Neural technologies continue to make a substantial impact in diagnosing and treating disorders of the nervous system and in improving the quality of life for individuals with these disorders, their families, and society more broadly. While there have been outstanding examples of successful translation of novel technologies from the bench to the bedside, challenges still remain for physicians, scientists, and engineers. Numerous promising technologies have not advanced to clinical trials, not met their primary clinical trial endpoints, not reached the market penetration levels necessary to maintain commercial viability, or have attained clinical and market success but took far more time and resources than was necessary.
Check out a video snippet from Dr. Marty Morrell, Chief Medical Officer of Neuropace, describing the creative spark that led to developing a therapy for treating epilepsy. See more in The Process: Lecture 2.
This lecture begins the online short-course program with a brief welcome followed by an overview of the format, quizzes, and certificate program. There is information on how the activities throughout the course complement the annual workshop in which participants discuss and receive constructive feedback from program faculty.
This lecture provides case examples of successful translation and commercialization of neurotechnology from the bench to bedside to market. Several clinical and med-tech experts provide vignettes on challenges that they faced and skill sets that they feel are important for being successful in translating and commercializing novel neural medical device technologies.
In this lecture, you learn how to define criteria to start, stop, or continue development, translation, and commercialization of neural medical devices. This is a critical lecture that utilizes a model for key decisions to either make a product successful or prevent it from reaching its clinical potential of impact and time to market. You are to consider four questions: (1) Do you understand what it means to develop technology that meets end user needs?; (2) Do you have a strategic plan for the technical, regulatory, reimbursement and other business needs?; (3) Do you understand the different phases along the pathway that you are navigating?; (4) Have you thought through the different go/no go decision points that allows you to traverse a go to market plan and have you identified resources that you’ll need?
Critical to the success of a device is the integration of the voice of the user and caregiver early on, as well as throughout the total product lifecycle, this lecture demonstrates how to develop best practices for implanting, optimizing, and using neural medical devices across multiple perspectives. The lecture reinforces the concepts through case study examples.
Understanding how device development, testing, and dissemination is regulated is critically important to understanding the path from the bench to the bedside. This lecture explains the paths and various challenges in working with the Food and Drug Administration (FDA). In the first part of the lecture, you learn about the different regulatory pathways and how to classify your medical device. This section covers FDA timelines and estimates on actual cost and duration for getting a product to market. The second part covers each regulatory process in detail, and case study examples from other medical device technologies that have navigated through the regulatory process, including Humanitarian Device Exemption (HDE), De Novo, 510(k), and Pre-Market Approval (PMA). You also gain knowledge about requirements and best practices for filing an Investigational Device Exemption (IDE) application with the FDA to facilitate first-in-human testing. The third portion of this lecture series covers post-market requirements, Centers for Medicare & Medicaid Services (CMS) approval and codes, navigating the FDA databases to bolster your submission, and the use of pre-submission and informational meetings while developing your regulatory testing plan.
Preclinical data on the safety and efficacy of neural medical devices are critical to advance the device into an Food and Drug Administration (FDA) submission. Yet, these studies often become time consuming and expensive, and need to be carefully considered to maximize their statistical power. This lecture focuses on studies that often need to be performed for implanted and non-invasive neural medical devices. There are real-world examples of data collected by companies as part of FDA application submissions and you learn about the objectives of these studies, the critical issues to consider when designing preclinical studies, and the resources provided by the FDA and elsewhere to guide study design. This lecture also provides guidance on how to approach preclinical study design with the FDA, best practices for implementing preclinical studies, how to decide when to incorporate Good Laboratory Practices (GLP) into your testing plan, and guidance on the types of partners to conduct studies including academic institutions and contract research organizations.
The safety and efficacy testing of a neural medical device requires careful thought as to which in vitro, in vivo, cadaver, and in silico models provide the most convincing data while at the same time managing logistical complexities, time to conduct the testing, and costs associated with the testing of the device. This lecture covers the rationales for choosing model systems based on case study examples of successful neural medical devices across a range of target engagement approaches from invasive electrodes to non-invasive imaging and stimulation modalities. You examine key factors for choosing your animal model, and when a preclinical animal model of disease is necessary in the context of submissions to regulatory agencies.
This lecture, in conjunction with the previous lecture, provides a comprehensive overview of the various International Organization for Standardization (ISO) standards for biocompatibility as well as standards related to device packaging hermiticity, electromagnetic interference testing, and electrostatic discharge testing. Case study examples illustrate the thought process for building a preclinical safety testing plan, using ISO standards and Food and Drug Administration (FDA) guidance, for your neural medical device.
This lecture explains the Food and Drug Administration (FDA) standards for Good Laboratory Practices (GLP) used for pre-clinical safety evidence of a neurotechnology (neurotech) device. By the end of this lecture, you recognize what a GLP study is, and what is required in it, to prepare you to identify a qualified contract research organization (CRO) that provides your study with the necessary GLP services. You learn concepts on study planning, developing a protocol, the rationale for selecting animal models, the personnel and facility requirements of a GLP study, GLP study methods, and the records and reports that the CRO provides the contractor and the FDA at the conclusion of the study.
This lecture covers quality systems, the pieces that make up a quality system, how it relates to the product design process, and includes a review of the differences between 21 Code of Federal Regulations (CFR) 820 for devices in the US, and International Organization for Standardization (ISO) 13485 for devices with international reach. The key points of this lecture cover user needs, design input, design control process, design output, design verification, validation, work instructions, standard operating procedures, risk management, human factors and the requirements for traceability which include the design history file.
In this lecture, you learn the What, Why, When, Where and Who of Clinical Trials for neurotechnology (neurotech). You review the different types of clinical trials: first-in-human clinical study, pilot study, and design pivotal, randomized-controlled trials. You also learn about different clinical trial designs, and what scientific evidence the Food and Drug Administration (FDA) needs from a clinical trial. This lecture also discusses the role of the FDA in a clinical trial.
This lecture discusses the combination products and the role of cybersecurity in relation to regulatory considerations with neurotechnology.
This lecture covers the bioethics associated with preclinical and clinical applications of neural medical devices. Responsible Conduct of Research (RCR) training and Institutional Review Board (IRB) oversight may not encompass all of the necessary bioethical issues at the cutting edge of neural device research. The National Institutes of Health (NIH) increasingly recognizes the importance of these emerging ethical issues; some Brain Research through Advancing Innovative Neurotechnologies® (BRAIN) Initiative grants require applicants to include a section on neuroethics. In this lecture, you consider three emerging ethical lectures that relate to neural device research for which there is little consensus or guidance: Informed consent, Post-trial responsibilities, Considerations of unintended consequences. Broadly, you learn how to approach neurotechnology development through an ethical lens.
The “Valley of Death” refers to the challenges of obtaining enough funds to fully develop, test, and translate promising technology. Many promising approaches fail to successfully navigate through this valley, in part, because they consider funding and funding organizations similarly. This lecture provides an overview of governmental and private funding opportunities and discusses how these align with the technology development stage. You learn about dilutive and non-dilutive funding, along with the stages of funding throughout the technology development lifecycle. The lecture covers best practices for interacting with foundations and building a relationship with funders. The lecture also discusses the National Institutes of Health/Small Business Innovation Research/Small Business Technology Transfer (NIH/SBIR/STT) grants, and gives an overview of the NIH funding opportunities that exist across the development spectrum. There is also an introduction to other government programs that support technology development including Command, Control, Communications and intelligence (C3i) (NIH) and iCorps National Science Foundation (NSF).
This lecture discusses when and how to file intellectual property (IP); how to explore the patent space for competing patents; how to determine if your IP is defensible; and writing disclosures, claims, filing patent process, and licensing patented technology. You learn about the academic and industry perspectives on intellectual property, as well as working with tech transfer offices to license IP back from a university as part of a start-up company.
In this lecture, you learn about industry collaborators and partners that have mutual interests. This lecture discusses writing contracts to ensure the control of intellectual property (IP) and the goals and expectations of industry in creating partnerships.
This lecture provides professional advice on market and user needs as well as the basics of fundraising and valuation. You explore the fundamentals of forming a commercial team, the different types of legal structures for the company, how to attract a partner with commercial expertise, and how to decide which positions to outsource. This lecture also discusses the business lifecycle, key considerations and realistic timelines for launching a company, along with tips for creating a commercially successful product launch!
In this lecture, you gain an understanding of the basics of a market evaluation for a new neurotechnology (neurotech) device. While the patient may be the final user of your device, she/he/they may not be the direct customer; the medical device market is very complicated. Here you acquire knowledge with market authorization, market access, and market adoption. You also learn about the roles of payors, distributors, hospitals, physicians, as well as patients in the neurotech market.
Important to the commercialization of medical devices is eventually getting the devices coded and reimbursed by public and private payers. In this lecture, you learn how neural medical devices are assigned procedure codes, which payment systems are available, implications for coverage and reimbursement based on coding, and the role technology assessment groups play in medical device review processes. You learn about the Medicare coverage decision process through the different contractors across multiple jurisdictions. Case examples help to emphasize how reimbursement decisions affect the commercialization of neurotechnology and the importance of engaging payers early on in your go-to-market plan.
In this lecture, you learn about how to raise money to develop your neurotechnology (neurotech) device from concept to market. You gain an understanding about the pros and cons of different sources of financial support, from government funding, family-and-friends, angel investors, venture capitalists, and strategic partners. You also learn about what each investor-type is looking for in their return on investment, and how to pitch to each one to best match interests.
This lecture summarizes all lectures covered in this series. There is an overview of the available resources and the critical considerations over the device development lifecycle. Through individual case studies, you learn about the key timelines for marketed neurotechnology and the lessons learned. There are additional exercises to further your knowledge and help you to apply what you learn to your particular medical technology development process.