Case study – Owen Mumford’s combined approach between manufacturing & design

We speak to Rachel Nagy, Project Manager at Owen Mumford and look at why a combined approach between manufacturing and design can make all the difference in medical device development.

The lifecycle of a medical device can last on average anything from one to four years, by which time an idea has to pass from initial concept and design through to manufacture and mass market distribution. Timescales can be long and further lengthened by the requirement to fulfil market or industry regulations. This alongside customer demands and the promise of delivery within a specified timeframe, can heighten the pressure on the industry and those working within it.

The project scope and requirements of a medical device can often be complex, requiring the input of multiple departments and functions. Project management is vital in successful deployment and can add significant value when effectively implemented.

To meet a specified timescale within budget and to reduce project risk, it is important to combine manufacturing and design in product creation and development. This integrated approach can make all the difference in a successful project completion.

 ‘Design for manufacturing’

A product lifecycle will begin with an initial design concept. A partnership of expertise between designers and manufacturers from this point onwards is important as this can allow for a more efficient and economic process. For a project manager, it is imperative to facilitate the communication between departments from the start of the project, reducing the risk of error or delay further down the line.

Designing and prototyping

Designers will build a prototype of the device through methods such as soft tooling or 3D printing which will allow the team to test the device there and then for any incompatibilities or inefficiencies. During prototyping, engineers can foresee any potential complications before the device hits production, whilst the real-world experience of manufacturers can influence the design stage. The earlier an issue is identified during the product development process, the more cost and time efficient it is to fix. This prevents the risk of a late technical discovery and reduces the time taken between device production and market delivery.

Market regulations and end-user factors

Product efficacy is key in medical device manufacturing. For the project manager to deliver a device fit for the market, they must work closely with design and manufacturing teams to produce an easy to use and effective device whilst delivering against customer requirements. Part of this includes making a product fit for use and responding to market regulations. Cross-functional design and industrialisation engineers can help to identify the materials that may be appropriate to use and will fit regulatory, user and manufacturing requirements. This early cross-functional work ensures that industry regulations and manufacturing requirements are considered at the design stage of the project, reducing the risk of further design iterations later down the line.

The verification and testing phase

Ahead of manufacturing, a designed device must pass through theoretical and physical testing. After the physical tests are complete, the performance reports are pulled together and compiled to evaluate performance. A close working relationship between the design and manufacturing teams is especially beneficial at this stage in observing and recording the results of verification testing and later resolving any issues identified.

Capabilities to innovate

Cross-functional design and industrialisation teams are capable of seeing through the entire lifecycle of the product. They are able to add their expertise into the development stages that could be easily missed in a non-cross-functional team arrangement. This allows the team to become more innovative with their design and manufacturing techniques and in turn offer the customer a new take on their brief and requirements. For the customer, this can be the key difference between taking a product to market and standing out against competitors.

Why an integrated approach works

A consistent team throughout the project, comprising of all key disciplines along the way, can ensure a smoother development, fewer surprises and better communication. For the project manager, there can be greater efficiency across differing stages of the product lifecycle alongside better control of costs as little to no outsourcing is required. This also reduces the risk of multiple incompatibilities which may arise from multiple suppliers.

From a customer perspective, using one team throughout the process can provide a continuity of knowledge, both in terms of understanding the end goal of the project but also the technical requirements to achieve the goal.

In addition to this, a collaboration between design engineers and manufacturing helps to ensure the devices are reliably manufactured to a consistently high quality in production. This means that the product will be delivered to the customer faster. This efficacy, partnered with consistent manufacturing, will improve the product output and the long- term relationship with the customer.