Intrepid Orthopedics

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May 12, 2014 Issue

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Full Service Medical Device Outsourcing

About Intrepid Orthopedics

www.intrepidortho.com

Intrepid Orthopedics’ mission is to help customers advance their ideas from conceptualization to commercialization. For over the last 20 years, the engineers at Intrepid have successfully developed over 30 medical device systems. Some were as simple as a cannulated screw, while others were as complex as a total disc replacement. Our team offers product development, testing, operations, quality, and regulatory expertise to entrepreneurs, surgeons, startup and major orthopedic companies. For more information about Intrepid, please visit our website at www.intrepidortho.com.

Lee Strnad
CEO


Intrepid Orthopedics President, Lee A. Strnad has a BSME from Ohio Northern University and has over 20 years of orthopedic experience in designing & developing internal fixation and non-fusion products in spine, trauma, extremities, foot, ankle et al. At AcroMed he worked closely with Dr. Marc Asher and other world-renown surgeons on the Isola family of products - Isola, Ti Isola, Anterior Isola, Pediatric Isola. He was instrumental in starting EBI's Spine Division, which achieved over $35 million in annual sales in less than five years. He led the engineering development of the Freedom Lumbar Disc at AxioMed Spine. At OrthoHelix Surgical Designs, Lee developed 4 internal fixation systems within 18 months. Lee founded Intrepid Orthopedics in 2007. Intrepid has successfully completed projects for over 30 companies in the orthopedic and medical device industries.

“With our experience, we can simply produce innovative and quality products much quicker than any of our competition. We have a track record of producing quality products for a quality price at a timing that is going to get our customers to market much quicker than what they are anticipating.” - Lee Strnad


Intrepid Orthopedics
3046 Brecksville Rd.
Richfield, Ohio
44286

330-659-0855

www.intrepidortho.com


 

 

 

Interview conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – May 12, 2014

 

CEOCFO: Mr. Strnad, what is the concept at Intrepid Orthopedics?

Mr. Strnad: We are a full service medical device outsourcing company. In other words, we can take a product from conceptualization through commercialization. Concept development, CAD design, FEA, prototyping, mechanical testing, and 510k submittals are just some of the services that we provide for our customers. Our customers come in variety of shapes and sizes starting from a single surgeon who has an idea to a multi-billion dollar orthopedic company needing to outsource a project.

 

CEOCFO: Are there some unique challenges in orthopedic devices that you might not find in other medical device areas?

Mr. Strnad: Orthopedics is primarily mechanics based, so we rely on solid designs, FEA and mechanical testing to insure that our products have the integrity to function as designed.

 

CEOCFO: At what points in the development process might a company come to you for help?

Mr. Strand: They can come to us at any time. Whether they are at the concept stage, prototyping, or simply need their product tested and submitted to the FDA. We can provide individual phases of the project, or can manage it from conception through launch if they desire.

 

CEOCFO: Do you have a preference?

Mr. Strnad: We prefer working closely with customers on entire projects starting with conceptualization. With our experience, we sometimes discover a better solution and at the same time, shorten the timeline to have an earlier commercial launch.

 

CEOCFO: It is certainly a field where there are many players. Why come to Intrepid? What might you understand about the process that others do not?

Mr. Strnad: Over the past 20 years, we have a successful record of accomplishment of developing over 25 unique orthopedic implant systems covering almost every bone in the human body. Implants have ranged from a simple cannulated screw to a complex total disc replacement using a proprietary polymer. Since we work as a team, customers benefit from tapping into our collective experiences and not just that of one engineer.

 

CEOCFO: How do companies find you?

Mr. Strnad: Most of our work has been through referrals with satisfied customers telling others about Intrepid. To expand our reach to those who might not be familiar with us, we utilize internet sites such as Orthoworld and LinkedIn, as well as started exhibiting at the two largest orthopedic conferences, AAOS and NASS. These conferences have been a great way to reconnect with a large number of orthopedic companies, surgeons, distributors, and sales representatives in a short period of time.

 

CEOCFO: Why this year?

Mr. Strnad: We have been successful without doing any marketing or advertising, but we believe there is an immediate opportunity to expand because of some favorable changes in market conditions. This has also opened up the flood gate to a number of new development companies that are aggressively promoting themselves even though they have little to no experience. Therefore, it was time for us to have a bigger presence at these meetings.

 

CEOCFO: How do you ramp up should many projects come your way at one time?

Mr. Strnad: We have a couple full-time engineers and a couple part-time engineers to offer us some flexibility. If we need additional capacity, we have plenty of talent around the area to bring on board.

 

CEOCFO: What goes through the process when someone comes to you with an idea? How would you handle it? What would be the steps you take to get it off the ground for them?

Mr. Strnad: We review the concept, create a timeline, and determine a cost analysis associated with the project. We include all project costs and educate the customer if they are new to the market. Many of our customers do not know the procedures or requirements associated with starting a company or commercializing a product. Once an agreement is in place, we begin concept development, and create solid models of the top concepts we want to pursue.

 

CEOCFO: What is the key to telling someone his/her idea will not make it?

Mr. Strnad: No one wants to see their idea as being ugly, so we sit down with our customer and explain the pros and cons of their ideas. If the concept has merit, we will discuss the necessary changes and begin the development cycle. If there are major issues with the idea, we would tell the customer that this idea should not be pursued, but at the same time offer other concepts to pursue.

 

CEOCFO: What have you worked on that has been most interesting for you?

Mr. Strnad: The most interesting project I worked on was the Freedom Lumbar Disc. This was an IDE project and was an extremely novel device. It consisted of many new technologies, manufacturing methods, and was truly cutting-edge technology. At the time of development, we believed it was truly going to improve the quality of life of many patients.

 

CEOCFO: What advances have you seen? What are you able to do today that you could not five or ten years ago?

Mr. Strnad: When I first started in the medical field, pedicle screws were not approved. Now they have been the gold standard for over 15 years. In the late 90s, threaded cages were the craze, and since then we have developed artificial discs, and many new dynamic stabilization devices. Lately, there seems to be a push toward commodity devices, where pricing is becoming more of an issue than technology. Unfortunately this seems to cause more and more 'me too' products and fewer and fewer innovative products.

 

CEOCFO: What is the key to keeping up with the new technology, so you know what is happening and should be incorporated?

Mr. Strnad: Attending the large shows and keeping up with all the current papers. Also staying in touch with key surgeons, distributors, and reps that are driving the industry and medical device products.

 

CEOCFO: What is the geographic reach for Intrepid?

Mr. Strnad: It can be global, but we focus on the US.

 

CEOCFO: When might a larger company come to you?

Mr. Strnad: We have actually had quite a few large companies come to us because we can develop product much quicker than larger companies. If they have their own internal resources, they might job out phases of the project to us. If they have no experience in orthopedics, they would utilize our experience to manage the entire project. They might be a billion dollar company, but need our expertise and knowledge to develop and help them launch product.


CEOCFO: Do you have manufacturing facilities as well?

Mr. Strnad: We have a prototype shop, so we can prototype metal or create SLAs. We can also perform mechanical testing. We do not perform full-scale production. We use our resources around the area and throughout the nation to do perform manufacturing for us.

 

CEOCFO: What has changed in prototyping? What are you able to take advantage of there with the newer technologies?

Mr. Strnad: The process is phenomenal these days. We can take a concept and model it in our 3D CAD software, then on our 3D printer we can create a model of the part and have it in our surgeon’s hands in a couple days. This allows us to receive instant feedback which allows us to fine-tune a project in a matter of weeks. Amazing compared to a few years back.

 

CEOCFO: How might Intrepid be different a year or two from now?

Mr. Strnad: We will continue attend the major conferences and plan to continue to grow. We have recently moved into a very nice 2,500 square foot office not including our prototype shop. We hope to begin hiring additional full-time employees and specifically engineers.

 

CEOCFO: Is it easy to find good talent these days?
Mr. Strnad:
Yes, primarily because of the area we are located. Cleveland was the home of the first spine company, AcroMed in the late 80s, so there was plenty of talent located here. When AcroMed was bought by Depuy/JNJ they eventually move out of the area, but most of the talented personnel stayed in Cleveland. Since then, many startups have grown similarly and as they sell, the majority of personnel seem to stay in Cleveland.

 

CEOCFO: Put it together for our readers. Why pay attention to Intrepid Ortho?

Mr. Strnad: With our experience, we can simply produce innovative and quality products much quicker than any of our competition. We have a track record of producing quality products for a quality price at a timing that is going to get our customers to market much quicker than what they are anticipating. Coming to market on time or before is huge when it comes to hitting your budgets and keeping a small startup on track.

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