Why the Path to Market Can Be Challenging
Bringing a medical device to market is a complex process that requires thorough planning to avoid common hurdles. Key challenges that can slow down your progress include:
- Designing a product that doesn’t meet the end-user’s needs.
- Failing to secure sufficient funding for prototyping, testing, manufacturing,
and marketing. - Overlooking crucial FDA regulatory requirements.
- Missing opportunities for strategic partnerships to access target markets.
How Occam Design Can Help You Overcome These Hurdles
Partnering with Occam Design can help you clear these obstacles efficiently. With over 30 years of experience, FDA registration, and ISO 13485:2016 certification, we provide the expertise to navigate the complex medical device landscape, helping you save time and avoid costly mistakes.
The Path to Market for a Medical Device: a Step-by-Step Breakdown
Step 1: Develop the Product with the End-User in Mind
Start by understanding your target audience and market needs; grasping the full scope of the needs of the end-user in the ideation stage ensures your device has a built-in market once it is in production. After developing a comprehensive, user-centered design, it’s time to prototype, test, and refine your device based on real-world feedback.
Partnering with Experts Like Occam Gives You an Edge
Occam Design leverages expert knowledge of end-user needs to streamline the ideation and design process, ensuring your product is aligned with both market demands and regulatory standards. Avoiding unnecessary delays from reconceptualization and revision clears the way for your device to come to market quickly and efficiently.
Step 2: Secure Funding for Your Vision
Funding plays a critical role in the success of the device design and development process. There are various sources of potential funding, including venture capital, grants from entities like the FDA and HHS, and angel investors. Establishing the necessary connections to secure this funding is essential for transforming a medical device from an idea into a marketable product.
Occam Design’s Proven Track Record Reassures Investors
Occam Design has a longstanding reputation for working effectively with funded startups, and we know the ins and outs of securing funding from a variety of sources. Partnering with a firm experienced in both securing and effectively using funding inspires confidence in investors, making it easier to secure the capital needed to bring your vision to life.
Step 3: Build a Solid Regulatory Plan
Fulfilling all FDA requirements and meeting ISO standards is crucial to bringing your medical device to market. All medical device manufacturers must register with the FDA and annually renew that registration. It is also imperative you go through the proper channels to list your device and secure the correct premarket notification approvals. Building a comprehensive regulatory plan can ensure your device stays on track because missing steps in regulatory compliance can cause costly delays that can derail your ability to bring your device to market.
Occam Design Streamlines Regulation by Working Closely with the FDA
Working with a partner already registered with the FDA and certified in ISO 13485 standards can streamline the regulatory compliance process. Consider one example: 501(k) clearance. Does your device require 501(k) premarket notification and subsequent FDA classification, or does it qualify for an exemption?
This is merely one critical question among many in fulfilling regulatory requirements, and Occam Design’s connections and experience can be invaluable in quickly developing a comprehensive regulatory plan, building a working relationship with contacts at the FDA, and meeting all regulatory requirements without having to invest a substantial amount of time and energy by starting from scratch.
Step 4: Market Strategically to Key Audiences
Targeted marketing to purchasing partners for hospital systems like IDNs and GPOs is integral to tapping into the market for your medical device. Working with a partner with a reputation for effectively positioning medical devices to be purchased by IDNs, GPOs, and hospital systems can help you forge connections that lead to purchases, saving you significant time and effort by tapping into strong working
relationships within existing systems.
When you market a medical device, you need to provide your target audience with information on not only how the device meets end-user needs, but also how the device compares to what the medical system is already using, and the ways that your device improves upon existing devices in terms of efficacy, cost, flexibility, and more. Knowing the existing market and your existing competitors is a critical component of strategic marketing for medical devices.
Navigating IDNs, GPOs, and Hospital Systems: Access Through Partnerships
When it comes to medical devices, direct marketing to physicians is only part of the picture. Hospital systems, group purchasing organizations, or GPOs, and integrated delivery networks, or IDNs are all key players in medical device purchasing. These entities negotiate contracts on behalf of member healthcare organizations for, among other things, medical device purchases from manufacturers; there is no path to market for most medical devices without networking with IDNs, GPOs, and hospital systems.
Building working relationships with IDNs and GPOs and positioning your medical device as a useful and effective addition to member healthcare organizations’ care plans is significantly easier when you’re partnered with a firm like Occam Design, with the experience and reputation to help clients establish essential relationships with these organizations.
Accelerate Market Entry by Partnering with Occam Design
With decades of design and development experience, Occam helps capture end-user needs in your device design. Our proven track record with fully funded startups builds investor confidence, while our FDA registration, ISO certifications, and expertise in working with GPOs, IDNs, and hospital systems ensure effective market access. Occam offers comprehensive services to expedite your device’s path to market.
If you’re ready to start the journey to getting your device to market, and you want to streamline the path from idea to profitable reality, connect with Occam Design today.
If you’re looking for experts in ensuring regulatory compliance for your medical device design, look no further than Occam Design. Our ISO 13485:2016 certification and FDA registration, alongside 30 years of experience developing medical devices means we have the expertise and experience needed to make your device concept a regulatory-compliant reality.