Solution Profile

Squeezed by a tightening timeline and surging demand, a multi-billion-dollar manufacturer needed to drastically reduce time and cost to accomplish crucial financial performance objectives.  This meant designing a far more consistent, less resource-dependent process for a 6-French subassembly for an atherectomy device.

The right contract manufacturer would have to:

• Design a more repeatable process to reduce inspection and quality control resources.
• Implement an efficient process to save production time and increase speed to market.

Seeking new breakthroughs, the customer looked to Velosity for a creative injection molding process. Offering the flexibility and innovation required for this challenge, Velosity confidently began redesigning the process testing its hypothesis for eliminating manual assembly.

The Current Process

The customer’s current process included manually shrink-wrapping techothane sheets around three components – a machined scoop, small-diameter lumen and platinum marker band – and then heating them with a Bunsen Burner – resulted in these fundamental issues:

• Part inconsistency – A trial and error approach inefficiently matched handmade components with machined parts resulting in increased scrap.
• Increased labor – Workers performed this tedious process from start to finish, wasting valuable resources of both time and money.

Solving the Manufacturing Challenge

Velosity decided that injection molding the part would significantly reduce costs while improving quality. However, these obstacles stood in the way:

• Filling the part accurately – the extremely thin wall (.002ʺ) was difficult to fill with enough pressure to flow around the entire scoop.
• Keeping the nitinol core stable – at .017ʺ, the core holding the lumen and marker band would flex during high-pressure injection molding.
• Aligning validation/inspection – both companies would need to measure and define the new manufacturing process the same way.

The Velosity Design and Engineering teams took a systematic, 3-phase approach to address and overcome these challenges, reducing both cost and risk:

• Proof of concept – Already validated and in production, the newly molded part’s geometry needed to match the current, already-produced parts. The first tool proved that injection molding worked.
• Proof of manufacturability – the next tool addressed the nitinol core’s flexing during injection. Building on the first tool, this next tool tested gate size and location.
• Production – The production tool was fine-tuned to meet the stringent specifications. An inspection plan was developed, and a consistent, repeatable process was achieved.

The process redesign that Velosity developed resulted in substantial, not incremental, cost reduction and innovations including:

• Reduced labor costs – no longer done by hand, man hours were slashed by 62.5%.
• Accelerating speed to market – the product was successfully launched after just 36 weeks, with ongoing programs experiencing reduced downtime of 49.9% – leading to lower costs and increased capacity.
• Decreasing manufacturing cost – as a result of increased automation, consolidation of the supply chain, and an improved tool performance, costs were reduced by 40%.