If you’re building in a regulated space (healthcare, finance, etc.), you’ve likely thought: “We’ll take care of industry requirements (e.g., HIPAA, PCI DSS or others) once we’ve found product‑market fit.” It’s a familiar, practical mindset. In the early stages, the focus is on building something people want, getting feedback, and iterating fast. Standards alignment and certifications can feel like a separate concern, something to worry about later.
But in many markets where trust, regulatory compliance, and system integration matter, those credentials play a different role. They’re not just stamps of approval after success; often they are the price of admission. For example, healthcare providers and payers might only consider solutions that meet industry standards, whether that’s an ONC-certified electronic health record (EHR) system, a HIPAA-compliant app, or adherence to interoperability standards like HL7® FHIR® for data exchange. Meanwhile, in finance, any product handling card payments is expected to be PCI DSS compliant from day one, and across supply chains, enterprises often mandate secure data exchange protocols (such as AS2 or AS4) for B2B integrations.
Simply put, if you aren’t aligned with the standards of your industry, you may not even get a seat at the table. That’s why it’s worth reframing how compliance and standards fits into your strategy. Instead of holding off until there’s traction, a smarter approach is to treat early alignment as an enabler. Introduced at the outset, regulatory and standard compliance becomes part of your go-to-market advantage. It opens access to partners, accelerates pilot opportunities, and gives your sales team a trust signal they can lead with from day one.
This is the idea behind the Standards and Compliance Flywheel. When regulatory and standards readiness is built in from the beginning, it creates a positive feedback loop that drives momentum. Furthermore, early adherence to industry requirements helps align your team’s efforts and builds the credibility needed to move faster toward product‑market fit.
Why Waiting to Achieve Compliance Slows You Down
To understand why early compliance makes such a difference, it helps to first look at what happens when it is delayed. From missed opportunities to costly rework, the consequences of pushing compliance to the back burner can quietly undermine your momentum.
Barrier to Entry
Delaying compliance can slam the door shut on valuable opportunities. In healthcare, for example, roughly 96% of U.S. hospitals and nearly 80% of office-based physicians have implemented ONC-certified EHR systems. An uncertified health IT product will be shut out of most of that market. More broadly, nearly one in three organizations have lost a new deal because they lacked a required compliance certification. Many procurement processes now treat certain certifications and attestations as must-haves, failing to show the right credentials can get your proposal rejected outright.
Simply put, if you aren’t compliant with the standards of your industry, you may not even get a seat at the table.
Costly Rework and Missed Design Opportunities
Postponing compliance can also be a detriment to your product development roadmap. Designing your product without regard to regulatory requirements means you’ll likely face expensive rework later on. Teams often discover late in the game that they must retrofit features or architecture to meet security, privacy, or data standards. This kind of last-minute overhaul is very expensive, is frustrating for your developers, and can delay the launch of market-driven features. Industry experts advocate a “shift-left” approach to compliance: address requirements early, when it’s far cheaper and easier to adapt. In fact, research shows that non-compliance ends up costing companies about 2.7× more than the investments needed to comply in the first place. In short, waiting to implement compliance is a recipe for higher costs and technical debt, and it squanders the chance to design things right from the start.
These risks make a strong case for rethinking when compliance happens. Rather than treating it as something to check off at the end, forward-looking teams are building it in from the beginning and seeing it pay off in real ways.
Compliance Beyond Traditional Certification
Not every product in healthcare or other regulated industries has a clear path to official certification. APIs, specialty modules, apps, and integration tools often fall outside formal programs like ONC’s. That absence of a certificate, however, does not remove market expectations or shield you from the consequences of being unprepared.
Buyers and integration partners still expect proof that your solution is secure, interoperable, and built to perform in their environment. Without early adoption of the standards they rely on, you risk hitting the same roadblocks as uncertified products in regulated markets: being excluded from procurement lists, blocked from integration opportunities, or forced into costly redesigns.
The examples are clear. A mobile health app that skips HL7® FHIR® support from the outset may later face expensive redevelopment to connect with EHR systems. An e-prescribing module that delays meeting EPCS requirements will be shut out of pharmacy workflows until it can prove compliance. A data exchange platform without AS2 or AS4 capabilities will struggle to do business with large enterprise networks that require those protocols.
The lesson is straightforward: even without a formal certification framework, aligning with the right industry standards early is critical. It preserves market access, prevents avoidable rework, and keeps your product ready to integrate and compete from the start.
Whether achieved through formal certification or early adoption of critical industry standards, this readiness lays the groundwork for stronger products and faster adoption. The next step is understanding how building it in from the start directly accelerates your path to product-market fit.
Early Compliance Accelerates Product‑Market Fit
Drives Focused Product Design
Industry standards aren’t arbitrary hoops to jump through; they reflect real needs and expectations in your market. Using them as design guidelines can actually sharpen your product’s focus.
When you build to meet rigorous standards (whether it’s ONC’s criteria for EHR modules, HL7 FHIR API guidelines, the DEA’s rules for e-prescribing, or GDPR privacy principles), you end up baking in features that users and regulators care about. Your roadmap aligns with what buyers need and what policies demand.
For example, if your solution will integrate with EHR systems, adopting the FHIR data formats and workflows from the beginning means your app will seamlessly plug into clinical settings. If your product handles prescriptions, building it to satisfy EPCS regulations (such as identity proofing, audit trails, and multifactor authentication) ensures it meets the security expectations of pharmacies and hospitals on day one.
Likewise, an ONC-certified EHR must support capabilities like patient data export, clinical decision support, and strict security controls. Those features directly improve the product’s usability, interoperability, and trustworthiness.
By targeting these benchmarks and best practices from the outset, you avoid the trap of developing in a vacuum. Even without a formal certification in hand, adhering to widely accepted standards forces clarity on what “good” looks like in your domain. The end result is a product designed to meet real-world expectations, which dramatically increases your chances of resonating with customers.
Key Takeaway: Early compliance (or conformance to key standards) enhances your product’s market readiness by design.
Generates Internal Alignment
An underrated benefit of tackling compliance and standards adoption early is the galvanizing effect it has on your team. Achieving a certification or meeting a strict standard is typically a cross-functional effort as product managers, developers, security engineers, and quality/compliance experts all have to collaborate closely.
Starting this process in the early stages of product development breaks down silos that might otherwise persist. It gets everyone on the same page about requirements and constraints before bad habits or divergent priorities set in.
This alignment helps reduce technical debt and prevents the “bolt-on” syndrome (where security or interoperability features feel tacked on as afterthoughts). Instead of a scramble to retrofit controls, the team builds with those considerations in mind from the beginning. Teams that treat compliance as a shared early goal often report stronger communication and fewer nasty surprises down the line.
Key Takeaway: Early compliance (or conformance to key standards) efforts build a culture of quality and accountability that pays dividends well beyond the certification itself.
Boosts Sales Enablement:
Finally, don’t overlook the marketing and sales advantages of early compliance or industry standard adherence Being able to say your product is “Drummond Certified” (or FDA-cleared, SOC 2 compliant, FHIR conformant etc.) arms your sales team with powerful proof points.
In competitive bids or enterprise evaluations, those official certifications and audit reports can make the difference between winning or losing a deal. Prospective customers might not grasp all the technical details of your solution, but they do recognize the significance of an independent certification. It provides impartial third-party validation of your claims.
Sales and marketing teams can leverage this by featuring certification badges on websites, highlighting compliance achievements in webinars, and proactively including security test results or compliance reports in proposals. RFP experts often advise documenting all relevant certifications in your proposals precisely to reassure evaluators that you meet their baseline requirements.
In a very real sense, early certification de-risks your product in the eyes of buyers, making it easier for them to say “yes.” It’s far simpler to sell a product that already meets the industry’s benchmarks for security, privacy, or interoperability than to ask customers to take a gamble on something unproven.
Key Takeaway: Compliance translates into shorter sales cycles, fewer objections, and a stronger competitive position.
The Strategic Takeaway: Comply Early to Earn Faster
Compliance and standards adoption isn’t just a necessity. It’s a revenue enabler. In regulated markets, being compliant opens doors that would otherwise remain closed. It shows customers, partners, and investors that your product meets the standards they already trust and expect. When done early, compliance doesn’t just reduce risk. It accelerates your path to revenue.
Instead of viewing it as a checkbox exercise, think of early regulatory adherence as a way to earn:
- Earn trust by signaling credibility from the start
- Earn access to high-value markets, pilot opportunities, and procurement channels
- Earn efficiency by building smarter, with fewer costly surprises
This effort translate into product clarity, sales momentum, and long-term scalability. With the pace of change in areas like AI governance, cybersecurity, and data privacy, building compliance into your foundation is more than a smart move. It gives you a lasting competitive advantage. As a result, the vendors who prioritize it will be the ones best positioned to grow, scale, and adapt.