New technologies and innovation have brought enhanced levels of precision, reduced recovery times and patient comfort to surgical procedures. Our team work with clients to develop user-centred surgical devices and systems that meet demanding functional requirements, are designed with the surgeon’s needs in mind and deliver better outcomes for patients.
Development of your device
KD has experience in a range of surgical devices including:
• Minimally invasive systems
• Robotic surgery
• Electrosurgical instruments
• Imaging and patient positioning
• Woundcare and closures
• Orthopaedic tools and devices
• Skincare therapies
We can support your surgical device development in a range of activities from research and strategic direction-setting through to manufacture, delivered as part of a comprehensive programme or more selectively targeted to your specific needs and to integrate with your existing capabilities and resources.
Research and strategy
KD’s research and strategy team can help qualify new opportunities, undertaking research with surgeons, and other clinical stakeholders to help you shape compelling clinical and business product propositions and translate these into user-centred designs concepts. Our work at this stage of a project can include research with users, key opinion leaders and payers, IP landscaping and technical evaluations.
Design
Our design team are able to support with physical and digital design development as well as important supporting components such as packaging, labelling, and instructions for use. Whilst enhancing the user experience throughout the design development process, our team maintain a keen focus on clinical and technical needs as well as commercial viability.
Engineering
Our engineering team are able to develop solutions from concept to design-for-manufacture state. KD has particular experience in designing parts for injection moulding and metal fabrication processes and utilises a range of modelling, simulation and in-house prototyping methods to iterative design and test solutions.Our electronics and software team facilities the integration of electronic control, assisted and automated systems and delivery of specialist electrosurgical techniques. Working under our ISO13485 quality management standards, our team have the capability to deliver medical device software approved by FDA under Software as Medical Device (SaMD) requirements.
Human factors
We have a highly capable human factors team with experience in running usability studies on surgical systems in the operating room environment.We undertake formative studies to inform the design process and summative studies in both Europe and North America to validate the safety and effectiveness of the user interface of a treatment in support of regulatory approvals. Drawing on a combined experience of over 25 years in professional practice, our team of HF consultants can identify potential usability challenges, make specific recommendations for improvements and advise on approaches to testing and risk management.
Manufacture
As part of the SteriPack Group, we are able to provide a route to a contract manufactured solution as an extension of our design and development services. Irrespective of your route to manufacture, our ability to draw on the manufacturing know-how helps us to create products with excellent design for manufacture built-in.
