You need more than technology to win in MedTech. Here's what 'more' means
It’s easy when developing innovative MedTech, Combination Product or Digital Health products to be excited about our technology. Perhaps we have a new technique that revolutionises drug delivery and efficacy. Maybe it’s a novel combination of sensing, biology, and chemistry enabling early diagnosis of a life-changing degenerative condition. Or perhaps a digital health solution helping patients live fulfilling lives while managing chronic disease.
Much harder is to answer is this: How do we avoid becoming one of the 75-90% of projects that fail to navigate to market and actively help patients?
Here's the good news: Your technology rarely drives this high failure rate. Typically we develop innovative product concepts well-grounded in science and able, at the functional level, to meet patient needs. The bad news is what does drive such failure: Everything Else.
'Everything Else'
Innovation is complicated.
Innovation in MedTech even more so.
Having our technology clears only the first of many hurdles.
Getting from technology to product, means delivering value beyond patients, to a complex stakeholder web, including practitioners, payers, providers, and users. It means demonstrating safety and efficacy sufficient for regulatory approval, while balancing costs against reimbursement. It also means demonstrating value greater than existing Standards of Care and competitors, to be adopted into healthcare systems with a strict “way things are done” and averse to introducing unnecessary new risk.
It is here that the “Everything Else” factors come into play. Not satisfying any one of the above demands, and more besides, turns our incredible technology into failed product; wasting our passion, energy, and finances, whilst leaving patient needs unmet.
Diagnosing this problem does not alone lead to effective treatment. Aware we face complicated challenges, we’re often unaware of how to address them, or even which are critical to focus on. This leaves us feeling like we stumble blindly forwards, hoping to learn enough along the way to avoid failure. Better is to be able to navigate; shaping and implementing a combined technical, commercial, and regulatory vision that makes our route one of the 10-25% leading to success.
Here then, are some “Everything Else” factors commonly hindering MedTech innovation and to be included as key elements in our successful navigation to market success.
1. Actively ensuring we deliver value to all stakeholders
With product-market fit a big topic within innovation, and healthcare having strongly defined patient needs, it’s perhaps surprising that delivering stakeholder value is a common failure point. This failure often happens because how MedTech differs from, for example, consumer goods, where a single stakeholder matters: The Customer. Customers determine the utility of a product, what it’s worth, and how widely to adopt it.
Not so in healthcare. Our products aim at fulfilling a patient need, but patients are frequently not users, who are instead healthcare professionals or carers. Neither patients nor users typically make pricing (reimbursement) or purchasing decisions, this being the responsibility of national health systems or insurers (payers). Our products must also fit into established healthcare system (provider) workflows. Compounding this, long development times and regulatory approvals make iterating to product-market fit possible in theory but hugely challenging in practice.
Establishing our value proposition in MedTech is therefore much more complex, requiring special attention. An invaluable tool here is the Target Product Profile (TPP), capturing collectively all key stakeholders and their needs. The World Health Organisation (WHO) have good documentation and examples on TPPs here. Combining this with a structured requirements tool such as Quality Function Deployment (QFD) means we ensure that our value proposition is ‘right first time’ and positively differentiated against the Standard of Care and competitors - greatly increasing our chance of success.
2. Recognising how, where, and by who our product will be used
Effective adoption of our products into a health system, means they must fit the expectations of the systems they will be used in, and capabilities of the people who use them. Crucial, early in development, is to understand how, where and by who the product will be used.
For example, if diagnostics data can’t be integrated into existing patient record systems, we create an unnecessary, potentially insurmountable barrier. A drug delivery device requiring extensive re-training will have its adoption critically slowed. Device use may need to accommodate patient populations with sight, dexterity, or hearing limitations to work effectively.
Avoiding failure means developing devices with users, environments, and processes known and in mind. This requires activities at every stage of development - researching use contexts and associated requirements, exploring design possibilities (including using Human Factors standards such as IEC-62366 and ANSI HE-75), and validating that our design is used effectively before finalisation.
3. Regulatory Positioning as a Strategic Tool, not a Tick box
In MedTech our regulatory and commercial positions are inseparable. Intended use and therapeutic benefit claims determine the regulations applied to our products, e.g. IVDR or MDR. They also define how, and how extensively, stakeholder needs are met, driving reimbursement. More tightly regulated products are reimbursed at higher rates, on average, as they more directly affect patient health.
Regulatory is often seen as a late-stage tick box exercise, however, to be minimised or, ideally, avoided. This limits our products’ reimbursable value, and was the dynamic behind many Digital Health failures, which aimed at avoiding regulation as medical devices, and so failed in delivering significant reimbursable value to patients or health systems.
Obtaining optimal value from our products means strategically exploring many possibilities for claimed intended use and therapeutic benefit, including their combined regulatory and commercial implications. We then consciously pursue a path that balances the resources needed for regulatory approvals with the reimbursable value that can be captured by the product on market.
4. Implementing sufficient Quality Management sufficiently early
Late implementation of a sufficient Quality Management System (QMS), such as ISO-13485 is another common factor in MedTech failure. The regulatory process requires approval of both the product performance and development process; with the development process being demonstrably appropriate, effective, and implemented to ensure the final product’s quality.
Where development work happened outside a suitable QMS, design information generated is insufficient for regulatory approval. In the best-case this means repeating work, adding significant time and cost. In the worst-case conflicting results may undermine regulatory approval altogether.
Preventing this means using a suitable QMS from earliest product development. Particularly important is the product development process, covered for example in Section 7 of ISO-13485. This outlines a managed process incorporating design and development planning, product requirements development and review, managed development of design outputs with regular reviews, explicit design verification and validation, and managed design documentation, design changes, and design transfer for manufacture.
5. Planning our Clinical Evidence
Most critical for any MedTech product is demonstrably delivering the therapeutic benefits claimed under its intended use safely and efficaciously. Clinical evidence then is the bedrock underneath our regulatory approvals and reimbursement, making it a common failure point.
Crucially this doesn’t only include our extent of clinical evidence, but also its type. Failure often comes from not measuring the right clinical end points to clearly demonstrate our products’ therapeutic value – wasting the time, cost, and effort of trials, and threatening our products’ success.
A key early activity is creating a Clinical Evaluation Plan, outlining the pre-clinical and clinical evidence to be generated, including clinical endpoints and their justification. This should include a systematic review of our target disease, technology, and product implementation, giving us all information required to make our clinical evidence decisions.
6. Consider how our route to market is resourced and financed
By far the most cost and time intensive journey stage is from advanced prototype to commercial product; creating a manufacturable product, taken through clinical trials and regulatory approval, and built on a robust and compliant manufacturing, storage, and distribution chain.
In addition to needing substantial resources, these activities require skills and experience very different from those required earlier. If we are lucky enough to be within a large well-established organisation, these skills and resources are likely already accessible. For a startup however, this picture is different, making large Pharma or MedTech companies a common gateway to market (as can be seen in the transition away from IPOs to licensing and acquisition for MedTech SMEs).
Another common failure point is not effectively planning to cross this funding and resource gap. Particularly for SMEs, partnering to market must be considered as an option early, adding an additional stakeholder whose needs must also be understood and incorporated, and whose needs which are often distinct, but equally important to the other stakeholder already identified.
Conclusion
New technologies are often the core of innovative MedTech products but alone are not sufficient for success. The major success drivers lie elsewhere; in the wider elements of the MedTech journey that must be understood and effectively addressed. We must ensure that we have shaped and implemented a strong technical-regulatory-commercial strategy that addresses the diverse factors that take us from exciting technology to real meaningful on-market patient impact.
Are you facing challenges in your MedTech or Combination Product development? Contact us to find out how we can help