What resources are required to work with Duckworth & Kent during the development of my project?
Following discussions and mutual assessment of the project, Duckworth & Kent will appoint a project team to meet your requirements and resources. Based on previous development projects, we recommend that you identify key personnel to include a project manager, a quality engineering contact and a marketing / sales contact. Dependant upon the status of the project when appointed the supply of any available working drawings, prototypes, models etc will shorten the timescales and costs to pre- production prototype.
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How can I be sure that my project is progressing on time and budget?
Dependant upon the nature of the project, Duckworth & Kent Medical Device Outsourcing provides a weekly reporting structure that tracks and monitors progress of some or all of the following key project areas:
• Maintenance of Critical Milestones
• Risk Management
• Budget allocation and utilisation
• Cost of Goods (COG's)
• Materials
• Quality Assurance requirements, compliance and progress
• Allocation of Resources
On-going monitoring and reporting of these activities, both internally and externally on a weekly basis allows Duckworth & Kent to maximise efficiencies in the design and manufacturing processes.
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We have completed prototyping and feasibility studies for a new product or project and would like Duckworth & Kent to complete the design to optimise manufacturing processes and move into production manufacturing. What is required to provide a quotation for these activities?
Duckworth & Kent would begin this process with a Product Specification and any design engineering documentation generated to illustrate the device. In addition Duckworth & Kent’s product development team would like to understand any schedule or budget constraints that may have been promised to the stakeholders. Prototypes and photographs are also helpful. If this documentation is not available we can assist in developing this information as part of the project.
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At what stage of product development can Duckworth & Kent get involved?
Duckworth & Kent's product development team utilizes a detailed product development process with clearly defined tasks and deliverables for all members of the team. This process allows the Duckworth & Kent team to begin work at any point during the development cycle from initial feasibility studies and concept development to detailed design for manufacturability, validation and transfer.
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Can Duckworth & Kent supply a quotation for optimising manufacturing efficiencies?
This is our area of core expertise! As Duckworth & Kent have invested significantly in the latest computerised manufacturing technology, so we have evolved into a specialist in designing cost saving measures into the manufacturing process. In such a competitive arena as the medical field, where product price rises are rare, we find more Companies are taking advantage of Duckworth & Kent’s expertise as a means of reducing manufacturing costs and increasing margin contribution.
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How can Duckworth & Kent reduce my manufacturing costs when all production is carried out within the UK at such high labour costs?
Duckworth & Kent have invested significantly in the latest computerised technology ensuring we have the capability to maximise efficiencies by fully utilising capacity. Running on a 24/7 basis reduces labour costs dramatically, allowing us to compete effectively with emerging markets without compromising our reputation for quality.
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Can Duckworth & Kent manage my Device History File (DHF) and Device Master Record (DMR)?
Duckworth & Kent has full document and release control capabilities. We have the ability to track both paper and electronic Device History Files (DHF).
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What is the advantage of using or involving Duckworth & Kent for contract design and development as opposed to a contract design firm?
Duckworth & Kent’s Medical Device Outsourcing division is focused on the development of medical products and devices. The team is skilled in design, analysis, manufacturing, quality, and operations. Input from these specialists at early stage, as well as that from experts from Duckworth & Kent’s extensive supply chain provide critical design and manufacturing input throughout the development process. This input and expertise ensures a seamless transition to the Duckworth & Kent manufacturing facilities, shortening development and manufacturing transfer time and reducing the time to market.
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How will the Duckworth & Kent team interface with our team and how will areas of responsibility be defined?
Each project and product has its own specific challenges and resource requirements. All projects begin with a Project Launch meeting. During this meeting, the project team structure, roles and responsibilities are defined and resources assigned from Duckworth & Kent as well as your organisation. Communication channels are established and clearly defined for routine activities, as well as regular updates of project development, budget and timelines. Contingency plans are established so that issues can be resolved quickly and effectively. It is the responsibility of Duckworth & Kent’s Head of Business Development to establish the appropriate interface structure with the client, and ensure the team is made up of the key skill sets to ensure the project outcome exceeds the Clients expectations.
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Will I have to provide quality engineering and design control functions for the Duckworth & Kent team?
No. In September 2004 Duckworth & Kent's Quality Management System was assessed and certified to the latest standards, ISO 9001:2000 and ISO13485:2003 covering the following scope of activities:
The design, manufacture, supply and repair of non sterile precision reusable surgical instruments. Subcontract machining of implantable titanium items. Subcontract assembly of electrical surgical instruments. Duckworth and Kent affix CE marking to all products according to Annex II of the Council Directive 93/42/EEC concerning Medical Devices.
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What technical skills does Duckworth & Kent have?
Duckworth & Kent employs a multidisciplinary team with experience in project management, mechanical design, design for manufacture and assembly, manufacturing, and quality engineering. In addition, Duckworth & Kent has established a network of clinical, technical and product specialists to further support the Company’s services. Duckworth & Kent process experts ensure the resulting design can be produced using capable processes.
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What is your project team structure?
Each project team consists of a Program Manager and the appropriate disciplines to meet the needs of your project. Because Duckworth & Kent’s Medical Device Outsourcing Division is an integral part of Duckworth & Kent, the Company has access to a broad range of skill sets and the ability to adapt to a wide range of projects.
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Can Duckworth & Kent provide clean room facilities as an integral part of a project?
Yes. At the Duckworth & Kent facility is a 15 square meter (160sq ft) Class 10,000 (ISO Class 7) clean room. Within the clean room environment we are able to carry out the following processes:
• Cleaning by automated multi - ultrasonic bath, temperature controlled and programmable
• Visual inspection of devices via high magnification microscope with facilities to record or capture images.
• Programmable and automated package sealing in heat-sealed airtight pouches.
All packaging equipment is fully validatable and incorporates total process controls. We have routine validation and monitoring of package seals using constrained burst testing, dye penetration and peel strength methods.
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Does Duckworth & Kent have the facility to supply sterile product?
Not within the Duckworth & Kent facility. The costs of maintaining and regulatory compliance with this facility would be uneconomic to our clients. However once products are packaged in our cleanroom, Duckworth & Kent can coordinate all aspects of sterilization and have your products sterilized using our certified processors.
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Duckworth & Kent is a recognised supplier of surgical instruments and I view you as my competition…..Why would I consider you as a supply partner, crucial to my success?
Duckworth & Kent are a highly respected and innovative manufacturer and supplier of precision surgical instruments with an enviable reputation within the industry for quality and service. However, we recognise and acknowledge that no sole supplier will dominate such a fragmented and specialised market. We have continually invested in technology and expertise that allows manufacturing processes to be streamlined, significantly reducing cost. We have embarked on a bold strategy to offer these benefits to all suppliers, whether established or emerging. We manage our business activities within the strictest ethical code and our mission is to ensure that our prospective clients, whether they operate within the same business segment or not, view Duckworth & Kent’s resources as providing a huge potential advantage, able and eagerly willing to contribute to their own success.
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What are your success stories? Do you have any references I can contact?
Duckworth & Kent will be pleased to provide more detailed information upon written request. This information will be crafted to provide details of appropriate projects without compromising the confidential nature of our long standing and highly valued client relationships.
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