Challenge
Our customer, an expert in an ENT therapy application, had a clinical application trial for local delivery of a drug therapy. Their solution would avoid the traditional injectable and systemic drug therapy delivery in favour of localised therapy delivery at the target treatment site.
Our customer would use localised delivery to treat the target location with higher concentration and reduced quantity of consumed drug and provide overall improvement in patient outcomes.
To deliver the drug therapy, our customer required a medical device to access and navigate to the target location (traditionally done with rigid tools and reusable endoscopes).
To get to the target precisely, they needed a device that could be manipulated to access the location, visualise the location (in this case using miniature cameras) and include mechanical functionality for an injectable needle to allow drug delivery.
This complex device had to be disposable; a single use device to support clinical usage.
Our customer required Proof of Concept (POC) prototypes for animal trials to challenge the therapy application of local drug delivery. The customer is an entrepreneurial innovator who did not have medical device or catheter expertise nor the catheter technology to build their solutions. They needed support for technical expertise and to move them to a POC feasibility animal trial in a tight time window that was critical to their needs.
Our Solution
After receiving the clinical needs and procedural requirements from the customer, we implemented our brainstorming process led by the senior ICS engineering team. Critically this process includes the customer who continually provides clinical input, ideas and validation on ideas generated and concept selections.
The selected ideas were refined into viable concepts and two early-stage concepts advanced for initial POC, once more with our customer fully involved in the review and decision-making process.
ICS designed, specified and scoped the concepts and agreed budget and schedule with our customer. We then proceeded to set materials and processes requirements in motion, including:
- Device with integrated steerable shaft.
- Integrated Camera with 120o plane of view.
- Injectable needle.
- Multifunctional Handle to support steering, needle injection, drug delivery and catheter shaft manipulation.
From customer contact to specified and detailed concepts took 2 weeks to complete.
From Idea to POC Prototype
ICS conducted initial design development trials pending receipt of custom materials on in-house ‘close enough’ alternatives. In parallel, ICS designed the handle and collaborated with camera manufacturers suitable for endoscopic application.
After initial developments and on receipt of sourced materials (e.g. cameras), ICS proceeded to prototype stage. Evaluation of the initial prototype provided vital input on process and design. This was then reviewed at ICS and by the customer, and vital inputs on the prototype were integrated in the second round of prototyping.
With the process further tuned and design tweaked, ICS completed the second round of prototypes, constructing five units ready for the animal trial.
ICS completed robustness testing, including catheter functionality and camera test, prior to release to customer. This provided the customer with full confidence on the functionality of the units before completing an expensive trial which involved vital Key Opinion Leaders.
Our customer completed the animal trial within three months after approaching ICS Medical Devices with their idea for localised therapy delivery using disposable endoscopic technology with drug delivery.
Key findings were gathered by the customer which will allow them to make calculated decisions on next steps for their project.
“To turn our idea into reality we needed to find an experienced partner to work with. The ICS team took the challenge and supported our concept with their technical expertise and technology. We completed the animal trial in 3 months.”
ENT Physician and Inventor, Europe
Contact ICS today to speak to one of our engineers about how we can help to guide you along your catheter development journey.