At Cover Biomedical we think it’s important to get things done right but not over complicated or filled with jargon. Here are some of the common questions and misunderstanding we often come across:
COMMERCIALISATION
Is "Commercialisation" the same as "Product Development"?
"Commercialisation" has become a buzzword in Australia's med-tech startup sector. It is often used interchangeably with "product development", which, while related and linked, is an entirely separate process.
From idea to market entails several areas of consideration, of which commercialisation is only one. Aspects of commercialisation can and should be incorporated into a project management process in product development, but they are dominated by business considerations rather than engineering design.
Contact us if you would like to learn more about the different areas associated with the idea to market journey.
ENGINEERING DESIGN VS INDUSTRIAL DESIGN
Can Industrial Engineers be used instead of Biomedical Engineers to develop Medical Devices?
Usually, the medical device "design process" refers to an Engineering Design process within which Industrial Designers may contribute their own knowledge, skills and processes in design as collaborators of the engineering team. The knowledge and skills of Engineers and Industrial Designers may overlap.
Defining the roles and responsibilities of project contributors is really important early in a project. This should be informed by the scope of professional practice for each discipline.
There is no recognised Standard of Practice for registering Industrial Designers in Australia. Biomedical Engineers can choose to be assessed to a recognised Standard of Practice by becoming Chartered (CPEng) or appointed to the National Engineering Register (NER).
Cover Biomedical has experience in collaboration with Australian-based industrial designers who have experience in MedTech and deliver to a high standard. Contact us for a referral.
BIOMEDICAL ENGINEERS
Is there anything I need to know before employing a Biomedical Engineer?
Registration of Biomedical Engineers is legislated in Queensland through the Register of Professional Engineers Queensland (RPEQ), as are other disciplines of Engineering. Victoria also requires the registration of engineers practising in the medical device sector. NSW does not require Biomedical Engineers to be registered, and other States and Territories have yet to finalise their registration requirements for engineering practice.
Cover Biomedical can help with writing or reviewing position descriptions and advising on salary expectations, so feel free to contact us if you need reassurance that you have everything covered and are considerate of your organisation's needs.
MEDTECH DESIGN
What does "Design" actually entail in a product development/R&D context in MedTech?
"Design" refers to an Engineering Design process within which:
research and stakeholder engagement are conducted, and an early prototype is developed and evaluated,
specific design requirements, informed by the research and prototype assessment process, are documented,
the physical design of a prototype is refined, documented and risk-assessed,
the manufacturing process is refined, documented, considerate of scale and risk assessed, and
rigorous testing and assessment are completed of the product of the design and manufacturing process before
transferring a product to a production environment appropriate for sale.
The Engineering Design process takes a project through phases such as:
Research and Planning,
User Needs and Design Inputs,
Design Outputs,
Verification and Validation, and
Transfer to Manufacture.
Each phase of the design control process informs the next, and a formal Design Review activity closes out each phase.
Design changes are required whenever a change is made to a design or manufacturing process. These are necessary to ensure all impacts of a change are identified and understood and appropriate actions taken where necessary.
All documented evidence of a medical device design process should be maintained in a file called a Design History File (DHF). This file may also include additional evidence relevant to the project, e.g., the Risk Management File, Usability File, and other documented outcomes of the original design plan.
These phases and reviews are often called the "medical device design control process" or simply "Design Controls". Design Controls are significant in regulatory compliance.
Cover Biomedical is an expert in the development and execution of design controls in MedTech and supports organisations in process development and team capability development based on best practices.
DESIGN FREEZE
When is the best time to freeze a design?
The rigour associated with each phase grows as a project progresses, with "Design Freeze" best completed before verification and validation. This is especially important if conducting clinical trials, as any design or manufacturing changes after this point may require repeating previously completed testing, which is expensive both in time and money.
If you are unsure if your design is ready to freeze, contact us at Cover Biomedical to arrange a review and risk assessment.
PROJECT MANAGEMENT
How is Project Management different from a Design Control process?
Project Management is the execution of a Project Plan, which should incorporate a combination of Design Controls and other deliverables associated with a documented Product Development process and/or design plan. It allows for scheduling design control deliverables in a way that best suits the project's outcome. For example, while the Design Input phase is not yet complete, Design Inputs and Design Outputs have been finalised for a sub-system, reviewed by the multidisciplinary team in a design review with approval to proceed to verification testing earlier than a design documented control process might otherwise demonstrate. A design control process would still be followed in this example but scheduled differently.
A design control process only sometimes considers deliverables typically expected in both best practice and from a regulatory perspective. For example, risk management and usability/human factors engineering files might be expected, but the activities must be explicitly documented within a design control process. These activities inform the deliverables of a design control process however, so are important to include in a product development process and scheduled where appropriate within a design plan.
Cover Biomedical can assist with refining an effective Project Management or Product Development procedure suitable to a range of regions.
