Today, we interview Haley Schwartz, one of our experts and most respected voices, to discuss strategies and tips for medtech start-ups, regardless of size, to achieve success in both the US and global markets.
Haley is a passionate commercialization expert with over ten years of customer-facing experience in medtech and a leader in driving technology adoption and advocating for sustainable process improvement in rapid-growth organizations. She works with medical device companies struggling to commercialize in the US by developing marketing plans, launch plans, go-to-market strategies, competitive analysis, and pricing models to ensure successful product launches.
Haley holds a BS in Biomedical Engineering from Rensselaer Polytechnic, a Healthcare Business Certificate from Cornell, and Certificate of Project Management from UC Berkeley. Outside of work, Haley enjoys outdoor activities like hiking, paddleboarding, or snowboarding near her home base in Southern California.
How did you get started in the medical device industry, and specifically helping organizations bring their products to market?
I initially pursued aerospace engineering before transitioning to biomedical engineering—a move that might seem substantial, but the underlying principles of fluid dynamics also apply to the heart, for example. While my career began in biomedical engineering, I soon discovered my strongest passion lay at the bedside. Progressing from a clinical specialist to a sales representative provided a perfect blend of my medical and business interests. This experience laid the foundation for my career in commercialization, where I've been able to extend my reach to more patients through strategic marketing efforts and now in consulting.
Who is your favorite type of client?
My favorite client is still in the early stages, passionate about their product, and has a sense of urgency about the end goal: getting this innovation into patient care and improving patients’ lives.
Is there a critical step that is often skipped by cash-strapped start-ups?
There is no silver bullet. Bringing a device successfully to market is a collaboration between engineering, regulatory, quality, and marketing. Cutting corners in one or more of these areas is unfortunately a common mistake, especially with cash-strapped start-ups, so it’s important to allocate money carefully from the beginning and understand the exit strategy as this space does have high barriers to entry.
What is something that start-ups often do, but is a waste of money or not relevant?
Over indexing on perfection. Every start-up is different, but each naturally plays to their strengths and overlooks other areas they may not be comfortable with such as compliance. As I mentioned, success here is dependent on balance and not only creating a great product but one that can be adopted in a regulated space.
When it comes to go-to-market strategies, what are investors looking for from start-ups at the pre-seed stage versus series A and beyond?
Pre-seed is more about understanding and defining the market gap a new product will address. Series A are about commercialization and who will consistently pay for the product. Series B and beyond are about profitability, cost-reduction, and scalability. Investors’ risk should decrease with each advancing stage and that is what the innovators must demonstrate to secure the next round of funding.
What advantage does a small startup have over a larger player like a Medtronic or Abbott?
I think they have two major advantages: flexibility and focus. As an organization grows and more human layers are introduced, the engine begins to slow, and priorities begin competing. At the early stages, take advantage of the chance to focus and prioritize well.
How does a company go about finding the right key opinion leaders?
Key relationships are the traditional-style rolodex developed through presence at trade shows, warm introductions from others, society events, and advertising. There are consultants who specifically do this matchmaking which may be a good route for early-stage companies.
How does reimbursement play into commercializing a new medical device?
I think what is valuable for people to understand is that the product should drive real value regardless of reimbursement. Reimbursement often results in coverage denials for new products and reimbursement strategies differ across the globe. For a product to be truly scalable, reimbursement should be a bonus, not a dependency.
PTL can help address go-to-market challenges
If you need help navigating go-to-market strategy development or implementation, or to learn more about how we can help you develop and refine yours, book a free consultation with one of PTL Solutions’ regulatory experts.
PTL Solutions can help answer all your go-to-market questions, even with the tightest turnaround times. Let us help you craft a winning strategy that gets it right the first time.
Our team is highly experienced, with decades of experience guiding medical device manufacturers through the go-to-market process, and 80 products successfully brought to market. PTL will customize a path to market for your device that considers engineering, regulatory and quality.
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