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.
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.
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 Clindox 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 Clindox eCRF and ePRO capabilities can support your trial
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, Clindox is an ideal platform to conduct them.
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 CROs 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 Clindox team contract with CROs and also directly with Sponsors. 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.
What Our Clients Say
"The Clindox team have been an incredible support and are always available to help in any way they can."
— MARIA GALLIGAN, PMD SOLUTIONS
"The time and cost saving is really significant. We're very happy with the performance of Clindox and I wouldn't hesitate to recommend it."
— DR SALVI, CRF HEALTH, INDIA
"Clindox eCRF, plus their helpful and accommodating staff, helped us quickly set up and personalize exactly what we and the clinical staff demanded."
— NIGEL MCLEAN, CYTOSYSTEMS, UK
"The Clindox team are dedicated and enthusiastic about accommodating the unique requirements of each individual study."
— KELLY SEAMANS, ATLANTIA
Next Steps
For system overview, click here. Seeing is believing. Book a consultation now.