This is a guest blog in collaboration with Nocturnal, a product development firm specializing in Class II and Class III medical devices and offering fixed-price projects to minimize the risk of time and budget overruns.
Translating a groundbreaking concept into a commercially viable medical device requires navigating a complex web of challenges, from securing funding to overcoming stringent regulatory hurdles.
Here are five common mistakes that can derail your medical device startup on the path to commercialization, along with actionable strategies to help overcome them.
Mistake #1: Not Optimizing your Regulatory Path
Imagine this: You’ve poured your heart and soul into developing a revolutionary medical device. It has the potential to change countless lives. But then you hit a brick wall—the regulatory maze. Deadlines loom, costs balloon, and worst of all, your device gets delayed.
The key to help avoid these pitfalls is having a comprehensive regulatory strategy from the get-go.
When considering regulatory pathways, there is more to it than PMA and 510(K). While device entrepreneurs are typically aware of the most common FDA programs, they may miss out on opportunities for more suitable options that are less commonly used, such as:
- De Novo: For novel, low-to-moderate risk devices without a predicate
- Humanitarian Device Exemption (HDE): For devices treating rare conditions
- Custom Device Exemption (CDE): For devices tailored to specific patients
- Expanded Access Program (EAP): For investigational devices used in serious conditions
- Product Development Protocol (PDP): For well-established technologies, allowing early agreements on safety and effectiveness
Additionally, in recent years the FDA has introduced several programs to expedite device approval, including:
- Breakthrough Devices Program: For devices treating life-threatening conditions, offering prioritized review and frequent FDA interactions.
- Safer Technologies Program (STeP): For devices improving safety compared to current treatments, providing interactive communications and early data development engagement.
- Early Feasibility Study (EFS) Program: Allows early clinical evaluations to gather preliminary safety and effectiveness data, facilitating early testing and iterative development.
One of the grave mistakes startups make is delaying engagement with regulatory authorities. Early interaction can help identify potential regulatory hurdles and provide guidance on the necessary studies and documentation. Q-Submissions, including Informational Meetings and Pre-submissions, allow sponsors to obtain FDA feedback on specific questions, which is particularly useful for complex products like implantable devices or innovative testing strategies. At the same time, there is never a second chance for a first impression, so make sure you are well-prepared for any interactions with regulators.
Last but not least, it is important to recognize that no matter which path you choose, regulatory considerations such as adherence to standards like ISO 14971 and IEC 62340 will significantly impact product development timelines, presenting specific requirements for risk management and documentation throughout the process.
Mistake #2: Trying to Do Too Much Too Soon
One of the most common pitfalls for medical device startups is the temptation to cram as much functionality as possible into the initial version of their implantable device. In reality, more is not always better, and trying to compete with mature, state-of-the art products on standard features is a distraction from proving the benefits of a novel and differentiating technology.
Getting a medical device to market is a journey riddled with regulatory hurdles and the constant pressure to prove market viability. Startups, forever resource-constrained, typically have just enough capital to reach the next critical milestone. This makes defining these milestones with laser focus absolutely essential.
To start with, minimizing regulatory burdens at the early stages of the device lifecycle is crucial. Complex devices with multiple components and extensive functionality require increased testing and documentation to satisfy regulatory requirements for approval. By concentrating on the core functionalities that prove the device’s efficacy and safety, startups can navigate regulatory hurdles more efficiently.
No less important is building trust with both regulators and end-users. By eliminating superfluous complexities in the initial release, developers can create a reliable device that consistently fulfills its intended purpose, fostering confidence with regulators and patients. This initial success establishes a solid foundation for subsequent iterations where additional functionality can be safely introduced.
Last but not least, overly complex designs can easily lead to cost overruns and project delays, jeopardizing crucial milestones. Conversely, a simpler design translates to streamlined manufacturing processes, reduced testing expenditures, and a more predictable development timeline.
To reduce risk and safely meet their funding milestones, medical device startups must resist the urge to overcomplicate their initial designs. Seeking the advice of product development experts with experience in developing similar devices can provide a well-balanced outside perspective to help you prioritize the essential functionality at each development stage based on a startup’s most crucial resources: money and time.
Mistake #3: Failing to Take Advantage of Existing Know-how
Medical device entrepreneurs take pride in being innovators. But there is a fine line between innovation and the tendency to “reinvent the wheel.”
The medical device industry has a history of innovation, with countless lessons learned from both successes and failures. Ignoring this history means you might waste valuable time and resources solving problems that have already been addressed. Proven product blueprints, established manufacturing processes, successful regulatory pathways, and tested clinical trial designs can help provide a solid foundation upon which to build, rather than starting from scratch.
The key to success lies in a nuanced understanding of the different technological components that make up the product architecture and their associated risks. By distinguishing these elements, startups can focus their innovation efforts where it counts, while utilizing existing assets and expertise to mitigate risks and streamline their path to market.
When it comes to implantable devices, off-the-shelf components are rarely suitable beyond the proof of concept stage. Depending on specific market requirements, it may be possible to reduce development cost and time by using off-the-shelf or “catalog” components for a first-generation device in places where development can be extremely expensive, such as leads, batteries, or hermetic feedthroughs.
What is more applicable yet commonly overlooked is existing know-how that can be transferable across devices and clinical domains. This know-how applies to device components that require specific medical and implantable device expertise but are not unique to your specific application. For instance, power management, signal acquisition, energy delivery, and data communications are common challenges for both cardiac and neuromodulation devices, as well as wearables
These building blocks require specialized features and cannot be sourced off-the-shelf. Yet they rely on technologies that are often already utilized, tested, and proven in other devices. Understanding where existing technologies and expertise can be leveraged and repurposed in your device can help reduce the cost, time, and risk associated with your product development.
Translating a groundbreaking concept into a commercially viable medical device requires navigating a complex web of challenges, from securing funding to overcoming stringent regulatory hurdles.
Mistake #4: Underestimating QMS and Documentation Requirements
In the fast-paced world of medical device startups, the focus often leans towards rapid development and getting a groundbreaking product to market first. However, neglecting a crucial element – a robust Quality Management System (QMS) and its associated documentation – can prove to be a costly misstep.
Regulatory bodies like the FDA demand a documented QMS that ensures consistent quality throughout the entire product lifecycle. Think of it as a detailed roadmap demonstrating your unwavering commitment to patient safety and product effectiveness. It allows auditors and regulators to trace every step of your product’s development, fostering trust and confidence in your product, while a weak QMS with sparse documentation can result in costly delays and roadblocks.
A well-defined QMS with clear procedures and documented processes isn’t just about regulatory compliance. It goes a long way towards building trust and transparency, the cornerstones of market confidence. This transparency can help unlock doors to partnerships, attract investors, and may ultimately translate to wider market adoption.
Well-documented quality management procedures also translate to increased operational efficiency. They help ensure consistency, minimize errors, and free up valuable resources for innovation. A robust QMS fosters a culture of quality, allowing proactive identification and mitigation of potential issues before they snowball into costly product recalls and reputational damage. It protects your brand, your investment, and your intellectual property.
While a robust QMS and comprehensive documentation require time and attention, they can also provide a strategic differentiator. Prioritizing these efforts from the outset could help ensure a smoother regulatory approval, reduce risk, and potentially shorten the path to commercial success.
The good news? Establishing a QMS doesn’t have to be an overwhelming task, even for startups. Here are some practical tips to keep in mind:
- Invest in Expert Guidance: Seek assistance from consultants and regulatory professionals, like those within Alira Health, who can help you navigate QMS implementation effectively.
- Harness Technology: Explore QMS software solutions specifically designed for medical devices to streamline documentation and process management.
- Leverage Partners: You don’t necessarily need to have your own QMS from day one. Instead, find a design partner that integrates QMS into their services.
Mistake #5: Failing to Manage Development Milestones and Cost
Medical device startups are in a constant race to secure the next round of funding. To raise the next round, they must hit performance milestones, which are typically tied to product development, clinical studies, and regulatory approvals.
The ideal milestone acts like a golden ticket, providing enough evidence of progress to secure the next round of funding. But it also needs to be achievable within the startup’s limited resources.
Startups that hire people to develop their product commit themselves to substantial recurring costs month after month. This can be a risky proposition, since most medical device entrepreneurs tend to underestimate the development effort required to bring their product to market or even to the next milestone.
Running out of funds before reaching a market-ready product is a recurring pitfall for device startups, often requiring the company to let go of key people they worked hard to recruit. Cutting costs and downsizing the team can be demoralizing and may lead to a loss of valuable talent. To mitigate these risks, be conservative with your hiring decisions, only bringing on board essential personnel that you know you’ll need in the long run.
Consider outsourcing strategically to provide flexibility and access to specialized skills while maintaining a predictable cash burn rate. Once your product has cleared regulatory hurdles and is ready for production at scale, you’ll be better prepared to hire additional resources and bring these skills in house.
Partnering with a design and development company that provides milestone-based pricing can mitigate the risk of exceeding product budgets. Working with a partner on a fixed price for predetermined milestones is also helpful for controlling scope drift. It makes startup leaders clearly aware of the time and cost that out-of-scope feature development would add to the project. When these tradeoffs are clear, it is easier to make the right decision.
Final Thoughts: How Can You Avoid These Mistakes?
The road to success for medical device startups is riddled with challenges. However, by understanding and addressing these common pitfalls, you may help increase your probability of success.
- Chart a Clear Regulatory Path: Plan early, explore alternative pathways, and seek guidance from experts.
- Prioritize Simplicity: Focus on core functionalities for a smooth regulatory journey and build reliability for patient trust.
- Leverage Existing Knowledge: Learn from past successes, utilize proven designs, and identify transferable know-how to save time and resources.
- Build a Robust QMS: Invest in a documented Quality Management System for trust, efficiency, and smoother regulatory hurdles.
- Manage Milestones and Costs: Hire strategically and consider partnering with companies like Nocturnal and Alira Health that offer startup-friendly pricing to reduce your risk
By proactively addressing these challenges, you can navigate the complexities of medical device development and bring your life-saving innovation to market faster.
Disclaimer: The opinions expressed in this blog are those of the authors and do not represent the views and opinions of RedCrow or its affiliates. The blog does not imply a recommendation or endorsement by Redcrow. RedCrow does not verify or establish the truth of the information obtained in the blog. These materials may not be relied upon for making any investment decision. Nothing in the blog is to be construed as a securities offering.
Securities offered through Alira Health Transactions Services, member FINRA/SIPC. Nocturnal and Alira Health Transaction Services are not affiliated entities.
