summary
OPD specialises in developing world-class medical devices that break new ground. We seamlessly integrate engineering and complex biology to help develop innovative products to achieve further investment or launch to market. Our multidisciplinary team of engineers, design and bioscience consultants have decades of combined medical device development expertise in:
- In-vitro diagnostic, including point of care
- Drug delivery
- Surgical
- Wearables
- Telehealth
With our deep understanding of market dynamics and requirements, we help our clients develop commercially successful, next-generation devices.
quality
All projects are internally led and managed by competent and experienced project leaders who will be responsible for scoping, budgeting, monitoring and communication.
Our project leaders benefit from leaning on our established and certified quality and risk management processes.
OPD has developed our bespoke independently certified (by LRQA) design & development ISO:13485 quality management system (QMS) to be flexible in its ability to support the diverse needs of our clients.
Our document control strategy allows us to collaborate directly with our clients and other external stakeholders to ensure robust and efficient maintenance and availability of a single source of truth.
Our risk management processes are compliant with ISO:14971 for the development of medical devices and accommodate for the tracking of commercial concerns without compromising compliance.
IP and novel developments
Your device, your IP. Our unique approach to developing novel technology ensures all intellectual property (IP) belongs to our clients. Often a roadblock of outsourcing development work, we alleviate this common constraint by guaranteeing IP belongs to our clients.
Our clients typically assume responsibility of the essential intellectual property (IP) that forms the basis of their core technology, while relying on us to develop the enabling IP that transforms foundational principles into marketable products.
OPD was available early and ensured they fully understood our project requirements and were ready to begin as soon as we’d secured our funding. Their pragmatic approach and breakdown of product development into discrete work packets made planning easier and costs transparent. Everything went smoothly and according to the planned timelines.
microbiology labs
Our +300 sq ft containment level 2 (CL2) microbiology laboratories (and our associated protocols) enable us to handle biological samples to support our research & development activities.
Both our labs are environmentally controlled and continuously monitored which combined with our electronics lab information management system (eLIMS) ensure traceability of all experiments and tests conducted.
Key equipment available:
- class II biological safety cabinets
- inverted fluorescent microscope
- UV/Vis microplate spectrophotometer
- cold storage at both 4°C & -20°C
- autoclave sterilisation
- hazardous waste disposal
pilot production
Our +900 sq ft white-room pilot production space allows us to setup pilot-production lines which are representative of the quality and traceability of end-product, meaning devices produced can be used for formal verification and validation.
The space is environmentally controlled, which can include airborne particulate filtration (5.0 to 0.5μm) and bio-burden monitoring.
Key equipment available:
- horizontal laminate flow cabinets
- compressed air (up to 8 bar)
- cold storage at both 4°C & -20°C
- humidity-controlled storage
- heat-sealing/pneumatic press machinery
workshop
Our +850 sq ft in-house prototyping and assembly workshop significantly speeds up design processes. This space is highly equipped enabling us to fabricate, modify and test components with pace and precision.
Key equipment available:
- SLA & FDM 3D printing
- 80W laser cutter
- flat-bed plotter
- programable thermal chamber
- electronics assembly & testing facilities
- measurement & inspection facilities, including microscope
Our flexibility allows us to adapt as plans change and evolve, remaining responsive to new information and changing circumstances.
we help you
We believe in working with you as a cohesive team, rather than just for you. Open communication is key to our approach; the more we know about your needs and goals, the better we can serve you. Transparency is essential, so we share our plans and files openly, ensuring that if something goes wrong, you'll be the first to know. You're always welcome on-site, as we work where we can add the most value to your projects.
Your success is inherently tied to ours—we succeed or fail together. We focus on mitigating risks by tackling big challenges first and creating project plans that prevent over-committing, taking manageable steps to ensure steady progress.
