Author Archives: leardonsolutions

Product Qualification : What To Know

September 25 2012  |   leardonsolutions  |  All Posts, Business Tips, Manufacturing, Product Development  |  Comment

Leardon Solutions Product Development

All About Product Qualification

One aspect of product development that is often overlooked and forgotten is product qualification. Product qualification refers to the tests that are done on prototypes or the final product to be sure that it will properly operate across all external conditions and will conform to all government regulations. Without these tests, the product development is incomplete. Here are some examples of things that have gone wrong on improperly qualified products.

  • After a long ocean shipment from Asia, an excited entrepreneur receives their shipment only to find that all the polyethylene bags that the product was packed has stuck to the product.
  • A customer purchases their product and quickly realizes that the display cannot be seen in normal outside daylight.
  • When a product is received on a pallet shipment, the products on the bottom of the pallet are smashed and destroyed.
  • When a company decides that they want to sell their product in Europe, they realize that their electronics aren’t suitable for the hazardous waste requirements in the region.
  • A new company has a hit product that sells 15,000 units in 3 weeks. After 1 month in the market, customers start returning the products since the labels start to come off of the product, making it unusable.

These are only a few examples of what can go wrong when the product isn’t qualified properly. Some of these examples might not seem too severe but all of these issues resulted in the company spending a large sum of money to rectify the situation and solve the problem. This could have been avoided if the product qualification was done properly from the start. Below, we outline the steps that should be taken to properly qualify your product. Even though it might be tempting to take a risk and skip some of the qualification steps to save money, it is not recommended.

  • List out all the normal operating conditions of your product. At what temperature will it be used? Will it be used with in the rain? Will it be used at high altitude? These are only some of the questions to be answered but it is imperative that you understand how your product will be used.
  • Determine the extreme conditions that the product (packaged and unpackaged) will need to withstand. In this step, think of all the extreme conditions that your product MIGHT need to withstand. Remember that you have no control on how your customers or shipping company treat your product, so expect that they will do the worst things possible to it. The product will get baked in a hot car, will get dropped in a gutter, will get kicked off of a table, and could possibly be stepped on. Determine which conditions you want your product to withstand and those which the product does not need to withstand.
  • List out each country that your product will be sold. Research what regulations are required to sell in that country. In Europe, you will need a CE mark. In the United States, you might need to get FDA approval. Each regulation will require some sort of testing which must be performed and passed.
  • Translate all the conditions and regulations into actual tests to be performed on your prototypes or production units. Examples of these tests include environmental stress tests, transportation tests, operating environment tests, electrical tests, and safety tests. A test lab will have standard test equipment that is used to run each of these tests.
  • Work with a laboratory to perform the test suite as required.

Product qualification and testing is a critical step in the product development life cycle. Be sure that the product passes the qualification tests prior to starting production and selling your product. While this phase of product qualification might seem excessive and expensive, remember that it is always less expensive to do the qualification properly from the start rather than hoping that nothing will go wrong. If something can go wrong, it most likely will go wrong.

If you need more information on the correct way to qualify your product, please don’t hesitate to contact us. Our team has years of experience qualifying products and designing quality into the product from the beginning. Please contact us with any questions or contact me directly at joseph.donoghue ( at ) leardon.com

Product Development and Manufacturing Ten Commandments

September 4 2012  |   leardonsolutions  |  All Posts, Business Tips, Engineering, Manufacturing, Manufacturing Tips, Northern Ireland, Product Development, Prototyping, San Diego  |  Comment

Leardon Solutions Product Development, Manufacturing, San Diego, Ireland, Southern California, Inventor, SME, Joe Donoghue

The Product Development and Manufacturing Ten Commandments

All product development teams that have gone through a full development cycle to design, prototype, and manufacture their product have learned that there are a set of rules that when followed result in a streamlined and successful process. Some SMEs and entrepreneurs learn this the hard way by making mistakes while others hire experts in the field who have the experience to prevent the mistakes. It doesn’t matter if you are a medium sized business in San Diego, Southern California or a entrepreneurial start-up company in Northern Ireland, the rules are the same and must be followed for success. We have taken decades of product development experience from our team and created the Product Development and Manufacturing Ten Commandments to benefit our readers.

1. Avoid feature creep by rigorously defining your product before making or designing any prototypes.

2. Decide if the product features, the project/product cost, or the project schedule is the most important project priority and manage the program appropriately.

3. Make early Proof-of-Concept and Integrated Design Prototypes to validate the product functionality.

4. Work with one service provider to avoid multiple design hand-offs during the development life cycle and increase accountability. This is typically considered an end-to-end solution.

5. Maintain a strong relationship with the chosen manufacturing supplier and understand all cultural differences.

6. Only release the design for production tooling when all prototype qualification is complete and purchase the appropriate tooling based on quantity, expected part prices, and tool life.

7. Before starting production of customer-shippable products, qualify all the production tools, parts, and the final product.

8. Allow enough time to make the initial order of customer products and staff appropriately with design and manufacturing engineers to resolve the inevitable issues encountered.

9. Only make changes to the design or manufacturing processes in production when there are serious issues that result in safety or shipment issues.

10. Manage the stable production and don’t get complacent.

If you have questions about any of these Product Development and Manufacturing Ten Commandments, please feel free to contact us.

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San Diego Based Aculief Discusses Prototyping

August 7 2012  |   leardonsolutions  |  All Posts, Business Tips, Manufacturing, Prototyping, San Diego  |  Comment

Joe Donoghue, San Diego Prototyping, Patents & Prototypes, Live Web Show, Product Development, Engineering Services, Manufacturing, Entrepreneurial Product DevelopmentLeardon Solutions’ customer Jon Duggan, CEO of Aculief of San Diego, California has recently launched a company around their namesake product. The Aculief product is a stylish wearable pain management device for people with active lifestyles. It was designed around the idea of applying pressure to the LI-4 meridian acupressure point located between the thumb and forefinger to provide tension relief. Jon has been working on the Aculief product for a couple of years, tuning the idea so that it not only works well but also has an aesthetic appeal to consumers.

Jon is a perfectionist and hence took the Aculief through many prototype iterations to make it exactly like he wanted. We decided that it would be beneficial to interview Jon about his San Diego prototyping journey and provide this advice for others working on prototypes. Here is the interview between Leardon Solutions and Jon.

Leardon: How did you come up with the idea for the Aculief?

Jon: When I was in college a friend of mine told me about the LI4 Acupressure Point to fix a headache. I took my thumb and used it to apply pressure to the area and it relieved my headache. After graduating college I said “I am going to design a product that you can wear to apply pressure to the LI4″. I talked about it for a number of years and 12 years later I was on a plane reading a Men’s Health Magazine article titled “30 second to cure a headache”. The article described how to apply pressure to the LI4 to cure a headache. I said to myself “I need to do this now”. After finding a local San Diego prototype company Leardon Solutions on the internet, we met and discussed the best way to prototype, design, and manufacture the product cost effectively. Working with a service provider who provided an end-to-end service (idea to manufacture) made the development, prototyping, and collaboration process easy.

Leardon: What was the most important thing you learned about the prototyping and new product development process?

Jon: Be patient and never compromise. Since you know what you want the end result to be, don’t settle for any less. Sometimes all that is required are a few prototype tweaks and it is exactly what you set out to create from the start.

Leardon: How important was prototyping Aculief?

Jon: The Aculief prototypes were critical. If you are creating a product from scratch you need to test it, break it and get feedback from others. Without a prototype this is not possible.

Leardon: How did you prototype the Aculief?

Jon: Leardon’s knowledge of plastics is amazing so we went with their suggestion on the type of plastic. Leardon then created a rough sample to test the plastic and it was what we needed. Next step was finalize the design and then they created a prototype based on the design and it was close. Finally, they tweaked the pressure and made some design changes to make it fit better and we had the final product.

Leardon: What did you learn from prototyping Aculief?

Jon: Feedback from potential consumers and testing of the product allowed us to make changes that will hopefully lead to our success.

Leardon: What prototyping recommendations do you have for others with product ideas?

Jon: Find a great partner and they will make it easy. Have the prototype made and present it to all your friends and family. Once they see it and you get their reactions you will know if you should continue with going into full production. You never know until you try!

Here are some additional resources about the LI-4 acupressure point and using the Aculief.

How to Relieve Pain Using Acupressure Massage at L14 (Hoku Point)

Acupressure Points and Massage Treatment

How to Use the Aculief

If you are interested in learning more about the Aculief, please contact them at info (at) aculief.com.

Need more information on new product development or the manufacturing process? Please contact us with any questions or contact me directly at joseph.donoghue ( at ) leardon.com.

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Scottish Newspaper Interviews Product Development Expert Murray Learmonth

July 10 2012  |   leardonsolutions  |  All Posts, News, San Diego  |  Comment

Leardon Solutions Product Development

Scotsman Murray Learmonth

It’s not very often that the an engineer who has developed close to a hundred products gets approached by a newspaper for an interview. As a Scottish expatriate, Murray Learmonth was recently contacted by the Scottish Times to talk about his success as Vice President of Engineering at Leardon Solutions, a San Diego based engineering, prototyping, and manufacturing company. Murray co-founded Leardon Solutions with Joe Donoghue in 2005 to help start-ups, entrepreneurs, and small/medium enterprises develop their inventions and products.

Murray grew up in Motherwell, outside of Glasgow, Scotland and completed his engineering education at Glasgow Caledonian University. Throughout his career, Murray has worked at several companies in Europe, the U.K. and the U.S. in the aerospace, medical, consumer electronics, and automotive industries. The weather of his current residence in San Diego is a far cry from the weather where he grew up, but Murray continues to travel back to Scotland as the Leardon Solutions business grows in the U.K.

Murray’s passion for product development shines through when he works with all companies. Murray can be directly held responsible for helping dozens companies from San Diego to Scotland become a profitable entity through his advice and work in prototype development, engineering design, and manufacturing. According to Murray, “There is nothing more exciting then seeing a company ship their products to customers and start generating revenue.”

To learn more about Murray, please read the interview with the Scottish Times in the article titled Motherwell to San Diego.

If you wish to contact Murray directly, please contact us with any questions or contact Murray directly at murray.learmonth ( at ) leardon.com

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I have found a manufacturer for my product idea. Now what? Part 3 of 3

July 3 2012  |   leardonsolutions  |  All Posts, Manufacturing, Manufacturing Tips  |  Comment

Leardon Solutions Product DevelopmentHow to Manage Production Quality From Your Manufacturer

This is the last of three posts covering the steps that should be taken once a start-up company, entrepreneur, or inventor finds a  manufacturer for their product. 

• First, the company should put all manufacturers through a supplier selection process to identify the one supplier to move forward with into manufacturing.

• Next, the company should qualify the product manufactured by the manufacturer prior to moving onto the next step of starting volume production and managing the production quality.

Once production begins, there are many checks and balances throughout the manufacturing and production system that are implemented to ensure that the resulting product functions as expected and all parts meet their documented specifications. These checks and balances make up the product quality plan which must be put into place and properly executed when the product is in production. The field of quality management has been around for over a hundred years and managing production quality is a skill that requires years of experience and training. Experts in this field not only understand the function of the product but also have a background in statistics, probability, and the theory behind product sampling plans. It is recommended that those not trained in the field ask the manufacturer for their product quality plan and take it to a professional who can provide advise on the validity and effectiveness of the plan.

The quality plan consists of those checks and balances that occur at different frequencies throughout the part fabrication and product assembly processes. Some common aspects of a quality plan are described below.

  • Incoming Quality Control The incoming quality control (IQC) occurs on parts and components that are used in the assembly process. Typically, this is done on an audit basis (inspect a sample of parts rather than 100% of the parts) and the complete lot is either accepted or rejected based on the results of the test.
  • In-Process Quality Control After the parts are accepted in IQC, they are sent to the assembly process. During the assembly process, there are many checks and balances carried out by automation or by humans. These checks ensure that the product is being assembled properly. Also throughout the product assembly line, there are functional tests that are performed on the complete assembly or subassembly to ensure it functions as expected. These checks occur on 100% of the products.
  • Outgoing Quality Control Prior to shipment of the final assembled product, a sample of the finished goods inventory (FGI) is passed through tests and checks to be sure that they meet the expected quality levels. If the sampled products pass all the required tests and quality checks, the complete lot of FGI is released for shipment. If a higher than allowed number of products from the sample do not pass the quality checks, the FGI lot is rejected with 100% inspection and rework/repair necessary.
  • Process Audits During production, a set sample of products are typically taken from the production line and checked to be sure the assembly and test processes are being performed properly. This audit ensures that the processes are not drifting from the expected values.
  • Functionality and Performance Audit Another audit that is done on the finished goods inventory (FGI) is a functional, life, and performance test of the product. These tests are done to be sure that the product is meeting its functional specifications throughout the operational life of the product.
  • Regulatory and Safety Audit Since every product must meet country-specific regulatory and safety requirements, audits are performed on a periodic basis to be sure that the product still meets the regulations.

When a manufacturer has a well defined product quality plan and executes it diligently, the product quality will be maintained at the highest levels and product returns from customers will be minimized. Work with the manufacturing supplier and a quality engineer to implement the quality plan and avoid unnecessary headaches.

Need more information on new product development or or how to select a manufacturer? Please contact us with any questions or contact me directly at joseph.donoghue ( at ) leardon.com

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New Invention heatboss To Reduce Heating Bill

June 26 2012  |   leardonsolutions  |  All Posts, Business Tips, Customer Profile, Product Development  |  Comment

Leardon Solutions’ customer Okotech Ltd from County Antrim in Northern Ireland, United Kingdom have been in the news lately. This led us to the latest winner of the Invest Northern Ireland Propel Programme 2012 Company of the Year to share some of their product development and manufacturing experiences with their wireless heating control product named heatboss. Leardon Solutions

We met entrepreneurs Janette and Gary O’Hagan in Belfast in 2011 as they were wrapping up the heatboss prototyping phase and were ready to launch production plastic injection molding tools for heatboss. Janette and Gary have been working together for 2 years on their start-up company. Their wireless heatboss system helps customers use their energy more efficiently by controlling the radiator settings in rooms that are not in use, resulting in heating cost savings up to 30%. The team at Okotech Ltd has recently been diligently reviewing the performance data from their first two customers in the care home sector, an industry that requires continuous heating. They are now preparing to grow into other sectors that require continuous heating requirements in regions where the product can provide the most benefit such as Ireland, the remaining parts of the United Kingdom and Northern Europe.

Janette O’Hagan describes some of the ups and downs of developing products in her interview with Leardon Solutions.

Leardon: How did you come up with the idea for Heatboss?

Janette: The continuously rising cost of central heating fuel in the United Kingdom was the big trigger, closely followed by the frustration with contemporary heating controls’ poor usability and inability to control individual rooms. We started off by going round the house and turning off the radiators in the rooms which we weren’t using during the day and that’s when we realised we could develop something to do this electronically – that’s when the idea for heatboss was born.

Leardon: What was the most important thing you learned about the prototyping and new product development process?

Janette: We’ve learned many things throughout the heatboss product development process, but the vital lesson is recognising the importance of the design and prototyping phase – and also when you’re dealing with a new hardware product remember that everything takes far longer than you think it will. The software side of things pretty much stuck to the timescales, but hardware is a different beast – resolving one issue or sourcing a small part can delay you for weeks.

Leardon: What did you learn about manufacturing a product? Did you encounter any issues?

Janette: Manufacturing a product like heatboss requires many different people with different skill sets and managing all these people can be time-consuming. If these skill can be found within the one supplier this process becomes a lot easier and less time-consuming to manage.

As a new start-up company we encountered many hurdles, but the biggest was as a result of not prototyping enough. The benefit of hindsight tells us that spending adequate time and effort at this stage will save money and time in the long run and ensures a solid product. Our eagerness to move fast and, as a result, not do enough prototyping meant that we went into tooling without all the issues being spotted and dealt with. So in the end we had to fix a couple of minor issues after the tooling was produced – meaning additional time, frustration and costs – but it worked out ok – we have a well designed product that is saving our customers between 28 and 40% of their heating costs. We’ll definitely give prototyping more attention in Version 2 though!

Leardon: Why was Northern Ireland a good place to develop the heatboss?

Janette: There are a couple of reasons why Northern Ireland was a good place to develop heatboss. Firstly, the region is one of the best for new-start funding opportunities. Invest Northern Ireland’s support has been integral to the development of heatboss. Their Propel Programme has brought us on the journey from concept to commercialisation.

Secondly, in terms of testing a heating controls product, Northern Ireland is the one of the best test-bed environments – the cold, wet and windy climate doesn’t do much for Northern Ireland’s tourism but it means that most of us have our heating on almost all year round, so we have been able to test versions of the product all year round! The other advantage is that we can therefore save our customers fuel and money all year round. heatboss loves Northern Irish weather!

Leardon: What recommendations do you have for others with product ideas?

Janette: If you have a product idea, take the time to ensure that you have good suppliers who are commercially minded and who you can trust to deliver – those, like Leardon, who have a strong track record of delivering products with efficiency, professionalism and, probably most valuable, have the in-house knowledge and experience that enables them to understand your product and help you avoid problems.

If you are interested in learning more about the Okotech heatboss product, please contact Okotech Ltd. at info (at) okotech.co.uk.

Need more information on new product development or the manufacturing process? Please contact us with any questions or contact me directly at joseph.donoghue ( at ) leardon.com.

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I have found a manufacturer for my product idea. Now what? Part 2 of 3

June 19 2012  |   leardonsolutions  |  All Posts, Manufacturing, Manufacturing Tips  |  2 Comments

Leardon Solutions Product DevelopmentHow to Qualify the Product

This is the second of three posts covering the steps that should be taken once a start-up company, entrepreneur, or inventor finds a supplier who can manufacture their product. The first step of selecting the supplier, described in the post How to Select a Manufacturer, should be done prior to moving onto the next step of qualifying the product manufactured by the supplier.

It typically isn’t possible to immediately start up production and manufacturing once a supplier is selected. Even a product that seem simple must be qualified with a number of tests and quality checks to be sure it is being made to the engineer’s specification and will function as planned across all the operating environments. For example, a simple product label that must be removed by the customer should be qualified in high temperature storage to be sure it can be removed once the customer receives the product and doesn’t leave residue.

Below is a summary of the steps to properly qualify a product with a manufacturer. Even though it might be tempting to take a slight risk and skip some of the qualification steps to save money, it is not recommended. A product can go through a diverse range of operating conditions (temperature, humidity, sunlight, altitude, etc.) and therefore the quick operational check done in the factory will not ensure that the product has been qualified for use by all customers.

  • Map out the qualification tests for the completed product. It is recommended that a start-up company, entrepreneur, or inventor work with an quality professional who understands the tests required for the product. This will depend on the expected operating conditions, countries of sale, method of shipment, customer use model, and government regulations. Once complete, review the test plan and determine how many products are required to fulfill all the tests. It is possible to reuse products for multiple tests. Typically, the test plan will require between 20 and 40 test prototypes.
  • Make the required number of prototypes using final production processes. The manufacturer should now produce the number of test units using the same processes that they will use in final production. Do not produce a large quantity of products at this stage as chances are high that these will need to be remade as issues and defects are found in the product and the manufacturing process.
  • Perform all qualification testing of your product. Execute the qualification test plan on the products that were produced by the manufacturer and document all the defects, failures, and issues that arise. These tests are done on calibrated test equipment where it is possible to measure the important variables such as temperature and force. Don’t attempt to run a high temperature storage test in a kitchen oven!
  • Determine required design changes. Review the defects, failures, and issues found in the last step with the engineering team to decide which require engineering design changes.
  • Review changes with supplier and implement changes into design. Revise documentation. The engineering team should meet with the manufacturer to review the changes that will be made to the engineering design and understand where it impacts the manufacturing process. Make changes to the manufacturing process where necessary and update all product and manufacturing documentation.
  • Evaluate any new pricing due to changes. Review any pricing changes with the manufacturer based on the changes that will be made to the product and manufacturing processes.
  • Remake the prototypes with the changes. Make the products again using the revised final production processes.
  • Perform final qualification testing to ensure the product functions as specified. Execute the product qualification plan on the new products to be sure that they meets all the required test specifications. Once all the specifications are met, the qualification phase is complete.

Product qualification and testing is a critical step in the product development life cycle. Be sure that the product passes the qualification tests prior to starting the final manufacturing and production. While this phase of product qualification might seem excessive and expensive, remember that one customer with a bad review of the qualify of the product could destroy a company.

Need more information on new product development or the manufacturing process? Please contact us with any questions or contact me directly at joseph.donoghue ( at ) leardon.com

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I Have Found a Manufacturer for My Product Idea. Now What? Part 1 of 3

June 5 2012  |   leardonsolutions  |  All Posts, Business Tips, Manufacturing, Manufacturing Tips, Product Development, Supplier Management  |  1 Comment

Leardon Solutions Product DevelopmentHow to Select a Manufacturer

One of the most common questions I receive from entrepreneurs, innovators, and start-up companies is about the manufacturer of their product. The question is typically something like “I found a great overseas manufacturer that says that they can manufacture my product for me. What do I do now?” or “How do I find a manufacturer that can make my product idea?” or “My manufacturer isn’t communicating well with me so what should I do?” Regardless of the exact question, the general topic of manufacturer management and procurement is a very important one to understand prior to venturing off into the world of product development and manufacturing. In this three-part blog series, we will discuss the steps required to ensure that you deliver a quality product to your customers and minimize the number of headaches along the way: (1) How to Select a Manufacturer; (2) How to Qualify the Product; (3) How to Manage Production Quality.

Here we focus on selecting the most capable manufacturer from the list of those identified as potential manufacturing candidates. It is expected at this point that initial communications have been made with the manufacturer and they have shown some interest in manufacturing your product. Before moving too far with one of the manufacturers, it is necessary to do some initial qualification of their capabilities to be sure they are the right fit to manufacture your product. It is also necessary to determine if they have similar working behaviors that fit well with your company’s culture and style.  Below are three recommended steps to determine if the manufacturer is the right one.

How to do a preliminary manufacturer evaluation

The list of potential manufacturers for your product could be very long or short, depending on the amount of prior research. Either way, it is necessary to perform a thorough manufacturing supplier evaluation process to be sure that the manufacturer is the best for you and your product. The overall evaluation involves a preliminary evaluation and an in-depth evaluation. The reason for doing a preliminary evaluation is to quickly weed out those candidates that aren’t capable of manufacturing your product or aren’t a good fit for your company. Based on years of experience, here is a tried and true checklist to use for a preliminary manufacturer evaluation:

  • Ask the supplier to provide the number of employees, machines, and annual product output of the manufacturer. (This helps determine if the manufacturer is willing to provide company information. If the supplier is unwilling to provide this information or any of the data seems to conflict to anything found on the web, then consider removing the supplier from the preliminary list.)
  • Ask the sales representative how long they have been with the company. (This helps you determine if the representative knows much about the company and if employee turnover is high. If the company turnover is high, you should consider eliminating the supplier from the preliminary list of manufacturers since you might be working with too many people over the span of your product life cycle.)
  • Ask the supplier to communicate their manufacturing capabilities and specialties. (This will help you understand if the supplier excels at the manufacturing processes you need to manufacture your product. If the supplier specializes in processes different than those you require, you should eliminate them from the preliminary list of suppliers.)
  • Ask the supplier if they make any products similar to yours. (This will help you understand if they specialize in making products like yours. If the manufacturer doesn’t make similar products, then it is still acceptable to keep them on the preliminary supplier list but be sure to be diligent moving forward.)
  • Ask the supplier to send you samples of products they currently have in production (This will help you understand if the product quality level matches your expectations. If any of the products you receive are of poor quality or don’t function properly, eliminate the manufacturer from the list of suppliers.)
  • Visit the manufacturing facility if possible and eliminate any manufacturers from the list if they don’t allow you to visit their factory (Manufacturers typically put their best foot forward on these first visits, so take everything you see and hear with a grain of salt.)

How to get references for each manufacturer

It is always very difficult to properly do due diligence on suppliers, especially overseas manufacturers.  Therefore, the best place to start is to ask the manufacturer to supply a list of customer references from companies who have used their services in the past to make custom products.  Be sure to get a list of at least five references and check that the references are currently working with the manufacturer, are companies similar to yours in size, and have produced similar production quantities as you are planning.  For example, it would not be appropriate to use a multi-billion dollar company producing hundreds of millions of parts as a reference for your start-up company that is expecting to make ten thousand parts in the first year.  This wouldn’t be a valid reference since chances are high that this multi-billions dollar company is being treated very well.   Ask each reference to provide insight into their experience working with the manufacturer.  Be sure to ask the references to tell you both the good characteristics and the bad characteristics of the manufacturer.  If the reference does not have anything bad to say about the manufacturer, then eliminate this reference from your list. Any customer who has worked with the manufacturer for an extended time will have some negative things to say about a supplier.

How to perform an in-depth manufacturing supplier evaluation

After the first two steps of manufacturing supplier selection have been completed, only two or three manufacturing suppliers should remain on the list. If a large number suppliers are still on the list, then go back and get more references to interview.

The final step in selecting the best manufacturer is to do an in-depth supplier evaluation. Large multinational companies have large internal teams to perform this task and some companies use consulting firms to do this final evaluation. If you don’t find it necessary to bring in external people to help you make the final supplier selection, follow the list of questions below to be sure that you address all potential issues and concerns prior to making the selection. Once each of these questions are answered for each of the remaining suppliers, it should be obvious which supplier should be selected as the final manufacturer.

  • Where will the products be manufactured? The place of manufacture will impact the costs of shipping and potentially import duties.
  • Ask the supplier to provide you with all the documentation that is followed for their internal quality processes. How do they ensure that the product is manufactured to specification?
  • How are the manufactured parts shipped? Boat, air, land? Does the manufacturer have strategic relationships with logistics companies to ensure products get through customs without any issues? What happens if the parts get stuck in customs somewhere in the world?
  • Does the manufacturer provide certifications of conformance of the products shipped including product measurement data, performance data, and raw material supplier information? Ask the manufacturer to provide certifications for products in manufacturing.
  • Does the manufacturer outsource any of the work to a third part? If so, what processes are outsourced and how is the quality managed?

Can the supplier provide any examples of product quality plans for products produced in the factory? This includes incoming inspections, quality inspections on all parts fabricated, assembly process checks, finished product testing, audits, and outgoing inspections.

  • What engineering documentation is required for the supplier to properly make the product? Typically this is a 2D dimensioned drawing done by a professional as well as a 3D CAD (computer aided design) file. Do not expect to get accurate quotations without these documents.
  • Ask the supplier to provide you with cost quotations for the product based on the engineering 2D and 3D files. Make sure the supplier quotes the quantity you require as well as multiple ranges of quantities above and below your expected production volumes. Be sure to get all costs including non-recurring expenses such as production tooling and variable costs such as the part costs.
  • What are the lead times for manufacturing the required quantities of your product?

This list provides the most important questions that should be asked when performing an in-depth manufacturing supplier evaluation. If the supplier selection process provided above does not result in a clear answer of the best supplier, then it might be best to bring in a professional who has years experience evaluating and selecting supplier.

Need more information on new product development or the manufacturing process? Please contact us with any questions or contact me directly at joseph.donoghue ( at ) leardon.com

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Pediatric Medical Device Innovation in Southern California

May 22 2012  |   leardonsolutions  |  All Posts, Medical Device, Product Development  |  Comment

Leardon Solutions Product DevelopmentIdentifying the unmet needs for pediatric medical devices, the Southern California Center for Technology and Innovation in Pediatrics (CTIP) opened in mid-2011 with the support of the University of Southern California (USC) and Children’s Hospital Los Angeles.

According to a study performed by the United States Government Accountability Office (GAO), pediatric medical devices lag behind adult devices due to the lack of financial incentives for manufacturers. Not only is the pediatric population smaller, but children are physiologically different than adults and there is a very small pool of pediatric clinical trial participants. The FDA Amendments Act of 2007 was written to help overcome these barriers to commercialization in small markets. Part of this Act allows for a FDA humanitarian device exemption (HDE) for diseases or conditions that affect less than 4000 people in the United States. All of these commercialization and development challenges in the pediatric medical devices led to the founding of CTIP.

Leardon Solutions is proud to be an industry partner of CTIP, helping Southern California clinicians and researchers design, engineer, and prototype their pediatric medical device products. This involvement led to an invitation to the inaugural Pediatric Venture Accelerator Forum held at Children’s Hospital Los Angeles. This forum brought together clinicians, engineers, industry, investors, and academics to discuss the latest in pediatric medical devices and to find innovative ways to accelerate pediatric medical device development.

To see the highlights from the Pediatric Venture Accelerator Forum in April 2012, please view the video below. For more information on the Southern California CTIP, please go to the CTIP website .

Need more information on new product development or the manufacturing process? Please contact us with any questions or contact me directly at joseph.donoghue ( at ) leardon.com

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How frozen pipes and flooded caravans led to the Floe product

May 15 2012  |   leardonsolutions  |  All Posts, Business Tips, Northern Ireland, Product Development, Prototyping  |  2 Comments

Necessity is the mother of invention. This phrase succinctly describes Jason Paul, Managing Director and Founder of Apt Innovations, a Northern Ireland, UK based company. Apt Innovations develops and manufactures products that help owners of static and touring caravans, holiday homes, mobile homes, and motorhomes drain the water from the pipes of their homes, thus preventing broken pipes in freezing conditions.

Apt Innovations’ first product, the award winning Floe Drain Down Device, was conceived as Jason needed a simple way to winterize his home without having to make an appointment or pay a professional drain down technician. The Floe is a simple device that hooks to the outside hose tap and utilizes a tire compressor to blow out the excess water in the pipes. Apt Innovations’ Floe was written up in the BBC News article “Cold winter inspires NI man’s pipe business”, won the Best Accessory Award from Practical Caravan, and is making sales inroads in many countries around Europe.

Leardon: How did you come up with the idea for the Floë?

Jason: I own a static park home in the lakes area of Northern Ireland. Sadly we were caught out by bad frost which damaged part of the plumbing system and flooded the home. Normally you would pay someone about $180 to drain it at the end of the season, but this is an antiquated system that entails the service engineer trying to push the water back down through the system (the wrong way) in reverse from each faucet. Unfortunately this is not possible on showers as there are non return valves in them, which only allows water to come out of them (the right way). To a service engineer, the shower therefore must be dismantled, rendering the property useless over the winter months until spring.

I wanted to do two things. First I wanted to be able to drain the property myself, without paying someone and I wanted to use the property throughout the winter months as well as the summer. Therefore my idea connects to an outside tap, air is pushed into the system and water released from taps and shower (the right way) By doing this I do not have to dismantle the shower, so I can use the property whenever I like and drain on leaving. I tend to do this once at the end of the season and a few times in winter. At $180 per draindown, this could amount to just short of a thousand dollars. Floë costs less than $30 and can be used for years, not a bad return.

Leardon: What was the most important thing you learned about the prototyping and new product development process?

Jason: First, get a patent or at least a Non Disclosure Agreement (NDA), then the next most important thing is to get the right people on board at the start. So many people go down a road without advice on relevant areas of their product. I would completely recommend that a company find a very experienced product development company to talk this though to the extent that there are no more surprises or guesswork. This will keep the price of product development and prototyping down to a minimum. Our such advisers were Leardon Solutions. Here you have two sides of advice, one for the business and selling of the product, i.e. what works and what doesn’t and second the engineering advice as to which is the most cost effective, yet visually appealing end product.

Leardon: How did you prototype the Floë?

Jason: I created a very ugly prototype for myself, which worked right through the winter. I then made some slightly more attractive but still inexpensive homemade versions that I sold to people for a very small price. Accepting payment means that there is some skin in the game from the customers and it also proves that people will pay something for an solution. Of course you could provide free samples, it is up to you. These worked for about 25 people through the next winter. It was then that we knew we had a potential product. We then got some Northern Ireland Government funding for a patent and prototype, which we then took to Leardon Solutions to create more basic prototypes and eventually the finished product.

Leardon: What did you learn about manufacturing a product? Any issues encountered?

Jason: It takes time. You need to take this time to get the product right. If you don’t, every thing else that you do can be flawed. A house can be stunningly beautiful, but if built on a flawed foundation, it could fall apart. A product is similar. Say you spend all of your time making a product, but there is a change that has been overlooked or not tested correctly. This could cause you problems. By the time you have realised it, you may have developed the packaging and photography which would all be wasted if the product has to be changed, or even sold some, in which case you will face returns.

Take time to test every opportunity and suspicion that you might have. I know most are bursting to get it onto the market but understand it will save you time in the long run.

Leardon: Why is Northern Ireland a great place to prototype and develop products?

Jason: Once upon a time Northern Ireland was a powerhouse in Engineering, Shipbuilding and Linen Manufacture. Much of the big industries sadly died away over the years leaving a large proportion of Service sector businesses in its stead. This is clearly not good for growth as manufacture and export are paramount. Northern Ireland has always had innovation brimming under the surface and now I am glad to say that local councils and Government are really pushing tech and innovation once again, really putting Northern Ireland on the world map again, so much so that the head of Government for Industry in China, felt it prudent to visit Northern Ireland last week

Leardon: What recommendations do you have for others with product ideas?

Jason: Get your product really ahead of the game and then when you are ready to be first to market, showcase the life out of it. It is being first to market that is important and stay there. Use every piece of homemade PR that you have in your arsenal. Magazines love to write articles for free on new stuff, in fact get someone to write it for you, then send it out to a range of media, who will print it up for you.

Time your marketing to when it will be most effective, particularly magazines. Newspapers and radio are more day by day but magazines take months. Also, use online forums etc, do a video and put it on youtube.com, then link it on your website. Use all of this.

Visit Apt Innovation’s website for more information and to get updates.

Need more information on new product development or the manufacturing process? Please contact us with any questions or contact me directly at joseph.donoghue ( at ) leardon.com

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