Med-Tech Innovation Advertorial
Ask eg How do we select a partner for manufacture?
Selecting the right manufacturer is critical to any product’s success in ensuring commercial delivery commitments are met on time, the quality of the product delivered meets desired levels and that budgetary limits are observed.
By building this rationale into the early stages of the development, a strong evaluation process can take place to assess the technical acumen, responsiveness and proactivity of potential partners alongside the service they provide. So how do you go about this?
Consider manufacturing requirements early on At eg technology, we believe that it is important for design to be the governing factor for a product. This means that we develop the best product to meet the customer and user needs and that we do not constrain the design by force fitting it to a particular manufacturing technology. Having sight of the variety of manufacturing techniques and processes early in the development pathway enables forward-thinking design.
Having considered process and capability it is also important to think about the requirements in terms of location, quality systems, lead-times, batch sizes and price point. Are you looking for part production, electronics build or full assembly? What is the current, ramp-up and target build quantities?
Identify suitable manufacturers
Once the manufacturing needs have been defined you can then start to identify possible partners. If you have a design partner they can really help here. At eg we have an up-to-date database of approved manufacturers with whom we have worked on previous projects. We add potential suppliers to this as we come across them and with most projects we also pursue alternatives on the client’s behalf to provide a range of options. Consider how long a potential manufacturer has been operating in your particular area, what quality certifications they possess, whether they have any plans for future expansion. What is their experience with similar products and is there any conflict of interest with current products? By evaluating these with other criteria such as part cost, tooling/set-up cost, delivery time, quality (of parts and process checks) and communications rating (technical acumen, responsiveness, proactivity) you can then select two or three leading contenders to take forward.
In-depth evaluation It is a good idea, once you have confidentiality agreements in place, to pull your shortlist into the design process before the design freeze stage. This allows you to incorporate relevant feedback into the design enabling higher quality or a reduced cost price. This also gives a good opportunity to assess their requirements for manufacturing handover packages and their ability to support the product into the future. For assembly providers, a site visit
typically takes place prior to a request for quote and is then followed by a technical site visit. For full assembly, a formal ‘Request for Quotation (RFQ) Package’ should be sent out to your shortlist. This should include technical documentation for the build, key activities the assembly provider is expected to include in their quote (such as electronic assembly, box build and test labour) and an overview of the product and project. The request should also outline batch sizes, stock holding agreements, set-up activities and quality and support expectations. The quotation is expected to include an outline of product pre-release testing activities, a definition of the deliverables (including QA release documentation, packaging storage and transportation costs) and information regarding timescales and submission requirements.
Final selection, transfer and ongoing support Once you have received proposals and undertaken site visits you will be able to make a final selection and start contract negotiations. Of course, you will have your own QA procedures for vendor qualification and this is a good point to follow your QA system with questionnaires and audits. You may choose to process more than one potential manufacturer to provide second sourcing in the future.
Once a manufacturer is selected and final details agreed, we provide an updated Manufacturing Package. This includes (as a minimum) the detailed Bill of Materials (BOM), PCB information, component files (drawings and CAD), label documentation, mechanical assembly drawings, instrument assembly instructions, software, test procedures and protocols, and any regulatory information. Your design partner should be able to make a significant contribution in
the transfer to manufacture phase of the project as well as ongoing support for the product life. We support a chosen manufacturer to ensure all file details are correctly translated and, during the first build we typically spend time on- site to check the assembly and quality control checks and review first products off the line. Once transfer to manufacture has taken place we can provide flexible support packages to support ongoing manufacture, and any changes or additions that may be needed, all on an as-required basis.
eg technology Ltd, Burleigh House, 13-15 Newmarket Road, Cambridge, CB5 8EG, UK tel: +44 (0)1223 710 799
www.egtechnology.co.uk
Email your question to:
expert@egtechnology.co.uk 34 ¦ September/October 2014
www.med-techinnovation.com
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