Bringing a medical device to market is an intense process filled with due diligence, engineering, and a lot of red tape. There are many steps in the process that will result in sleepless nights and a maybe even a few gray hairs.
While every step is important, the clinical trials that your device must pass are one of the most nerve-wracking and crucial pieces.
You’ve poured time, resources, and emotional energy into getting your device this far. So, it’s understandable that you may be reluctant to sit by the sidelines while your device is used for the first time in a trial.
However, many medical device manufacturers — big and small — are doing just that.
Contract Research Organizations (CROs) can monitor, audit, and manage your clinical trial from beginning to end and help you navigate the compliance challenges that await you. Your CRO's expertise can be invaluable to your clinical trials, especially if they have experience with devices in similar therapeutic areas and in the countries that you plan to market into.
With this process being so critical to the overall success of your device, how do you choose the right one? To start with, you need to learn what other regulations will impact your decision when you’re selecting a medical device CRO for your clinical trials.
Regulations Which Impact Medical Device CRO Selection
It’s well-known that the new European Medical Devices Regulation (EMDR) has increased the requirements placed on you for clinical research. The EMDR has already limited the number of investigators that are qualified to perform clinical studies — but that isn’t the only regulation that will affect your decision. (For more, check out our post on the EMDR timeline.)
Let’s take a look at some of the other regulations that you will need to consider if you’re going to choose the best CRO for your device and target market.
1. Good Clinical Practice (GCP)
What is GCP?
GCP is an international scientific quality and ethical standard with regards to the conduct, design, monitoring, performance, recording, auditing, analysis, and reporting of clinical studies performed with human subjects.
Why is GCP certification desirable?
CROs are not required to be certified in GCP, but you might prefer that they are.
Compliance with GCP and ISO 14155 helps assure the public that the rights, well being, and safety of the subject in your study are protected and that the resulting clinical data is credible.
Additionally, if you fail to address GCP or ISO 14155, you may experience compliance concerns that can delay your approvals. These concerns can include problems such as omitted studies, studies that are improperly designed, missing oversights, and other failures that result in an inability to meet key regulatory requirements.
2. 510(k) Substantial Equivalence
What is 510(k) Substantial Equivalence?
The 510(k) premarket notification process was first implemented in 1976 as part of the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act. Since then, the 510(k) has widely become one of the most-used regulatory pathways for manufacturers to use when bringing a new medical device or diagnostic product to market in the United States.
Why is Substantial Equivalence a good thing for your CRO to have?
Nearly 75% of first-time 510(k) applications are rejected by the FDA. It’s not enough to simply fill in all the questions on the form. You need to know what the potential issues are going to be in the approval process and how to navigate them.
An experienced CRO will be able to help you develop a strong, substantial equivalence argument, build a solid risk-mitigation strategy, and help you get your submissions cleared with fewer delays and rejections.
RELATED READING: 4 Reasons Overhauling FDA 510(k) is a Great Move
3. Premarket Approval Application (PMA)
What is a Premarket Approval Application (PMA)?
A PMA is different from a 510(k) premarket notification. A PMA is the process of scientific and regulatory review outlined by the FDA to assess the safety and effectiveness of Class III medical devices. Class III devices include ones that sustain or support human life, are important in preventing the impairment of human health, or present a potential unreasonable risk of injury or illness.
Why should your CRO be experienced in PMAs?
Class III devices have a high level of risk associated with them, and they fall under much more rigid scrutiny with the FDA.
The FDA requires these Class III devices to pass premarket approval under section 515 of the FD&C Act before going to market. According to the FDA, receiving approval is contingent upon providing “sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s).”
With such a broad definition, it’s easy to see how it could be hard to determine what “sufficient” means. A CRO with experience in meeting PMA requirements can be a crucial partner to have to avoid delays in bringing your device to market.
4. Investigational Device Exemptions (IDE)
What are Part 812 CFR Title 21 Investigational Device Exemptions?
According to the FDA, an investigational device exemption (IDE) allows your investigational device to be used in a clinical study for the purpose of collecting safety and effectiveness data.
Why should your CRO have experience with 21 CFR 812?
If your device is an investigational device, then it must have an approved IDE before your study can be initiated. Investigational use can also include clinical evaluations of specific modifications to existing devices or for new intended usage of devices that are already on the market legally.
If your device has not been cleared for market, then there are specific and exacting criteria for the clinical evaluation of your device.
A CRO with the proper experience can help you make sure that you follow all of the required steps to help you secure your IDE without any additional delays.
Ensuring Proper Quality from Research to Market and Beyond
All medical device companies that are successful at avoiding regulatory issues have one thing in common — they all understand the value of quality management.
These organizations use electronic quality management systems (eQMS) to catalog, review, and act at every stage of their device’s lifecycle. Their QMS platforms help them build a culture of quality in their companies and apply that culture across all device development efforts.
We’ve compiled some of the top strategies that we’ve seen executed successfully in companies of all sizes to improve quality across their development process into one powerful ebook. Download 7 Things You Can Do Now to Improve Quality in Medical Device Product Development today and make a positive culture shift in your business.