Med-Tech Innovation Product development
• You are not locked in to them • They create your data, with your data you can select a manufacturer
• Creation of intellectual property (IP): negotiate that the developer agrees that all IP generated for the device belongs to you; it is not in your interests to provide a paid opportunity for a manufacturer to develop its own related IP that may be generated during device development; partnering with a CDO means that you are not necessarily tied to a patented manufacturing process.
The abilities of a CDO
The organisation should be able to manage a broad spectrum of services. Some will be from internal resources such as pre-project consultation, design and test, design for industrialisation and scale-up, and others it may manage by having familiarity with those services. The fewer subcontractors you have to deal with allows you the best opportunities to speed up the entire process.
The CDO you select should have the experience needed to plan and implement a project quickly; methodological and technical competence means a much shorter start-up. Make sure your instructions are explicit and the milestones unambiguous. Also, agree the unknowns and be ready with the CDO to adjust the programme path to follow feasiblity studies and developments. Ascertain expertise in integrating a functional design with correct moulding and assembly procedures to create optimal value. Do not view, or allow your team to view the CDO as the competition, or try to be “clever” by hiding key information. Ask what information it needs. A good organisation is looking for a long-term relationship and will be on your side. The CDO should have standardised protocols that need limited customisation for each new project. This can shorten the validation process considerably and speed up the approval process with the relevant regulatory agencies. It should have a long and positive track record with
previous clients on similar products. This can also make a positive contribution to the approval process and, for example, help avoid time lost in dealing with unexpected problems. Good design leads naturally to compliance when the CDO is experienced. Radical, cutting edge, designs or processes have their place, but only when it can be demonstrated that the gains, be they financial or therapeutic, outweigh the extra time and risk that the new technology will inevitably require.
The CDO you work with should have the infrastructure and capacity available in terms of technology and personnel, especially if a request comes at short notice. Finally, consider the people. Ask to meet all the members of the team who would work on the project. The organisation may say it cannot be sure because it depends on when the contract is placed. You will be talking possibly daily and you are going to want be comfortable with the people in its team (and not paying high costs for a big consultancy that is providing the output of someone fresh out of college). Encourage openness, even a “no blame culture,”
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so that mistakes, from both sides, are rectified head- on, quickly, cleanly and everyone is wiser.
Getting your developer started Ideally, once a project is initiated, even if the device is basically a “me-too” product, a cross-disciplinary team is formed. The members may comprise: • Chair/Project manager • Client • Device designer/developer (CDO) • Assembler • Tooling • Moulder/manufacturer(s) • Pharmaceutical controller • Regulatory expertise • Primary pack filler.
Not all these member companies will be identified at the beginning, but it is usual that “the sooner the better” rule is applied. The Chair of the team, usually from one of the team companies, needs to keep a record of tasks, task responsibilities and completion dates to keep the project on track. The more experienced the members of the team are
the greater awareness they have of the issues they affect and are affected by. Keeping the members of the core team as small as possible increases effectiveness. Each team has a dedicated project manager to ensure efficient communication. The team members consult and plan intensively to determine the production process that will move the product from development to market production without significant delays. The steps in the project are defined and formulated as a checklist and include milestones to measure progress. With careful
Intranasal device hand assembly machines for
laboratory quantities
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