 - CPT® Code in category: Work Related or Medical Disability Evaluation Services 99456 are both designated to cover work-related or medical disability exams. covers an exam provided by someone other than the treating physician. 99457: “Remote physiologic monitoring treatment management services, 20 minutes or more of clinical staff/physician/other qualified healthcare professional time in a calendar month requiring interactive communication with the patient/caregiver during the month.” 99458 (Remote physiologic monitoring treatment management services, clinical staff/physician/other qualified health care professional time in a calendar month requiring interactive communication with the patient/caregiver during the month; additional 20 minutes) 98970, Per CPT; “For online digital E/M services provided by a qualified nonphysician health care professional who may not report the physician or other qualified health care professional E/M services (eg, speech-language pathologists, physical therapists, occupational therapists, social workers, dietitians), see ).” 98970 Qualified nonphysician health care professional online digital evaluation and management service, for an established patient
How are you measuring your progress toward your impact goals?
Measurement Specific Aims:
Aim 1) Implement and confirm the TelePack Ai onboard software to determine and verify the user interface on device and web based tiered supervisor interface is user friendly (usability) and able to capture the H2F domains 1) physical fitness, 2) sleep, 3) nutrition, 4) mental and 5) spiritual readiness measures additionally 6) Working heart rate, 7) MVO2 measures. The goal of >90% positive satisfaction surveys with user interfaces and accuracy of data input. Aim 2) Implement and confirm the TelePack Ai device accurately dispenses packets of nutritional supplements. The goal would be a <10% error rate for dispensing nutritional supplement packets. Aim 3) Implement and confirm the video communication is >90% reliable (when internet connection is available) and Avatar coaching (no connection) is personalized and useful to positive user >90% satisfaction survey rate.
Prior Research Study – HHS - FDA Phase I grant (1R43FD006302-01) Title - Pill Identification using a Mobile Phone App for Assessing Medication Adherence and Post-Market Drug Surveillance. Research paper link https://arxiv.org/abs/2004.114... ABSTRACT Objectives: Medication non-adherence is an important factor in clinical practice and research methodology. There have been many methods of measuring adherence yet no recognized standard for adherence. Here we conduct a software study of the usefulness and efficacy of a mobile phone app to TruMedicines A2314-052- A2D-0519 measure medication adherence using photographs taken by a phone app of medications and self-reported health measures. Method: A total of 34 participants were recruited to participate in the study. Out of these, 26 (76.5%) participants were able to complete study questionnaire while 8 (23.5%) were not able. Participants volunteered in a study of the efficacy of a mobile phone app for medication adherence and measurement of mood and health measures. Participants used their own android mobile phones and downloaded our phone application. Participants were instructed to take a photo of 1 harmless placebo pill (breath mints) a day for 2 weeks, and record their answers linked to a Research Electronic Data Capture (REDCap)[1] data collection server using MyCap[2] enabled phone application. Pill image and self-reported health measurements were recorded daily. Participants were paid for a stipend for participation. Results: The participants were asked by the app ‘would help to keep track of your medication’, their response indicated 92.9% felt the app ‘would you use this app every day’ to improve their medication adherence. The subjects were also asked by the app if they ‘would photograph their pills on a daily basis’. Subject responses indicated 63% would use the app on a daily basis. By using the data collected, we determined that subjects who used the app on daily basis were more likely to adhere to the prescribed regimen. Conclusions: Pill photographs are a useful measure of adherence, allowing more accurate time measures and more frequent adherence assessment. Given the ubiquity of mobile telephone use, and the relative ease of this adherence measurement method, we believe it is a useful and cost-effective approach. However we feel the ‘manual’ nature of using the phone for taking a photograph of a pill has individual variability and an ‘automatic’ method is needed to reduce data inconsistency
What is your theory of change?
To complete development and testing of our software, TruMedicines has partnered with clinical investigators from the Department of Psychiatry and Behavioral Sciences, Dept. of Psychiatry, University of Washington and the Center of Excellence in Substance Abuse Treatment and Education (CESATE), Veterans Affairs Puget Sound Health Care System to focus on determining measures of mental and spiritual readiness. Our hardware partners include Product Creation Studios in Seattle that has had a 20 year history of engineering excellence developing medical devices for the University of Washington and the Fred Hutch Cancer Institute. Given our prior Phase I progress, we believe that the direct to Phase II SBIR is the appropriate mechanism for our application. Results of the enhanced software development and testing will be used to guide our Commercialization Plan, which is part of this application package.
Our project goal is to demonstrate to the patient our TelePack device user interface that is capable at a minimum of accepting inputs thought the touch display screen (manual), delivering individualized TruMedicines A2314-052- A2D-0519 coaching using video conferencing or instructional avatar coaching and tracking performance data in 1) physical fitness, 2) sleep, 3) nutrition (vitamins & supplements), 4) mental and 5) spiritual readiness measures. TelePack system will be provided to three Soldier test groups in a 3 Phased approach. TruMedicines development team will monitor the data captured from each device and log user feedback defects into a “bug” database. Each bug will be assigned a number and a software engineer will fix the defect and implement the change to the testing group on a daily basis during the testing period.
Describe the core technology that powers your solution.
US Patents# 8,888,005; 9,152,913; 9,477,810; CA Pat 2,858,923-Marked Pharmaceutical Tablets
Uniquely identifiable drug dosage form units May 31, 2013 The present invention provides products, systems, and methods for the unique identification of individual drug dosage form units. The invention includes: random integrated optical identification marking of an individual drug unit; a lack of direct surface-to-surface contact between a marking instrument and the drug unit, i.e., deposition of a mark; drug unit image data based on the identification mark; a secondary product identifier associated with the individual drug unit; and comparing the marked drug unit to drug unit image data.
Skip to: Description · Claims · References Cited · Patent History · Patent History Description CROSS REFERENCE TO RELATED APPLICATION This application claims priority to provisional application Ser. No. 61/811,616 to David Prokop, which is incorporated by reference in its entirety.
BACKGROUND OF THE INVENTION In the United States, commercially available individual solid oral drug dosage form units (“drug units”) are not conventionally separable and uniquely identifiable on a per unit basis. Instead, each individual drug unit is identified based on its conformity to a uniform standard established for each drug product, such that drug units for a given drug product are typically indistinguishable from each other.
Current drug product identification is, in part, governed by Title 21 of the Code of Federal Regulations, Section 206.10, which provides a mechanism for the routine identification of solid oral dosage form drug products. That is, no drug product in a solid oral dosage form may be introduced or delivered for introduction into interstate commerce unless each of its drug units is clearly marked or imprinted with a “code imprint” that, in conjunction with the unit's size, shape, and color, permits the identification of the drug product and the manufacturer or distributor of the drug product. A code imprint can refer to any single letter or number or any combination of letters and numbers, including, e.g., words, company name, and National Drug Code, or a mark, symbol, logo, or monogram, or a combination of letters, numbers, and marks or symbols, assigned by a drug firm to a specific drug product. Such code imprints are usually uniformly coarsely embossed, debossed, engraved, stamped, or printed with ink onto or into each unit of a particular drug product as part of, or after, the manufacturing process.
While standardizing drug product appearance and requiring that each unit of a particular drug product conforms to the same criteria assists identification of drug units by comparison to a pre-set type for drug products generally, such uniformity also facilitates drug counterfeiting and obstructs the tracking and authentication of individual drug units. Once a counterfeiter is able to passably replicate the appearance of a single drug unit, production of mass quantities of drug units of a particular counterfeit drug product can proceed relatively unhindered. Counterfeiting is also aided, for example, by the ready commercial availability of tablet and pill manufacturing equipment, well-known and openly published fabrication methods, and fabrication methods and parameters that may be easily derived from direct observation of the code imprint and drug unit.
Efforts to create separable and uniquely identifiable drug units and drug unit authentication systems have been made. For example, the use of bar codes, engravings, stamps, etc. has been proposed as a way to uniquely identify individual drug units. However, such proposals require surface-to-surface contact between a marking instrument and each drug unit to identify each unit. Such direct surface-to-surface contact is undesirable for several reasons including, but not limited to, insertion of additional, expensive, slowing, and/or complicating steps into the process of manufacture, possible interference with other uniform drug product features useful for general product identification, and/or compromising the surface integrity and/or stability of the drug unit. Further, such efforts typically require that the end user have some sort of non-human machine visual or optical scanning device or reader to ascertain the meaning of, and to track and authenticate, each marked drug unit. The need for and reliance on such non-human analytical tools elevates the cost associated with using such marks and restricts patients and/or other end users' access and ability to independently authenticate marks.
SUMMARY OF THE INVENTION In its broadest sense, the present invention includes products, systems, and methods comprising: a random integrated optical identification mark on an individual product unit; product image data based on the identification mark; a secondary product identifier; and product unit authentication or tracking based on comparison of the identification mark to product image data.
In one embodiment, the present invention includes products, systems, and methods comprising: a random integrated optical identification mark on an individual product unit; product image data based on the identification mark; a secondary product identifier associated with the individual product unit; product unit authentication based on comparison of the identification mark to product image data; and providing electronic, computer, mobile, wireless, and/or web-based technology to facilitate comparison of an identification mark on an individual product unit with the product image data.
In another embodiment, the present invention includes products, systems, and methods comprising: a random integrated optical identification mark on an individual product unit, wherein the random integrated optical identification mark is made without direct surface-to-surface contact between a marking instrument and the product unit (herein the term “deposited” is used to describe an identification mark made without direct surface-to-surface contact between a marking instrument and the product unit); product image data based on the identification mark; a secondary product identifier associated with the individual product unit; product unit authentication based on comparison of the identification mark to product image data; and providing electronic, computer, mobile, wireless and/or web-based technology to facilitate comparison of a marked product unit with the product image data.
The present invention has wide applicability to the consumer products and the regulated products market because it provides for the first time elegant products, systems, and methods by which individual product units can be marked and authenticated. For example, the principles of the present invention and variations thereof may be applied to various products including, but not limited to, electronics hardware, fashion, publishing, medical devices and disposables (such as vials or syringes), medical records, educational and professional credentials, banknotes, contracts, professional service products, etc.
For our present purposes, however, this application specifically focuses on a preferred embodiment of the present invention for use with creating a secure drug product system involving the random marking of drug product units to facilitate authentication. Accordingly, the present invention can be used to protect public health and industry by providing an elegant solution to widespread drug counterfeiting, derivation, and authentication problems.
Conventional technologies related to drug product manufacture, optical and pattern recognition, and electronic, computer, mobile, wireless, and/or web-based technology may be used together with the present invention; nonetheless, it is also contemplated that further developments in each of these technology areas may be forthcoming that may also be used together with the present invention. Further, the present invention, as a whole, substantially builds on and significantly departs from each these widely divergent technological fields. Accordingly, the present invention gives rise to wholly new and fundamentally distinct products, systems, and methods and significant and unexpectedly superior results leading to easier, cheaper, faster, better, safer, more certain, and more user-friendly unit-level product authentication.
Contrary to conventional drug product identification regimes for individual solid oral drug units which involve the identification of drug units based on conformity to a general pre-set type, the present invention involves random integrated, i.e., non-separable, marking of drug units to track and authenticate individual drug units.
One of many advantages arising from the present invention is that it can be synergistically used with existing and/or forthcoming drug product identification systems and regimes. That is, the present invention may be synergistically used with other secure labeling practices (e.g., QR codes, bar codes, RFID systems, etc.) already used, or to be developed for use with, drug product packaging to track and authenticate individual drug units. A further advantage is that the present invention may be implemented on a per unit basis together with current “code imprint” requirements such that it need not interfere with other uniform drug product features. Such other secure labeling practices and/or drug product “code imprint” requirements may comprise one or more “secondary product identifiers” in accordance with the present invention.
Another principle advantage of the present invention is that marking is deposited, such that it does not require surface-to-surface contact between a marking instrument and each solid oral drug unit in order to uniquely mark each unit. This feature of the present invention fundamentally distinguishes the present invention over the use of bar codes, engravings, stamps, etc. Not only are marking products, systems, and methods that involve surface-to-surface contact more complicated, more time-consuming, and likely more expensive to implement, but such an approach also risks compromising the integrity and/or stability of the drug unit due to the increased pressure, temperature differentials, and extra handling involved with the direct marking contact required to uniquely identify each drug unit.
Another principle advantage of the present invention is that it is highly adaptable to accommodate a wide range of varying levels of tracking and authentication security. For example, the present invention may only require that a user visually compare a randomly marked drug unit with drug unit image data (e.g., one or more secured captured images) in order to authenticate the drug unit. Thus, the present invention delivers a means of drug authentication directly to the drug unit consumer that does not require that the consumer either have or know how to use fancy, expensive, and/or complicated image data tools. Accordingly, this invention empowers individual patients by giving them a greater measure of control over their own health care, since the present invention allows the patient to “trust their own eyes” using their own independent visual authentication. Alternatively, the present invention also permits an extremely high level of authentication security that can involve the use of secondary product identifiers, varying levels of image analysis, biometric data, etc.
BRIEF DESCRIPTION OF THE DRAWINGS FIGS. 1A, B, C, and D depict prior art marked drug units suitable for use with the present invention.
FIGS. 2A and B depict marked drug units including exemplary data indicators used in the analysis of marking information.
FIG. 3 depicts a packaging line station for drug units according to the present invention.
FIG. 4 depicts variations of drug unit markings that may be used in accordance with the present invention.
FIG. 5 provides a flow chart for an exemplary low security marked drug unit authentication process.
FIG. 6 provides a flow chart for an exemplary production process involving the integrated marking of drug units.
DETAILED DESCRIPTION OF THE INVENTION This invention comprises: random integrated optical identification marking of an individual drug unit; a lack of direct surface-to-surface contact between a marking instrument and the drug unit, i.e., deposition of a mark; drug unit image data based on the identification mark; a secondary product identifier associated with the individual drug unit; and comparing the marked drug unit to drug unit image data.
As used herein, the term “drug unit” refers to any solid and/or semi-solid drug dosage unit for external or internal use in a human or animal subject, including, but not limited to, pills, tablets, capsules, lozenges, wafers, patches, therapeutic bandages, suppositories, and/or other solid or semi-solid absorbables placed outside of or within a body. Drug units are in no way limited to solid oral drug dosage forms.
As used herein, the terms “mark,” “marked,” and “marking” refer to the random optical modification on the surface of and/or within each drug unit itself using one or more of dots, spots, shapes, splashes, sprays, splatters, speckles, threads, granules, or the like. Optionally, marking may comprise multiple tiers and, for example, additionally include one or more additional nano-blocks, nano-cubes, nano-particles, or nano-dice embedded in the drug unit.
As used herein, the term “secondary product identifier” refers to any additional drug product identification, such as QR codes, bar codes, RFID systems, etc., located on the drug product packaging (including boxes, bottles, lids, blister packs, labels, tags, information sheets, pamphlets, etc.), any associated information such as a receipt or a prescription, any uniform drug product characteristics, and/or any such removable component associated with the drug unit, etc.
As used herein, the term “internet website” refers to any electronically-aided communication, and may or may not involve the internet and may or may not operate in a public or private sphere.
1. Drug Unit Marking
Drug unit-level marking is based on random optical modification on the surface of and/or within each drug unit itself using one or more of dots, spots, shapes, splashes, splatters, speckles, threads, granules, or the like, to mark each drug unit. The random unit-level marking is done by deposition, i.e., without requiring any direct surface-to-surface contact between a marking device and the drug unit surface. Random marking of each drug unit itself can be accomplished by: (1) dotting, spotting, splashing, spraying, splattering, speckling, adding threads, and/or adding granule marking materials to the surface of the drug unit; and/or (2) mixing or otherwise integrating marking components (e.g., colored granules or other components) into a base formulation of the drug unit. The marking of each drug unit may involve one or more of various colors and/or materials. Optionally, marking may comprise multiple tiers involving both surface markings and one or more marking components integrated within the base formulation of the drug unit, such as threads, granules, nano-blocks, nano-cubes, nano-particles, nano-dice, etc.
Importantly, the marking of each drug unit is integral and inseparable from each drug unit itself. Accordingly, the marking cannot be removed from the drug unit without detectable destruction of the drug unit itself.
In a preferred embodiment, the marking materials can be used in a manner complementary to, and not impeding, drug product “code imprints” or other general characteristics used to identify particular drug products.
The visual or optical marking modification of the drug unit surface optionally allows for varying levels of penetration of one or more marking materials into the drug unit surface. Marked drug units may optionally include a protective, sealing, and/or otherwise image-enhancing top or outer coating.
The one or more marking materials can be applied to an entire external surface of a drug unit. Alternatively, the one or more marking materials can be applied to a particular surface or surfaces, location, segment, region, or limited area of the drug unit. The marking materials can be applied in a particular sequential order, series, and combination, or simultaneously. The marking materials may or may not generally conform to a general design or pattern, a set tolerance allowance for unit-to-unit variability, etc. The marking materials may be visible or invisible to the naked human eye, and/or visible or invisible with the aid of technology-enhanced vision, machine-aided, and/or computer-aided vision. The marking materials may alter the surface texture and/or tactile feel of the drug unit.
In one embodiment, materials and methods used for the random marking of drug units may, optionally, vary for each production lot, batch, production date, or any other such production groups. This production group level of variation can both 1) further aid drug unit-level tracking and authentication by further increasing the ability to provide unique and readily identifiable markings tied to other production information, and 2) decrease the likelihood of effective counterfeiting efforts by continued alteration of random marking production parameters.
Conventional methods and materials, including regulation approved (e.g., U.S. Food and Drug Administration (“FDA”)) materials, can be used to accomplish the random marking of drug units. Accordingly, marking materials may comprise one or more inks, dyes, and/or color additives, including but not limited to, alumina (dried aluminum hydroxide), annatto extract, calcium carbonate, canthaxanthin, caramel, β-carotene, cochineal extract, carmine, potassium sodium copper chlorophyllin (chlorophyllin-copper complex), dihydroxyacetone, bismuth oxychloride, synthetic iron oxide, ferric ammonium ferrocyanide, ferric ferrocyanide, chromium hydroxide green, chromium oxide greens, guanine, mica-based pearlescent pigments, pyrophyllite, mica, talc, titanium dioxide, aluminum powder, bronze powder, copper powder, zinc oxide, FD&C Blue No. 1, FD&C Blue No. 2, D&C Blue No. 4, FD&C Green No. 3, D&C Green No. 5, D&C Green No. 6, D&C Green No. 8, D&C Orange No. 4, D&C Orange No. 5, D&C Orange No. 10, D&C Orange No. 11, FD&C Red No. 3, FD&C Red No. 4, D&C Red No. 6, D&C Red No. 7, D&C Red No. 17, D&C Red No. 21, D&C Red No. 22, D&C Red No. 27, D&C Red No. 28, D&C Red No. 30, D&C Red No. 31, D&C Red No. 33, D&C Red No. 34, D&C Red No. 36, D&C Red No. 39, FD&C Red No. 40, D&C Violet No. 2, FD&C Yellow No. 5, FD&C Yellow No. 6, D&C Yellow No. 7, Ext. D&C Yellow No. 7, D&C Yellow No. 8, D&C Yellow No. 10, D&C Yellow No. 11, and/or other FDA approved color additives.
2. Drug Unit Image Data
The present invention additionally involves capturing at least one image corresponding to each randomly marked drug unit. Multiple images of each drug unit may also be taken from one or more perspectives. Multiple images of each drug unit may also be taken under one or more different environmental, lighting, and speed conditions. Multiple images of each drug unit may also be taken at one or more discreet times.
Images of drug units may be taken separately for each individual drug unit. Images may also be taken of multiple drug units together. Images of drug units may be taken prior to, during, or after packaging. For example, one or more images may be taken of multiple drug units comprising parts of the same production run. Also, one or more images may be taken of multiple drug units packaged together in a transparent blister pack. In another example, one or more images of the contents of a particular pill bottle, including each of the individual drug units, may be taken.
Information, including secondary identifier information, can be associated with each captured image and/or drug unit image data. Additional information, such as the production details associated with the batch and lot number, production date, production location, source, type of drug, amount of drug, drug formulation, dosage information, expiration, prescription information, and storage information, etc., can also be associated with captured images and/or drug unit image data. Such additional information can be associated with the captured image at the time of image capture or at any time subsequent to image capture.
Image and/or any image-related data will be securely maintained. Secure maintenance of the image data and any image-related information can be performed by, for example, the drug manufacturer or company, a trusted third party or service, or any other secure intermediary.
In a preferred embodiment, image capture occurs upon the initial production of each randomly marked drug unit at the manufacturing plant, and as soon as possible after the random markings are “fixed,” or static.
In another preferred embodiment, the images are captured under particular controlled environmental, lighting, flow rate, production, and/or throughput conditions. Image capture, according to the present invention, can be accomplished in production environments involving high-speed and high volumes of individual drug units. In an alternative embodiment, image data for marked drug units is captured for slowed, stalled, still, or non-moving drug units.
In addition to image capture, the present invention can include the use of conventional optical and/or pattern recognition technology based on captured images to authenticate, verify, and track marked drug units. Such optical and/or pattern recognition and image analysis can be performed for one or more images corresponding to each marked drug unit. The optical and/or pattern recognition and image analysis can be performed for each marked drug unit regardless of whether the drug unit has a flat, non-flat, regular, irregular, curved, three-dimensional, smooth, non-smooth, shaped, bumpy, etched, or otherwise non-uniform surface. In a preferred embodiment, the optical and/or pattern recognition technology can properly orient, compare, and/or combine or match images relating to the same drug unit but captured from different angles or perspectives relative to the drug unit and/or using only a portion of a marking.
The optical and/or pattern recognition and image analysis can involve any one or more of several characterization/analysis techniques. For a given marked drug unit, this includes, but is not limited to, measuring the distance of a random spot(s) center to edge of a drug unit, determining the equation of a line drawn from marking fragment to marking fragment; basing analysis on a grid x,y location, basing analysis on vector length and radius angle from the center point of the drug unit, etc. The optical and/or pattern recognition and image analysis can occur at any time contemporaneous with, or after, the one or more images of the drug unit are captured.
The optical and/or pattern recognition technology and the implementing electronics, computers, computer programs, computer applications, software, wireless, and/or mobile technologies and applications used with the present invention can also be especially adapted to interface with each randomly marked drug unit and captured image data and/or image-related data as discussed further below.
3. Secondary Product Identifiers
The present invention may also be synergistically used with additional separable marked product packaging, product labels, and/or other secondary product identifiers for drug product tracking and authentication (e.g., QR codes, bar codes, RFID systems, etc.). Such secondary product identifiers are conventionally used. The present invention, however, also contemplates the incorporation of additional secondary product identifiers yet to be developed.
4. Security
The present invention provides for varying and customizable levels of security and includes numerous low security, medium security, and high security embodiments. It is understood that myriad variations of the examples noted below are within the scope of the present invention.
According to the present invention, any drug unit image data is securely stored. For example, drug unit image data can be stored in a secured database. In a preferred embodiment, access to, and use of, the secure drug unit image data is triggered by user request. The present invention allows one or more of any of the drug unit manufacturer, the drug unit provider, the drug unit distributor, the drug unit retailer, the drug unit dispenser, and/or the drug unit consumer to set one or more of varying security levels.
In one preferred embodiment, the drug unit manufacturer sets a minimum security level that may be heightened by a downstream drug unit recipient seeking greater assurance as to drug unit authenticity.
An example of a low security embodiment that excludes the use of machine-aided vision or optics, but instead involves readily accessible human visual verification, provides that: (1) the user provides secondary product identifier information associated with the product packaging for a drug unit to an internet website; (2) the user receives a response that includes one or more drug unit images associated with the secondary product identifier information; and (3) the user makes a visual comparison of the drug unit with the one or more drug unit images to determine authenticity of the drug unit.
An example of a medium security embodiment involving visual and exchanged image data verification provides that: (1) the user provides secondary product identifier information associated with the product packaging for a drug unit and a photograph of the drug unit to an internet website; (2) the user receives a response regarding the authenticity of the drug unit that includes both a machine-vision analysis of the drug unit photograph provided by the user as compared to the captured image data for the drug unit and one or more drug unit images from a captured image database; and (3) the user, optionally, separately makes a visual comparison of the drug unit with the one or more drug unit images from the captured image data database to determine authenticity of the drug unit.
Another example of a medium security embodiment involving visual and exchanged image data verification provides that: (1) the user provides secondary product identifier information associated with the product packaging for a drug unit to an internet website; (2) the user takes a drug unit photograph that is analyzed by the user's image capture device; (3) the user's image capture device sends the analyzed image data to an internet website; (4) the analyzed image data prepared by the user's image capture device is compared to the captured image information for the drug unit in or from the captured image database; (5) the user receives a response regarding the authenticity of the product from the internet website and one or more drug unit images from the captured image database; and (6) the user, optionally, separately makes a visual comparison of the drug unit with the one or more drug unit images from the captured image database to determine authenticity of the drug unit.
Still another medium security embodiment additionally involves user-specific identification, which may include requiring that a user access code based on the product serial number be allocated to the specific person to have custody of the product before any drug unit image data is provided for comparison.
An example of a high security embodiment involves a secondary product identifier and exchanged image data verification as noted above in the medium security embodiments, and further involves requiring that a public encryption key be sent to an internet website along with a photograph of the user. In this high security embodiment, the public encryption key is matched to a private database key, and the photograph of the user is identity-matched to stored image information for the user. The user may be presented with the drug unit image data and the user image identity comparisons between the user-provided information and the private database may be shown side by side. Optionally, as presented, the compared image data may receive a numerical estimate of authentication match, such as “99.3% match” or a statement such as “accuracy of estimate is to within one of 48 billion.”
Another example of a high security embodiment involves performing the drug unit authentication at a secure location. That is, the secure location includes any tools involved in the authentication including, for example, scanning (if necessary) the secondary product identifier and taking a photograph of the drug unit and, optionally, taking an identification photograph of the user. This securely obtained information is then compared to stored image information for the drug product, drug unit, and, optionally, the user. For example, the secured locations may be any of a pharmacy, hospital, clinic, distribution center, retailer, etc.
Whenever there is no match between compared images and/or image data, or a negative response is generated, a text message, website address or link, or telephone 1-800 hotline may be provided to the user to report the potential counterfeit product. The drug unit company and/or appropriate authorities may also be notified. Cash rewards or other incentives can be provided to the user to report and/or deliver the counterfeit material to an appropriate entity.
5. Systems
Computer programs, software, applications, electronic systems, and methods, including wireless and mobile applications, are part of the present invention.
In a preferred embodiment, the invention relates to a system involving: random integrated optical marking of individual drug product units and secondary product identifiers (e.g., QR codes, bar codes, RFID systems, etc.); captured, analyzed, stored, transmitted, and/or compared drug unit image data; and remote devices (such as smart phones, etc.) used for drug unit authentication.
Systems of the present invention can involve one or more computers, servers, computer programs, computer applications, wireless or mobile devices, electronic systems, software programs and/or applications, and/or the like, to authenticate, verify, and track marked drug units at multiple locations and/or over time by capturing, analyzing, storing, encrypting, communicating, and/or comparing drug unit image data.
In a preferred embodiment, drug unit image data is captured, analyzed, stored, and encrypted in a first location and the drug unit image data is communicated between and/or compared at at least a first location and a second location. In another embodiment, drug unit image data is captured, analyzed, stored, and optionally encrypted, in both a first location associated with drug unit creation and a second separate location associated with user authentication.
Communication and comparison of the drug unit image data can occur using public and/or private channels and can occur at one or more of any number of locations. In a preferred embodiment, communication and comparison of drug unit image data is done over the internet and involves at least one secured drug unit image data location. Locations according to the present invention can be numerous and are not geographically limited.
The present invention comprises a system for drug authentication comprising: a uniquely marked individual drug dosage form; one of optical and pattern recognition technology; and one of a computer, computer program, computer application, and/or software to collect, analyze, store, encrypt, transmit, or communicate information related to the uniquely marked individual drug dosage form. The unique mark of the individual drug dosage form is an integral part of the drug dosage form. The unique mark of the individual drug dosage form is one of on the surface of, impregnated within, and distributed throughout the drug dosage form. The optical or pattern recognition technology includes imaging information specific to the uniquely marked individual drug dosage form. The imaging information is collected from a three-dimensional surface of the uniquely marked individual drug dosage form.
A preferred embodiment the present invention, however, relates to a secure drug system comprising:
integral security marking directly on the surface of, impregnated on the surface of, or otherwise within the drug products themselves;
individual unique integral security marking for each solid and/or semi-solid drug dosage unit, including, but not limited to, pills, tablets, capsules, lozenges, wafers, patches, therapeutic bandages, suppositories and/or other solid absorbables for external or internal use in a human or animal subject;
individual unique integral security marking for each production lot, batch, or other such production unit comprising solid or semi-solid drug dosage forms;
individual unique integral security marking materials comprising one or more inks, dyes, and/or color additives, including but not limited to, alumina (dried aluminum hydroxide), annatto extract, calcium carbonate, canthaxanthin, caramel, β-carotene, cochineal extract, carmine, potassium sodium copper chlorophyllin (chlorophyllin-copper complex), dihydroxyacetone, bismuth oxychloride, synthetic iron oxide, ferric ammonium ferrocyanide, ferric ferrocyanide, chromium hydroxide green, chromium oxide greens, guanine, mica-based pearlescent pigments, pyrophyllite, mica, talc, titanium dioxide, aluminum powder, bronze powder, copper powder, zinc oxide, FD&C Blue No. 1, FD&C Blue No. 2, D&C Blue No. 4, FD&C Green No. 3, D&C Green No. 5, D&C Green No. 6, D&C Green No. 8, D&C Orange No. 4, D&C Orange No. 5, D&C Orange No. 10, D&C Orange No. 11, FD&C Red No. 3, FD&C Red No. 4, D&C Red No. 6, D&C Red No. 7, D&C Red No. 17, D&C Red No. 21, D&C Red No. 22, D&C Red No. 27, D&C Red No. 28, D&C Red No. 30, D&C Red No. 31, D&C Red No. 33, D&C Red No. 34, D&C Red No. 36, D&C Red No. 39, FD&C Red No. 40, D&C Violet No. 2, FD&C Yellow No. 5, FD&C Yellow No. 6, D&C Yellow No. 7, Ext. D&C Yellow No. 7, D&C Yellow No. 8, D&C Yellow No. 10, D&C Yellow No. 11, and/or other U.S. Food and Drug Administration approved color additives;
individual unique integral security marking materials comprising one or more inks, dyes, and/or color additives as applied in a particular sequential order, series, combination, and/or generally conforming to a general design or pattern, etc.;
individual unique integral security marking materials comprising one or more inks, dyes, and/or color additives, wherein the inks, dyes, and/or color additives are visible or invisible to the naked human eye, and/or visible or invisible with the aid of technology-enhanced vision or computer-aided vision;
optical and/or pattern recognition technology and computers, computer programs, computer applications, and/or software to interface with the individual unique integral security marking;
optical and/or pattern recognition technology and computers, computer programs, computer applications, and/or software to interface with the individual unique integral security marking, wherein each individual unique integral security marking may be in one or more various colors;
optical and/or pattern recognition technology and computers, computer programs, computer applications, and/or software to interface with the individual unique integral security marking, and to analyze, capture, store, and/or compare an image and/or information associated with the individual unique integral security marking;
optical and/or pattern recognition technology and computers, computer programs, computer applications, and/or software to interface with the individual unique integral security marking, to analyze, capture, store, encrypt, and/or compare an image and/or information associated with the individual unique integral security marking, and to transmit, relay, encrypt, and/or communicate the image and/or information with one or more other computers, including mobile devices such as smart phones, etc.;
optical and/or pattern recognition technology and computers, computer programs, computer applications, and/or software to interface with the individual unique integral security marking, to analyze, capture, store, encrypt, and/or compare an image and/or information associated with the individual unique integral security marking, to transmit, relay, encrypt, and/or communicate the image and/or information to and/or from a first location of image and/or information analysis, capture, storage, and/or comparison to and/or from a second location involving one or more computers and/or devices that are local and/or distant;
optical and/or pattern recognition technology and computers, computer programs, computer applications, and/or software to interface with the individual unique integral security marking, to analyze, capture, store, encrypt, and/or compare an image and/or information associated with the individual unique integral security marking, to transmit, relay, encrypt, and/or communicate the image and/or information to and/or from a first location of image and/or information analysis, capture, storage, encryption, and/or comparison to and/or from a second location involving one or more computers and/or devices that are local and/or distant, wherein the transmission, relay, and/or communication is via a private network and/or via the internet and may, or may not, involve one or more computers, servers, and/or mobile devices;
optical and/or pattern recognition technology and computers, computer programs, computer applications, and/or software to interface with the individual unique integral security marking, to analyze, capture, store, encrypt, and/or compare an image and/or information associated with the individual unique integral security marking, to transmit, relay, encrypt, and/or communicate the image and/or information to and/or from a first location of image and/or information analysis, capture, storage, encryption, and/or comparison to and/or from a second location involving one or more computers and/or devices that are local and/or distant, wherein the transmission, relay, and/or communication is via a private network and/or via the internet and may, or may not, involve one or more computers, servers, and/or mobile devices, and wherein the second location also includes an optical and/or pattern recognition technology and computers, computer programs, computer applications, and/or software to interface with the individual unique integral security marking to authenticate, encrypt, verify, and track the marked product;
optical and/or pattern recognition technology and computers, computer programs, computer applications, and/or software such as that described above available in a web-based application for use on mobile devices, including smart phones, etc.;
optical and/or pattern recognition technology and computers, computer programs, computer applications, and/or software to interface with the individual unique integral security marking, wherein each individual unique integral security marking may be on a non-flat, three-dimensional, smooth, or non-smooth surface;
a controlled environment optical and/or pattern recognition technology and software, wherein the controlled environment may involve particular lighting, high-speed, high volumes, and/or high throughput;
any method of practicing the invention involving any of the various embodiments described above;
any method of practicing the invention involving any of the various embodiments described above to counter, prevent, or reduce the counterfeit drug trade; any method of practicing the invention involving any of the various embodiments described above to assure an end user subject that the drug they have is authentic and its origin and history is known; and
any method of practicing the invention involving any of the various embodiments described above wherein a user of a computer and/or mobile device, including an individual patient, doctor, or pharmacist, can authenticate, verify, and track a product marked and analyzed in accordance with this invention.
6. Methods
Recipients of drug units marked with random optical integrated identification markings, such as patients, pharmacists, hospitals, clinics, physicians, nurses, etc., can use secondary product identifiers associated with the drug units, hardware incorporating or implementing appropriate computer software, computer applications, computer programs, wireless technologies, mobile applications, and an “internet website” to use drug unit image data, for comparing and authenticating the drug units.
In one preferred embodiment, recipients use visual image data corresponding to secondary product identifiers to visually verify and confirm drug unit authenticity without machine-aided or computer-aided vision. For example, a user may obtain one or more captured image photographs corresponding to the drug unit and, simply by looking, authenticate the drug unit.
In another embodiment, downstream drug unit recipients can use machine-aided or computer-aided assistance together with secondary product identifiers associated with the drug product to optically compare, verify, and confirm drug unit authenticity based on drug unit image data. For example, a downstream recipient may take and send one or more photographs corresponding to the drug unit for comparison to potentially corresponding drug unit image data to authenticate the drug unit.
The present invention includes any method of practicing the invention according to any disclosure provided in this application including any of the various embodiments described above. The present invention also includes any method of practicing the invention to counter, prevent, or reduce the counterfeit drug trade. The present invention also includes any method of practicing the invention to ensure drug unit authenticity and provide confidence to a user that the drug they have is authentic and its origin and history is known.
Claims 1. A drug unit authentication system, comprising:
a plurality of drug units, each drug unit containing a drug common to the plurality of drug units, and each drug unit having a deposited random integrated optically identifiable marking on a surface of or within a drug unit, wherein the marking of each drug unit in the plurality of drug units is unique and differentiatable from the markings of all other of the drug units in the plurality of drug units; drug unit image data unique for each of the plurality of drug units and being related to the unique and differentiatable marking of each of the plurality of drug units; a secondary product identifier common to the plurality of the drug units and related to the common drug of the plurality of drug units; and a comparator configured to perform an optical comparison of a selected one of the drug units and the drug unit image data associated with the selected one of the drug units. 2. The system of claim 1, wherein the deposited random integrated optically identifiable marking includes one or more of dots, spots, shapes, splashes, sprays, splatters, speckles, threads, and granules.
3. The system of claim 1, wherein the deposited random integrated optically identifiable marking is both on a surface of and within the drug unit.
4. The system of claim 1, wherein the drug unit image data comprises information based on the deposited random integrated optically identifiable marking.
5. The system of claim 4, wherein the drug unit image data further comprises information associated with the secondary product identifier.
6. The system of claim 4, wherein the drug unit image data further comprises information associated with drug unit production details.
7. The system of claim 1, wherein the secondary product identifier is on or within a removable component associated with the drug unit.
8. The system of claim 1, wherein the secondary product identifier is one of a quick response code, bar code, and a radio-frequency identification system.
9. The system of claim 1, further comprising customizable security levels.
10. The system of claim 1, wherein the system comprises human-readable drug unit image data.
11. The system of claim 1, further comprising one of electronic, computer, mobile, wireless, and web-based technologies.
12. The system of claim 1, wherein the drug unit image data comprises information based on one of optical and pattern recognition technologies.
Which of the following categories best describes your solution?
A new application of an existing technology
Please select the technologies currently used in your solution:
Artificial Intelligence / Machine Learning
Imaging and Sensor Technology
Internet of Things
Software and Mobile Applications
Which of the UN Sustainable Development Goals does your solution address?
3. Good Health and Well-being
10. Reduced Inequalities
In which countries do you currently operate?
United States
Your Team
What type of organization is your solution team?
For-profit, including B-Corp or similar models
How many people work on your solution team?
4
How long have you been working on your solution?
5 years
What is your approach to incorporating diversity, equity, and inclusivity into your work?
Using Ai generated talking personality Avatars, we are able to display any ethic group, speak any language, dispense any oral medication, with or without communication to the internet, at the lowest possible cost to the healthcare system and to patients
Your Business Model & Funding
What is your business model?
Business Model – Medicare Part D Coverage Reimbursement The product offerings that will be developed by TruMedicines is a Hardware and software service that tracks/traces/authenticates drug doses to monitor patient drug regime compliance. Insurance & Medicare coverage, the Current Procedural Terminology (CPT®) codes offer doctors and health care professionals a uniform language for coding medical services and procedures to streamline reporting, increase accuracy and efficiency. CPT codes are also used for administrative management purposes such as claims processing and developing guidelines for medical care review. The TelePack device is covered TruMedicines A2314-052- A2D-0519 and can expect reimbursement payments from healthcare insurance providers participating in Medicare Part D coverage by the following CPT codes 99453, 99454, 99457, 99458, 99473, 99474, 99607, 99490. Descriptions of Telemedicine CPT codes developed from the American Medication Association (AMA) Reference link https://www.ama-assn.org/pract... 99358 Prolonged physician services without direct patient contact; first hour Note: This code is no longer an “add-on” service and can be reported alone. 99359 each additional 30 min. (use in conjunction with 99358) 99421: Online digital evaluation and management service, for an established patient, for up to 7 days, cumulative time during the 7 days; 5–10 minutes 99422: Online digital evaluation and management service, for an established patient, for up to 7 days cumulative time during the 7 days; 11– 20 minutes 99423: Online digital evaluation and management service, for an established patient, for up to 7 days, cumulative time during the 7 days; 21 or more minutes. Clinicians who may not independently bill for evaluation and management visits (for example – physical therapists, occupational therapists, speech language pathologists, clinical psychologists) can also provide these e-visits and bill the following codes: G2061: Qualified non-physician healthcare professional online assessment and management, for an established patient, for up to seven days, cumulative time during the 7 days; 5–10 minutes G2062: Qualified non-physician healthcare professional online assessment and management service, for an established patient, for up to seven days, cumulative time during the 7 days; 11–20 minutes G2063: Qualified non-physician qualified healthcare professional assessment and management service, for an established patient, for up to seven days, cumulative time during the 7 days; 21 or more minutes. G2012: Brief communication technology-based service, e.g. virtual check-in, by a physician or other qualified health care professional who can report evaluation and management services, provided to an established patient, not originating from a related e/m service provided within the previous 7 days nor leading to an e/m service or procedure within the next 24 hours or soonest available appointment; 5-10 minutes of medical discussion. G2010: Remote evaluation of recorded video and/or images submitted by an established patient (e.g., store and forward), including interpretation with follow-up with the patient within 24 business hours, not originating from a related e/m service provided within the previous 7 days nor leading to an e/m service or procedure within the next 24 hours or soonest available appointment. Virtual check-ins can be conducted with a broader range of communication methods, unlike Medicare telehealth visits, which require audio and visual capabilities for real-time communication. 99444: Online evaluation and management service provided by a physician or other qualified healthcare professional to an established patient, guardian or health care provider no originating from a related E/M service provided within the previous 7 days, using the internet or similar electronic communications network 99451 Interprofessional telephone/internet/electronic health record assessment and management service provided by a consultative physician, including a written report to the patient's treating/requesting physician or other qualified health care professional, 5 minutes or more of medical consultative time. TruMedicines A2314-052- A2D-0519 99451 is reported by the consultant, allowing him/her to access data/information through the electronic health record (EHR), in addition to telephone or internet. 99452 is reported by the requesting/treating physician/QHP (e.g., the primary care physician). 99453: “Remote monitoring of physiologic parameter(s) (e.g, weight, blood pressure, pulse oximetry, respiratory flow rate), initial; set-up and patient education on use of equipment.” 99454: “Device(s) supply with daily recording(s) or programmed alert(s) transmission, each 30 days.” What to know: CPT 99454 offers reimbursement for providing the patient with a RPM device for a 30-day period. Note that 99454 can be billed each 30 days. 99455 - CPT® Code in category: Work Related or Medical Disability Evaluation Services 99456 are both designated to cover work-related or medical disability exams. covers an exam provided by someone other than the treating physician. 99457: “Remote physiologic monitoring treatment management services, 20 minutes or more of clinical staff/physician/other qualified healthcare professional time in a calendar month requiring interactive communication with the patient/caregiver during the month.” 99458 (Remote physiologic monitoring treatment management services, clinical staff/physician/other qualified health care professional time in a calendar month requiring interactive communication with the patient/caregiver during the month; additional 20 minutes) 98970, Per CPT; “For online digital E/M services provided by a qualified nonphysician health care professional who may not report the physician or other qualified health care professional E/M services (eg, speech-language pathologists, physical therapists, occupational therapists, social workers, dietitians), see ).” 98970 Qualified nonphysician health care professional online digital evaluation and management service, for an established patient Regulatory Status – Class I – Exempt Daily Assistive Device Regulatory Classed Medical Device FDA Class I exempt CFR 21 § 890.5050-NXB 2799, GMP exempt (Daily activity assist device) The product will be a "plug and play" product that will fit to any existing clinical data capture system with Medicare Part D reimbursement. The product will be sold online as a subscription service SAAS (software-as-a-service) in conjunction with hardware TelePack rentals. TruMedicines plans to produce the product through contract manufacturing, and is not planning to establish its own facility for production. TruMedicines will use OEM manufacturing according to the unique chosen design in the end of the development process. In the first year of commercial sales production of hardware will be carried out through our developing partner (up to a level of 100,000 devices per year). Product is intended to be sold first in leading North America, USA, Mexico and Canada. Initial placement of the product in North America will lead, in our opinion, to faster adoption of our novel technology in rest of world. Initial product placement will be in USA, which are leading in number of clinical studies and are an accessible market. TruMedicines plans to sell the product through online distribution channels. In the first stages, sales will be established through online distributors of hardware equipment, while the technical and scientific TruMedicines A2314-052- A2D-0519 support will base in the company itself. Further expansion of sales will be established through partnerships with large contract hardware equipment manufacturers such of computer devices such as Cardinal Health, Amazon Pill Pack, CVS drugs, Healtch Insurance companies Bright Health, BlueCross Blue Shield, Aetna. Our marketing strategy is dual – the general promotion of the new technology will be led by the company with focus on a mix of sponsoring and participating in Medicare reimbursement conventions, sponsoring lectures by key opinion leaders in conventions and large medical centers and by web based promotion. It is the intention of TruMedicines to establish a web based virtual training for Medicare reimbursement setup and deployment of the TruMedicines platform. The second arm of our promotion strategy will be executed through our distributors, through direct contact with Health insurance Medicare Part D providers and heads of Healthcare Insurance divisions in order to directly promote and educate about our technology. It is our intention to invest significantly in education and training of our distributors in order to accomplish this end. Pricing strategy – TruMedicines will sell the software a subscription service online and hardware sales and support through its distributors, with a base target yearly subscription price of approx. $1,250/user including a distributor commission of 20%. The price for each customer will be based on number of users and number of hardware devices needed. TruMedicines will license to use the technology for a single procedure and services (technical support and problem solving). We have considered additional pricing strategies including fixed licensing fee per patient or a period of time since each new customer. This will require significant resources in following up license periods and customer details. As the use of the technology expands we will consider licensing agreements with large centers on a basis of number of procedures per period of time. Our Five year Financial Strategy We are currently in the Grant Round of our product development strategy.
Do you primarily provide products or services directly to individuals, to other organizations, or to the government?
Organizations (B2B)
What is your plan for becoming financially sustainable?
TruMedicines plans to sell the product through online distribution channels. In the first stages, sales will be established through online distributors of hardware equipment, while the technical and scientific TruMedicines A2314-052- A2D-0519 support will base in the company itself. Further expansion of sales will be established through partnerships with large contract hardware equipment manufacturers such of computer devices such as Cardinal Health, Amazon Pill Pack, CVS drugs, Healtch Insurance companies Bright Health, BlueCross Blue Shield, Aetna. Our marketing strategy is dual – the general promotion of the new technology will be led by the company with focus on a mix of sponsoring and participating in Medicare reimbursement conventions, sponsoring lectures by key opinion leaders in conventions and large medical centers and by web based promotion. It is the intention of TruMedicines to establish a web based virtual training for Medicare reimbursement setup and deployment of the TruMedicines platform. The second arm of our promotion strategy will be executed through our distributors, through direct contact with Health insurance Medicare Part D providers and heads of Healthcare Insurance divisions in order to directly promote and educate about our technology. It is our intention to invest significantly in education and training of our distributors in order to accomplish this end. Pricing strategy – TruMedicines will sell the software a subscription service online and hardware sales and support through its distributors, with a base target yearly subscription price of approx. $1,250/user including a distributor commission of 20%. The price for each customer will be based on number of users and number of hardware devices needed. TruMedicines will license to use the technology for a single procedure and services (technical support and problem solving). We have considered additional pricing strategies including fixed licensing fee per patient or a period of time since each new customer. This will require significant resources in following up license periods and customer details. As the use of the technology expands we will consider licensing agreements with large centers on a basis of number of procedures per period of time. Our Five year Financial Strategy We are currently in the Grant Round of our product development strategy. Our
Share some examples of how your plan to achieve financial sustainability has been successful so far.
