Real planning is the key to success for any business but to an even greater degree in the medical device manufacturing industry.
- High costs of product design and development
The main driver behind the high cost of new product development is the amount of time essential to take an idea from conception to realization. By deciding a solid foundation for a design project with clear and concise necessities specifications, these costs can be condensed, and organizations will understand faster “to-market” times and improved ROI. This is possible by initial expert involvement in design and development.
- Regulations and government
Regulatory and Quality team are essential contributors when it comes to addressing the norms for patient safety offered by the current medical device regulatory atmosphere.
However, it’s important for all members of the team, particularly engineers and project leads to have at least a high-level understanding of the requirements, as you will likely run into problems impacted by the regulations throughout the design process. Discuss thoroughly with all stake holders, come to consensus decision, if any issue, seek help from external expert and finalise approach.
- Technology and security
As the Internet-of-Things (IoT) becomes more and more combined into society and more devices are carrying consumers’ important personal data, privacy and trust is a growing security challenge for medical device companies. Any leakages of personal data can cost company heavily.
- Product quality and high recall rates
Along with regulatory agency implementation actions and data breaches, product recalls are another way in which a company’s brand and bottom-line can be quickly and incredibly affected. More significantly, poor product quality can lead to serious end-user injuries or even death. While even the most basic medical devices face these challenges, newer, more technologically advanced products are at an even higher risk. Risk assessment tool is available to all stake holders. ISO and all other regulatory standard like MDR, FDA also talks of usage of this tool. In-house strong procedure of risk assessment with training to all stakeholder is must. As you are aware that even products are also categorised in risk category like 1 which is less risky and 3 which is most risky. This also brings applicable controls in that order, so patient gets most safe product.
Need some help with WHS training to support your remote and isolated workers?
There are some factors to consider when assessing the risks to health and safety of working alone.
Some solutions will be for the hazards and risks of the job and others will be related to working alone.
Read here for more details - https://www.sentrient.com.au/blog/working-alone-risk-assessment-checklist
IT (Information Technology) risks refer to the potential threats that could be faced by a company as a result of the technology it uses for research, communication, control and delivery on a day to day basis.These risks need to be managed to ensure that a company does not face economic losses, collapse or even legal action due to data loss.IT governance is not an isolated discipline but an integral part of enterprise risk governance.
While the need for governance at an enterprise level is driven primarily by demand for transparency across enterprise risks and protection of shareholder value, the significant costs, risks and opportunities associated with IT call for a dedicated, yet integrated, focus on IT governance.NS global provides the IT governance framework, structures, processes, assurance and information aligned to enterprise business strategies and objectives, enabling the enterprise to take full advantage of IT, maximizing benefits, capitalizing on opportunities and gaining competitive advantage.
NS Global assure enterprises that IT governance is a combined business and IT issue that requires a business-driven approach.This is done through ensuring that the information technology it employs is reliable and secure.A company employs IT to ensure maximum production, gain a competitive advantage and remain relevant in the business world.
NS Global Consulting offers IT risk governance assurance and consultancy services.Firms have different reasons for coming up with IT governance frameworks.
These may be to ensure that the IT they employ is in line with their business objectives, optimization of IT resources, legal requirements and corporate governance requirements.IT governance is currently being placed at the forefront of many companies as they realize the importance of ensuring their information is well protected to boost their organizational performance.
Boards of management of different companies are looking keenly into this area before business ventures such as mergers and acquisitions.
