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