Ophthalmology is an exciting and dynamic area within MedTech product development for several reasons - making it a key area for cutting edge innovation - and a primary area of focus at Fearsome.
Ophthalmology
Ocular Innovation: Surgical and Diagnostic Expertise
We are passionate about ocular device innovation for both the cutting-edge technical challenges and the remarkable and positive impact on patients' lives.
We are engaged in complex, high-risk medical device development programs in surgical, drug delivery, and diagnostic spaces, collaborating with cutting-edge start-ups and global strategics.
As an ISO 13485 certified organisation, we maintain robust design control systems to ensure safety and precision.
Human Centric Design
A careful, deliberate focus on the clinician and patient usability needs and wants is critical throughout the Medtech device development process. The insights gained help when making decisions about conflicting requirements.
For ocular devices, for instance, technical challenges such as precision and stability often compete with user-focused requirements like accommodating a broad patient population and high-paced clinical workflows.
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We work closely with those who will engage with the product to understand market needs, behaviours, and user interactions to first capture, then guide product development, and we test against those goals as the product evolves.
Building devices that can be successfully, comfortably, and safely used by a wide range of patients is a multifaceted issue, including biomechanics, anthropometrics, cognition, perception, and use environment.
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We have developed an efficient in-house process that leverages large anthropometric datasets and captured 3D scan data to efficiently design and accurately test multiple design iterations. This allows accelerated testing of options and testing against patient populations before recruiting patient groups. This digital process complements physical prototype testing and is an effective tool to test and verify designs as they mature.
Innovation, by definition, is something new. Defining the unknown and developing novel technologies is intimidating. We combine in-depth user research and testing, a relish for technical challenges, and novel test methods to define the unknown and develop people-centred products.
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User Research
We engage in qualitative research with clinicians and patients so we can understand their needs and wants firsthand.
Digital Simulations & Specialised Software
Unique ways of testing multiple design options. System architecture and form development and optimisation, utilising global anthropometric data and 3D scans.
Physical Workflow Simulation
Workflow and use environment research enable quick, relevant, and iterative prototype testing—helping our clients find success sooner.
Technology Development And Engineering
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To realise a novel medical device, a wide range of technical problems will need to be solved, and increasingly, a project team will require several engineering disciplines to work in harmony through the development phases. Our team includes strengths in biomedical engineering, product design, chemical engineering, cell biology, human factors, mechanical and electrical engineering, mechatronics, neuroscience, and manufacturing.
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Clients have complimented us on the calibre of individuals we have on the team- and that engineering talent needs a solid framework and the right resources to achieve optimum results. Accordingly, we work hard on our D&D processes, invest in cutting-edge equipment for workshop and lab, and constantly seek better physical and analytical methods of prototyping.
The objective is always to thoroughly investigate and understand the problem, to characterise and develop potential solutions, to create robust, high-fidelity test methods to verify system performance, and ultimately to validate that the problem has been addressed.
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We appreciate a technical challenge, and over the years have built experience in several areas, including:
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Surgical instruments
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Complex electro-mechanical systems
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Robotic and digitally guided systems
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Physical and digital prototyping
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Materials and finishes
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And more.​
The transfer of design to manufacture (DFM) is a crucial part of the process, where many things can go wrong if not controlled carefully. Within the team, we have manufacturing personnel whose role is specifically to bridge design and production, and to ensure products can be consistently made to the required quality and cost. Substantial effort has been made in recent years to develop a reliable manufacturing network, helping clients build solid supply chains.
Technical Rig Development
By building and testing early and often, we learn fast and help clients succeed sooner.
Technical Precision At Any Size
The devices we work on often need to be very small to support safer surgeries, quicker patient recoveries, and shorter, more repeatable procedures.
Full System Design
Our approach to complex systems require rigorous, nimble and well manage teams. This allows both creative thinking and process control.
Fluid Delivery Systems
A core part of our work is the design of microfluidic systems for the precise and accurate delivery of therapies. Carefully considered designs are needed to minimise residual volume and wastage of high-value drugs and biologics. By selecting ultra-pure inert materials, and controlling surface finishes, treatments, and coatings, we can create delivery systems that minimise the risk of drug-device compatibility issues, e.g. API concentration loss through adsorption or particulates.
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Our expertise in fluid seal design allows us to create fully custom fluidic systems. Whether developing an ultrasonically welded hermetic seal or a piston-barrel interface to control break-loose and glide forces, we are able to deliver robust fluidic systems that ensure stable and repeatable delivery of therapies.
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Our in-house fluidic testing capabilities allow us to characterise system pressure and flow with high-accuracy microfluidic sensors, and to develop and validate custom test methods to verify system performance and ensure regulatory compliance.
Canula Development
When designing cannulas, we need to consider many factors, including lumen design, ergonomics, materials, coatings, sterilisation, tip and port design, to name a few.
Complex System Design
Our approach to complex systems requires rigorous, nimble, and well-managed teams. This allows both creative thinking and process control.
Understanding Requirements
We interview and observe the multiple stakeholders involved in each aspect of the therapy delivery, from aseptic pharmacists to ward staff, ensuring the device being developed meets each set of requirements.
Design Assurance
Our product development process and project teams are structured to apply design assurance processes throughout the product life cycle, from project conception through to post market, ensuring we deliver safe and effective products that meet the needs of users and stakeholders. User Needs are defined during initial project planning, translating Voice of the Customer (VOC), marketing claims and indications into clear and concise requirements to provide the foundation for product development. Risk management and usability engineering are also started early in the development process, to identify and learn from hazards associated with similar devices. Our design teams benefit from direct ownership of risk management and usability engineering outputs, supported by design assurance and clinical experts, ensuring design, use and process related hazards are identified and controlled during early product development.
We have experience within verification and validation test plans for a range of complex, novel, invasive and combination device types, employing in-house inspection, mechanical and fluidic testing, alongside trusted third-party services for biocompatibility, drug compatibility, packaging, sterilisation and electrical safety testing.
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Projects managed under our ISO 13485 certified Quality Management System benefit from the control and traceability afforded by the Greenlight Guru eQMS platform, ensuring client data is controlled and presented in format compliant with ISO 13485:2016, ISO 14971:2019, 21 CFR Part 820 and 21 CFR Part 11.
