Regulatory, Clinical, and Quality Considerations for Device Research

In response to a growing demand for faster, approved, and cost-effective medical devices for chronic diseases, medical device manufacturers and emerging biotech companies are facing increasingly complex pathways to successfully bring their innovative ideas to the market.

If a new medical device, software as a medical device (SaMD), or in vitro diagnostic (IVD) is poised to successfully make it through the development process to commercialization, sponsors must consider a trifecta of interconnected systems involving:

• Regulatory strategy and submissions
• Quality assurance and risk management
• Clinical evidence generation

When these elements are working in tandem, they can create a pathway for real value and establish market credibility for an emerging biotech seeking to attract investment and/or a strategic partnership for their new product. This blog will explore how each of these works to support a successful development process and why their interconnectivity is important.

Regulatory Pathway Assessment

Developing a regulatory pathway assessment (RPA) is a formal exercise for any new company or device to establish the way a regulator may accept the device in terms of risk-benefit. Also critical to this assessment are four key factors leading to important regulatory discussions:

• Indication for use
• Intended use
• Mechanism of action (MOA)
• Device description

Without these factors being well constructed and thought out, discussions with regulators could be a challenge. Business decisions are often measured with regard to the lowest level of evidence to gain market clearance, usually on predecessor technology, or conversely, to completely introduce a new treatment paradigm with a novel, first-in-class device or technology.

Often, what may influence a company’s assessment is the fastest path to commercialization – the lowest bar. This is usually a condition of the available funding: limited resources may impede longer or more complex approaches. In contrast, some companies may decide their device or technology is a complete game changer to the current state of the art or standard of care. The latter scenario is a longer and harder road, but it sometimes produces a far greater return on investment (ROI).

Meeting with the Regulators

Regulators are not your adversaries. They are important stakeholders who are interested in supporting your device development. Just as it’s vital to meet and get to know your end users or patient groups, medical advisors, and key subject matter experts (SMEs), it is similarly important to develop strong, transparent relationships with regulators. After all, they are a part of your team as the group responsible for confirming your device’s safety and efficacy profile meets all standards for approval or clearance.

Key areas to consider are the type and timing of your submissions, as well as the time needed for regulators to respond. Are you basing your submission on a similar device or technology such as a 510(k), or do you believe your device will be novel, and first-in-class such as a de novo application? Have you considered whether your device may be classified as a class III risky device requiring pre-market authorization (PMA)?

The following are types of submissions to consider:

• 513(g): Enables Food and Drug Administration’s (FDA’s) determinations about the risk and proposed pathway
• 510(k): Requires substantiation of equivalence to similar technology
• Q-Submission: Enables strategic questions with FDA, addresses uncertainty about device classifications or similarities to other technologies you could use
• Breakthrough designation request: Demonstrates your device meets the breakthrough guidance definitions
• Investigational device exemption (IDE): Allows your investigational device to be used in a clinical trial to collect safety and effectiveness data

If you are pursuing an IDE submission, make sure you first have your strategic questions addressed via the Q-Submission process. This step ensures your clinical trial protocol is ready for approval during the IDE review process.

No matter what, be prepared. Prepare for your submission type with the questions you need to know to take your company to the next level. Set yourself up for success by reviewing online regulatory guidance documents relevant to your device.

Additionally, don’t forget about checking regulatory requirements for other markets like the EU, Canada, and other countries.

Quality Assurance

A solid quality management system (QMS) is necessary to demonstrate your device is developed with proper controls and procedures. Where funding may be incremental, it may be necessary and acceptable for a phased development of a QMS.

Everyone in your organization must be a part of continuous quality improvement. All persons must be trained and experienced to carry out their job functions in accordance with the regulations and international standards. Training is paramount to a company’s success.

Organizations are typically more successful when they establish a company culture of quality. The cost of poor quality is significant. It could mean job loss, loss of revenue, and loss of reputation, among other things. No company is perfect, of course, but it is productive to strive for a continuous quality improvement paradigm.

Clinical Evidence Generation

Clinical evidence generation, when completed correctly, can add real value to your company and attract further investments. Some device trials can be small, while others need to be large randomized clinical trials, depending on the device’s risk-benefit profile and the regulator’s current thinking.

Building a compendium of evidence is one of the most important facets of your business. Consider starting small: First-in-man (FIM), proof-of-concept (POC), or early feasibility studies (EFS) are acceptable means to test the simple safety of a device. They can also help you consider how a clinical trial’s operational characteristics may work in a larger setting (i.e., many more participants and research sites).

After early studies are completed and published, the next step is larger randomized trials or validation trials. Thinking through the methodology and techniques to enable the smallest trial participant population is another way to add value to your company. In addition, this also minimizes risk to participants.

Key Takeaways

As in many things in life, it’s always better to measure twice and cut once. That way, you don’t unnecessarily waste resources, nor do you have to repeat work or upset your early investors.

• Don’t cut corners in planning – take advantage of every opportunity to obtain expert input from regulators and others. The more you prepare upfront and consider how all your different decisions and plans interact with each other, the more successful your organization will be
• Positive regulatory feedback should be viewed as a ROI
• No matter what, there are no cookie-cutter recipes. Each company must take a customized approach with the regulators
• Quality and regulatory framework drives clinical evidence and publication programs

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