A tremendous amount of innovation occurs in academia and the medical industry, where medical devices are conceptualized and developed to improve the lives of populations and produce favourable clinical and economic outcomes.Regulatory approval, reimbursement, and market adoption of medical devices involve a variety of stakeholders, each with unique requirements. All groups expect some degree of clinical and at times economic evidence (herein referred to as clinical evidence) to aid in their decision making.
The level and extent of clinical evidence (completed and published studies) required for regulatory clearance and approval of Medical Devices can vary based on factors such as the risk level and regulatory class of the device, existence of similar products with established safety and performance profiles on the market, and the nature of the disease state addressed by the device.
In the US for example, the FDA Premarket Approval process requires more rigorous clinical studies, while devices that are cleared through the 510k process can benefit to some extent from the published data on a predicate device. Minimally manipulated tissue products on the other hand are not considered medical devices and are bound to less stringent requirements.
For developers and manufacturers of medical devices, balancing the upfront cost and timeline of conducting clinical studies with the desire for speed to market, ramifications on market adoption and reimbursement are integral parts of the strategic planning during medical device development and commercialization.
As a Medical Affairs leader in charge of teams driving initiatives to foster safe and effective adoption of medical devices, I experienced first-hand the advantage of launching medical devices with robust published clinical evidence. That is, clinical studies of appropriate type and scope that clearly demonstrate the clinical and economic benefits of the medical device and meet the expectation of the stakeholders mentioned above. This is an attainable undertaking once it is planned well-based understanding of stakeholder needs and available types of studies and sources of data.
In contrast, running into objections or a slow adoption in the market and having to plan and execute studies in retrospect, leaning on data from other, similar technologies to support a newly introduced product, can decelerate the desired momentum of a device launch and slow down access of the patients to advanced therapies.
The strategy for evidence generation involves understanding the requirements and timelines of stakeholders and geographies, identifying gaps in existing evidence, selecting appropriate study types to generate the right level of evidence, designing studies, partnering with field experts, securing budgets, selecting journals for publication, and specifying appropriate forums for presenting the data.
Different mechanisms for creating clinical evidence include company-sponsored studies, investigator- initiated studies, and mining real world evidence databases. Types of clinical studies include phase I-IV studies, randomized clinical trials (RCT) to case series, and prospective and retrospective studies collecting clinical and economic data. Also, secondary analysis of existing data sets, systematic reviews, and meta-analysis of published literature can help establish the safety, efficacy, and economic outcomes of medical devices.
Educational and marketing communications should be founded on evidence-based scientific platforms. Equally important as evidence generation, is the communication of such evidence to demonstrate clinical and economic outcomes of the devices via (ideally open access) publications, conference presentations, medical education, and peer-to-peer discussions.
In the absence of such a foundation, many innovative products have failed in the marketplace, depriving patients of the benefits and the companies of the successes they would have experienced.
Evidence generation, medical communication, and evidence-based scientific platform for medical devices are within the expertise of Exquisite Biomedical Consulting.
Exquisite Biomedical Consulting (EBC) is a boutique-style medical affairs consulting firm based inVancouver, BC, Canada with roots in San Antonio, TX, USA. The company is led by Shabnam Vaezzadeh, MD, MPA, who has extensive experience in this field in corporate and consulting capacities. She is joined by expert clinicians, biostatisticians, and reimbursement professionals to best serve the Medical Affairs needs of funded medical device companies.
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Company: Exquisite Biomedical Consulting Ltd
Shabnam Vaezzadeh, MD, MPA, BCMAS, CEO