Manufacturing


Manufacturing is perhaps the most risky aspect of product development. Not because things go wrong, but because usually challenges are underestimated, and the unplanned work and costs end ups terminating a project.

In my experience everything is possible to make, as long as you are willing to pay enough to develop the process and technology and you are not defying any law of physics. New materials and processes keep emerging, that prove this, but are often too expensive and time consuming to be adopted by non- specialized products.

My approach in this field is to first stick with the known. Use conventional materials and processes as much as possible and only when this is not possible, then look into adapting an existing process and ultimately if this fails, developing your own process.

My experience across several sectors and industries allows me to recommend the most convenient material and process from an early stage, reducing with this developing time and costs. Also, my experience allows me to help clients and companies on stablishing the required specifications, approval processes and quality systems to ensure that a new product is made the right way from the beginning.

In addition, my network of international suppliers allows me to recommend or trusted manufacturers that can be a good match for each project.


Design for manufacturing (DFM)

Through the design process, I never lose attention from the manufacturing aspects, but it is usually on the detailing stage when a considerable effort has to be in place to ensure that the product and all its parts are fit for manufacturing.

Within this field I look in simple aspects like mouldability, (draft angles, mould flow, wall thickness, gate points, ejector points, etc.), but also more analytical areas such as tolerance analysis and process optimization. 

 

 
 
 

Tolerance analysis

In this area, simple stack analysis could be conducted to define the manufacturing tolerance windows for all critical features within a product. The downside is that the tighter the tolerance, the more complex a manufacturing process requires to be, thus increasing the cost and timescales. Therefore in some cases statistical tolerance analysis is used, which allows increasing the tolerance windows by using statistical analysis. In any case, the ideal solution, is to have a design that does not rely on a tight tolerance to start with, however this is not always possible.


Designing for injection moulding

Designing products to be made in high volumes is not a secret, but experience in this field helps in foreseeing challenges and features that may not be formed correctly.  I follow a series of guidelines and reviews through the design process to ensure that the manufactured product will meet the requirements and stakeholder’s expectations.

Within the detail design process I look into wall thickness, draft angles, mold flow analysis, sink marks analysis, deformation and bending analysis, gating and ejecting. All this tools, along with experience and moulders reviews allow me to create designs that will be made as intended.


 

Industrialization and New Product Introduction

Manufacturing validation process

In the medical sector and in other regulated industries it is vital to comply with high quality standards. In my line of work, I don’t finish the process by handing over design specs to a manufacturer partner, but in many cases have to work in close collaboration with them in validating the manufacturing process. The objective is to ensure that the product (or device) is made as it should and will always be made the same way. In this process we also hand over the “design authority” from the development team to manufacturing. So that no change is made to the design without having the manufacturing team fully involved.

To validate the manufacturing process we need to set up a series of test and evaluations plans where we will be defining what an acceptable part and device will be. The process looks at the equipment, the tooling and the process itself, and its describe by the FDA in the following way:

Process Validation:

Means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.  

 

Installation Qualification (IQ)

Simply put in guidance, is everything installed correctly.

• Equipment design features

• Installation and Environmental Conditions

• Safety features

• Supplier documents, Calibration, preventative maintenance and spare parts.

Operational Qualification (OQ)

Challenge process parameters to assure the process will result in product that meets requirements.

• Determine process control limits

• Material specifications and handling

• Process change control and training

• Determine potential failure modes, action levels and worst case scenario

• Perform software V&V for intended use </p>

Performance Qualification (PQ)

Demonstrate the process will consistently produce acceptable product under normal operating conditions.

• Approved procedures and limits from OQ

• Acceptable product

• Simulate actual manufacturing conditions

• Is the process repeatable and stable long term

 

 

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