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How To Speed Up Medical Device Product Development

Joe Donoghue, San Diego Prototyping, Patents & Prototypes, Live Web Show, Product Development, Engineering Services, Manufacturing, Entrepreneurial Product Development, medical deviceMedical device product development has a reputation of being difficult, lengthy, expensive, and out of the reach of most startups and small businesses. The reality is that product development of medical devices can be achieved by startups and small businesses. With the right product development team, medical product development costs can be significantly reduced.

Working with an end to end product development engineering firm can provide consolidated resources and reduced costs while encouraging a lean startup culture where all parties involved are looking for the best solution at the best price, quality, and time to market.

Working side by side with medical device regulatory personnel

It is important to include a medical device regulatory individual on the product development team and design review committee. It is the goal of this individual to interpret the domestic and international regulatory standards and help implement them into the product design. When regulatory personnel are actively involved in the development process from the beginning, the following pitfalls are avoided:

  • The team follows the proper design methodologies and design controls from the start.
  • The team properly documents the design.
  • The team is privy of the performance requirements (design input) of the device.
  • The team performs the proper verifications and validations to fulfill requirements set forth in guidance documents.

For more information regarding medical device product development, contact us today.

 

 

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Best Tips For Successful Medical Device Product Development

Joe Donoghue, San Diego Prototyping, Patents & Prototypes, Live Web Show, Product Development, Engineering Services, Manufacturing, Entrepreneurial Product Development, medical device design, medical device product developmentIt is an exciting time to be in the medical device product development industry. With medical device technology evolving so rapidly, the sky is the limit provided one’s character has the ability and resilience needed to find the right resources to help build a medical device on time, on budget and then bring it to market.

We have worked on a number of medical devices for startups and small businesses and in that time learned a great deal about building a medical device with limited resources. Here are 5 helpful tips to consider when your team is ready to take on the challenge.

1) You Don’t Know What You Don’t Know

The statement seems obvious but to effectively bring a medical device to market on time and on budget, the learning curve is steep and you don’t want to learn what you don’t know on a tight time frame with limited funds.

Our advice: Look for help early in the game to help sidestep the pitfalls and deal breakers of medical device product development. Even if it’s just to make relationship for use at another time, gather as much knowledge as you can to limit your exposure to costly surprises.

2) Regulatory Red Tape Can Be Avoided By Being Smart About It

Regulatory red tape can stop a project dead in its tracks. This can be a major problem at anytime in the medical device product development lifecycle and even worse, after.

Our advice: Work with medical device regulatory personal early on in the process to help steer the product development in the right direction from day one. This will help avoid costly mistakes.

3) Work with experienced partners that have trusted relationships

Finding out that your sourcing solution or engineering team isn’t capable of delivering what they said they could halfway through your budget and timeline is a bad place to be stuck.

Our advice: Do your homework. Dig into their portfolios and check references. Get specifics of what they have done on projects they use for examples. Ask a lot of questions and don’t be shy or afraid to hurt feelings, this is your time and money. You deserve to know everything that you can.

4) Documentation, Documentation and More Documentation

Communication is key especially when dealing medical device product development. Along with the usual challenges of product development comes the added challenge of meeting regulatory standards both domestically and abroad.

Our advice: Document everything, keep a strict revision history to documents and hold individuals accountable for documenting procedures, agreements, and revisions.

Need more tips for successful medical device product development? Contact us for more tips and a free development quote.

 

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Product Development Problems

Joe Donoghue, San Diego Prototyping, Patents & Prototypes, Live Web Show, Product Development, Engineering Services, Manufacturing, Entrepreneurial Product DevelopmentProduct Development Problems Can Balloon Quickly

Regardless of the experience of the team, product development problems will arise during your product development process. The ability to recover from these problems will largely dictate the overall success of the product.

At Leardon Solutions, new clients sometimes come to us with problems that need immediate solutions to save the product from certain death. Problems can arise in any number of areas from prototyping to manufacturing. If the project has been mismanaged to any degree, only a highly experienced team can right the boat for smooth sailing with minimal damage and loss of speed.

If you have found yourself in a bind with your current vendors and suppliers, not all hope is lost. Teams like Leardon work tirelessly to correct problems with your current vendors to avoid the cost overruns associated with moving tooling to other vendors, renegotiating contracts and repairing damaged relationships/partnerships.

Like the game of Dominoes, failures in the pipeline will affect the overall product. Do not allow your product development problems to balloon to the popping point, step in and get a second opinion if you feel uncomfortable with the current process.

For more information, contact us or visit our product development forums

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Is Rapid Prototyping Right For You?

Joe Donoghue, San Diego Prototyping, Patents & Prototypes, Live Web Show, Product Development, Engineering Services, Manufacturing, Entrepreneurial Product Development

Is Rapid Prototyping Right For You?

At Leardon here in San Diego, we often run across entrepreneurs that are confused by all the different types of prototyping such as Rapid, 3D and Machine Prototyping. If you have been in the business of building prototypes, the differences are very clear, but if you’re new to the scene a quick education can go a long way to save money and headaches.

The goal of prototypes is to prove that the form, fit and function of the product meets your specifications. Considering these factors as you move forward will get you close to your end goal of developing a prototype that is as true to the production product as possible.

So lets discuss different types of prototyping and what they are good for:

Rapid Prototyping: This method of prototyping is a quick and efficient way to get an idea of the form of the product but falls short of providing real feedback on fit and function. This is due to the fact that a prototype from this rapid prototype fabrication method is typically made of a plastic material that often isn’t the suitable for the final product material. For example, if you are looking to manufacture a product from aluminum, a rapid prototype may give you the initial feedback on how the product feels, but the product will not have the right tolerances with mating parts and therefore will fall short on proving anything to do with fit and function.  This will result in yet another prototyping process later on down the road. Learn more..

3D Printing: 3D printing is a process that is achieved from a digital master CAD (computer aided design) file. 3D printing is very quick when a digital file is available. The 3D printing is achieved on a materials printer. This form of prototyping is great for industrial design visualization and form but leaves many areas of production overlooked, such as tooling, tolerances, materials and functional specifications. Learn more..

Machine Prototyping: Machining your prototype from the same material you intend on using on the final product is the best bet for certain types of products. Products using multiple parts, tight tolerances, high use functions, serviceable parts and different types of materials i.e. plastic, aluminum, steel, etc. 

While machining might not be the least expensive option, a machine prototype can save a lot of money in the long run by avoiding design issues. It allows the product development team to learn about the design with the proper materials early in the product development life cycle so that issues can be addressed and resolved long before mass production begins. 

For more information regarding prototyping and product development, please contact us.

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Need Help Getting Product To Market? Tried HSN?

Leardon Solutions Product Development, Joe Donoghue, San DiegoGetting Product To Market With DRTV models like HSN and QVC

You have worked hard developing several prototypes and nurturing your product into reality.  Now it’s time for the equally challenging task of getting your product to market and selling enough to at least beat the odds that society has placed against you as an inventor and entrepreneur. If you are determined to make money on your brain child, you’ll need to explore a lot of opportunities available to you.

There’s trade shows, magazines, and the internet but what about DRTV? (Direct Response Television ) think QVC and HSN. For the right product, these powerhouses offer the opportunity to get your product sold and quick.

Joe Donoghue and Eric Hanscom took questions from the community of inventors and entrepreneurs and asked Marcy McKenna, an inventor and HSN seasoned pro these questions on the live monthly web show “Patents & Prototypes“. Below is the interview, it’s about 30 minutes long and full of great information that will help you determine if you should submit your product for review to a DRTV solution like HSN or QVC.

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Patents and Prototypes – The Live Show Airs Tonight!

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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Tips to Cut Product Development Costs – Part 2

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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Tips to Cut Product Development Costs

Leardon Product Development Tips, Manufacturing ServicesMany innovators, entrepreneurs, start-up companies, and small/medium enterprises have very limited product development budgets. Therefore, these companies need to be very smart about properly spending their money to continue moving forward in the product development life cycle and saving cash for later in the product development game. In order to save costs, many organizations try to cut corners by integrating or altogether skipping product development phases. This not only ends up costing more money but the total time it takes to complete the product will also inadvertently increase.

Product Development is a process that when followed properly results in a tangible product that can be sold to customers for revenue and hopefully profit. In order to get quickly into the revenue stage, it is important to develop a process that results in fast product time to market, high quality, and minimal development costs. Throughout this process, there are ways that the entrepreneurs, innovators, or small companies can save money without cutting corners.

This is the first article of two providing tips on how how entrepreneurs and companies can be smart and spend the least amount of money throughout the product development life cycle. Check out these first three tips:

Define Your Product Before Starting Anything!
This might sound like an obvious suggestion but many companies and entrepreneurs begin product development without really knowing what they are trying to design and produce. The first step before commissioning new product development should be to document the required features and functionality so that there are goals for the team to pursue. Without first defining and communicating these requirements, the team will be moving forward blindly, wasting valuable time and money on unnecessary changes caused by the vagueness and ambiguity of the cosmetic, material, functional, and engineering requirements.

One way to compile a complete list of product specifications is to answer the following questions:

  • How will the product perform and what are the functional characteristics?
  • Will the product interface with other products outside of your control?
  • What are the industrial design requirements (the look of the product)?
  • What are the human factors requirements (the feel and human interaction of the product)?
  • Are there any installation, support, service, and maintenance requirements?
  • What type of qualification, regulatory, safety, and standards compliance are required?
  • Should the product be compatible with other products and if so what are these requirements?
  • What are the packaging, shipping, and labeling requirements?

The effort required to generate the product specifications list might seem unnecessary or excessive before starting new product development. On the contrary, this list is necessary to determine the product goals, will be used throughout the product development life cycle, and will save the team valuable time and money by focusing the team on the proper goals and objectives.

Make Sure The Product Functions as Envisioned.
Once the product specifications have been defined, the team must determine which specifications have yet to have technical feasibility proven. This phase of proving technical feasibility requires the use of proof-of-concept prototypes that bear little resemblance to the final product. As the name implies, the goal of this proof-of-concept prototype is to validate that the idea and concept is technically feasible and functions as envisioned.

For complex products that have multiple functional aspects, do not try to save money by integrating all of the functions into one all-inclusive prototype. Instead, it is more efficient to create proof-of-concept prototypes for each of the independent functions of the product. Remember that the goal is not to make a prototype that looks like the final product. The goal is to prove that it is possible to make the prototype function as specified in the product specification list. Making multiple proof-of-concept functional prototypes will allow the team to efficiently make changes to each prototype to find the optimal conditions that result in the function required.

Limit the Quantity and Increase the Utility of Prototypes.
Every prototype fabricated in each product development phase should be utilized as efficiently as possible. This means that there should be a qualification and test plan associated with each prototype. By documenting the test plan for each prototype rather than just blinding ordering a large quantity of prototypes, the organization becomes aware of the costs associated with each prototype while increasing the utility of the prototypes.

During the product development life cycle of the floe from Apt Innovations, the qualification tests for each prototype produced were clearly specified. As quoted in the BBC news article, Managing Director Jason Paul states that the prototypes looked “smarter” than past prototypes but in fact these prototypes were also smartly utilized. New new prototypes were only ordered after qualification tests were performed and design changes were required, saving Apt Innovations significant money and minimizing waste.

Only fabricate the quantity of prototypes sufficient to meet the qualification needs of the team plus a small number of replacements. Do not order a high quantity of prototypes in order to get a lower price per prototype. The additional prototypes purchased will usually be a total waste of money since design changes and prototype reworks could be required after performing qualification testing. Even worse, the additional prototypes might need to be scrapped as significant design changes could be needed to continue the qualification testing.

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

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Business Tips for Entrepreneurs with Prototypes

Leardon Solutions, Business tips, Product DevelopmentEntrepreneurs who are building a company around a product idea and are following the proper steps of product development typically have a prototype built. Of course, it is a natural part of innovation to build a prototype but sometimes these prototypes are not used to their full potential. Here are five business tips for entrepreneurs on what to do with a functional and professional looking prototype.

1. Develop realistic cost models using the prototype design.
Developing credible financial plans is absolutely necessary for the entrepreneur to properly step out and launch their product into the market. When the entrepreneur has a prototype, enough information exists to develop realistic financial models. The prototype design will allow the team to work with suppliers to determine the expected non-recurring expense (production tooling, set-up costs, engineering expenses, qualification costs, etc.) and the total cost of the product (direct materials cost, direct labor cost, and indirect costs such as support labor, distribution, and shipping). These are important inputs into the financial model that are used to accurately portray the long term financial forecast.

SCORE, a non-profit entity that provides business advice, has many good profit and loss and cash flow templates that can be used to develop these models. If an entrepreneur is seeking investment to take their product into production, a three-year cash flow statement will be important to determine the amount of cash needed to build the company.

2. Demonstrate the intellectual property for potential licensees.
Entrepreneurs typically protect their product idea by filing for intellectual property such as design patents, provisional patents, utility patents, copyrights, or trademarks. Many times, the goal is to “sell” this intellectual property to licensees in return for a small percentage of sales and let the licensee handle all the manufacturing and distribution. This is convenient since these licensees typically already have factories and sales channels in place. The prototype is a great method of demonstrating the intellectual property to these potential licensee.

3. Include the prototype as the centerpiece for investor presentations.
An article in Entrepreneur Magazine confirms that professional prototypes will help an entrepreneur describe their product to investors. When you are up in front of potential investors, a great looking and functional prototype can be the centerpiece of the presentation and can more effectively describe the product than any words on a presentation.

While a prototype is essential in this presentation, remember that it is also necessary to be working with a great product development team. Investors not only invest in the product idea, they also invest in the team. Always be sure to have the right people on your team.

4. Receive feedback from target customers, distributors, buyers, and retailers.
A prototype is a great tool to get valuable feedback from all potential customers. These customers not only include individuals that might purchase the product, but also distributors, retailers, and buyers for retail chains and catalogs. Put your best foot forward with an excellent looking prototype and absorb the feedback received. Try not to go on the defensive when bad feedback is received. One trait of a good entrepreneur is to find, admit, and correct mistakes or issues in your product.

It is also important to show your prototype to industry influencers or thought leaders for feedback. Not only do these individuals have great insight to the trends in the industry, but they can indirectly influence others to purchase your product.

5. Validate the idea on crowd funding sites such as Kickstarter.
On crowd funding sites such as kickstarter.com, creative companies offer unique benefits or pre-ordering opportunities to individuals who pool their money to help support the effort of a company. In essence, these crowd funding sites are not only a good way for an entrepreneur to get the financial resources to manufacture their product, but also a great way of validating their product ideas. When product description, pictures, and videos of the functioning prototype are posted on the crowd funding websites, it allows potential customers to evaluate the idea and determine if it would be worth ordering. If the idea is fully supported, not only does the entrepreneur receive the funds to start manufacturing but also validates that the idea will actually sell once available.

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

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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