Clinical Studies, R&D
Support for devices that are under development
If your medical device requires sophisticated support during clinical studies (pre-approval or post-market), FirstClinTech has the expertise you require. In addition, our experience can add significant value to your research and development, leading to improved offerings to your customers.
We would like to make one thing clear. First Clinical & Technical Services Limited is NOT a large Clinical Research Organisation (CRO). CRO’s are the experts on many aspects of Clinical Trials and Studies which FC&TS does not offer – for example study monitoring on a large scale. CRO’s seldom offer the dedicated support that FirstClintech specialises in. FirstClinTech staff could therefore work in partnership with a CRO – with the positive outcomes of improving results, better enrolment, and better feedback. For smaller studies, or post-approval marketing studies, FirstClintech can provide local study support working with Client staff. Our logistics capabilities offer you a cost-effective and hassle-free way to manage device accountability, traceability and vigilance.
Feedback to R&D
When your R&D team is based on another continent, it is difficult for them to obtain comprehensive feedback from the field. Early use of devices, as is typically the case in Clinical Trials, can provide invaluable sources of feedback into the design validation process. It can flag up opportunities to iterate products at an early stage. Or, it could identify specific aspects of device use that could be addressed through improvements to training or labeling –
We have dedicated facilities for explanted devices where we can collect, process, document and ship onwards, meeting appropriate technical standards (e.g. preserving biological integrity) as well as environmental rules such as UN regulations on shipment of biological material or hazardous chemicals.
Explanted / Removed Devices
There may be many reasons to retrieve a medical device and get it back to the manufacturer. Often, novel devices under clinical trial must be analysed for wear and other performance criteria. Alternatively, a patient may experience an adverse event which requires complex post-event device analysis to prove or disprove relatedness.
This photo was taken at 2am, in the operating room, immediately after emergent explant. The presence of a well-run logistics service ensures that everything is retrieved, fixed in formaldehyde, processed, and returned for analysis.
Most hospitals, on the other hand, are pre-occupied with treating the patient, and once a device is removed from service it is (understandably) not a high priority for the staff. This can lead to critical information being lost, for example if an explanted device is not fixed and stabilised rapidly. It is important to prevent further contamination or degradation of the explanted material – for example with new pathogens, dust etc. Finally, there are significant regulatory barriers to be overcome to ship material that is potentially hazardous.
This could be a biohazard risk, or alternatively a chemical risk introduced by the fixation of the devices. To adequately address these needs, FirstClinTech has its own Decontamination Facility immediately adjacent to our warehouse/offices. With separate entrance, processing and storage space it is completely separate from products and activities used supporting ongoing patients and projects.
Shipping Hazardous Materials
Tonny De Mooij, FirstClinTech’s Logistics Manager, is fully trained and experienced in techniques and regulations for shipping hazardous materials. His experience, and that
of our regular logistics partners Van Den Heuvel mean that explanted devices will arrive back at the manufacturer in the best possible condition, withing the most effective time period.
For additional information, please contact us