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Medical Device Prototyping

February 12 2013  |   Cliff  |  All Posts, Medical Device  |  Comment

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Medical Device Prototyping

Looking for the best team for your medical device prototyping? Take note that an experienced team with strong relationships in manufacturing and sourcing can help bring your medical device prototype to reality in less time and for less money.

So what does an experienced team look for in an entrepreneur or startup before they begin a medical device prototyping project?

In our experience, the most successful entrepreneurs and startups are eager to learn what they don’t know and look at every possibility before eliminating ideas or accepting them.

It is extremely important that an entrepreneur or startup team understand and embrace change because that’s the name of the game when your team is headed into uncharted waters and solving unique problems that innovators must overcome.

A mixture of creative problem solver with tenacity builds a solid base for an entrepreneur or startup team. While it helps to have experience within the industry that you want to launch a product into, it’s not always necessary. In large part, the character trait of being a tenacious quick study can make up for the lack of experience or industry knowledge by attracting those who do have the needed experience.

Last but not least, the ability to look beyond the details and keep an eye on the big picture. Many times, proprietors will get distracted by all of the variables in their project and stray off the path of success only to chase their tails. Great entrepreneurs and startup teams wisely delegate tasks to the right team members. For example, if you’re not a details person. Find someone that is.

Have questions about medical device product development or product development in general? Contact us here, we can help.

 

 

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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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How To Speed Up Medical Device Product Development

January 31 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 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

January 29 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 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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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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5 Reason To Develop A Medical Device In Southern California

December 20 2012  |   Cliff  |  All Posts, Business Tips, Medical Device, San Diego, Southern California  |  Comment

Joe Donoghue, San Diego Prototyping, Patents & Prototypes, Live Web Show, Product Development, Engineering Services, Manufacturing, Entrepreneurial Product Development5 Reasons To Develop A Medical Device In Southern California

When it comes to developing a great medical device, you can do no better than to look for services and team members in Southern California to help get your medical device developed and to market.

With a variety of research institutes, universities and some of the best medical device and diagnostic companies in the world located in Southern California, there is an abundance of top tier talent and thought leadership. This is especially true for areas such as Orange County and San Diego.

So where does an entrepreneur or startup team begin when it comes to building a product in Southern California for the medical device industry? Here is our advice:

1) Finding Talent

When it comes to developing a medical device, terms like “design controls”, “compliance”, “regulatory” and “ISO” will come in to play. If you are unfamiliar with these terms, find a consultant, service provider or team member that knows enough about these areas to avoid the major pitfalls.

Use Linkedin, friends, forums, social networks, events and local San Diego / Orange County Universities to help find qualified people to bring into your group.

2) Local Groups

There are many entrepreneurship groups in San Diego and Orange County. These groups are teeming with folks interested in medical device and diagnostic ideas since both San Diego and Orange County are medical device and life-science hubs. A few organizations to look into:

3) Access to Manufacturing

While many products are manufactured overseas, some medical device and diagnostic companies in Southern California manufacture in Southern California or have secured high quality manufacturing just over the border in Mexico which is a short drive from San Diego.

4) Local Product Development Teams That Specialize in Medical Devices

Because of the density of entrepreneurship and experience in Southern California, it’s not uncommon to run across local product development companies that have experience with medical device and diagnostic product development. Look around locally for a team so that you can have the value add of face to face meeting time with your vendor(s).

5) Access to Investment Dollars

Developing a medical device can be a pricey endeavor but fortunately Southern California has it’s fair share of investors that understand the medical device and diagnostic space. Developing your product locally will help get the word out and hopefully attract some capital in the process. 

Need more information about medical device product development, please contact us here.

 

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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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