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The Best Medical Device Prototyping Tips

February 5 2013  |   Cliff  |  All Posts, Business Tips, Medical Device  |  Comment

Joe Donoghue, San Diego Prototyping, Patents & Prototypes, Live Web Show, Product Development, Engineering Services, Manufacturing, Entrepreneurial Product Development, medical device design, medical device product developmentThere are a million ways that an individual, startup or small business can build a medical device product starting with a prototype. However, there are only a few ways to build a prototype and actually have success in getting a product to production and then market. Here are a few tips to consider when prototyping a medical device.

So what sets a medical device product apart from other similar type devices?

Well the truth is, aside from regulatory compliance, not a whole lot. The prototyping process for a medical device starts like any other device. First a problem is identified and then a person or team gathers their thoughts and has the “There’s got to be a better way” moment. Then it takes a few sleepless nights and a constant drive to want to succeed to enter the next phase which is sketching out a prototype or creating a document with the basic functional requirements of that particular product.

How do you go from an idea to a physical prototype with just a sketch or basic document?

There are a number of ways. You can take your idea to an experienced team of medical device product development specialists to help prototype the concept, DIY up your own version if you are crafty enough or seek capital by using your contacts and a great sales pitch. We discourage seeking capital until you have a well flushed out prototype. It  can take a LONG time to find money in today’s economy. Do what you can with what you have and leverage your resources until you have a convincing product to show and tell.

Medical device prototypes can be designed on a computer in a 3D environment via CAD, Solidworks, or similar type programs. The right team can also build a physical prototype so that investors and others get a solid grasp of the product. Being able to present something (fully functional or not) goes a long way and also helps develop the fit, form and function of a product.

Can rapid prototyping work for your idea?

The answer is .. kind of. If you are looking to build a product that needs to be built of high quality materials and conform to exacting tolerances, rapid prototyping may not be your solution. Rapid prototyping is typically used to grasp the overall design and form of a product but leaves fit and function out of the equation to a large extent. It’s also important to note that rapid prototyping rarely lends itself to meeting the standards of designing for manufacturability.

How much will a medical device prototype cost you?

There’s no easy answer to this question. Each project and product is completely unique and while there is a product development lifecycle strategy that is closely followed to reduce costs, failures and time to market, many variables must be taken into account. Your best bet is to surround yourself with a team of people that have experience with medical device product development and have them quote the job to get a ball park figure. Avoid service providers that work only on the hourly rate.

Interested in learning more? Feel free to contact us with any questions.

 

 

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Best Tips For Medical Device Manufacturing

January 17 2013  |   Cliff  |  All Posts, Business Tips, Manufacturing Tips, Medical Device  |  Comments Off

Joe Donoghue, San Diego Prototyping, Patents & Prototypes, Live Web Show, Product Development, Engineering Services, Manufacturing, Entrepreneurial Product DevelopmentWhen it comes to medical device product development, the fragmentation of the industry can be challenging. Medical device development and manufacturing have seen many changes in the last decade and it is arguable that global product development is one of the most exciting topics related to medical product development.

Leveraging the global supply chain for Medical Device Manufacturing

#1) With a large amount of investment dollars earmarked for medical devices, competition for the business is fierce. Not too long ago, manufacturing anything in a different country was risky and time intensive but now new communication technologies have allowed for the rapid development and manufacturing of medical devices overseas which has reduced costs and time to market. Developed and developing countries are investing in high quality medical device manufacturing facilities that allow sourcing of design and manufacturing throughout the world.

Don’t re-invent the wheel. Seek out experienced professionals

#2) Partnering up with a team that is familiar with medical device product development and manufacturing can make the process much easier. Experienced teams will:

 

  •  Provide proper documentation of design history files and device master record

 

  •  Make use of medical grade materials that eases certification and submittable requirements

 

  •  Manufacture the product locally to supply the local market demand

Understand domestic and globals standards

#3) When looking for a product development and  / or a manufacturing partner, consider working with an experienced team that can help navigate the stringent domestic and global standards from day one to avoid costly redesigns or sourcing issues.

Have questions about medical device product development and manufacturing? Contact us here.

 

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Why Choose A World Class Manufacturing Partner Early

November 26 2012  |   Cliff  |  All Posts, Business Tips, Insider's Perspective TIps, Inventing Profit  |  Comment

Leardon Solutions Product Development, Joe Donoghue, San Diego, prototyping, manufacturing

Reasons to choose a world class manufacturing partner early.

You’re the design engineer / inventor/ team and you have this great innovative product, you’ve cogged together 10 units, spent a ton of hours and money on getting them built and running and and countless more hours keeping them running. The good news, you’ve got your funding and the OK to move forward, the challenge, taking this design from the “fragile-works-mostly-with-a lot-of support” to producing 10’s of thousands of units with inexpensive parts, simple/fool proof/low cost assembly, with 100% part, assembly and top level yields. A world class manufacturing (WCM)  partner can get you a long ways to this end game with your product. 

Shortly after I started my R&D career at Hewlett Packard two key changes were made in how we organizationally approached product development. First, everyone went to the 3 day workshop on “Market Driven Product Development” and got the religion. No more cool product ideas by the R&D geeks to be developed THEN marketed.  The second big change was the move to cross-functional integrated product development teams (Marketing, Finance, Quality, Manufacturing/Production, and R&D), staffed from the start. The effect of the integrated team was to eliminate the functional silos that existed along with all of the associated problems and inefficiencies associated with the inevitable “us vs. them” thinking. These changes were key enablers to HP becoming a printer powerhouse.  In today’s world of outsourcing and/or off-shoring of manufacturing the silos are back and more problematic. My single most significant piece of advice is eliminate the silos with your outsourced partners and work very hard to be that “well-oiled” integrated development team. Select them early and get them involved early.  

As I mentioned above, by engaging a World Class Manufacturing partner early in the design cycle you can improve product cost, quality, production agility, and time to market in some of the following ways:

  • Taking advantage of economies of scale in the existing supply base. For components and fabricated parts.

  • Fabricated parts designed with high yields ( work every time, fabrication process can easily produce parts to specifications, failure rates are reduced) – See an example of weak yields here ( Apple scrambles to fix it )

  • Avoiding part designs that can be assembled incorrectly.  Parts whose orientation during assemble does not matter or parts that only fit will improve product yields and quality.

  • Avoiding special tools, fixturing, and/or tests on the production line.

These are just a few of the obvious benefits that should flow from a world class manufacturing partner. If not, consider engaging a manufacturing engineering consultant to work with your manufacturer to achieve the benefits of Design for manufacturability.

Have questions about manufacturing? Contact Us Here.

This post is written by Mike Hoggatt – Leardon’s Director of Product Development

 

 

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Patents and Prototypes – The Live Show Airs Tonight!

May 1 2012  |   Cliff  |  All Posts, News, Patents and Prototypes  |  2 Comments

patents, prototypes, leardon solutions, intercontinental IP, Joseph donoghue, eric hanscom, live showWe have been very busy here at Leardon Solutions helping Entrepreneurs and businesses with their ideas and products. It seems the busier we get, the more inspired we are to reach out and touch the community in new ways. Social media has been a great way to keep in contact with entrepreneurs, inventors and businesses. However, tonight marks the start of a new community outreach program that Leardon Solutions will be part of.

Starting at 6:30pm/pst our very own Joe Donoghue co-hosts a monthly live web show just for entrepreneurs, inventors and businesses owners. The show is all about the product development and patent process. We’re very excited because it’s our way of reaching out and speaking with a community that we don’t often get to see face to face outside of our own geographic areas. It gives us the opportunity to answer questions in real time and an offers an opportunity for the community to interact with each other via chat and webcam.

We hope that you can make it. Here is a link to the show schedule and a link to the live show that starts at 6:30pm/pst. Just login as a guest using your real name so that we know who you are and bring those patent and prototype questions!

Thanks and hope to see you there!

The Leardon Team

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Best Tips when Designing a Product

April 3 2012  |   leardonsolutions  |  All Posts, Business Tips, Product Design  |  2 Comments

Leardon.com, Prototype, Benchmark, Think Simple, Product Development

Below are a few tips to consider when designing a product. These tips are based on years of experience from the Leardon team and are overall the best high-level tips to take into consideration as you begin your entrepreneurial venture into new product development.

A good product development team consists of individuals from different disciplines with diverse goals, objectives, and perspectives. When at the stage of designing a product, be sure to choose a group of talented individuals that are able to compromise for the success of the project.

The product designers and engineers on a project are key to a successful product design but typically have different objectives for the project outcome. Engineers tend to enjoy the “objective” goals of product development such as product reliability, quality, dimensional details, and manufacturing processes while product designers tend to focus more on the “subjective” aspects of product development such as customer profile, product design features, human factors, and the user interface. When embarking on the initial stages of product design, it is important that all team members work together to achieve the goals of the project. Early in the product development life cycle, consider these three tips when starting the product design phase of the product.

Think Simple
There is no reason to complicate any problem and product design development is no exception. The best product designs are typically those that form a simple connection between function and design. If a designer overcomplicates the design, the customer will be alienated and the resulting product will not do well in the market. The goal of a good product design is to pull in the customers with a nonthreatening design that seems inviting and easy to use.

When initiating the design phase of the product, be sure that the design team thinks “simplicity” so that the design concepts, user interface, and human factors can be easily implemented later down the product development life cycle.

Benchmark
It isn’t necessary to reinvent the wheel and in fact sometimes customers would prefer that you don’t. It is a good idea when starting out on the product design path to review and research all the competitor products on the market and gauge which design features make the product successful and which resulted in failure in the market. Obviously, improve the successful features and avoid the failures.

When benchmarking new products, evaluate how the similar features similar are implemented in product design and then determine how new features and functions can be implemented into the product design. Remember not to change things that are familiar and mainstream for customers. For example, it would be a bad idea to try and reinvent how the automobile gear shifter is designed and integrated into the interior design. Customers are too familiar with the current embodiment and would probably reject any major design changes.

Prototype and Test
Once the first release of a product design is “ready for the world to see”, it is best to prototype and test the design prior to releasing the design to the engineering team for detailed engineering in CAD. There are many ways to prototype the design, including foam models, rapid prototyping, computer simulations, or functional prototypes. When testing the prototype, show it to people unfamiliar but interested in the product. The test can be done through focus groups, informal studies, and on-line surveys. It is best to interview as many people as possible to be sure to get a large amount of feedback from a diverse group. Once this feedback is received, implement this back into the product design to improve the design to meet as many requirements as possible.

If you are interested in showing off your work, learning more, or posting topics for discussion in the industrial and product design community, you should visit Product Design Forums.

Need more information? Please contact us with any questions or contact me directly at joseph.donoghue ( at ) leardon.com

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Tips to Cut Product Development Costs – Part 2

March 13 2012  |   leardonsolutions  |  All Posts, Business Tips, Manufacturing Tips, Product Development, Prototyping  |  Comment

Leardon Product Development Tips, Manufacturing ServicesIn Part 1 of Tips to Cut Product Development Costs, three ways that innovators, entrepreneurs, start-up companies, and small/medium enterprises can be smart and spend the least amount of money throughout the product development life cycle were discussed. Here are the next three ways that entrepreneurs, innovators, or small companies can save money without cutting corners or skipping product development phases.

Avoid Multiple Hand-Offs During the Product Development Life Cycle
Most entrepreneurial, start-up, or small/medium companies do not have large internal staffs to handle all stages of the product development life cycle. These companies typically nearsource or outsource much of the work in an attempt to minimize product development costs and maximize development speed. While nearsourcing and outsourcing can improve your costs and speed, it unfortunately can create a costly and slow system if not managed properly.

Many service providers and suppliers do not provide an end-to-end product development solution from product idea to manufacturing, forcing companies to hire multiple service providers throughout the product development life cycle. When entrepreneurs piece together a product development team by hiring these outside firms, an inefficient team that doesn’t have visibility to the tradeoffs between cost, schedule, and scope is sometimes created. To create an efficient system, the innovator or entrepreneur should try to minimize the number of hand-offs throughout the cycle by hiring an end-to-end engineering, prototype, and manufacturing firm that internally handles all the hands-offs without dropping or losing any of the knowledge gained in the last phase.

Here are some tips for an efficient product development team:

  • Have one experienced internal program manager for the complete project that is responsible for product/project cost, schedule, and scope.
  • Minimize the number of hand-offs by hiring one company that can take the project from design concept to manufacturing.
  • Eliminate any supplier agents, go-betweens, or representatives that don’t allow you to work directly with the suppliers doing the work.

Don’t Buy Production Tooling Until Final Production Qualification.
When a product enters mass production phase, fabrication methods different from those used to produce prototypes are required to meet the quantity, cost, and schedule goals of mass production. Some examples of these production tooling methods include injection molding for plastic parts, progressive stamping for metal parts, production lines for efficient assembly, and wave soldering for printed circuit board assembly. Prior to starting mass production qualification, there is no need to purchase these production tools early in the product development life cycle. Delay the cost of these production tools by using early proof-of-concept and design prototypes for as much testing as possible.

There is usually no need to spend money on any production tooling in the proof-of-concept or design prototyping phases. Even if a production-like method must be used to produce a part in a prototype, the cost can be minimized by fabricating only what is absolutely necessary to make the parts. For example, if you are producing a rubber seal in a prototype, a prototype tool can be fabricated inexpensively to yield the high quality part required. Do plenty of research if a prototype company says that they need to produce a high-volume production tool for a part being used in your prototype because more than likely this is not required.

Minimize the Amount of Product Inventory Purchased.
Once you enter into the production qualification phase, try not to lock up cash in expensive inventory by purchasing large quantities of your product. Work with a supplier who is happy to provide you with a smaller volume, say 1000 production products, that will allow you to test out the market prior to ordering more. This will also prevent expensive inventory reworks.

A misconception in the world of entrepreneurial product development is that all suppliers require entrepreneurs to buy tens of thousands or even hundreds of thousands of products on their first order. For a custom product, it is recommended that the entrepreneur only buy as many products as necessary to fulfill the immediate customer demand of the product. There is a high chance that changes will be required as sales begin so keeping inventory low will minimize the financial pain of any design changes, reworks or repairs.

There are many entrepreneurs who are “up-sold” to higher quantity orders for a lower product price. There are other entrepreneurs who are shocked to learn that a supplier is unwilling to take a low quantity order and will not to work with the customer unless a large order is placed. It is important to know the prices at all order quantities early in the relationship with the supplier. If the supplier is unwilling to fulfill low quantities in the range of 1,000 products, it might be best to switch to another supplier. Chances are high that there are hundreds of other suppliers that are capable of supplying the product and willing to work with entrepreneurs.

Need more information? Please contact us with any questions or contact me directly at joseph.donoghue ( at ) leardon.com

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How to Avoid Feature Creep and Scope Creep: Tip #3

February 14 2012  |   leardonsolutions  |  All Posts, Insider's Perspective TIps, Manufacturing Tips, Product Development  |  1 Comment

Product Development, Leardon Solutions, Manufacturing, San Diego, Southern California

Tip #3: How to Avoid Feature Creep and Scope Creep During Product Development Lifecycle

Scope Creep. Feature Creep. Creeping Featurism. Featuritis. Project Creep. These are all terms used to describe the state in a project where the scope or features of the product continually change as the project progresses. Many of the articles written regarding scope/feature creep discuss software feature creep or methods of managing creep. Of course, feature creep is an issue that can adversely impact any project, including software, hardware, or service. If it isn’t avoided and managed properly, the project will end up at the point of no return.

Here are some methods of avoiding feature creep during the product development process.

A. Focus the team on the project priorities. There is always a tradeoff between product cost, program schedule, and product features/scope that cannot be ignored. One objective cannot be changed without affecting the others and a successful team leader is one who will prioritize these objectives. If the team is focused on these priorities then feature creep will take a back seat to proper program management. For example, if Project Scope is prioritized on the program, then it would be acceptable for the program manager to methodically consider new features. But if Product Cost or Program Schedule were the highest priority, changes in features would typically never be considered. One program that was successfully introduced into the market in less than six months was the Floe Winter Drainage System by Apt Innovations located in Northern Ireland, United Kingdom. The Managing Director Jason Paul was very thoughtful in his approach to managing the project. He stated clearly that the priorities of the program were (1) Program Schedule, (2) Program Scope, and (3) Product Cost. This allowed him to make wise decisions about avoiding any creep of the product features when he learned more about new potential customer segments for his product. He left these changes to the next product iteration.

B. Create and manage a product requirements document. It is extremely important that a program is initiated with a formal phase of documenting the program requirements. These requirements are driven by the customer and require in depth research to determine exactly what the customer wants and needs. Once the customer requirements are documented, the engineering team can translate these customer requirements into engineering requirements. This allows the engineering team to initiate their work and begin design and qualification. When features are changed or new features are introduced, the engineering team needs to revisit the engineering requirements document and rework many of the designs and qualification tests already performed. This results in wasted time and money.

C. Feature scope, if any, should only be customer driven. If a product program is being managed with a top priority of product scope, changes in the scope or features can be considered. Sometimes it is necessary to make changes to the features based on new learning from the market and customers. It should be noted though that the marketing team needs to be careful that they don’t react too quickly to requests by customers as this will end up whip cracking the engineering and development team. If features changes are going to be made, make sure that the customer was the original reason for the change.

D. Create a process to evaluate all potential changes to the feature list. When changes are going to be seriously considered, it is necessary to have a team process that is used to make a decision to implement or discard the new feature. The program manager should implement a review process that the whole team understands and follows. The evaluation team should consist of all functional members including technical, financial, marketing, and sales so that all member’s needs are considered. The decision criteria should be an objective metric that considers all financial and schedule outcomes of the decision such as net present value (NPV).

Successful product development teams focus on their original product requirements and don’t let scope and feature creep derail their schedule and financial goals.

Need more information? Please contact us with any questions or contact me directly at joseph.donoghue ( at ) leardon.com

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8 Product Development Myths to Know…..Part 2

January 17 2012  |   leardonsolutions  |  All Posts, Inventing Profit, Manufacturing Tips, Product Design, Product Development, Program Management, Prototyping, San Diego  |  Comment

Product Development MythsPart one of this blog series outlined hardware product development myths, basically it was four misconceptions that many entrepreneurs believe are true and hence prevent them from starting down the product development path. To recap, the myths were (1) Hardware development is prohibitively expensive, (2) Service providers and suppliers do not want to work with small companies or Entrepreneurs, (3) My idea will be stolen by my suppliers, and (4) I need to manufacture in China to be successful.  We know you’re eager to read the last four on our list. Also, if you have some of you’re own, don’t hesitate to include them in our comment section below.

(5) Hardware development takes too long
All types of new product development, including software and hardware, require considerable amounts of time for innovation and invention. Hardware development is different than software development in that tangible tools, fixtures, and automation are required but that doesn’t always mean that hardware development takes longer than software development. To minimize the amount of wasted time in any new product development project, it is best to follow a product development life cycle. With the proper deliverables in each phase and checkpoints prior to exiting and entering phases, the overall process will be streamlined using less time and less money.

(6) I need to buy a large quantity of products from my supplier
The misconception is that all suppliers require that the entrepreneur buy tens of thousands or even hundreds of thousands of products on their first order. For a custom product, we recommend that the entrepreneur only buy as many products as needed to fulfill the immediate customer demand of the product. There is a high chance that changes will be required as sales begin so keeping the inventory low will minimize the financial pain of any design changes, reworks or repairs.

There are many entrepreneurs who are “up-sold” to higher quantity orders for a lower product price. There are other entrepreneurs who are shocked to learn that a supplier is unwilling to take a low quantity order and will not to work with the customer unless a large order is placed. It is important to know the prices at all order quantities early in the relationship with the supplier. If the supplier is unwilling to fulfill low quantities in the range of 1,000 products, it might be best to switch to another supplier. Chances are high that there are hundreds of other suppliers that are capable of supplying the product and willing to work with entrepreneurs.

(7) I can’t afford to hire all the individuals on a product development team
A hardware product development team consists of development engineers, tool makers, process engineers, software engineers, technicians, fabricators, procurement engineers, buyers, program managers, among others. Many entrepreneurs try to piece together the product development team with service provides or suppliers that perform only one aspect of the product development life cycle. Since these service providers and suppliers do not provide an end-to-end product development solution from product conceptualization to manufacturing, it forces the entrepreneur to take on the burden of managing all the suppliers and the work performed. If the entrepreneur is unfamiliar with the product development life cycle, this creates an inefficient team without accountability or visibility to the tradeoffs between cost, schedule, and scope.

To create an efficient system with full accountability of the work performed, an entrepreneur should minimize the number of hand-offs throughout the cycle by hiring an end-to-end engineering, prototype, and manufacturing firm that internally handles all the hands-offs without dropping or losing any of the knowledge gained throughout phase.

(8) Hardware development isn’t as cool as software development
Without hardware, there would be no use for software. Without software, most hardware would be boring. Both hardware and software development are challenging and fun so go ahead and pursue your product idea!

Need more information? Please contact us with any questions or contact me directly at joseph.donoghue ( at ) leardon.com

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The Entrepreneur And Product Development : Lessons Learned

January 3 2012  |   Cliff  |  All Posts, Inventing Profit, Manufacturing, Product Design, Product Development, Prototyping, San Diego  |  2 Comments

Inventor, Product Development, Prototype, Lawn MowerYou might remember that we helped Entrepreneur Steve Hartman with the product development on his Cyclemower, a product that eventually ended up being featured in the Inventors Spotlight at the Las Vegas National Hardware Show. It’s time to check back in with the Entrepreneur Mr. Hartman and the Cyclemower to ask a few questions pertaining to product development and lessons learned along the way.

Q: Steve, what have you learned about product development?

A: The learning curve on prototype development is a long one, which I am still going through. At first, I had a design in mind, which I though I could just kick out and be done with it. I soon learned that there were a number of design details, at least with a relatively complex product like Cyclemower, that caused one problem to exacerbate another. With my first prototype, I was looking to prove that I could achieve my expected blade speed, which I succeeded in doing. I was unable to cut grass with it, and the design was really ugly. When we finally got to our current design, it was still not what I initially envisioned, but it had all the functional elements. It not only spun the blade at speed, but we eventually were able to cut grass. It has a cool look as well, but we also have found a number of weaknesses that makes it unsuitable for a final product. Notably, its too heavy, and the bottoms of the sideplates drag on uneven terrain. This causes the blade to stop spinning. We also can’t seem to get the back roller to function, so we can’t establish an even cutting height. For demonstration purposes, we are basically limited to perfectly flat and well tended lawns, which are hard to come by. To summarize, I think the biggest thing I learned is that the details never stop, and you can never assume that you have figured them all out.

Q: What did you learn from attending the Las Vegas Hardware show?

A: I learned from the hardware show that it is not necessarily a good place to find manufacturers who want to invest design and engineering resources into a new product. The hardware show is a good place for existing manufacturers to show their products to distributors and retailers.

Q: When building a product again, what will he do different next time?

A: If we need to develop another prototype, it will become all about the details. We will want to take all the shortcomings we have learned from our current design, and eliminate them, one by one. We will also want to directly compare ourselves to our competitors, in order to point out the superior aspects of our design. This is a long and tedious process, but one where nothing can go unaccounted for, no matter how seemingly insignificant. We will want our design to be perfect, from form and function all the way to packaging and shipping.

Q: Suggestions for others building hardware for the first time?

A: My suggestion for others would be to take a long, hard look at what you are trying to accomplish, and identify potential shortcomings in a brutally honest and thorough way. I can’t overstress the issue of details, as it only takes a small malfunction to make your whole design look bad. Have faith in your convictions, but take all the advice you can and apply good ideas that make sense to you. One thing I learned along the way is that there will always be people who will tell you how stupid your idea is. Most of the time, these people should be ignored. On occasion however, someone will come up with a legitimate criticism which should be considered and applied to improve your design. Inventing is hard work, and most people can’t do it. Quitting is easy, and most people do that all the time. There are so many obstacles to overcome in creating a new product, but you have to keep at it while maintaining faith in yourself. No one is going to succeed for you.

We would like to thank Steve for taking the time out for our Q&A. If you are an Entrepreneur entering the product development cycle, it’s great to hear from people that have been there and done that. They can help shed some light on the process of product development, prototyping and product marketing.

Need more information? Please contact us with any questions or contact me directly at joseph.donoghue ( at ) leardon.com

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Pitfalls of Manufacturing : Entrepreneur Beware!

December 20 2011  |   leardonsolutions  |  All Posts, Manufacturing, Manufacturing Tips, Product Development  |  1 Comment

When working with outside suppliers and vendors to take your idea into manufacturing, there are many pitfalls that can hurt your chances as an Entrepreneur for a successful product introduction. Manufacturing a product is a process that must be followed with rigor. There are five common pitfalls that entrepreneurs encounter when taking their product into production. Review the advice below and improve your chances of a successful manufacturing introduction.

Take Ownership of the Design and Manufacturing Tooling

When working with outside suppliers to design and manufacturing a product, it is important that you maintain ownership of the product design as well as any manufacturing tooling. For example, the supplier might be hired to design and prototype the product per your specifications. If you are paying this supplier, it is important that you make it clear that you own the product design, intellectual property, and the entire computer aided design (CAD) files generated. Be wary when a supplier performs all the design work for free but will not allow you access to any of the original design files.

It is usually necessary to purchase production tooling in order to fabricate your product. This could include plastic injection molding tools or metal stamping tools. If this is the case for your product, be sure that any money you pay gives you full ownership of the tools and allows you to move them to another supplier if necessary. Supplier-owned tooling puts you at a severe disadvantage when negotiating the price of your product.

Sign off on all Manufacturing and Design Changes

One of the scariest situations in manufacturing is when changes are being made to the product without the client’s knowledge. Changes should only be made to resolve an issue or defect and change require a large suite of qualification prior to implementation. Therefore, it is necessary that all changes are approved by the client. Without knowledge of these changes, the client will most likely be surprised when new production units arrive.

Many times throughout prototyping and manufacturing, the supplier might say “We’ll solve that issue in the next batch of products” when discussing a current issue or defect. This isn’t an acceptable solution since there is no proof that the solution will resolve the issue. Be sure to make new prototypes with each change prior to kicking off a new order of production units.

Know the Price at all Order Quantities

Early in the relationship with a supplier, it is important that the client knows the product purchase price at all manufacturing quantities. Many times, a supplier will provide an enticing price quote for an extremely high quantity of products that is usually higher than the needs of the client. Chances are low that an entrepreneur’s first order will be a high quantity and therefore it is important to know the cost structure and supply chain costs at all order quantities. It is recommended that you get cost estimates at 1,000, 10,000, and 100,000 order quantities so you can get a good idea of the costs across all volumes. This will also give you an indication of the supplier’s ability and desire to supply low and high quantities. This will ensure that there are no surprises when you make your first orders.

Buy Only what is Necessary for Immediate Sales

Only buy as many products as you need to fulfill the immediate demand of your product. There is a high chance that changes will be required as you begin to sell you product so minimizing the number ordered will eliminate the expensive reworks or repairs required.

There are many entrepreneurs who are “up-sold” to higher quantity orders in order to get a lower price. There are some other entrepreneurs who are shocked to learn that a supplier is unwilling to take a low quantity order and will not work with the customer unless they order a higher quantity. It is important that you know the prices at all order quantities early in the relationship with the supplier. If the supplier is unwilling to fulfill low quantities in the range of 1,000 products, you probably should move to another supplier.

Don’t Pay until Quality is Confirmed

Finally, many suppliers will ask for 100% of the payment up front in order to start the product production. If you pay all the money up front, then you run the risk of having no recourse if the product does not meet your specifications upon receipt. It is more standard to pay 50% up front with the final 50% due upon receipt of your products.

You should also verify that the product meets all your specifications and quality levels upon receipt prior to paying the final 50% of the payment. Verify that the product meets all the specifications including product dimensions and materials as called out on the 2-dimensional prints and operational specifications as called out on the product specification document. With respect to verifying the materials, be sure to ask for Certification of Conformance on all the materials used in the product as it is important that no changes have been made since the prototypes were supplied.

When entering into manufacturing, be sure to own the design and tools, monitor all changes, know the pricing structure, buy only as many products as you need, and pay when quality is confirmed. This will ensure that you don’t fall into any of the pitfalls of manufacturing and successfully get your product into the hands of customers.

Need more information? Please contact us with any questions or contact me directly at joseph.donoghue ( at ) leardon.com

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