Determining the appropriate regulatory pathway

Determining the appropriate regulatory pathway

A Wearable Company entering the Medical Device space

Background

A US-based company that initially entered the consumer general wellness wearable market wanted to get into the medical device space. For such a business expansion into the device space, the 20-person organization understood the need for a strong regulatory partner, and sought Elexes’ support.

The company was designing a prescription-only, battery-powered stimulator to achieve protection from Traumatic brain injury (TBI) and also tackle the concussion crisis in youth sports. The technology developed by the company was used by researchers and athletes throughout the United States.

Challenges 

The following were the challenges faced by the Client:

  1. Type of submission and classification of the device – Puzzled by the regulatory maze

Though the Client wanted to enter the medical device market, a regulatory team who could guide them through the maze of regulatory requirements to obtain approvals and bring the device to the market was not available, in house. 

  1. Project management – Absence of a Leader to guide and oversee project execution

The Client had a strong design team, but had no one who could lay down a regulatory strategy considering the timelines and the entire device lifecycle. The Client team lacked a leader who could develop regulatory strategies and execute/manage the pre-compliance activities and get the device to the market on time. 

  1. Regulatory requirements – Missing experience with Global regulatory requirements 

The Client understood that there was a huge potential market for the device in various parts of the world, but they were unaware of the intricacies in the regulatory landscape and requirements for market entry. 

Solutions

  1. Type of submission and classification of the device – Determining the pathway

Elexes worked closely with the Client and helped them frame their indications for use and specific clinical application. Elexes conducted due diligence on similar devices and determined Class II as the best regulatory classification and DeNovo as the applicable regulatory pathway. 

  1. Project management for the submission – Conceptualisation to market

    First, the Client was made aware of the overall process flow and timeline at the FDA’s end for De Novo application, as shown in the flowchart below. 

Elexes worked with the engineering team of the Client to formulate a thorough project plan defining all internal and external dependencies. Elexes acted as a Project Manager for the submission and leveraged their experience to preemptively address issues before they could impact the timelines.

  1. Regulatory requirements – Bringing Global regulatory experience  

While the Client was preparing to get to one market, by leveraging the global regulatory insights from Elexes, the Client could also plan to get to other bigger markets across the world. Elexes conducted meticulous gap assessments between what the Client already had in place vs. what was needed to get the product to the intended markets. 

Gap assessment was the first step, post which Elexes helped the Client to get all the requirements addressed by creation of several documents.

Results

Getting into the medical device category, through comprehensive assessment, apt classification, right regulatory pathway, and effective project management, helped the company increase its customer base manifold and create a neat niche. The company significantly increased its revenue and got qualified into reimbursement categories. The hands-on expertise of Elexes helped the company in turning things around. 

Key Takeaway

When getting into a medical device category, there are numerous requirements a company should know of early on at the product development and conceptualization phase. An early on regulatory diligence and effective project management goes a long way and ensures success. 

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