The CanuSoft advantage of quality and product features is measurable and apparent to our customers as well as to our end users.
Our skill and expertise in medical device manufacturing helps in giving us a decisive advantage over most competitors.
Product/Quality
Attribute |
The CanuSoft Advantage |
What to avoid in competing products |
| Needle Quality |
Best-in-class, all-Japanese needle
Triple facet (back cut) as per ISO 10555-5 |
Lower quality needle from cheaper sources, or produced in-house with lack of validation
Lancet point needle not suitable for venipuncture |
| Catheter Quality |
Best-in-Class catheters with European technology
Choice of PTFE, FEP or PUR
Wide range of sizes, from 12G to 26G |
Restriction to one catheter material, irrespective of end-user preference
Limitations in producing 12G, 13G or 26G catheters
Inconsistent catheters from low quality sources |
| Needle & Catheter penetration force |
Unique in-house technology to ensure extra-smooth and low-pain venipuncture
Usage of tools developed and maintained in-house for catheter forming and asenbly with needle |
Dependence on third party technology for catheter forming and assembly, lack of reliable source for forming and assembly tools
High penetration force for needle and catheter
Inconistent fitment between needle and catheter due to improper forming of catheter tip |
| Flashback |
Fully validated flashback
Option of flashback assisted with hydrophobic filter |
Inconsistent flashback, leading to repeated insertions and failure
Non-availability of hydrophobic filter |
| Siliconization |
Robust in-house technology for siliconisation |
Arbitrary siliconisation methods, non-compliant with ISO-10555-5 |
| Sterilization |
In-house sterlization with ETO gas, validated and operated as per ISO 11135 and ISO 11138
All batches tested for sterility |
Dependence on outside sterilizers, leading to risks of process compromises and higher lead times
Infrequent testing or re-validation of sterilization |
| Packaging |
Wide choices of packaging with soft/rigit film, paper / tyvek, etc, all validated as per ISO 11607
Online printing to provide maximum flexibility and safety for OEM labels
Labeling and bar codes as per ISO 15223 |
Restrictions of packaging methods and materials irrespective of end-user preferences
Arbitrary or non-standard packaging materials or methods leading to risks of contamination
Dependence on outside printing for primary labels, leading to risks of contamination and improper labeling
Arbitrary methods of labeling or barcode control |
| Analytical testing |
In-house laboratory for physico-chemical and microbiological testing
All batches tested for pyrogenicity |
Dependence on outside laboratories, leading to risks of process compromises and higher lead times
Infrequent and unreliable testing |
| Biocompatibility |
Ue of certified biocompatible materials
Biocompatibility tests as per ISO 10993-1 |
Choice of materials dependent on cost and availability rather than biocompatibility
Inadequate or incomplete testing for biocompatibility |
| Product features |
Full service, in-house design and development
Unmatched flexibility for adding or modifying product features
Rapid prototyping for new product or variant launches
More than 20 different formats of IV Cannula available |
Limitations in adding or creating new product features to suit user requirements
Restricted or fixed product range
Non-availability of critical product featuers (e.g. safely catheter) leading to ineligibility for entering user segments
Inability or long lead times for new product creation |
| Environment control |
Manufacturing facility located in well-developed, no-polluting industrial area
Assembly and production areas validated and operated as per ISO 14644 |
Inadequate environment controls in assembly areas, especially injection moulding, component storage and product inspection |
