A combined approach to design & manufacturing

Posted on 14 Dec 2016 by The Manufacturer

Rachel Nagy explores why adopting an integrated approach can make all the difference when it comes to designing and manufacturing medical devices right first time.

Within the medical device manufacturing sector, product lifecycle management 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.

Rachel Nagy, project manager, Owen Mumford.
Rachel Nagy, project manager, Owen Mumford.

Timescales can be long and further lengthened by the requirement to fulfil market or industry regulations. This teamed with customer demands and the promise of a comprehensive completion of work within a specified timeframe, can heighten the pressure on the industry and those working within it.

For medical devices, a project scope and its requirements 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 reduce project risk, it’s important to combine manufacturing and design in product creation and development. For a successful project completion, this integrated approach can make all the difference.

‘Design for manufacturing’

Product lifecycle management 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’s imperative to facilitate communication between departments from the start of the project, reducing the risk of error or delay further down the line.

Design & 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, while the real-world experience of manufacturers can influence the design stage.

About Owen Mumford

In business for more than 60 years, Owen Mumford is a major medical device manufacturer that develops pioneering medical devices for its own Owen Mumford brand and custom device solutions for the world’s major pharmaceutical and diagnostic companies.

Owen Mumford’s goal is to improve quality of life, encourage adherence to treatment and reduce healthcare costs. With a history of world firsts in device solutions, the company offers proven design, development and delivery services from a broad base of proven self-injection and blood sampling platform devices and intellectual property.

The earlier an issue is identified during the product lifecycle 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 & 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 while delivering against customer requirements.

Part of this includes making a product fit for use and responding to market regulations. One such regulation is how biocompatible the device is, which must be considered before the device is sent to manufacture. 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.

Verification & 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 resolving any issues identified.

Capabilities to innovate

Owen Mumford: Behind the scenes: R&D in medical device design 1
For the project manager to deliver a device fit for the market, they must work closely with design and manufacturing teams – image courtesy of Owen Mumford.

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 this approach works

A consistent team throughout the duration of the project comprised of all key disciplines along the way, can ensure 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. As all stages are managed under the same remit, 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 long- term customer relationships.