Starting a company is a significant undertaking in any industry and especially challenging when the focus is on developing a new implantable medical device. New devices have the potential to revolutionize healthcare and improve patients' lives, but they also come with unique challenges and hurdles, from fundraising to the regulatory landscape to commercialization. In this blog, we'll provide valuable tips for entrepreneurs looking to launch a startup in the field of implantable medical devices.
Identify a Gap in the Market
The first step in launching a successful implantable medical device startup is identifying an unmet need in the healthcare industry. Many medical device entrepreneurs are clinicians with firsthand experience with a care gap or problem that can be solved. The desire to create solutions and help people drives practitioners, along with others, to create businesses, but it can also lead to a common experience: struggling to bring a great idea from concept to market.
For non-practitioners or anyone who isn’t already sure that demand exists for a solution to the problem they’re setting out to solve, it’s important to look for areas where existing devices fall short or where there is a lack of effective solutions. Engage with healthcare professionals, surgeons, and patients to gain a deep understanding of the problem you aim to solve. Then test solutions by talking about what success would look like, what others would pay to solve the problem, and the runway needed to develop and commercialize the product.
Assemble a Diverse Team
Building a team with diverse expertise is crucial. You'll need engineers, medical professionals, regulatory experts, and business-savvy individuals. Collaborating with professionals from various backgrounds will help you navigate the complex world of medical device development. Keep in mind that assembling a team doesn’t mean hiring full time employees for every role you need. In fact, there are several advantages to identifying 3rd party partners and trusted advisors to fill knowledge gaps, including freedom to focus elsewhere and flexibility to leverage their skills for as short or as long of a time as you need.
Understand the Competition
Study the competitive landscape. Understand who your competitors are and what they are offering. Analyze their strengths and weaknesses. Keep in mind that your competitor could be something other than a company, for example, the status quo of not embracing a new scientific method or technology. What you're competing with, this knowledge will help you refine your product's unique selling points and positioning so you can clearly articulate the problems it solves as it relates to potential alternatives.
Develop a Clear Value Proposition
Clearly define what sets your implantable medical device apart from the competition. Your value proposition should explain how your product addresses the unmet need you identified and why it's a superior solution. This will be vital for marketing and investor pitches.
Secure Adequate Funding
Developing medical devices, especially implantable medical devices, requires significant financial resources. Funding can be secured from a variety of sources, including venture capitalists, angel investors, grants, and partnerships with larger medical device companies. Make sure you have a well-thought-out business plan to attract potential investors and are aligning yourself with others who share your values and vision.
Map Milestones
If you’re a startup, it’s important to understand the phases of product development: what’s needed for each phase and how to leverage milestones to progress your goals, especially when it comes to continued fundraising. In a prior blog post, we outlined the most common phases of medical device product development across medical device companies of all stages and key aspects to consider during each. The most important thing to keep in mind is what decisions need to be made upfront to avoid potential delays and unexpected costs down the road. Often, these relate to product design, such as technical and user experience requirements, and/or regulatory and compliance requirements.
Understand Regulatory Requirements
Regulatory approval is one of the biggest challenges in the medical device industry. Familiarize yourself with the FDA's regulatory pathways for implantable devices, such as the 510(k) or PMA process, and work closely with regulatory experts to ensure you meet all requirements. Start the regulatory process early in your product development to avoid costly delays or design changes needed.
Prioritize Intellectual Property
Securing strong intellectual property rights, such as patents, is essential. This protects your technology from competitors and can be valuable when negotiating partnerships or licensing agreements. Consult with a patent attorney early to develop a robust IP strategy. Note that this can be quite expensive and it is still recommended to do earlier rather than later. Trademarks, copyrights, and patents can be powerful tools to protect your business and it can take a long time to secure intellectual property rights.
Focus on Quality Control
Implantable medical devices must meet the highest quality and safety standards. Implement a robust quality management system (QMS) that complies with ISO 13485 and other relevant standards. Prioritize quality at every stage of development to ensure patient safety and regulatory compliance and avoid unexpected costs and delays during the approval and commercialization process.
Establish Clinical Partnerships
Collaborate with medical professionals and institutions to conduct clinical trials and gather real-world data. Clinical evidence is crucial for regulatory approval and market adoption. Building strong clinical partnerships can help you access patient populations and experienced researchers. There are a myriad of online resources for medical device startups to help navigate clinical trial requirements and best practices, such as the FDA’s Clinical Trials Guidance Documents. The National Institutes of Health (NIH) and associations like NeuroTech Network that specialize in specific areas can also be great resources for medical device companies just starting out.
Plan for Post-Market Surveillance
Once your implantable device is on the market, ongoing monitoring is crucial. Establish a post-market surveillance program to track device performance, gather user feedback, and ensure the long-term safety and effectiveness of your product. While this is something most medical device startups don’t think about right away, and that’s ok, funders will likely expect to see that a plan exists.
You Don't Have to Be An Expert in Everything
Starting a medical device company focused on implantable devices is a challenging and rewarding endeavor. Success in this field requires a deep understanding of the medical industry, robust product development, regulatory expertise, and a commitment to patient safety, but you don’t personally have to be an expert in all – or even more than one – of these areas. By starting with these tips and seeking guidance from experienced professionals, you can increase your chances of launching a successful implantable medical device startup that has a lasting positive impact on healthcare and, most importantly, patients’ lives.
As always, reach out with questions about your goals, whether you're in search of the best power for your medical device or simply want to connect with companies who have gone from pre- to post-market. We'd love to help.
