The best use
Beth Harlen* looks at the technology helping doctors and medical device developers make better use of materials information to help engineering enterprises use them creatively in their products.
When it comes to achieving product design objectives, materials decisions are pivotal. But often these decisions are based less on the best material for the job, and more on supplier recommendations, previous materials choices, or even the personal experience of the design engineer. Helping engineering enterprises to step away from this process is difficult – particularly in highly regulated, understandably risk-averse sectors like medical devices, shifting regulatory demands only add to this challenge.
Take the new European Medical Devices Regulation (MDR). Due to be fully in force by 2020, MDR replaces both the previous Medical Device Directive and the Active Implantable Medical Device Directive (90/385/EEC), and is focused on transparency, traceability, and sustainability. This new regulatory framework requires medical device manufacturers to implement greater scrutiny over their technical documentation, provide clinical evidence proportionate to risk, and improve the traceability of their medical devices throughout the supply chain. For these enterprises to be successful – and sustainably so – they must ensure their products are compliant with all regulations, while remaining competitive.
Such factors can act as a brake on innovation. They can dampen down the constructive circular relationship that exists between material innovations and device advances. The development of new materials like bioabsorbable magnesium alloys drives new medical device technology, while external pressures such as gaining reimbursement in an environment of cost cutting and risk reduction push the healthcare sector to explore broader material options – for example, substituting metals with plastics in some applications. Let’s look at how we can get this virtuous circle going, and capitalise on the benefits of materials science engineering.
The information challenge
Part of this is that we need great materials information management. Having the correct materials information available in the right place, and at the right time, to drive good design decisions can provide the confidence to support material changes. Not only this, but managing this information well, simultaneously meets the challenge of regulations, since these are all about being able to audit decisions and follow back to the data on which they were built.
Medical device enterprises must control and apply materials information, connect it to application information, and, critically, pair that with understanding. This can be particularly beneficial early in design, when it can empower decisions that have more impact for least cost. Moreover, any potential risks can be identified and understood so that they can be mitigated, or avoided.
Good materials information helps engineers choose new or replacement materials, exploring factors that impact the strength, fatigue life, and biostability of the device. Where they are constructed of multiple materials – hip implants, heart valves, and artificial hearts for example – it’s also important to link this information to good data on the joining methods. Connecting materials to data on related surface treatments rounds out the picture.
But ensuring complete and fully traceable materials property data brings its own challenges – this can require capture of large amounts of test data and analyses, with all their inter-connections. This information is not static, but changes as new tests and analyses are performed. Often, particularly in the medical field, disparate project teams build isolated siloes of data, so potentially valuable data is inaccessible, and processes for ensuring test results travel downstream can be lacking.
Materials information management
It’s an all-too familiar scenario – materials experts find themselves wasting valuable time looking for, or validating, specific materials information. Gaps in corporate knowledge need to be filled, and potentially reusable test data becomes lost in archives. Implementing an effective materials information strategy requires a specialist system to ensure that all corporate data on materials, specifications, and processes can be captured and managed with full traceability.
One such system, GRANTA MI, does this by creating a single gold source for a company’s materials information. This enables designers and engineers across the enterprise to find the information they need quickly. For medical device organisations, this can have life and death consequences.
Medical devices manufacture Ethicon Surgical Care offers a prime example of the impact made by effective materials information management. One of the main challenges the enterprise faced was that materials decisions were being made by several people, using often unrelated data sources – one of which was an off-site facility that stored relevant and archive data. The process was inefficient, led to redundant testing and revalidation, and had the potential to introduce risk into the design process.
The solution was to centralise its materials information in a searchable database based on GRANTA MI. Through this, proprietary in-house materials information can be supplemented data sources that combine material, and application data. One example, the ASM Medical Materials Database, run by ASM International, links engineering property and biomedical response data for hundreds of materials, coatings, and drugs to medical device application and recall information from the FDA databases.
How Ethicon manages its materials information
Ethicon dubbed its system the integrated material optimisation environment (iMOE). This database provides quick access to device-level materials contents, and information on where a material is being used across the company. Among the benefits is the ability to identify replacement materials if there is a supply problem – due to ceased production of a material or when a vendor announces a force majeure – access to historical data to aid new product development, and response times to patient-on-the-table queries about materials in medical devices. At a Granta Design seminar, Jackie Anim, Principal Materials Engineer at Ethicon Surgical Care, gave an example of how the facility to access historical information impacted product development.
Ethicon wanted to develop a new medical device with a tracker. The tracker itself was not new – an engineer had evaluated it a decade earlier, but it had never been incorporated into a device. Good news for the project team was that it had been tested to ISO10993 standards, and full biocompatibility information was available in the database. Accessing this information saved around US$200,000, and the 22–26 weeks it would have taken to test it again to meet the standards. No material implantation retesting was necessary, and only device-level testing was required for full validation. ‘Something that would have taken [the team] 18 months, took them less than three or four months to get to the same conclusion,’ says Anim.
In addition to improving product development within Ethicon, the database has positively impacted the enterprise’s ability to respond to time-critical medical device queries. Anim gave an example of a doctor checking whether a device to be used in a medical procedure contained natural rubber latex. As the patient on the table had an allergy to the material, the procedure couldn’t go ahead without confidence that the patient wouldn’t come into contact with the polymer. The doctor contacted Ethicon, quoted the information on the device label, and one of the staff used a multi-dimensional search facility – in this case, the product name on the device label – within the iMOE system to check the device’s composition.
‘At that moment, the life of the patient doesn’t depend upon the hospital, it’s not even in the hands of the doctor – it’s in our hands. How fast can we give a response to that doctor,’ Anim explains. The database search showed that the device had 42 components, none of which contained latex. Within a few minutes of the request, the team was able to confirm that the device didn’t contain natural rubber latex, and that the medical team could safely proceed with the operation.
Ready for anything
Effective materials information management can also help companies like Ethicon cope with unforeseeable circumstances. According to Anim, when a Nylon 66 manufacturer of a proprietary material sent a force majeure notification on their product, Ethicon had to rely on the iMOE system to conduct a where-used search to determine the extent of the impact, as well as any potential business risk. The output of this provided information on the application points and included access information on all vendors – injection moulders – that order that grade of material. The approach enabled the business risk to be evaluated with ease, and without the need to put together a large team to pull and review engineering drawings, or travel to vendor sites to conduct an assessment.
Finally, the recent expansion in plastic use in the design and manufacture of medical instruments, and digital medical devices has brought further benefits, gained from the iMOE system. Anim explains, ‘The system has enhanced capability to view and compare internal, customised material properties side-by-side with all the associated internal and external regulations. The introduction of material risk flags and indication of medical grade are pending benefits that our internal design engineers will have when selecting material for new projects, or replacements for legacy devices.’
The benefits of a holistic approach
To be successful, any effort to make design and engineering more productive should have robust materials information management at its heart. For sectors like healthcare, an optimised, holistic approach to that management could not only be worth millions of US dollars, but could have significant impact on patient lives. In terms of strategic business drivers, better-informed materials decisions lead to improved product performance, and reduce the risk of costly recalls.
Valuable corporate IP can be reused, and enhanced by validated, trustworthy reference data. Essential materials information can be quickly and securely accessed by those who need it, when they need it. In a competitive and highly regulated sector like healthcare, medical device manufacturers can’t afford to take a different approach.
*Beth Harlen has more than 10 years’ experience within technical, scientific, and engineering sectors. Former editor of an international B2B magazine targeting modeling and engineering, high-performance computing, and life sciences, she joined Granta Design in 2017 as Technical Marketing Communications Specialist.