navigate the medical device development process with a proven … · 2019/2/13 · combination...

Navigate the Medical Device Development Process with a Proven Regulatory and Clinical Strategy that Works

David R. DillsDirector of Regulatory Services

CROMSOURCE is a privately owned international, full-service Contract Research Organization providing ISO certified clinical research services. CROMSOURCE was founded in 1997. Our successful growth over the last 20 years has been built on stability, integrity, and high levels of customer satisfaction, all of which contribute to a high rate of repeat business. We have grown steadily, but responsibly, to become an organization of over 400 organized and well-trained experts. We offer high quality, full-service clinical research support to pharmaceutical, biotechnology, vaccine, and medical device clients worldwide across several therapeutic areas.

Background

Southern California Biomedical CouncilFebruary 13, 2019

CROMSOURCE


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In formulating a successful regulatory and clinical development strategy, medical device companies must consider not only the needs of regulators, but also anticipate marketplace expectations around product uniqueness and value.

Your strategy develops together with your device during the distinct phases of product development as design decisions might influence both risk management and claims.

Med Dev: Regulatory & Clinical Strategies


A good clinical strategy gives you a competitive advantage, by bringing your device to market faster and supporting unique claims with solid clinical evidence.

Regulatory and Clinical Strategies


Combination products involve components that would normally be regulated under different types of regulatory authorities, and frequently by different FDA Centers, they raise challenging regulatory, policy, and review management challenges.

Differences in regulatory pathways for each component can impact the regulatory processes for all aspects of:

Product Development Preclinical Testing Clinical Investigation Marketing Applications Manufacturing and QC Adverse Event Reporting Promotion and Advertising Post-approval modifications

Regulatory and Clinical Strategies - Example


The regulatory strategy is often a formal document (regulatory plan) that aligns the regulatory activities, together with the business strategy, to bring a new or modified medical device product to market.

It identifies the important regulatory elements to be addressed and provides overall definition and direction to the project team.

It should outline which path to take and the rationale of why a specific path is selected or recommended.



Regulatory strategy should be planned at the earliest possible stage of product development.

It usually consists of key information such as: Medical device intended use and its technology Target markets for commercialization Medical device classification Regulatory requirements Overall project milestones and timelines/forecasts



What type of pre-clinical information should be collected?

Pre-clinical trial is essential for the provision of reasonable evidence of safety and efficacy of medical device prior to clinical trial. The pre-clinical data should include a comprehensive description of the medical device.

In the regulatory strategy, you will need to list the parameters or types of pre-clinical trials for your device. This will also help you in the allocation of time and budget needed for the pre-clinical trial.



Is a clinical trial required for my medical device?Clinical evaluation is usually performed first to understand the risk profile of the product. It will help to determine if clinical trials are required.

Regardless of their classification, medical devices require some type of clinical evaluation to demonstrate safety and performance.



The global regulatory landscape presents varied compliance issues, requirements, accepted test methods and standards, and clinical experiential factors.

Navigating the maze of global requirements can be a daunting task, and requires a concerted effort at the project planning stage to make the best use of available company resources.

Global differences in regulations and requirements typically result in a long and costly path to global regulatory approval.



According to the U.S. Department of Commerce, the medical device marketplace worldwide is expected to experience a 5%+ annual growth rate over the next few years.

By the year 2020, the total market is expected to reach approximately $440 billion. The U.S. accounts for 45% of this market share.

However, emerging markets, including Central and Eastern Europe, the Middle East and Africa are expected to grow even more rapidly as the marketplaces mature, and as access to medical care in these regions expands.



In light of the expanding complexities to bring product to market, the importance of developing a comprehensive go-to-market strategy for a new device, or an expanded market area for existing medical devices, can readily be seen.

An effective strategy must contain a number of elements, including:• Determining a cost/return on investment for anticipated market areas• Perceived market demands• Current competitive landscape• Distribution methods• Reimbursement strategies and policies• Legal issues, including intellectual property protection• Ability to leverage approvals gained in primary markets to extended markets• Financial, professional and technical resources



The expansion of the global medical device market will undoubtedly result in regulatory authorities increasing the complexity of the regulatory landscape.

In fact, we have already seen the evidence of this over the past few years, as more standards, updated standards and additional guidance documents are published more often by the various regulatory agencies.



From Idea to Clinical Trials to Market



Consider information about your medical device, including:device description and specificationsintended clinical application(s)labeling claimsavailable test datahuman safety tests might be conducted during the prototype phasepivotal studies usually occur during the pilot phasepivotal studies may occur during the production phase to add new indications for usepost-market surveillance, post-approval studies, registries, or marketing studies usually happen during production phaseliterature referencesreview and identify possible predicate devices, standard methods, procedures and/or practices, FDA and ROW submission guidance documents, and other applicable regulations and policies



Are you developing an innovative medical device?Does it employ a novel technology? Does it provide novel diagnostic information or therapeutic benefit? Is it a combination or borderline product or a companion diagnostic? Do your plans to demonstrate safety, performance and/or efficacy utilize an approach that regulators have not seen before? Is your clinical evaluation based on equivalence? Or are you planning to conduct a clinical trial to support the device development effort? If the answer is YES to any of those questions, early interaction with regulatory bodies may reduce regulatory risk and reduce approval cycles.



A strategy should start with the collaboration of a cross functional team to identify important questions about the product. List all that is known or will be asked about the product such as: What is the device, How is it to be used, What markets will be served, Is this a new/novel product or is it a modification of an existing device, are there similar devices being distributed and what claims will be made?Other considerations are the type of Regulatory submission, device risks, and any lifecycle considerations. Regulatory Strategies should be living documents that are reviewed and updated as the project evolves.



The global medical device regulatory space is becoming increasingly complex, making a well defined and researched regulatory strategy vital for medical device and in-vitro diagnostic (IVD) companies.

With many changes planned for the next few years, a regulatory and clinical strategy ensures that you are well informed and aware of all existing requirements as well as any new or updated ones, which may impact the marketing of your device.

We define the regulatory strategy as the ‘roadmap to market’ – because this describes the regulatory requirements that need to be addressed.



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Website: www.cromsource.com Email: [email protected]


navigate the medical device development process with a proven … · 2019/2/13 · combination...

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