2B Consulting

Category: PRODUCTS

  • Risk Management Doesn’t Have to Hurt — It Has to Happen Early



    If risk management feels like a burden, you’re probably doing it too late.

    Let’s be honest.
    Risk management is often seen as the slow, painful part of medical product development.
    An obligation. A checklist. A regulatory tax you pay at the end.

    But here’s the truth we live by at 2B Consulting:

    If risk management feels like a burden, you’re probably doing it too late.

    Done right — and done early — it’s not a blocker. It’s your unfair advantage.

    1. Risk Management Is Not Just Compliance — It’s Design Intelligence

    Yes, ISO 14971 and your QA team want a risk file. But that’s not the point.

    The point is:

    • Catching critical issues while they’re still cheap to fix
    • Designing safer, smarter systems
    • Making decisions with clarity, not gut feel

    When you start risk evaluation early — even rough, even informal — your design improves in real time.

    It’s not about paperwork. It’s about better products.

    2. Don’t Delay — Design to Mitigate

    Too many teams treat risk management like a fire drill:

    • Write the file
    • Run the tests
    • Hope for the best

    That’s backwards.

    Design mitigations — changes in architecture, interface, feedback loops — are far more powerful than slapping on late-stage verifications.

    You can’t test your way out of a flawed design. You have to design your way past the risk.

    3. Usability Risks: Where Winners Differentiate

    Most teams focus on technical risks.
    Few go deep on usability.

    That’s where you can stand out.

    • What could the user misunderstand?
    • What happens when they’re tired, rushed, distracted?
    • What if they make the wrong input — does your product protect them or punish them?

    Real-world use is messy. And great design anticipates that mess.

    The best systems don’t just perform well — they forgive well.
    They warn the user. Block dangerous paths. Fail safely. Recover visibly.

    4. A Safer Product Is a Faster Project

    It sounds counterintuitive, but it’s true:

    Early risk management saves time.

    • It prevents costly redesigns.
    • It clarifies what to test — and what not to.
    • It avoids regulatory delays caused by patchy justifications.

    And it helps your team sleep better — because they know the foundations are solid.

    How 2B Consulting Helps

    We don’t just “do risk files.”
    We help companies build a culture of risk-informed design thinking — one that’s practical, lightweight, and effective.

    • We embed early risk reviews into your design cycles.
    • We guide usability-focused risk analysis that uncovers hidden traps.
    • And we help your product development stay smart, safe, and realistic.

    Want to stop firefighting and start designing with foresight?

  • Discipline Is Not a Checklist



    Discipline Is Not a Checklist: Milestones Must Serve the Work — Not the Other Way Around

    In diagnostics and medical devices, we love structure.
    Milestones. Deadlines. Stage gates. Design freezes.

    They give direction, keep teams on track, and help leadership sleep at night.
    But here’s a reality check we’ve seen over and over at 2B Consulting:

    A milestone isn’t real just because it’s on the slide deck.

    If it’s not truly achieved — if the work behind it isn’t solid — then marking it “done” does more harm than good.

    And we get it. The pressure is real.

    1. Sometimes It’s Not the Team — It’s the Timeline They’re Given

    Let’s be honest: milestone pressure often comes from above.
    From owners, boards, investors — people who want to see visible progress. Fast.

    That’s natural. Nobody wants to be told their product is behind schedule.

    But if that pressure forces a team to “accept” a milestone they know isn’t ready —
    that’s not acceleration. It’s slow-motion failure.

    Real discipline means managing upward, not just downward.
    It means giving decision-makers clarity and confidence — without bending reality.

    2. Milestones Should Focus and Prioritize — Not Just Check Boxes

    Milestones aren’t the enemy. When done right, they’re incredibly useful.

    • They focus teams on the most important tasks right now.
    • They help prioritize effort in chaotic environments.
    • And yes, deadlines can drive real momentum.

    But only if they’re connected to facts, not just forecasts.

    If the milestone says “design freeze” but firmware isn’t verified or user feedback isn’t integrated —
    you haven’t frozen anything. You’ve just introduced fragility.

    3. Hitting Pause Isn’t Failure — It’s Smart Management

    No project goes exactly to plan. The question is:
    Do you see the cracks early enough to adjust?

    Strong teams don’t pretend things are fine. They:

    • Reassess based on data
    • Communicate honestly
    • Re-focus without shame

    That’s not weakness — that’s how real innovation survives uncertainty.

    4. Discipline Without Energy Is Just Bureaucracy

    Structure helps. But people build the product.

    If your milestones don’t leave room for real conversations, micro-wins, or creative detours —
    your people burn out. Your project becomes a job, not a mission.

    True discipline means:

    • Making the hard calls with honesty
    • Holding deadlines that matter
    • And keeping the spark alive while you do it

    How 2B Consulting Helps

    We work with companies to keep both the structure and the soul of innovation intact.

    • We help you define milestones that matter — technically, strategically, and emotionally.
    • We help navigate stakeholder pressure without sacrificing integrity.
    • And we support teams in building what’s real — not just what looks good in PowerPoint.

  • The Requirements Are Late — And So Is Your Product




    Why Skipping User Needs Turns Innovation into Imitation

    Let’s cut to the chase:


    If you’re writing requirements after the prototype is done, you’re not managing — you’re documenting failure.

    At 2B Consulting, we’ve seen too many projects rush into specs, draw from competitor datasheets, throw in a few buzzwords, and call it product design.

    And the result?
    Another “me too” device that nobody loves, few understand, and even fewer buy.

    1. Timing Isn’t Everything — It’s the Only Thing

    Good requirement management is not a formality.
    It’s the architectural blueprint that holds the product vision together.

    Do it too late, and you’re just reverse-engineering what you already half-built.
    Do it on time, and it becomes your navigation tool: what’s critical, what’s optional, and what should be left on the whiteboard.

    It brings clarity to:

    • Priorities
    • Risks
    • Development scope
    • Communication between software, hardware, assay, and regulatory

    2. The Trap of “We Know What They Want”

    Here’s the dirty secret behind many failed medtech and diagnostics products:
    They were built for the specs — not for the people.

    Copy-paste specs from a market leader’s brochure, and you might match them on paper.
    But unless you deeply understand the user, you’ll never build something that’s loved.

    True innovation comes from uncovering:

    • Unspoken pains
    • Workarounds users won’t admit to
    • Implied needs that even the customer hasn’t articulated yet

    These are the seeds of killer products. The ones that don’t just compete — they own their category for a decade.

    3. “Must-Have” vs. “Nice-to-Have” — The Million-Euro Distinction

    Not all features are equal. But without structured requirements, everything feels urgent — and soon your project collapses under complexity.

    Great requirement work separates:

    • What you must deliver
    • What you should deliver
    • And what you can deliver if time, budget, and sanity allow

    Done right, this creates alignment — not just within the team, but across stakeholders, suppliers, and even regulators.

    2B Consulting Can Help You Get It Right — From Day One

    We don’t just help teams write requirements.
    We help them ask better questions.
    The kind of questions that prevent wasted months, misaligned teams, and forgettable products.

    With decades of experience in regulated environments, diagnostics, low-power electronics, embedded systems, and IP strategy, we help you build the right thing — not just build the thing right.

    Let’s rethink your product’s foundation.

  • CE Mark ≠ Success



    CE Mark ≠ Success: Why Regulatory Approval is Just the Beginning

    A diagnostic product gets its CE mark. The press release goes out. The team celebrates.

    And six months later, the product quietly disappears.

    At 2B Consulting, we’ve seen this pattern repeat across the diagnostics and medtech space. Teams spend years navigating regulatory approvals — only to realize too late that regulatory success ≠ market success.

    Here’s what many innovators don’t expect — and what most consultancies won’t tell you.

    1. Clinical Reality Doesn’t Care About Your Label

    Getting a CE mark or FDA clearance means you’ve met the minimum requirements to enter the market — not that anyone wants your product.

    Clinicians, nurses, or lab techs don’t adopt new tools because they’re legally cleared. They adopt them when:

    • They trust the results.
    • They understand the workflow.
    • The test fits into their existing systems and routines.

    A CE-marked POCT device might technically be “rapid,” but if it’s awkward to use in a chaotic ER — it won’t stick.

    2. Distribution and Reimbursement are the Hidden Bosses

    It doesn’t matter how clever your tech is if:

    • Distributors don’t know how to position it,
    • There’s no reimbursement pathway,
    • Or local clinical guidelines don’t include your method.

    These factors vary wildly across Europe. What works in Germany may flop in Finland or France — even with the same regulatory clearance.

    Many teams assume regulatory approval opens doors. In truth, it’s often when the real maze begins.

    3. Post-Market Commitments Can Strain You to Death

    Getting your CE mark is just the start of post-market surveillance obligations under IVDR.

    • Performance data updates
    • Usability feedback loops
    • Vigilance reporting
    • Quality system overhead

    If your company hasn’t built capacity (or the right partnerships) to handle this, you’ll find your team constantly reacting instead of improving.

    So, What’s the Play?

    A successful diagnostic product requires early alignment between regulatory strategy, product lifecycle thinking, and market entry planning.

    That’s where 2B Consulting comes in. We’ve helped teams not only achieve CE marking, but translate that clearance into real-world clinical uptake and long-term viability — across the DACH region, Nordics, and beyond.

    We also speak the “cultural language” of different systems — because sometimes the difference between success and stagnation is understanding how doctors in Austria think differently than those in Finland.

  • Why Most Diagnostic Innovations Fail — And What No One Talks About


    “The science worked. The prototype worked. The team was brilliant. And still, the product never made it.”

    We’ve heard this story too many times. At 2B Consulting, we’ve lived it from the inside — and we will help to prevent it from happening again.

    While diagnostic technologies are booming with innovation — from rapid molecular POCT platforms to smartphone-based lateral flows — most never make it to meaningful market impact. And no, it’s not just about technical failure.

    So what’s really going wrong?

    1. The Missing Bridge Between Innovation and Integration

    Many diagnostic devices are built in R&D silos. The science team delivers great performance in the lab — but the result doesn’t integrate well with manufacturing, clinical workflows, or user behavior in real-world settings.

    What’s often missing?

    • Early assay-instrument co-design
    • Clear pathways to scale
    • Realistic sample types and use cases

    It’s not just about a working device — it’s about one that fits into the world.

    2. IP Comes Too Late — Or Is Too Broad to Be Useful

    We’ve seen it over and over:
    Patents are filed too early, too broad, or without a strategic anchor. By the time a true product-market fit emerges, the IP no longer protects what matters — or worse, blocks your own next steps.

    Effective IP doesn’t just “protect ideas.” It shapes platform thinking, licensing leverage, and freedom to operate in fast-moving diagnostics fields.

    If your IP team isn’t embedded in your R&D thinking early, you’re running with one engine off.

    3. Regulatory “Success” is Misleading

    Getting a CE mark (or even FDA clearance) is often treated like a finish line. It’s not.

    Many diagnostic products hit the market only to learn that user trust, distribution channels, and clinical behavior haven’t caught up. Sometimes the problem is cultural. Sometimes it’s that the device isn’t as “rapid” or “simple” as users expected.

    True success requires aligning regulatory readiness with real-world acceptance.

    So What’s the Fix?

    We believe success in diagnostics comes from working across boundaries:

    • R&D + IP + usability + market logic
    • Tech realism + manufacturing foresight
    • Not just invention — but translation

    At 2B Consulting, we help companies navigate these intersections from day one. With deep experience in diagnostics, IP strategy, electronics, and embedded systems, we help you design things that don’t just work — but work out.

    Let’s talk before your great idea becomes another cautionary tale.