The Search for the Right Design and Manufacturing Partner. -- MEDICA - World Forum for Medicine


Integrated Technologies Ltd.

The Search for the Right Design and Manufacturing Partner.


You have a significant new product concept in place and are creating the financial resources to support it, but you still need to find and engage in a relationship with the most suitable and able design and manufacturing partner - one that you can rely on and who exhibits all the necessary skills and experience to bring it to reality. Knowing your new idea and your market well, you will doubtless have a feel for the type of expertise needed, based on your target application, but there will probably be several companies offering design consultancy services, several more offering impressive manufacturing capabilities and some of them, offering both.

So how do you differentiate between them and what skills do you really need to identify in them to ensure a successful path from concept into a commercially viable and profitable business proposition?

Preliminary considerations

Right from the start it is important to consider how your chosen partner will support you - right through to completion. It will be obvious at this early stage that you need someone who will understand your concept and be able to turn this into reality with solid design capabilities.

It may also be on your mind that if they can manufacture for you too, then you will have a seamless transition from design into production, which is of course a good thing.

You may have given less thought to what you will do to ensure you are not held up by lengthy certification processes, which could slow your route to market, potentially to the point of being uncompetitive.

In addition, in an ideal world when your product ramps up to high volume, how will you go about transitioning to the benefits of Far East manufacturing? Do you really want to have to find a new manufacturer at such a critical time, or would you prefer the guarantee of a transfer to an identical factory and process already established and qualified by your current manufacturer?

Then, what about shipping and customer support? There are certainly benefits if your partner could also manage shipments, customer field support, returns and warranties.

If you think about it, these long-term activities may seem a long way off from your concept phase but, with a single efficient and capable partner that you trust, delivering all of these services for you, your business will be more effective, more efficient and ultimately more profitable.

Research suggests that something like 80% of start-ups that do not meet their objectives refer to the fundamental impact of poor partners or suppliers, and it seems clear that high levels of integrated support can mean the difference between life and death, success and failure.

Therefore, in a nutshell, you need to look not just for the services themselves, but also for the linking and supporting skills that bring all of those vital services tightly together and deliver them competitively and professionally to your market.

What the customers of a design and manufacturing partner need and ultimately come to depend on is the highest possible quality of service at every single stage. But this is now a "given" in a competitive market place and actually what is needed is something more. It is about delivering at the next level and providing seamless continuity of service throughout every stage of the partnership, ideally right from initial concept creation and through manufacturing to post-sales support.

The flip side to the 80% statistic above of course is that a truly supportive partner, knowing all the pitfalls of manufacturing, certification and post sales customer support, can be the absolute life-blood in a start-up success story.

Ten things to look for in the ideal partner

So, digging a little deeper, what exactly are the skills, services and capabilities you should be looking for in the search for your new design and manufacturing partner?

The top criterion is finding a supplier that can truly provide you with a fully integrated design and manufacturing solution.
You will know your market and the relevant application(s) for your concept, so you do need to be happy that any research and development operation is able to provide all of the design disciplines relevant to the market segment.
Particularly important for any medical/clinical or safety critical application, you need to be sure the partner can deliver the right regulatory accreditation for the market being addressed. It is also important that product development itself occurs within the right regulatory framework for the product. US Food and Drug Administration (FDA) compliance and approval for the US market, for example, can be difficult to achieve and has on occasions caused months or even years of delay to a project.
Look for a solid reputation, by recommendation. It is essential to be sure that any partner can demonstrate it is able to understand your product, the requirements and the specifications, that they can "talk the lingo."
Again, based on reputation, identify the ability to always deliver cutting edge designs, to maximise market advantage and useful product lifecycle revenues for you.
If you already have a design that you wish to migrate to a new technology, manufacturing process or geography, then investigate the ability to convert existing designs to the relevant compliant process(es) for efficient manufacturing. Dig into Installation, Operational and Performance Qualifications (IQ/OQ/PQ) and the ability to transition to components obtained from approved vendor list(s).
Be sure there is recognition of the importance of the future of the product and ability to execute in areas such as product cost reduction, design revision and regeneration, and support for volume production for example, the option to manufacture in China and the need for re-qualification.
Look for risk analysis skills and an understanding of relevant legislation, including Failure Mode Effects Analysis, Worst Case Analysis, new regulations and new software standards, latest FDA submission processes and implications of new product liability rules. In short, be sure your potential partner really understands the regulatory environment.
Question and understand its abilities to professionally support the product in the field post-launch: consider outgoing QA procedures, after sales service, returns and repairs. Also, think even longer term on areas such as obsolescence management services and future product upgrades in the field.
Lastly and perhaps most importantly, make sure you are engaging with a team that you feel comfortable with. If the partnership is going to be successful, you will be working with them for many years, so it is essential to feel sure there will be trust and confidence between the parties at every stage.
In summary, with all of these factors in mind, the process of choosing a design and manufacturing partner need not be a daunting one and in fact your choice can be one of the most valuable decisions you ever make for the future of your company.

Lucy Malby is New Business Development Manager at Integrated Technologies Ltd, a research and development, design, certification and manufacturing company, Viking House,
Ellingham Way,
Ashford TN23 6NF, UK, tel. +44 (0)1233 638 383, sales@