Our track record and capabilities have been in the development of a range of specialty medical devices for cardiology, cardiac-vascular, critical care monitoring, anaesthesiology, pulmonology and orthopaedics. We work closely with our customers and clinical consultants to provide complete and optimal solutions for complex problems and applications. Our in-house engineering capabilities, machining, molding, rapid prototyping, product design and tooling experiences allow us to work with our customers from design inception through to product completion. Consequently, we have the required capabilities to successfully lead the translation of innovative public sector technologies to medical devices that satisfy unmet market needs.
Our team of engineers and scientists operate in a R&D facility, including an engineering workshop, a demonstration area which has the access to a cleanroom facility that provides the manufacturing scale-up activities. Stage-Gate® is a value-creating business process and risk model designed to quickly and profitably transform an organization’s best new ideas into winning new products. With Stage-Gate® process in place, Aurum Healthcare aims to create a culture of product innovation excellence – product leadership, accountability, high-performance teams, customer and market focus, robust solutions, alignment, discipline, speed and quality.
Aurum Healthcare offers project implementation consultancy services with the aim of providing customized solutions for the complete medical manufacturing requirements. We are a full service leader in the custom injection molding offering comprehensive manufacturing services with single-point accountability. We have the experience, expertise and the reputation to inspire absolute customer confidence. These services are managed by our team of professionals from project managers, R&D specialists, logistics planners and master schedulers. The proven and tested experience and expertise of these professionals will ensure our clients of our best possible consultancy services.
In order to commercialise technologies to new products, it requires not only a carefully managed team of specialists but systematic proven processes. Aurum Healthcare adheres to The Stage-Gate process as a proven methodology for successful medical device development. Our team is experts in the use of these processes.
Aurum Healthcare’s translation activities are designed to incubate, develop the product, facilitate and support SME to carry out business activities. We have a unique on-line gap analysis tool (Questionnaire with 125 questions) which assesses the value of the technology, identifies the key gaps to be filled and the budget required to fill these gaps – leading to a comprehensive report for each technology. This report covers all areas of translation: product development leading to manufacturing, IP strategy the budget, market insight, commercial, market and business planning, clinical trialing, regulatory, quality management systems and manufacturing. From this report a series of plans can be developed and then executed through the next stages of our stage-gate approach to commercialisation.
1. Unmet Need and Our Solution
Our partners include Research institutes, universities, polytechnics and hospitals. These public institutions have a great deal of sophistication to create breakthroughs in science and medicine. They have talented individuals overseeing the portfolio of patents that are created from these breakthroughs. However, they are currently lacking the operational bandwidth to commercialise these ideas on their own. Aurum Healthcare will bridge the gap to commercialisation where public sector capacity is limited or not effective, or where private sector resources are not available to undertake full-scale invention, design and development activities. We will assist the public institutions and the supporting companies to forge a uniquely transformative and integrative approach for translational activities leading to investment readiness and/or product release.
Aurum Healthcare aims to advance and nurture a cadre of well-trained investigators, research and engineering personnel by forming cross-functional teams with our own specialists. This approach aims to synergize multi-disciplinary, inter-disciplinary clinical and translational research to commercialise new medical technologies. We endeavor to work towards the ultimate goal that all investment and effort is to generate more value for SMEs and to grow the economy through the creation of value-added new products, via innovation and technology transfer.
2. Our Stage-Gate Process
The medical device development process has become increasingly complex in recent years. The advent of new technology concepts, stricter regulatory requirements, and the ever increasing importance of reimbursement decisions for successful device commercialisation require careful planning and strategy-setting, coordinated decisions, and consistent, rigorous business processes. The design and implementation of such processes, often captured in development model and accompanying standard operating procedures, have become a key determinant of the success of device commercialisation.
We understand that regulatory agencies fundamentally want to see that your product has safety in mind and complies with processes according to ISO13485:2003. To do so, Aurum Healthcare will ensure compliance throughout the commercialisation process. We will be agile to respond to change and effectively manage technical complexity by collaboratively building solutions with partners and customers to ultimately deliver what the customer wants.
We will adopt the Stage-Gate® process as our product realization methodology which has been developed as a version of the FDA’s recommended Waterfall product development process. This includes the following five phases: (1) initiation – opportunity and risk analysis, (2) formulation – concept and feasibility, (3) design and development – verification and validation, (4) final validation – product launch preparation, and (5) product launch and post launch assessment. The stage-gate processes are the predominant development model used in the medical device industry and complies with both CE and FDA regulatory requirements.