Collaboration as a Tool to Reduce Project Risk

Collaboration Is an Aid to Reduce Project Risks

Project management has become digitally based. With key gateways, milestones and phases managed at the click of a button. This has obvious advantages to quickly gauge the status of a project at any given time, and make information easily accessible to the project team, and line managers alike.  

Research has become more insular. Information available on the internet, and how easy it is to access that, especially through AI assisted research, leads us all to use these facilities to home in on certain aspects of the project. As such project teams have begun to move away from discussions with experienced people, especially outside their own organisation. Missing resources that can often offer insights based on real world experience and give snippets of knowledge about related influences that a focused search can miss.  

My concern is whether our field of view has become too narrow.  Have we become more focused on what triggers that click to move the project on and in trusting search engines to find everything we need to know, rather than checking for hidden risks and problems to come, that may have been uncovered by more human interaction? 

This paper explores the importance of early stakeholder engagement, especially with external supply chain partners and service providers – as a means of reducing project risks and avoiding costly delays. 

Why Is Early Stakeholder Engagement Critical in Medtech Projects?

It is important to remember that various parts of your supply chain and services providers work in silos, often bound by confidentiality agreement, and as such are unaware of each other’s influence on the project. Engaging them earlier can prevent issues that would otherwise emerge late in the project, when changes are difficult or even impossible to implement. 

Medtech leaders can utilise their supply chain and service providers sooner by considering: 

• Who will be involved downstream? 
• What roles will they play? 
• How might their contributions affect timelines and outcomes? 
• Are there dependencies between various parts of the project that these stakeholders can clarify? 

This simple check list can assist in finding the right stakeholders to address early on. 

What Risks Arise from Involving Suppliers too Late in Material Selection?

Material selection illustrates the importance of early engagement. Research suggests that suppliers are approached over 50% through a project. At that stage the materials are likely to have been selected, and some testing may already have been completed. Add in the fact that the further you are through a project the more costly, in time and resources, it is to change something. Plus, that at certain later stages of a healthcare project, changes would not be acceptable, and the risks increase.  

Early discussions with material experts gain insights that can uncover negative influences that may be imposed on a later project phase, such as in processing, finishing and sterilisation or packaging, even influences on testing and validation that weren’t foreseen. A few targeted meetings with stakeholders can save significant time and resources later. 

What Must be Considered When Selecting Medical Device Materials?

Medical device projects often involve complex decisions. The project team will have a list of requirements that they try to match against available materials. However, material selection often involves trade-offs: 

•  A material with excellent wear resistance may be unsuitable for printing. 
• A polymer with low warpage may be cost-prohibitive. 
• High optical clarity might come with poor chemical resistance. 

Requirements must be prioritised and a decision made whether it’s better to have several well match parameters or one highly critical specification met exactly.  

This can be further complicated as medical devices tend to be multiple components with different requirements and thus the research is often done per component. At some point those components must integrate seamlessly into one medical device. That can bring unexpected issues  

• Joining methods. 
• Sterilisation compatibility. 
• Cleaning processes.
• Aesthetic consistency (e.g., colour matching across different materials). 

These complexities underline the value of involving supply chain partners early. They can advise on suitable materials, reduce the likelihood of downstream incompatibility, and guide decisions before designs are finalised and tools are cut. 

Why Are Regulatory and Quality Considerations Often Addressed too Late?

Another issue can lie in regulatory and quality management. Generally regulatory statements are checked early on, such as material compliance with the relevant pharmacopeia and whether they have been tested for biocompatibility such as ISO 10993.  

However, devices need to be tested so these statements only give more confidence the device testing will be successful, so the control needs to be on material changes, not what has been tested on the material itself. 

Project teams rarely consider what is needed in terms of documentation and supply chain services at this early stage such as: 

• Supplier audits. 
• Change notifications triggers and periods.
• Quality agreements.
• Regulatory questionnaires. 

These requirements often emerge close to commercialisation, when procurement and quality assurance teams begin engaging with suppliers. At that stage, assumptions about supplier responsiveness and flexibility may no longer hold true. 

This is especially relevant in the medical device sector, where low-volume, high-specialisation projects are common. A device may use only a few batches of a given material per year (insignificant from a manufacturer’s standpoint). Consequently, not all suppliers are equipped to provide customised services, respond to detailed questionnaires, or support audits for every client. 

The MedTech Industry often equates to a few percent of material manufacturers annual business and providing dedicated resources is limited to a few manufacturers who offer medical grades and the specialist services to go with them. 

What Challenges do Manufacturers Face with Medical-Grade Material Supply? 

Even with a medical grade what is included in the service package varies significantly: 

• Change notification periods can range from 12 to 36 months. 
• Some manufacturers release formulation details under NDA, while others do not. 
• Quality agreements may range from full acceptance of a client’s QA terms to simple statements of compliance with ISO standards (e.g., ISO 9001). 

Distributors with a strong medical focus can offer tailored support and streamline early material selection, ensuring alignment with regulatory, functional, and commercial requirements. 

Navigating these nuances requires early and informed conversations. Engaging suppliers who offer a wide material portfolio and healthcare-focused expertise can help avoid costly missteps. With a dedicated healthcare Team ALBIS is one such resource.  

How Does Collaboration Reduce Project Risk in Medical Device Development?

The key takeaway is simple: engage stakeholders early. Consider the downstream implications of decisions made during initial phases. If a material, process, or design choice may affect, or be affected by, an external supplier later on, it’s worth bringing them into the conversation now. 

Collaboration with partners who understand the complexities of healthcare projects can uncover hidden risks, clarify regulatory constraints, and improve the overall efficiency of the development process. These stakeholders share your investment in a successful outcome. 

As a distributor, ALBIS offers the unique advantage of access to a wide range of medical-grade materials, coupled with a team of experts dedicated to healthcare projects. We can assist you in selecting the most appropriate materials and combinations, supporting compliance, performance, and manufacturability. 

By taking a collaborative approach from the outset, project teams can focus on what they do best: delivering safe, effective, and innovative medical devices to market, on time and within budget. 

References

Challenger Performance Optimization, Inc 

European Plastics 2014 

Disclaimer. The views and opinions expressed in this article are solely those of the author and do not necessarily reflect the official policy or position of Test Labs Limited. The content provided is for informational purposes only and is not intended to constitute legal or professional advice. Test Labs assumes no responsibility for any errors or omissions in the content of this article, nor for any actions taken in reliance thereon.