Mechanical engineering

The physical device: the parts, how they fit and how they are made, with biocompatibility under ISO 10993 in view from the first material choice.

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When mechanical engineering is the right step

Once the concept and the form are chosen. Mechanical engineering turns them into parts that fit, seal, carry load and can be made at the cost you need.

Turn a concept into parts
A proven concept or an industrial design that now needs detailed parts, assemblies and drawings.
Make it manufacturable
A prototype made by printing or machining that must move to moulding or another production process, at a cost that works.
Solve fluid, heat or seal problems
Fluid paths, thermal limits and sealed or sterile-barrier features, where the physics decides the design.

What you bring, and what you get back

You bring

Requirements, with numbers where you have them
Industrial design surfaces or a prototype
Target cost and expected volumes
Materials and suppliers you already use
How the device is cleaned or sterilised

You get back

3D CAD models
Released 2D drawings, with tolerances
Tolerance stack-ups
Design for manufacture review
Mechanical test reports
Bill of materials

Biocompatibility belongs to the finished part

ISO 10993-1 evaluates the device as it is made, not the raw material. Processing, colourants, mould release, cleaning and sterilisation can all change what the body is exposed to. The evaluation depends on the kind of body contact and how long it lasts. A 'medical grade' label on a material is a useful start, but it is not evidence for your part.

How mechanical engineering works

Step 1
Set the architecture
How the parts fit, move, seal and carry load, from the requirements.
Step 2
Design in detail
CAD, tolerances and design for manufacture, with the supplier in the loop.
Step 3
Prove it
Analysis and prototypes for stress, heat and flow where they matter.
Step 4
Release
Drawings under change control, and test reports against the requirements.

Questions clients ask

Why involve a supplier during design?

A moulder or machinist sees draft angles, wall thicknesses and tolerances that add cost or cause defects. A change in CAD costs less than a change to a tool.

Do we need finite element analysis?

Where a part carries load, gets hot or moves fluid, and its failure could harm someone, analysis helps settle the design before testing. Where a simple test answers the question, a test is often the better choice.

Which parts need a biocompatibility evaluation?

Every part that touches the patient or the user, directly or through a fluid path. ISO 10993-1 sets the evaluation by the type and the duration of contact. Parts with no body contact do not need it.

Can we start with 3D-printed parts?

Yes, for fit and function. Printed parts often differ from moulded parts in strength and surface, so their test results may not stand for the production part.

Two engineers reviewing a CAD model on a laptop

Engineers in one team

Mechanical engineers work beside industrial design, electronics and verification in one team of nine disciplines, with our design office, labs and assembly in Navi Mumbai.

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