If you’re in the business of developing a Class III medical device, you need to count on the FDA.
But then again, you can’t count on the FDA.
What do I mean by that?
In the world of big data, there is limited FDA data that you can use.
For example, if you want to learn from the failures of others, the FDA does not keep a database of failed Premarket Approval (PMA) clinical trials for confidentiality reasons.
Other limitations include mistakes, omissions and under-reporting that can make it difficult to determine whether a medical device directly caused an injury or death.
Let’s face it . . .
You’re making life-sustaining products.
You may even be facing the “death zone.”
It’s not a game for the faint-hearted.
With so many variables outside your control, and with so much data unavailable from the FDA, how do you shorten the time and lower the cost of a successful PMA?
This article, a brief checklist, will identify three factors that will help improve the odds of your company getting a Class III medical device approved.
What is a Class III Medical Device?
According to the FDA, “These devices usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury. Examples of Class III devices include implantable pacemakers and breast implants. 10% of medical devices fall under this category.”
Of course, to be able to sell a Class III device, it must go through a rigorous FDA process, resulting in a premarket approval (PMA).
There’s a lot at stake.
Just look at these facts regarding time and money:
- Class III takes on average five years
- Cost of a PMA approval typically ranges between $50-$95 million (compared to the cost of 510(K) is $30 million)
With so much on the line, how do you manage time and money to ensure a successful Class III approval?
Three factors that improve your odds of getting a Class III approval
1. Strategy
The strategy is the high-level overview plan that takes into account all the steps, the personnel involved and the outcomes you hope to achieve.
To be clear, this isn’t an all-inclusive list of components in a strategy, but rather this is a list of the key components that should be included in any strategy.
A. Site location
One of the most important aspects of a clinical trial is selecting optimal study sites.
The ability to identify, engage, and effectively work with experienced and competent sites is a key factor of clinical trial success.
A competent site would be one that has a high volume of relevant cases and competent physicians in your clinical discipline.
B. Plan risk management
The purpose of the clinical trial is to prove safety and efficacy.
If risk management is all about managing internal and external risks, then what are the factors that tell me that I’m within acceptable guidelines?
The International Organization for Standardization spells out the standards for medical device risk management in detail under ISO 14971: Risk Management for Medical Devices and ICH Q9: Quality Risk Management.
These are the standards, but the question is: what is the best way to achieve them?
You achieve those standards by following a proven risk management structure:
- Identify (What could go wrong?)
- Assess (What is the probability that something will go wrong?)
- Mitigate (What can be done to reduce/eliminate risks?)
- Review (Review of risks as a continual iterative process)
You want to identify and anticipate any issues as early as possible.
The more situations you can anticipate, the better you can respond and avert large financial losses.
Your leadership needs to understand the big picture of your strategy, its implications, and impact on the design of the trial.
2. Protocol Execution
According to the University of California San Francisco Clinical Research Resource Hub:
“Every clinical investigation begins with the development of a clinical protocol. The protocol is a document that describes how a clinical trial will be conducted (the objective(s), design, methodology, statistical considerations and organization of a clinical trial), and ensures the safety of the trial subjects and integrity of the data collected.”
The protocol document typically includes these key ingredients:
- Background information
- Logic
- Objectives
- Design
- Methodology
- Statistical/data record keeping
- Structure
Why is following protocol important?
If you deviate from the document, or the “rules of the road,” you increase the risk.
The idea is to control as much as you can control, while reducing the risk variables.
3. Management
It goes without saying that to be an effective leader through the clinical trial process, one must have an understanding of the strategy and execution factors of the clinical trial life cycle.
However, the clinical trial can fail if you don’t have effective people and interpersonal skills.
You need to ensure there is engagement between leadership and the trial.
Operating in an ivory tower is a sure road map to losing control over the many variables.
This loss of control leads to increased time and increased costs.
This is where the bridge between technical prowess and people skills is vital.
These leadership skills include:
- Building relationships with physicians, investigators, and FDA personnel
- Communicating with all vital personnel (principal investigator, research nurse, data manager, physician, etc.)
- Managing the messaging with the FDA
- Presenting complex findings clearly (be they negative or positive)
- Forecasting leading risk indicators
- Engaging throughout the PMA process
Summary
The clinical trial process for a Class III medical device is complex, costly, and time consuming.
With so many variables outside of your control, you need to focus on those areas that you can control.
What can you control?
You can control who is on your leadership team so that they can focus on the strategy, execution, and management to increase your odds of clinical trial success.
JP Boyle & Associates is a health technology executive search firm serving clients in North America, Europe, Asia and the Middle East.
