In a recent episode of the Focus on Precision podcast, engineers and innovators from the precision optics space went deep into something far more foundational than design or manufacturing: regulatory strategy. Episode guest, Tiffini Wittwer, COO and founder of MedEdge, offered a compelling case for why startups should make regulatory planning a priority. Now.
From Frustration to Purpose: The Birth of MedEdge
Tiffini and her sister launched MedEdge back in 2018 after grappling with a common problem: most regulatory and clinical consultancies just didn’t feel “startup-friendly.”
Her goal was to build a boutique consulting firm focused on early-stage companies developing novel medical technologies, companies that needed nimble, deeply involved support from concept through commercialization.
Regulatory, Quality, Clinical: MedEdge Does It All
One of MedEdge’s biggest differentiators is its integrated approach. Rather than siloing regulatory, clinical, and quality work, Tiffini’s team offers all three under one roof:
Many regulatory consultants don’t “do quality,” she says, but at MedEdge, they see quality and regulatory work as deeply intertwined.
Several team members have clinical backgrounds, too, which means MedEdge can help clients think through how regulatory strategy, clinical development, and future reimbursement or market access all connect.
For companies in the optics and imaging world, this is particularly relevant, because these devices increasingly combine hardware, software, AI, and potentially even network-connected components. Tiffini notes that optics devices are often among the first to confront regulatory scrutiny around software, cybersecurity, and machine learning.
The Regulatory Landscape Has Shifted. Here’s How:
- Predicate Devices Are Harder to Use for 510(k) Submissions
Because technology is evolving so quickly, companies often struggle to find predicate devices that are “close enough.” Tiffini says MedEdge helps clients draw apples-to-oranges comparisons, proving to the FDA that, functionally, very different-looking devices can be equivalent in safety and performance.
- More Startups Are Choosing the De Novo Route
De novo is an FDA pathway for moderate-risk devices without a clear predicate, devices that don’t quite belong in existing classification.
Tiffini’s observations:
Many investors now prefer de novo, because a clinical study done early can support not just regulatory clearance but also product claims, marketing, and investor confidence.
Although de novo requires more upfront effort, the clinical burden isn’t necessarily huge (often ~30–50 patients in a single-arm study, she says), and the regulatory payoff can be significant.
- Changing FDA Experience Is a Wild Card
One major shift: the “middle layer” of experienced FDA reviewers has thinned out. According to Tiffini, many of the seasoned reviewers who once guided newer staff are leaving, which can slow processes and mean less institutional knowledge.
Her team works proactively to manage this risk. For example, by leveraging pre-submission meetings with FDA to recommend certain reviewers or ensure continuity.
- Cybersecurity & Software Validation Are Non-Negotiable
Especially in optics-based devices, which often rely on connected systems, user interfaces, or machine learning, regulatory expectations for cybersecurity and software validation are growing fast. MedEdge helps its clients address these expected regulatory “checks”, sometimes even before the device is fully developed, to futureproof their submissions.
Why Regulatory Strategy Should Be a Cornerstone of Your Startup Plan
Tiffini and her co-hosts stress that a strong regulatory strategy is not just a compliance checkbox, it’s strategic business planning.
Here’s why:
Clinical Data as a Leverage Tool
Whether you’re raising money or clarifying your value proposition, early clinical data can be repurposed:
- for FDA submissions (510(k) or de novo),
- for health economics or cost-benefit analyses,
- to build investor confidence,
- and to support marketing or reimbursement claims down the line.
User Validation Isn’t Just for Software
MedEdge recommends early user validation, even for mechanical devices, to not only gather user feedback, but to create engagement and data that can strengthen regulatory submissions.
Efficiency Through Outsourced Expertise
The modern MedTech startup ecosystem allows founders to outsource critical capabilities: regulatory, clinical, manufacturing, engineering, and more. The overhead of building everything internally is no longer required. But you do need trusted, aligned partners.
From this episode of Focus on Precision, one thing comes through loud and clear: regulatory work is not just a hurdle, it’s a foundation for innovation.
You can’t treat it as an afterthought; you have to build strategy around it, because the regulatory pathway you choose will deeply influence your development timeline, your funding, and your long-term business model.
Thanks to thought leaders like Tiffini Wittwer and her team at MedEdge, and partners like Precision Optics, startups have a roadmap and a partner model that is not just reactive, but proactive and aligned with modern MedTech realities.