4 strategies to get your connected device faster to FDA submission

Don’t look at drug studies. Look at your own product and patients first.

Crossing the chasm from R&D to patients is tricky

Introduction

What is the baseline cost? (hint don’t look at the costs of drug studies)

Findings: In this study of 59 new therapeutic agents approved by the FDA from 2015 to 2016, the median estimated direct cost of pivotal efficacy trials was $19 million, with half of the trial cost estimates ranging from $12 million to $33 million. At the extremes of the distribution were 100-fold cost differences, and patient enrollment varied from fewer than 15 patients to more than 8000 patients.

By comparison, the estimated cost of medical device clinical trials to support approval by the FDA, ranges from $1 million to $10 million. A report from May 2017 surveyed the costs of medical device clinical trials and the potential of patient registries to save time and money. The report has some interesting numbers:

1.The average cost to bring a low-to-moderate concern device from concept to 510(K) approval is $31 million. 77% of that is spent on FDA-related/regulatory-affairs activities.

2.The average cost for a high-risk PMA device averages $94 million, with $75 million spent on FDA-related/regulatory-affairs activities. Average of 4.5 years from first contact with FDA to device approval.

3.Clinical trials outside the US are 30% to 50% cheaper. Less than 50% of medical device trials are now conducted in the US.

I. Better study designs

RWD and RWE can be used in 4 ways improve the design of medical device clinical trials when there is a predicate device that is already being used for treating patients.

1.Use RWD/RWE to improve quality and efficiency of device evaluation at study phases (feasibility, pivotal, and post-market), allowing for rapid iteration of devices at a lower cost.

2.Explore new indications for existing devices

3.Cost efficient method to compare a new device to standard of care.

4.Establish best practices for the use of a device in sub-populations or different sub-specialties.

You will need to factor in the cost of obtaining access to the data and cost of data science.

But real-world data may not be reliable or relevant to help design the study. As FDA notes in their guidance for Using Real-world evidence to support regulatory decision making:

RWD collected using a randomized exposure assignment within a registry can provide a sufficient number of patients for powered subgroup analyses, which could be used to expand the device’s indications for use. However, not all RWD are collected and maintained in a way that provides sufficient reliability. As such, the use of RWE for specific regulatory purposes will be evaluated based on criteria that assess their overall relevance and reliability. If a sponsor is considering using RWE to satisfy a particular FDA regulatory requirement, the sponsor should contact FDA through the pre-submission process.

II. Site-less trial model

The considerable savings accrued by eliminating site costs, need to be balanced with the costs of technology, customer support, data security and salaries and travel expenses of nurses visiting patients at homes.

III. Mostly-digital data collection

1.Collect patient reported outcome data using a mobile app or text messaging

2.Collect data from the connected medical device using a REST API

3.Enable the CRC (clinical research coordinator) to collect data from patients (IE, ICF for example) using a Web or mobile interface (so-called eSource) and skip the still-traditional paper-transcription step. In drug studies, this is currently impossible because hospital source documents are paper or they are locked away in an enterprise EMR system. For connected medical device studies in pain, cannabis and chronic diseases, most of the source data can be collected by the CRC with direct patient interviews. Blood tests will still need to be transcribed from paper. Mostly-digital means mostly-fast. Data latency for the paper source should be 24 hours and data latency for the digital feeds should be zero.

There are a number of companies like Litmus Health moving into the space of digital data collection from mobile devices, ePRO and wearables. However, unlike validating a connected medical device for a well-defined intended use, Litmus Health is focused on clinical data science for health-related quality of life.

IV. PCM (patient compliance monitoring)

Summary

However, not every business model or DCT application may be a good fit for your product. Contact us and we will help you evaluate your options.

For more information read Gail Norman’s excellent article Drugs, Devices, and the FDA: An overview of the approval process

Originally posted on the Flaskdata.io Blog

I am a physicist by training, serious amateur musician and everyday biker. Working in cybersecurity and AI-driven monitoring of clinical trials.

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