Why Consulting Services Can Come in Handy when Doing Pharma or Medtech

Navigating treks in pharma and medtech entirely on your own will sometimes lead to unpleasantries such as burnout, missed opportunities, and strategic stagnation. That’s because Internal teams, if they are there, are often stretched, trapped in operational silos, or simply lack the up-to-the-minute expertise required to tackle specific problems.

External consultants can be understood as strategic reinforcements: specialized, sometimes more objective, and hopefully with knowledge of how to deploy capabilities when and where they’re needed most. This guide will outline some of the likely core challenges making your trek feel difficult, explain why external expertise often provides an important edge over the DIY approach, clarify what these consultants actually do (beyond crafting impressive slide decks), and back it up with some evidence.

You Can’t Always Do Everything by Yourself

The challenges faced by pharmaceutical and medical device professionals aren’t always minor operational hiccups; sometimes, you’re dealing with systemic, deeply entrenched pressures that threaten growth, innovation, and the ability to serve clients or patients effectively.

Challenge 1: Navigating the Regulatory Labyrinth (Without Getting Lost)

The regulatory environment, while necessary and not always sufficient for safety, is less a clear path and more a constantly shifting maze designed by M.C. Escher, particularly when operating globally. To not make this unnecessarily long, let’s stick to some US Food and Drug Administration (FDA) and European Medicines Agency (EMA) examples this time.

Let’s start with launching. Trying to launch complex products, especially advanced therapies like cell and gene therapies (CGTs) may require dealing with contradictory instructions. The US Food and Drug Administration (FDA) might offer faster, albeit potentially more uncertain, expedited pathways (like RMAT, Fast Track, Breakthrough Therapy), often relying on surrogate endpoints and real-world evidence. Conversely, the European Medicines Agency (EMA) typically demands more comprehensive clinical data, larger patient populations, longer follow-up periods, and stricter efficacy/safety standards before granting approval, often leading to significant delays compared to the US.

Another example is market surveillance requirements. We see significant differences – the FDA mandates extensive long-term follow-up (often 15+ years for CGTs), while the EMA relies on a decentralized pharmacovigilance system with country-specific compliance needs. While both agencies focus on Good Manufacturing Practices (GMP) and data integrity, their inspection processes and enforcement styles can differ, with the FDA often seen as more stringent and the EMA potentially varying based on national authorities.

Let’s not ignore medtech. For medical device companies, the transition to the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) continues to cause significant headaches. These regulations drastically increase the burden of proof for safety and performance, demanding more extensive clinical evidence, rigorous quality management systems (QMS), and engagement with Notified Bodies for conformity assessments. The complexity and cost involved can slow down market entry for innovative devices, impacting timelines and potentially hindering growth, especially for smaller actors. Compliance requires meticulous technical documentation and robust post-market surveillance integrated within the QMS.

It’s also exciting to take a look at the rapid integration of Artificial Intelligence (AI) and Machine Learning (ML). The integration of these technologies into medical devices presents a novel regulatory challenge. Regulators are scrambling to keep pace with technology. The EU’s AI Act, for instance, classifies most AI-enabled medical devices as high-risk, demanding proof of security, accuracy, and transparency. The FDA is developing comprehensive guidelines focusing on managing AI systems throughout their lifecycle via predetermined change control plans (PCCPs). This adds another complex layer of AI regulation compliance on top of existing medical device regulations.

Speaking of cool technology, as devices become increasingly connected (wearables, remote monitoring, telemedicine), cybersecurity transforms from an IT issue to a fundamental patient safety and regulatory compliance crisis. The potential costs are staggering (earlier projected at $10.5 trillion globally by 2025), and the risks include data breaches of sensitive patient information (including genetic data for personalized medicine) and potentially even malicious hijacking of device functionality. Consequently, regulators worldwide are imposing stringent requirements. The FDA has updated its cybersecurity guidance, the EU has integrated cybersecurity into MDR/IVDR alongside GDPR and the Cyber Resilience Act, and other nations like the UK and China are introducing new legislation. Companies are now responsible not just for the device itself, but for the security of the data it handles and the networks it connects to.

Finally, one cannot ignore a certain level of global disharmony. While international bodies like the International Medical Device Regulators Forum (IMDRF) and collaborative efforts between agencies like the FDA and EMA aim for global harmonization of standards, progress is often slow. Initiatives like the UK MHRA‘s new framework targeting 2025 aim for alignment. However, achieving true global synchronicity remains a significant challenge. While harmonization promises consistency, it also carries risk: a compliance failure in one major region could potentially jeopardize a company’s standing across multiple markets as standards converge.

One can argue that this compounding complexity makes it fairly difficult for internal teams, often focused on specific products or regions, to maintain a comprehensive, real-time grasp of the entire, interconnected global regulatory landscape. This environment may well favor the engagement of third parties who dedicate themselves to tracking these global requirements and possess the experience to navigate them effectively.

Challenge 2: The R&D Treadmill to Uncertainty

There’s a productivity paradox that we want to understand. Despite unprecedented R&D spending (over $300 billion annually) and a burgeoning pipeline (over 10,000 drug candidates in clinical development), R&D productivity is in a somewhat of decline. Financial indicators show that R&D margins are projected to shrink significantly by the end of the decade, falling from 29% to just 21% of total revenue. Biopharma’s internal rate of return (IRR) on R&D investment has lowered to 4.1%, falling below the typical cost of capital, suggesting that R&D is, on average, no longer generating sufficient financial returns to justify the investment. Now, rapid developments in AI may have a major impact on the extent to which these projections will correspond to reality, but we still need to take these numbers into consideration, at least for now.

Also worth mentioning, the journey from lab bench to patient bedside is long and uncertain. The likelihood of a drug entering Phase 1 trials eventually reaching the market has reduced, with success rates dropping 6.7% in 2024, down significantly from 10% a decade earlier. These attrition rates mean that a significant portion of R&D investment ends up funding failures, further inflating the cost of the few successes.

And let’s not forget the importance of clinical trial design. More often than not, clinical trials are long and complex. According to a Contract Pharma survey, major bottlenecks consistently reported by industry executives include patient recruitment (cited by 56%), site activation and start-up (43%), and regulatory approval delays (43%). Product developers who want to participate in precision medicine need to have design considerations in place that account for small, biomarker-defined subgroups.

Many organizations are still hampered by traditional, linear clinical trial models that struggle to cope with the demands of complex therapies (like personalized medicines or combination products) and value-based healthcare markets. Furthermore, a significant portion of the industry has been slow to modernize its clinical IT infrastructure. While some top companies have invested heavily, others have made limited progress or haven’t started, hindering their ability to adopt more agile approaches like decentralized clinical trials (DCTs), effectively integrate advanced analytical tools (AI/ML), or ensure seamless data flow for faster decision-making and submissions. Only about one in five organizations reports having a holistic, integrated approach to driving clinical trial transformation, suggesting efforts often remain siloed and suboptimal.

This confluence of factors presents both opportunities and challenges. Opportunities include the chance of building products that address a larger spectrum of conditions or that address them more effectively. Challenges associated with increased scientific and trial complexity, coupled with rising drug development costs, include the need to design and implement more complex clinical trial protocol designs, so you don’t have to deal with low success rates and high attrition.

Challenge 3: Operational Quicksand

Beyond R&D and regulatory stuff, fundamental operational challenges create drag and risk. For instance, ongoing disruptions caused by raw material shortages, shipping delays, and manufacturing bottlenecks may limit the availability of essential medicines and devices, potentially impacting patient outcomes.

There’s also the issue of quality management overload. Maintaining a compliant and audit-ready quality management system (QMS) is time-consuming. The workload increases substantially once a product hits the market; according to one report, companies with commercialized products spend roughly three times longer (52 hours/month vs. 17 hours/month) on reactive quality remediation activities compared to pre-commercial companies.  Integrating mandatory postmarket surveillance activities adds further complexity.

Challenge 4: Market Access Mayhem & Pricing Pressure Cooker

The global market is substantial (estimated at $501.8 billion in 2022 and growing), but accessing it requires navigating a fragmented landscape of stakeholders – including government programs, private insurers, and health technology assessment (HTA) bodies – each with their own demanding requirements for clinical evidence, cost-effectiveness data, and clear value propositions. Coding is not for everyone; obtaining the correct billing codes (like CPT, ICD-10, or HCPCS) is essential for payment, and errors can lead to denials or delays.

You typically have to build a compelling case demonstrating how a product not only improves patient outcomes but also offers economic value to the healthcare system – for example, by reducing hospital stays, minimizing complications, or improving operational workflows. This requires generating the right kind of evidence, often including real-world data and health economic modeling, and tailoring the message to specific payer needs.

Let’s not forget about pricing as a challenge. Manufacturers face intense downward pressure on their pricing strategy. Payers want robust evidence that a new product offers significant advantages over existing standards, often through formal health technology assessment (HTA) processes. They are also employing strong negotiation tactics, demanding substantial rebates and discounts, and exploring value-based pricing arrangements.

The consistent message emerging is that market access, pricing, and reimbursement cannot be treated as late-stage considerations. Payer requirements for robust clinical and economic evidence must inform clinical trial design and data generation strategies. So, quite often, you need to understand the diverse global payer systems, health economics, HTA methodologies, and pricing rules.

Can Internal Teams Do It All?

As you can see from the information above, individuals and companies participating in the cognitive and life science sectors can face significant challenges when wanting to build products. Whether your internal team can handle all of these challenges is likely to depend on the extent to which you have enough people with specific skills and knowledge.

And when it comes to expertise, it often has to be across multiple fields and industries. Deep experience in specific therapeutic areas can certainly be of help, but exposure to things such as emerging technologies,  regulatory pathways in unfamiliar territories, diverse operational models, or global best practices being implemented across different companies and industries can make a difference.

Even if you have the perfect team, it may (or may not) be the case that the team’s objectivity is influenced by historical biases, allegiance to existing structures, or reluctance to challenge the status quo. External consultants, on the other hand, are more likely to judge each case with less subjectivity and are less likely to feel unproductive pressure to go in one direction or another. Sure, external consultants are not always a better deal. But let’s take a close look at what they may be able to do for you when you suspect they are the right choice for you.

Here Are Some Things that External Consultants Can Do for You

Let’s map some specific consulting activities that can help pharma and medtech companies.

Strategic Sherpas

• Services: High-level strategy consulting, including portfolio analysis and optimization, product lifecycle management, market entry strategies, growth planning, competitive intelligence gathering, market opportunity assessment, and M&A advisory.
• Problem Potentially Solved: Providing direction amidst market uncertainty and economic headwinds. Helping identify the product opportunities and prune underperformers. Developing roadmaps for entering new therapeutic areas or geographic markets. Supporting complex decisions around mergers, acquisitions, and divestitures. Assessing where a company has the “right-to-win” in increasingly crowded fields.

Regulatory Wranglers

• Services: Developing regulatory strategy, preparing and managing submissions (INDs, NDAs, BLAs, 510(k)s, PMAs, MAAs), navigating pathways with agencies like the FDA and EMA, ensuring ongoing regulatory compliance (cGMP, QMS, cybersecurity standards, AI regulation), interpreting and implementing new regulations (EU MDR, IVDR), and managing interactions with health authorities.
• Problem Potentially Solved: Navigating the intricate and diverging requirements outlined in Challenge 1. Mitigating risks (delays, rejections, recalls, fines) associated with non-compliance. Potentially accelerating approval timelines through submission management and agency interaction. Helping organizations adapt proactively to the constantly evolving regulatory landscape.

Clinical Trial Whisperers

• Services: Clinical development consulting, encompassing trial design (including adaptive designs), protocol development, clinical trial optimization, site selection and site activation support, developing effective patient recruitment and retention strategies, data management and analysis strategy, advising on and implementing digital clinical trials (DCTs) and leveraging AI/Real-World Evidence (RWE), and overall R&D process streamlining.
• Problem Potentially Solved: Addressing R&D productivity. Improving clinical trial efficiency, reducing excessive timelines and drug development costs, improving success rates through better design and execution, and overcoming bottlenecks in enrollment and start-up. Helping companies modernize their trial operations with new technologies and approaches.

Market Access Mavens

• Services: Market access consulting, including developing pricing strategy, navigating reimbursement pathways across different markets, facilitating payer engagement, preparing health technology assessment (HTA) submissions and value dossiers, advising on coding strategy, developing commercialization strategy and launch plans.
• Problem Potentially Solved: Overcoming the market access and pricing hurdles. Increasing the likelihood of securing favorable pricing and reimbursement by building a compelling, evidence-based value proposition. Effectively communicating product value to diverse stakeholders (payers, HTA bodies, clinicians). Maximizing the commercial potential of approved products.

Digital & Data Dynamos (Future-Proofing Your Ops)

• Services: Advising on and implementing digital transformation initiatives, leveraging AI consulting for applications in R&D (drug discovery, trial optimization), diagnostics, manufacturing, and commercial operations, enhancing data analytics capabilities, modernizing core IT systems (clinical applications, QMS, ERP), developing robust cybersecurity strategies, and optimizing supply chain and manufacturing processes.
• Problem Solved: Helping companies harness the power of AI, digital health tools, and big data. Improving operational efficiency across the value chain. Turning data into actionable insights for better decision-making. Addressing critical cybersecurity vulnerabilities. Building more resilient and efficient supply chains.

Deal Doctors (Facilitating Growth & Investment)

• Services: Conducting thorough due diligence for potential investments, M&A, or partnerships, performing data-driven asset valuation for drugs, devices, or royalties, providing licensing and partnering support to structure favorable deals, and assisting with funding strategy development.
• Problem Potentially Solved: Enabling informed investment decisions by de-risking opportunities. Ensuring assets are valued appropriately for transactions or fundraising. Facilitating the creation of successful strategic alliances and partnerships. Supporting companies in securing necessary capital.

Sounds good, right? And while consulting will not always bring you the desired results, it will often increase the likelihood of experiencing the desired results in question. How do I know it? Because there’s data supporting this.

Consulting Outcomes in Data

External consulting will typically cost more than utilizing internal resources. On the other hand, the value and return on investment (ROI) is often positive. While comprehensive ROI studies across the entire industry are scarce, specific examples and data points illustrate the potential financial and operational benefits. To summarize some key quantifiable benefits reported:

Consulting Value Snapshot

In other words, the data is saying the following:

• Trial start-up speed: Tufts CSDD’s multi-sponsor benchmark shows CRO led studies finish site activation ~20 % sooner than sponsor-led ones, provide a double-digit acceleration potential.
• Trial length:  Multiple recent tech implementation reviews converge on 25 30 % overall timeline savings once e-source, automated query resolution, and remote monitoring are fully deployed.
• Database lock: There’s an industry “average 36 days” benchmark; the Rho ADHD Phase III study illustrates best-in-class 24-hour lock, proving the > 30-day to < 24-hour swing is achievable.
• R&D productivity/trial success: IQVIA’s 2024 productivity report attributes the jump in the composite success rate (to 10.8 %) to predictive biomarkers, adaptive designs, and decentralised methods.
• IT cost modernization: Accenture’s 2024 “Race to Cloud” survey shows a consistent ~25 % IT run rate saving once legacy hosting is fully migrated to cloud platforms; life sciences respondents follow the same pattern.
• Commercial lift (sales & revenue): BCG’s 2024 AI value study quantifies both the doubling of frontline sales rep productivity in digitally mature pharma/med tech organizations and the 50 % revenue growth outperformance of AI leaders overall.

Need Help Navigating Your Next Trek? Feel Free to Try Our Services

At On Treks, we provide Consultancy Services in Cognitive and Life Sciences. We have two main categories of services, namely Advisory & Consulting Services and Strategic Data & Insights Services. Our list of Advisory & Consulting Services includes Clinical Trial Consulting, Regulatory Consulting, Medical Writing & Scientific Communication, Due Diligence, Asset Valuation, and Licensing & Partnering Support. On the list of Strategic Data & Insights Services we have Scientific Data Analysis, Market Intelligence, Conference Intelligence, and Funding Strategy Support.

So, if you like our vibe, feel free to contact us, and we’ll give you a 30-minute free consultation. Whether those 30 minutes become weeks, months, or years is up to you.