Journal Issue:
Intellectual Property-Regulatory

Thumbnail Image

Volume

Number

Journal Title

Journal ISSN

Date Published

Journal Volume

Journal Volume

Description

Keywords

Collection

Issues

Filters

2019 - 202021
Reset filters

Settings

Search Results

Now showing 1 - 10 of 21
  • Publication
    Intellectual Property: Commercializing in a University Setting
    (2019-09-26) Dahl, Cynthia
    For latest version: please go to https://academicentrepreneurship.pubpub.org/pub/av7544wl/release/4 An academic entrepreneur must clarify ownership of their invention and establish an intellectual property protection plan before commercializing. In most cases, a university employer will own the invention created by its researchers and faculty in conjunction with their employment, and will make intellectual property protection decisions. A university may either license out the entrepreneur’s invention to a third-party company to further develop and commercialize, or may license the invention back to the entrepreneur so that they may commercialize it themselves through a start-up. Such license agreements will assign responsibility for paying for patent coverage to protect the invention, set a fee or royalty schedule, and clarify ownership of further improvements or developments. Should the entrepreneur decide to commercialize the invention themselves, besides licensing the invention from the university, they should also be mindful of disclosure issues, contract clearly with founders and other interested parties to clarify issues of equity and intellectual property ownership, and consider whether they need to establish freedom to operate.
  • Publication
    Digital Health: Software as a Medical Device
    (2019-09-30) Novelo, Mauricio; Gooneratne, Nalaka; Weimer, James
    For latest version: please go to https://academicentrepreneurship.pubpub.org/pub/software-as-a-medical-device/release/3 Software, such as mobile device apps or telemedicine, creates exciting new opportunities for patient engagement and for improving healthcare. There are three main types of mobile apps: native, web, and hybrid. The wireless technologies in smartphones and wearable sensors, such as smartwatches, offer the potential for additional biometric data collection. HIPAA compliance requires multiple levels of oversight and auditing. The software development costs for healthcare are considerably higher than for consumer-oriented products due to FDA regulatory requirements; testing out proof-of-concept through low-cost alternatives is an important development strategy.
  • Publication
    Working with the University Technology Transfer Office
    (2019-09-26) Fauzan, Ryan; Gooneratne, Nalaka
    For latest version, please go to https://academicentrepreneurship.pubpub.org/pub/gn0c2t4w/release/4 Academic technology transfer is a rigorous process that involves many different constituencies within the university with different perspectives and interests. Aligning those interests is crucial to a successful transfer of inventions that ultimately result in commercialization of value-added products and services. Individuals within universities should leverage the technology transfer office’s (TTO) resources and advice as early as when the idea was originally conceived. TTOs can help move the innovation process forward and keep track of progress to guide the next point of inflection. In building relationships throughout the technology transfer process, inventor(s) must understand the terms and policies involved. Starting with the TTO, they must pay careful attention to the university’s intellectual property (IP) policies. When dealing with outside companies, investors must negotiate the terms carefully to make sure that every party has their interests aligned. The TTO would be of valuable help in conducting negotiations to achieve this. In addition, they can be a link to other internal and external resources, including investment capital and mentoring that can help the academic entrepreneur commercialize their innovation.
  • Publication
    Surgical Device Development
    (2019-09-30) Driscoll, Nicolette; Prajapati, Mohit; Brooks, Ari
    For latest version: please go to https://academicentrepreneurship.pubpub.org/pub/ix4cdtm1/release/5 The pre-development phase takes an idea to a concept with a business case for developing the device. Key elements include defining user needs, generating different concepts and their respective regulatory pathway, intellectual protection strategy, reimbursement model and overall commercialization strategy. The development phase is an iterative process that converts the concept into a product that is tested and evaluated through the verification and validation process, and ready for regulatory submission. Design Transfer is a set of procedures that are required to ensure that the device’s design is correctly translated into production specifications and performing a market preference evaluation prior to a full scale product launch. Following product launch, the product enters the post-market activities phase, in which operations are scaled up to reach sales targets, the product is maintained and improved if possible, and strategies for product refresh, product extensions, seeking new markets.
  • Publication
    Reimbursement Strategies and CPT Codes for Device Development
    (2019-09-26) Kuo, Tai-Yun; Manaker, Scott
    For latest version: please go to https://academicentrepreneurship.pubpub.org/pub/1fani3y6/release/3 Reimbursement refers to the complicated process by which physicians and hospitals deliver products and services and then receive payment from third-party payers. Reimbursement consists of three factors: coding, coverage, and payment. The Current Procedural Terminology (CPT) codes include category I, II, and III codes, each with a different purpose and criteria. Requesting a new CPT code for a new device is a complicated and lengthy process, so an early understanding of the process is important to identifying the necessary resources. Working with CPT code consultants and a medical specialty society can help a startup obtain new CPT codes to ensure reimbursement for new medical devices, or determine if the new device fits within an existing CPT code.
  • Publication
    Overview of Device Development
    (2019-09-30) Kumar, Anupam; Gooneratne, Nalaka
    For latest version: please go to https://academicentrepreneurship.pubpub.org/pub/d3v70grd/release/2 Device development can be summarized by the Three I’s: Identification, Invention, and Implementation. The current era of “first to file” requires early patenting. There are a number of public and private sources for seed investment. Determining the appropriate pathway for regular approval requires accurate risk classification.
  • Publication
    Orphan Drugs: Understanding the FDA Approval Process
    (2019-09-27) Srivastava, Gauri; Winslow, Ashley
    For latest version: please go to https://academicentrepreneurship.pubpub.org/pub/einr3b30/release/2 In the U.S., a rare disease is one that affects fewer than 200,000 patients. There are more than 7,000 rare diseases today but relatively few specific therapies for them, mainly because the manufacturers cannot recoup their drug development costs. Orphan drug status allows sponsors to apply for incentives such as the Orphan Drug Tax Credit (ODTC), marketing exclusivity for seven years for the first orphan drug for a given rare disease, and an attractive drug-pricing scheme, amongst other benefits. Orphan drug trials are generally single arm (no placebo arm), nonrandomized, and open label. Safety Phase 1 trials are not usually required, and Phases 2 and 3 can be combined when the patient population is very low. Sponsors of an orphan drug can make use of expedited Food and Drug Administration (FDA) programs such as the Fast Track, Breakthrough Therapy, and Priority Review designations, as well as the Accelerated Approval pathway and unique grant funding opportunities, such as the Orphan Products Clinical Trials Grant program. The FDA facilitates patient-focused drug development (PFDD) meetings, wherein they collect patient experience data from the patients, their family members, their caregivers, and disease foundations. These data can help the orphan drug developers for a given rare disease in determining clinical endpoints and the route of therapy administration for their clinical trials.
  • Publication
    Laws and Ethics in relation to Medical Entrepreneurship
    (2020-01-05) Iyer, Ramesh; Solomon, Jeremy
    For latest version: please go to https://academicentrepreneurship.pubpub.org/pub/oibkkvvo/release/3 Some healthcare laws affect academic entrepreneurs who may also be practicing healthcare providers. Understanding the regulatory agencies and relevant laws is essential to avoiding legal entanglement with regulatory authorities and creating a successful health business venture. It is important to follow ethical standards in starting and managing a company. Ethical shortcuts may yield short-term benefits but pose substantial risk in the long run, including the potential for ethical and financial malfeasance.
  • Publication
    FDA Device Regulation: 510(k), PMA
    (2019-09-25) Van Batavia, Jason; Goldenberg, Seth
    For latest version: please go to https://academicentrepreneurship.pubpub.org/pub/gxp74m44/release/4 In the U.S., medical devices are classified into one of three groups based on potential risk to patients and this plays an important role in determining the appropriate FDA regulatory pathway. The three most common regulatory pathways through which the FDA clears or approves devices are: 1) exemption status, 2) 510(k), and 3) premarket approval (PMA). Early understanding of likely pathways is essential for planning device design and research strategy. All devices with more than a low or non-significant risk potential must be granted clearance, approval, or an Investigational Device Exemption (IDE) from the FDA prior to use in human subjects. Pre-submission, or Q-sub meetings, allow innovators and device companies to meet with the FDA for free and obtain feedback on the potential pathway and research protocols in an effort to have higher success with a future formal application. Early involvement of a regulatory expert or consultant can lead to a reduction in time to market and important cost savings.
  • Publication
    My Invention Already Exist? Conducting a Patent / Prior Art Search
    (2019-09-27) Kannan, Toshitha; Stein, Elliot; Maloney, Mark
    For latest version: please go to https://academicentrepreneurship.pubpub.org/pub/dswh4b84/release/2 Patent/prior art searches are an essential step in the process of establishing the novelty of a product or solution. Increasing the comprehensiveness of a prior art search enhances the likelihood of success for a new patent because the inventor becomes more aware of the state of the field, can create and perceive distinctions between their invention and existing inventions, and is able to preempt sources of conflict with prior patent literature. Publicly available resources are the best place to start a prior art search. Follow this mantra—brainstorm, search, retrieve and expand! Documentation of all search results is a necessity and may prove essential in later discussions with a patent professional or when filling patent paperwork to demonstrate that a reasonably extensive search was performed. Resources from the university can offer counsel. There are almost always people who are trained to be experts in prior art searches and will be more than willing to help out.

DSpace software copyright © 2002-2026 LYRASIS