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Overcoming Market Entry Challenges in MedTech with Ranfac's Expertise



Planning, developing, and launching a medical device is a marathon for medtech companies. On average, it takes three to seven years to officially bring a new device to market. Due to the highly sensitive and complex role of medical devices in protecting patient safety, medtech companies must overcome a significant number of hurdles before initiating commercial rollout.


Evaluating Hurdles on the Road to Market 


From product development and pre-testing to regulatory submissions and post-approval sales and marketing, the journey to a medtech launch is rife with hidden obstacles that can block even the most innovative devices from getting to market, including:


  • Regulatory complexities. The medtech regulatory compliance landscape is not only increasingly complex but can also vary widely depending on the type of device, what region a company is attempting to commercialize in, and what level of clinical and quality documentation is required to successfully obtain FDA approval and other clearances. Likewise, the cost of regulatory approval can be astronomical—as high as $31 million for a 510(k) clearance. Obtaining the necessary approvals and ensuring compliance with diverse regulatory frameworks can stall a device launch and increase overall costs, especially for startups that may not have decades of experience bringing new devices to market.


  • Resource limitations. First and foremost, developing a medical device requires substantial financial investment throughout the entire process, most notably during product development and manufacturing, which may prove to be a challenge for many startups that lack access to major funding sources. A limited budget not only impedes research and development efforts, but can also impact manufacturing capabilities—due to costly manufacturing processes and supply chain shortages—and, ultimately, jeopardize market penetration.


  • Competitive market entry. The medtech industry is, by nature, highly competitive, with established players dominating major segments of the market, leaving little room for startups to make their mark on the industry. The key to successful market entry and penetration is anticipating and adapting to shifting market dynamics and customer preferences; however, this level of agility can be difficult to achieve throughout the product launch process, especially for smaller startups with constrained resources. 


Three Steps to Market Entry Success


With so many threats in the go-to-market journey, startups should leverage specialized partnerships to help optimize costs and accelerate timelines whenever possible. For product planning and development, Ranfac is the trusted medical device manufacturing partner proven to help startups create efficiencies and stay within budget when producing their custom medical device solutions. Ranfac ensures successful product launches by:


  1. Leveraging medical device expertise. Succeeding in your medtech launch requires robust knowledge of the regulatory landscape and cutting-edge product expertise that aligns with current industry demands. Ranfac’s experienced team understands the nuances of obtaining approvals and maintaining compliance throughout intricate manufacturing workflows necessary to produce leading-edge technology.


  1. Optimizing resources with scalable production. The medtech supply chain has yet to fully recover from the COVID-19 pandemic, but the need for medical device innovation only continues to grow. Instead of battling supply shortages and further delaying your launch, partner with a single-sourced manufacturer that controls every piece of the supply chain in house, mitigating the risk of shortages and inflated material costs.


  1. Strategically planning upfront. Production volumes fluctuate throughout the go-to-market process, making high-mix, single-source manufacturing crucial to startup success. Ranfac helps startups optimize their investment by manufacturing small product quantities upfront with a strategic plan to scale up production once the device obtains regulatory approval, keeping a finger on the pulse of industry trends and future demand.


From contract manufacturing needs to OEM medical devices, Ranfac meets every startup need by knocking down barriers to market entry, driving successful penetration and large-scale adoption. With full in-house production control throughout our 40,000 square foot facility, Ranfac continues to help startup medtech companies overcome product launch challenges with time- and cost-effective production made possible by scalable, cutting-edge manufacturing capabilities.






Sources


  1. Van Norman G. A. (2016). Drugs, Devices, and the FDA: Part 2: An Overview of Approval Processes: FDA Approval of Medical Devices. JACC. Basic to translational science, 1(4), 277–287.

  2. Silvestrini, E. (2023, September 5). Premarket Approval (PMA). Drugwatch. https://www.drugwatch.com/fda/premarket-approval/ 

Comments


CLIENT TESTIMONIALS

Without Ranfac, I would have failed. Failed to change a process that was affecting women negatively all around the world. Ranfacʼs COO, Barry Zimble, knew the importance of this. He knew the initial process as they were already working in this space, he could use the names of the original inventors but he understood the importance of changing the manufacturing. It was their deep experience in this field that was a really important reason to go for Ranfac. Bringing a new device is a journey and it is not a straight line, you canʼt plan everything and have it all to fall in line. It is a very bumpy process, and Ranfac really was there for us with every one of these bumps. They really stuck with us and were very creative with the solution to get us back on track. We kept throwing curveballs at them and they were incredibly resilient.
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NANCY CONFREY
CEO, Health Beacons (Acquired by Hologic)
Ranfac has supplied my company for over twenty years. We have developed a number of new products together and overcame many manufacturing and supplier issues over the years. It was always teamwork to resolve whatever challenge we incurred - no finger pointing or negotiation. It is so refreshing to share open discussions with the Ranfac team to provide quality solutions to our customers. Of course, Ranfac CO ,Barry Zimble, was always actively involved as the quarterback for the Ranfac team. He's always been realistic, pragmatic and candid as we worked through our challenges. His integrity is beyond reproach. If he commits his team to a goal, you can count on them.Over the years, Ranfac has continually re-invested in their equipment, facilities and their people. When I chose Ranfac as our primary supplier, it was one of the best business decisions that I ever made.
ALLAN DARR
CEO/ Owner ProAct, Ltd.

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