Turn clinician’s innovation into reality
We ‘get it right’ faster, thus saving significant time and cost on needless design iterations.
ADVANCED PROTOTYPING CONCEPTUALISATION IN PARTNERSHIP WITH CLIENT
Integrate our intimate knowledge of the clinical workflows with the design concept, form factor.
Our Industrial Design experts assess the product attributes according to market suitability. Our experts have years of hands-on experience in complex, novel medical device development in a world class start-up environment, understand the challenges and constraints of a high-tech start-up
Not just 3D printing, hand-crafting the prototype, supported by local manufacturing for components; tight tolerances and quality control
Medical Device usability and clinical design considerations for:
– Usability Tests (HFE and IEC62366)
– Animal Studies
– First-in-Human Trials
ADVANCED PROTOTYPING INDUSTRIAL DESIGN
We assess the product design based on its ergonomic features, its overall appearance and other physical attributes according to market suitability.
We provide consulting to help you assess your product for compliance for IEC62366, human factors engineering and perform gap analysis to identify the right resources and facilities to perform product usability testing, particularly to identify and mitigate any associated risks.
We help you identify the relevant standards and regulatory requirements based on these factors early on during prototyping, to streamline the design and development processes – from the technology used, to the assembly of its various parts
What is a technical file good enough for technology licensing? Too much, it becomes restrictive to the licensee. Too little, there’s not enough definition and granularity for licensee to understand. Access-2-Healthcare’s immense experience with various academic, institutional, and hospital research organisation around the world provides you with the ‘JUST RIGHT” Technical File, that has the flexibility for a full Design History File to be completed, or be changed according to the new indications for use and designs.
We aim to keep documentation burden to a minimum.
‘ON THE GROUND’ PROTOTYPING AND MANUFACTURING
We operate out of a local facility quipped with quality equipment typical of a medical device start-up laboratory.
This allows us to quickly take idea to prototype, sometimes within a single day.
If you have a facility space available, we provide services to outfit a laboratory to suit your operations.
Eventually, your start-up will grow to require production of units. Mostly, it will be low volumes for the first years. If by now you have insourced development and prototyping, you would have already developed the processes for building the devices hence it would be easy and natural to scale up and insource initial productions. We are able to provide support in the form of setting up audit/certification support, line setup, process development and production controls and documentation.
Scope of Work
Turnkey Manufacturing Line Setup
Building and Construction
Factory facility and environmental assessment
Equipment Installation and Commissioning
Process Validation and Control Plan
Quality systems setup and Certification
Hand-over to Client
Process Equipment Maintenance; Servicing
One Time service fee, in milestones
Flat monthly fee; Annual term