Patent (novel, non-obvious and useful) vs. Innovate Yes - we CAN do both! The 2015 ASQ Innovation Conference September 19-20
Invention (Patent) vs. Innovation Education vs. Training Can we start with this analogy Education and training are often used interchangeably. Though closely related, education and training are not the same. Education usually refers to the acquisition of information (knowledge). Training usually refers to the acquisition of skills (both cognitive and psychomotor). Thus there is a need for pre-training education. 2
Invention (Patent) vs. Innovation Education vs. Training The trainee needs to know What to do, What not to do, How to do what they need to do, and How to identify when they have made a mistake. Now back to Invention vs. Innovation 3
Invention (Patent) vs. Innovation Invention vs. Innovation A common misconception is that invention and innovation are synonyms. Invention is when you dream up the next great product, and the subsequent work that goes into developing the idea such as creating drawings or building a prototype. 4
Invention (Patent) vs. Innovation Innovation Innovation is when this new idea is used alone, or in combination with other ideas, to develop a useful product that creates value such as a medical device that enhances patient care, improves performance of a surgical procedure, reduces cost compared to equivalent devices on the market or improves access to care in underserved areas. 5
Invention (Patent) vs. Innovation Innovation Thus, innovation (i.e., bringing a device to market for use), and not just invention (i.e. your idea), creates true value (2). A simple way to think about these terms is that invention typically utilizes resources (time, money, expertise, etc.) to create, whereas innovation creates values (improved healthcare outcomes, revenue, etc.). 6
Invention (Patent) vs. Innovation Innovation A healthcare professional (HCP) who has a great idea for a new medical device can become an innovator by successfully commercializing (i.e. bring the device to market) their concept! The process of commercializing a medical device can be overwhelming and complex. Providing HCPs with a general process overview helps them develop a basic understanding, beginning with an initial business and technology assessments. 7
Medical Device Life Cycle Human Factors & Usability Regulated Phase Ethnographic Research Testing & Validation 8
Intellectual Property Assessment
Intellectual Property Assessment Freedom to Operate It is important when commercializing a product to ensure the product does not encroach on a previously granted patent while providing you with the right to exclude others from making and selling the device. Clarification Point: A U.S. patent does not grant the inventor the right to make their device, but the right to exclude others. 10
Intellectual Property Assessment Prior Art Survey previously granted patents, as well as the medical literature, for any prior art that could be used to disqualify your patent application. Prior art entails any knowledge available to the public, including previous U.S. and international patents, previously disclosed research or concepts in the medical literature or presented in any type of public forum. In order for a patent to be granted, the device must be useful (utility), new (novel) and non-obvious (the device should be non-obvious to a person having ordinary skill in the area of the invention). The term of a U.S. patent grant is 20 years from the date of filing (5). 11
Intellectual Property Assessment Novel, non-obvious and useful In order for a patent to be granted, the device must be new (novel), non-obvious (the device should be non-obvious to a person having ordinary skill in the area of the invention) and useful (utility). The term of a U.S. patent grant is 20 years from the date of filing (5). 12
Intellectual Property Assessment First to File File a provisional patent application since it is relatively inexpensive, does not require you to determine the claims of the patent, and establishes an earlier filing date (12 month grace period prior to filing a non-provisional patent application which requires claims and is essential to have a patent granted). The U.S. transitioned from a first to invent to a first to file system in 2013. Since this change, the patent is now granted to the first person to file, and not the first person to invent (5 and 6). 13
Intellectual Property Assessment Patent Filing Use a patent attorney with knowledge of patent law to draft and file the patent. A full patent can take up to several years to be granted, and cost tens of thousands of dollars in fees, but is highly recommended if you are considering commercializing or licensing the device. Patent cost is relatively small compared to the total cost of commercialization of a medical device. The patent application will also provide you some legal protection against imitators and will be required by most investors prior to funding any startup company based on your product idea. 14
Business & Technology Assessment
Business & Technology Assessment Idea/Product Viability There are a number of factors that are important to the success of a new product or new medical device idea, ranging from creating a financially sustainable business model to obtaining intellectual property to protect your idea. Consider the following assessments: Market Risk Business Risk Technology Risk 16
Business & Technology Assessment Market Assessment What is the problem your product is trying to solve? Does this problem create an unmet need in the market, and if not why would consumers use your product over others already on the market? What is the potential size of the market for your product? What is product use frequency (single use or reusable product) both nationally and globally? Who are the users of your product and will it be adopted by those potential users? What is the possible market penetration of this product? Who are the closest competitors? What percentage of the market do they control? 17
Business & Technology Assessment Business Risk Assessment Cost: Can the product be developed and manufactured at a cost to allow competitive pricing? Early adopters: Have Key Opinion Leaders (KOLs) been identified to perform product beta testing and become product champions? Sales/Distribution: Are independent sales representatives or a direct salesforce be utilized? Licensing: Will you license the product or launch a startup venture to commercialize the product? Startup Funding: Personal funds, angel investors, venture capitalists or institutional investors? Who will manage the company on a day-to-day basis (management team)? For medical devices: Does reimbursement currently exist? 18
Business & Technology Assessment Technology Risk Assessment Does the product use technology that is currently available, or will technology need to be developed? What are the engineering challenges to develop and manufacture this product? Does the product use off the shelf components or do custom components need to be manufactured? For regulated products: Beyond product compliance requirements, do you have the capability to design, develop and manufacture this product adhering to applicable U.S. and International regulatory requirements? 19
Innovation IP Approaches
Intellectual Property Approaches Patent Assignment Working in the academic environment, like working in industry, patent assignment is typically to your employer. As an independent (non-university) inventor working with the University s Innovation Center, patent assignment must be negotiated. The negotiation starts with the University assigned all rights (to be licensed in the future) and potentially ends with the University waiving all rights. Most agreements have terms in between these two extremes. 21
Intellectual Property Approaches Take IP off the Table (it need not be an impediment) Leverage the institution s Technology Transfer programs through licensing. Bring filed IP for development not research. Invest in clearly identifying the problem or most appropriate root causes. The solutions (ideas, intellectual property, value) are often elegantly simple, straight forward and need not be outsourced. Test and Fail Fast. Confirmatory testing of an idea may be research, but does not in and of itself create intellectual property. 22
Product Development Phases
Discovery and Conceptualization Phases Conceptualization Phase Key components for a successful conceptualization phase, prototyping, proof of concept testing and iterative redesign. This is the phase when design tools like the Toyota Method are employed 7 3 1 The initial discovery and conceptualization phases are considered non-regulated, meaning that the design and testing of the device does not need to be controlled under a Quality System, as described by the FDA s Code of Federal Regulations (CFR) and international regulations (3). 24
Medical Device Life Cycle Human Factors & Usability Regulated Phase Ethnographic Research Testing & Validation 25
Product Development Phases Planning and Inputs Phase(s) With the initiation of design planning, the medical device development process is regulated, meaning that the design and testing of the device must be controlled under a Quality System, as described by the FDA s Code of Federal Regulations (CFR) and international regulations (3). The design plan is to further develop, test, manufacture and deploy the product embodiment identified in the conceptualization phase. A process like the Toyota method may or may not have been used to focus in on a single product embodiment. 26
Product Development Phases Planning and Inputs Phase(s) Charter a multidisciplinary team and refine Voice of the Customer (VoC) data. Using tools like QFD or the House of Quality, derive product design inputs (non-solution dependent requirements). Design Inputs (Design Requirements) are to: address the intended use of the device, include the needs of the user and patient, be complete, unambiguous, free of conflicting requirements and testable. Automated tools can help facilitate requirements management both during development and post market launch but are user dependent (GIGO). 27
Innovation Development Approaches
Development Approaches Multidisciplinary Teams Form the team as early as possible (i.e. before the regulated phases) using internal/external resources or both. The core team should be comprised of individuals with expertise in at least the following areas: Engineering and Design Human Factors Engineering and Usability Business, Finance and Accounting Clinical and Scientific knowledge in the medical field of intended use Regulatory Affairs and Quality Assurance Intellectual Property and Business Law 29
Development Approaches Go back to Discovery Immerse the team in the use environments to gain knowledge and experience training. 30
Development Approaches Go back to Discovery Identify an inclusive set of users. Medical device users in clinical and home use environments can be an extensive list of Healthcare Providers (HCPs) and lay users. In the clinical setting, users range from the surgeons, to sterile reprocessing technicians, to supply chain staff. The product team can first hand identify all their potential users (customers). 31
Development Approaches Go back to Discovery Voice of the Customer is a design input. Team members acting in user roles can use predicate products, competitive products, and the proposed product including the device, its packaging, and labeling. 32
Development Approaches Go back to Discovery Risk Management is a design input. While in use environments with users, the team can establish potential harms, harm severity, and likelihood of occurrence. 33
Development Approaches Go back to Discovery Formative Usability is a design input. Surrounded with users, this is the time for the team to develop design mitigations to prevent use error and envision training and labeling requirements. Assure Design Inputs (Design Requirements): address the intended use of the device, include the needs of the user and patient, are complete, unambiguous, and free of conflicting requirements. 34
Development Approaches Go back to Discovery With biologics, pharmaceutical and combination products, affects on patients must be understood. Learn what medications are delivered to patients while using your devices/products. Teach the team how medications may affect use environments. The HCPs can help the team identify the medications associated with the medical procedures/therapies being studied. 35
Focus on Innovative Inventions
Innovative Inventions Creating value by enhancing patient care, improving performance of surgical procedures, reducing costs, and improving access to care in underserved areas are all successful business propositions. Protect the business opportunity and assure the creation of value with diligent Freedom to Operate review and filing for patents with novel, non-obvious and useful ideas. 37
References 1. Aaron K. Chatterji, Kira R. Fabrizio, Will Mitchell and Kevin A. Schulman Physician-Industry Cooperation In The Medical Device Industry Health Affairs, 27, no.6 (2008):1532-1543 2. Barriers to innovation in the field of medical devices: background paper 6. World Health Organization, Geneva, August 2010. 3. Overview of Device Regulation. FDA.gov. http://www.fda.gov/medicaldevices/deviceregulationandguidan ce/overview/ 4. Classify Your Medical Device: Device Classification Panels. FDA.gov. http://www.fda.gov/medicaldevices/deviceregulationandguidan ce/overview/classifyyourdevice/ucm051530.htm. 5. General Information Concerning Patents. USPTO.gov: http://www.uspto.gov/patents-getting-started/generalinformation-concerning-patents 38
References 6. USPTO.gov: America Invents Act (AIA) Frequently Asked Questions (http://www.uspto.gov/patent/laws-and-regulations/americainvents-act-aia/america-invents-act-aia-frequently-asked) 7. Mugan, John. Prototyping: Comparing Prototype Techniques. MDDI Medical Device and Diagnostic Industry News Products and Suppliers (http://www.mddionline.com), January 1, 2009. 8. Good Manufacturing Practices. FDA Code of Federal Regulations, Title 21, Part 820. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearc h.cfm?cfrpart=820 9. Usability/HFE - FDA Guidance Document. http://www.fda.gov/medicaldevices/deviceregulationandguidance /guidancedocuments/ucm259748.htm 10. Good Laboratory Practices (Non-clinical testing). FDA Code of Federal Regulations, Title 21, Part 58. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrs earch.cfm?cfrpart=58 39
References 11. IDE and Good Clinical Practices (GCP). FDA. gov. http://www.fda.gov/medicaldevices/deviceregulationandguidan ce/howtomarketyourdevice/investigationaldeviceexemptionide/ default.htm 12. PMA Application. FDA Code of Federal Regulations, Title 21, Part 814. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsear ch.cfm?cfrpart=814&showfr=1 13. Emergo Group. How long it takes the FDA to approve a 510(k) application. http://www.emergogroup.com/resources/research/fda-510kreview-times-research 14. RAPS.org. FDA data show the worst is over for 510(k), PMA applications. http://www.raps.org/regulatorydetail.aspx?id=8533 15. FDA. Device Post-Market Surveillance. http://www.fda.gov/medicaldevices/safety/cdrhpostmarketsurv eillance/default.htm 40
Contact Information Thank You Mark Moyer, MBA, BSME markmoyer@health.usf.edu Administrative Director, USF Health CAMLS Innovation Center Representative on the AAMI Standards Committee IEC 62A/JWG 4 Medical devices- general requirements for safety and essential performance Usability. Mark Armstrong, MD, MSBE armstrongm@health.usf.edu Preclinical Research Administrator, USF Health CAMLS Innovation Center Stuart Hart, MD, MBA, MS, FACOG, FACS shart1@health.usf.edu Medical Officer, USF Health CAMLS Innovation Center http://www.camls-us.org 41
CAMLS Innovation Center Where Healthcare Meets Innovation
Abstract Economic forces can foster new models of design and innovation. For example; tightened FDA device evaluation and enforcement, the expansion of home health care delivery and the impact of the medical device tax are just a few of the challenges stressing the medical device industry s ability to move to market quickly. An environment for healthcare providers, engineers and academics to collaborate in the design, testing, validation of and training on medical devices can help speed improved medical device solutions to patients and improve outcomes. CAMLS Innovation Center is an example, at the forefront, implementing new approaches with broad applicability. 43