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Introduction to Medical Device Investigations

The medical device industry covers large multi-nationals with departments dedicated to R&D, compliance and clinical trial management. At the other end of the spectrum lies the SME, the smaller of which may be entrepreneurs with a great business idea and innovative product they need to get to market. Both ends of the spectrum and all those in between have the same basic regulatory requirements and processes to fulfill. Our objective here is to help give some basic guidance to those for whom clinical investigations are maybe a one-time challenge, not a career. If that sounds like you, you’re in the right place!

The section contains links to our ‘info sheet’ series, relevant articles and our medical device study glossary.

Need to get up to speed with all the device investigation terms and acronyms? Click here for our Glossary
A handy reference tool of common terms, abbreviations and acronyms for those new to medical device clinical investigations… those who need a refresh… or simply anyone who’s stumbled across a term their unfamiliar with – it happens to us all!

How technology supports your choice of trial protocol

Click here to learn more about the technologies available for medical device investigations.

Study Design Considerations

Deciding on what type of study to run is a complex matter with many interlocking factors to be taken into consideration. It’s important to understand that all of these factors can impact on study design – for ALL study types. See our INFO SHEET – Study Designs Considerations.

Where to Start?

Start with the regulations

If you’re here, you’ve likely already an idea that you need a clinical investigation. The recent European MDR guidelines have moved a variety of goalposts for pre-market products and not everyone is fully conversant with the implications. A good starting point here is our article on MDR and our related info sheets, below.

You can access all of our info sheets and articles by visiting the Medical Device Resource Centre.

Understanding the regulations
Our Medical Device Regulations page looks at the compliance situation with respect to clinical investigations
Info Sheet – MDR and compliance for medical device investigations
A guide to the current market situation and requirements driven by the MDR regulations.
Article: The True Impact of MDR: a Clinical Affairs Perspective
An experienced Clinical Affairs Director shares his insights on how MDR will impact the European market

Is Your Product New to Market?

Pre-market Investigations

If you have a product that’s new to market, and you’ve established you require an investigation, then CRFWEB is the ideal solution to conduct an efficient, compliant clinical study for your device. Whether that investigation requires researcher-led or subject-led data collection, we have the technology to deliver. Read more in our Technologies for clinical trials section, our pre-market investigation page and in-depth info-sheet on MDR for pre-market trials.

Technologies for Medical Device Studies
Visit our technologies pages for a comprehensive look at how CRFWEB EDC and DDC capabilities can support your trial
Info Sheet – MDR for new devices to market
An in-depth look at MDR for new medical devices
Pre-Licence Medical Device Studies
Is your product new to market? This section covers how CRFWEB helps with pre-licence investigations

Does Your Device Require Ongoing Post-market Research?

Post Market Surveillance & Post Market Clinical Follow-up under MDR

If your device is already in the market place, you are now required to continually demonstrate its efficacy and safety. You may not need a clinical device investigations to do this, but if you do, CRFWEB is an ideal platform to conduct them.

Info Sheet – PMS & PMCF under MDR: an Overview
What you need to know about PMS and PMCF under MDR with links to further information
Article: Sustaining profitable market access under MDR: the PMS & PMCF business case for EDC
It’s not simply just additional cost – enhanced PMS & PMCF under MDR is an opportunity, too.
Take a deeper look at how CRFWEB can support your PMS/PMCF activities
This section covers how CRFWEB helps with post-market investigations

Go it alone or Seek Assistance?

Do You Need a CRO?

Dealing with a variety of size of medical device businesses, we are often asked whether it’s necessary to contract a CRO. That’s a choice as a sponsor you will have to make yourself – there are obvious advantages and risk mitigation that comes with using a CRO but naturally it also comes at a cost.

Some of the key matters you will need to consider:

Have I got sufficient resources and expertise in the therapeutic area or product type AND in running a clinical trial?
Do I know the geographic region(s) and associated regulatory/cultural challenges?
Am I able to achieve compliance without a third party managing the process?
(If I am placing my studies with a variety of CROs) – do I want to keep ownership of the data and standards (SOPs) in-house to allow better control, harmonization, cross study and program analytics?

Click here for a more in-depth discussion of this critical issue.

The CRFWEB team contract with CRO’s and also directly with Sponsor’s. We are happy to work with whichever model best suits the circumstances of our clients.

Understanding the Clinical Trial Process: Our 21 point checklist

Whether sponsor self-managed or conducted by a CRO, there are a number of tasks that need to be performed to take your trial from start to finish. If the planning is correct and well project-managed so all tasks are done in a time-orderly fashion, the prospects of a smooth running and efficient trial improve exponentially.

We’ve produced a step-by-step process for clinical trials to help those new to clinical trials understand the tasks and processes required, in order, to manage your project.

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