Manufacturing

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Medical Device Industry Challenges

1. Regulation and traceability

The manufacturing sector, like so many sectors, is facing increasing regulation and compliance measures. Everything from health and safety to waste management is surrounded in red tape. Now more than ever, manufacturers must ensure they have complete visibility throughout their supply chain for their own compliance and that of their suppliers. Regulations often require the ability to track items and materials used during the manufacturing process.

2. Product development and innovation

We live in a consumer driven world and as such product development and innovation moving at a lightning pace – to stay relevant, manufacturers need to be able to keep up with the pace. As companies vie to be first to market with a new concept, the temptation to compromise on quality can be huge, however manufacturers need to be stringent and avoid cutting corners. Fast times to market mean that companies need to become more structured in their approach to managing innovation – great product ideas cannot be left to chance. Implementing procedures that keep a steady stream of new product ideas and innovations in the pipeline is essential to manufacturing success.

3. The manufacturing skills gap

The baby boomer generation is reaching retirement age and leaving a considerable skills gap in the workforce. While manufacturing firms are doing what they can to inspire a new generation of manufacturing employees and experts, there is still a considerable void when it comes to skills and experience. Manufacturers need to work with schools and universities in their communities to ensure that manufacturing focused subjects are being well promoted and taught. In addition, manufacturers need to bridge the gap by encouraging their older employees to gradually slow down to retirement, passing on valuable skills to younger employees during a transition phase.

4. Healthcare costs

The manufacturing sector is certainly not the only one to be hit, but rising healthcare costs for workers is putting a considerable strain on already fragile manufacturing cost structures. Manufacturers in the U.S. in particular face the burden of providing healthcare while their competitors in other countries are not required to. Manufacturers need to be aware of this rising cost, and managed budgets accordingly, to ensure healthcare doesn’t push up the price of products beyond commercial viability – it can be a balancing act.

5. Environmental concerns and considerations

While it is undeniably good news for the local environment and employee wellbeing, sustainability and environmental regulations can be expensive for manufacturing firms. Manufacturers need to be aware of these costs when outlining their quarterly budgets.

6. Balancing maintenance with throughput

Keeping equipment functioning is an essential part of running a manufacturing facility. Regular preventive maintenance can help increase throughput and ensure customer satisfaction with delivery lead times. Sometimes manufacturers are tempted to postpone or delay preventive maintenance or they replace factory components with lower-quality items. This practice may create unsafe conditions in harsh manufacturing environments if these lesser components can’t stand up to operating conditions. Poor maintenance can cause health and safety issues, as well as cause unplanned or excessive downtime. Manufacturers need to perform preventive maintenance on recommended schedules to keep operating costs low and throughput high while helping to ensure worker safety.

Sharrix Solution

The Sharrix risk management solution has out of the box DFMEA, PFMEA and Control Plan models that provide comprehensive risk assessment tools to promote best practices and utilise valuable lessons learned data that can be used in your new electronic designs and production operations. We help General Manufacturing companies identify, analyze, and mitigate operational risk within one plate form that allows timely closed loop, workflow driven, action tracking on any mobile device no matter where the action assignees are geographically located.

Sharrix provides Operational Risk Management solutions that empower you with a comprehensive view of your risk management priorities and help to create corporate best practices and provide a way to share lessons learned across your operations. Sharrix helps simplify Quality Risk Management activities by providing:

  • A consistent corporate standard for all risk management processes, ensuring that risks are identified, measured and mitigated in similar ways with shared best practices;
  • Audit trails to ensure compliance with regional and adopted regulations;
  • The ability to predict and prevent issues from occurring by uncovering leading and lagging indicators and understanding patterns of risk;
  • A continuous improvement approach to risk management, integrating risk studies with mobile capable Action Tracking;
  • The ability to transform risk management data into key decision making criteria;
  • Corporate visibility of risks, aggregate risks, risk management adoption and regulatory compliance across regions, business units, and sites.