Industry perspective: Challenges in commercializing academic biomedical and bioelectronic research Open Access

The innovation economy and the importance of translational science are increasingly prominent in the agendas of governments such as the UK’s.¹ Indeed, the importance of translational university science was exemplified in the response to the COVID-19 pandemic—in the UK with the Oxford-AstraZeneca vaccine and further afield with the BioNTech mRNA vaccine (BioNTech’s co-founders Uğur Şahin and Özlem Türeci are both academic entrepreneurs). Furthermore, the UK in general and the Cambridge ecosystem in particular are usually held up as role models in the successful commercialization of fundamental research, with major successes including Humira (Cambridge Antibody Technology, later commercialized by AbbVie), which was for some years the world’s highest selling pharmaceutical product.² 

However, despite the headline successes, the translational research ecosystem is complex and challenging, with significant room for improvement. Particularly in areas such as medical devices, there are a number of additional challenges beyond getting the basic technology to function reliably, and yet most translational scientists have little information on these requirements as they begin their development pathways. For example, medical devices often rely on electronics to support their key functions, which in turn require power sources, but besides the basic functionality, there are a number of regulatory and usability based considerations that can critically affect the pathway to regulatory approval and clinical adoption. A failure to consider these points at the initial stages of device design may be fatal for the success of such a translational project.

In this Perspective, I will signpost a range of issues that one notices within what one may call “translational academia,” in the hope that these learnings can guide other like-minded scientists and policy makers to transform our academic centers of knowledge creation into engines of societal benefit and wealth creation. This Perspective will focus on issues in the biomedical (med-tech/biotech) space and with a UK background, although it is likely that similar issues may be relevant to various degrees in other fields/countries. I will first discuss considerations relevant to the use of electronics in biomedical devices, which may be of particular interest for readers of this journal, before addressing wider challenges in the translational ecosystem. At the end of each section, I propose a series of “practical recommendations” that summarize some actions that can be undertaken to mitigate the issues discussed, which I trust will be of benefit to the community.

When translating basic academic research into new medical technologies and/or medical devices, the design of the associated integrated electronics is crucial. Whether the electronics are fundamental to the therapeutic application (the so-called “electroceuticals”³) or instead used to sense and/or transmit data to support the use of the device, the electronics design and power requirements lie at the heart of any such translational projects. It is important to recognize that these requirements go beyond the basic functionality of the device. For instance, if one is developing a device for use in surgery, one has to ensure that there is no significant electromagnetic interference with other instruments in the operating theater; designing the device to meet electromagnetic compatibility requirements is therefore necessary.⁴ Battery life and charging needs will depend on whether the device is implanted within the body (e.g., pacemakers), whether it is just used temporarily (for instance as a surgical aid), or whether it is external to the body, which means that it can be charged more easily and/or batteries can be replaced. Battery placement and risks such as crush risk need to be taken into account at the earliest stages of product design.

Simply being functional and compliant with the necessary standards is also unlikely to be enough. Human factor interactions will play an important role in whether the device is accepted by the patient/medical community, and these can be dramatically affected by the electronics designs, battery requirements, and their usability. Speaking to end users at the earliest stages of prototyping and performing user needs and human factor interaction studies can help de-risk this aspect of product design.

Any such medical device products, especially if implanted, ideally need to be compatible with industry standard sterilization procedures;⁵ challenges can arise either when bespoke sterilization needs arise or when different sterilization techniques are applicable to different parts of a device. These could substantially increase costs and subsequently lead to commercial failure. Products should also limit the use of surfaces that can seed infection sites—this means minimizing the use of wires, especially for implantables or surgical aids, where infection risks are high and a major consideration. Thus, incorporating electronics to make products wireless is often a key developmental step for medical devices. Designs also need to consider how the electronics are shielded from damage by bodily fluids, mechanical stress/strain, changes in ambient operating temperatures, etc. Here, the danger is not just physical damage, but also the risk of the electronics malfunctioning due to, for instance, a wrong calibration, if the operating conditions change, which could have serious impacts on patient safety.

These are all engineering challenges one encounters in medical device development, which are not often considered at the beginning of a research project when the core novel technology claims most of the research effort. However, these considerations are crucial to the successful translation and commercialization of any such research, and in these regards, the technology needs to be de-risked as early as possible in product development.

• Engage with end users of potential products at the earliest stages of design to understand user needs and human factors necessary to drive adoption.

• Conduct a feasibility analysis to assess whether your medical device can be made wireless.

• Explore sterilization methods for your device—if non-standard sterilization processes are required, explore all options carefully to overcome this, since non-standard processes can dramatically increase downstream production costs and make the product non-viable commercially.

• Check the materials being used for biocompatibility, and if not biocompatible, explore whether there are equivalent biocompatible materials that could be substituted instead.

• Consider charging/battery needs at the outset, and factor this into the design process.

Working in the biomedical space, one of the most important issues to consider at an early stage is the numerous regulatory barriers that a product must overcome before it can reach patients. For academics starting out in this area, it is crucial to engage with regulatory experts as soon as possible, since this will have a major impact on how the relevant technology is developed and indeed whether it is even feasible to take the project forward. For medical devices, there are a range of different standards that apply, starting with ISO 13485 as the standard governing quality management systems for medical device development. Specifically related to electronics and medical electrical equipment, there is a standard (ISO 60601) that deals with electrical safety testing for medical equipment, which may influence the choice of the underlying electronics. Having a regulatory expert check designs at the early stages of prototyping may reduce the risk of substantial redesigns at the later stages of product development, which may be costly, particularly if the project has advanced into its formal design control phase.

Regulatory routes also determine markets of interest, given that there are differences between, for example, regulatory requirements in the USA and the UK and/or Europe. The challenges are amplified when regulations remain in flux and when major changes to the regulatory landscape (such as the shift from EU Medical Device Directives to Medical Device Regulations) are implemented—these can lead to delays in getting a product through the approval process, which can be fatal for translational ventures if not factored in in advance. For medical devices, the US FDA’s 510(k) pathway offers an expedited route to market, provided that one can prove substantial equivalence to a predicate device already on the market. This is an attractive proposition for developers, especially given that the decision turnaround times are typically around 90 days.

Regulatory planning must therefore be central to any such translational ventures and its costs (both monetary and time-wise) factored in at the start. There is a broader societal debate to be had on the sheer number of regulations that industries face today, which ties into our societal appetite for risk. It suffices to say that for supporting an innovation driven economy, streamlining of the regulatory landscape, faster turnaround times for approvals, and a convergence in regulatory standards among at least the major economies would be welcome. Simply adding further regulations without first removing or reforming existing ones risks stifling the innovation landscape, which is already under stress.

• Engage with regulatory and quality management experts at an early stage of product development.

• Explore whether your medical device may be suitable for the FDA’s 510(k) pathway—the FDA has a 510(k) guidance document and a 510(k) database of products and decision letters, which are a very useful source of information.

• Speak to people in the industry to understand current timelines for processing regulatory submissions in the different regulatory regimes.

• Consider setting up a document management system with document version control and a clear structure of review/approval procedures to build towards an ISO 13485 compliant quality management system.

For translational projects to secure crucial initial funding and impetus, it usually helps if the project focuses on solving a real-world problem from the outset, rather than a research team trying to find a real-world problem to shoehorn its novel technology towards. However, in either case, identifying both end users and customers (not necessarily the same) for the technology at an early stage is vital. One of the first steps usually should involve conducting market research, which can be commissioned from external consultants who may have access to far more relevant commercial materials and reports than a university. It is important to acknowledge that one may have the greatest possible solution to a real-world problem, but if there is a failure of the market, the project may not succeed in the long term. This has been learnt painfully in the antibiotics industry, where market failures have been the main impediment to bringing new drugs to clinic, despite the ever-increasing threat of antimicrobial resistant infections.⁶ 

It is therefore important to canvass opinions from a broad range of stakeholders to ensure that the product one develops in a translational venture actually has a market waiting at the end of the development journey. This also means that academics in these projects must be willing to pivot and potentially give up on their initial ideas regarding their product, with a focus on solving the broader problem and the market’s need. For example, when contemplating production scale-up, design-for-manufacture (DFM) considerations can involve substantial changes to products to make them compatible with large scale manufacturing processes. This includes considerations on whether the electronics and their integration into the device are compatible with high-volume manufacturing techniques. These DFM-related changes may be vital to be able to produce the product at a cost-point that the market will accept.

In the biomedical space, academic founders must also consider the wider health economics and reimbursement landscape to understand who actually pays for a product. Unhelpfully, this varies greatly depending on the country one is targeting. In some countries, it will be insurance providers or government bodies who ultimately decide what products get reimbursed (and at what cost point); in other more privatized settings, patients or medical professionals may be in charge of purchasing decisions (in which case, the end users may become the customers). Furthermore, given the long timelines involved in bringing a product to patients, it is often the case that early-stage translational ventures in biotech and med-tech develop their product to a certain degree (usually some stage of clinical trials) and then (if successful) get acquired by a global company that takes the product through the later (and more expensive) phases of clinical trials. In such a case, the translational team needs to understand that they are building a company to sell via a trade sale, rather than developing marketing streams of their product to patients/healthcare systems. This can significantly influence commercial strategy and positioning.

• Commission a detailed market research report at an early stage of a translational project.

• Conduct stakeholder interviews early, particularly with end users, targeting a broad spectrum of experience.

• Be flexible, and recognize that the initial academic idea may not be suitable for high volume manufacturing—pivots are often required.

• For biomedical applications, commission health economic and/or reimbursement analyses in key target markets to understand payor mechanisms and potential price points, which can be used to understand the margins on each product sold. This will inform the development of subsequent business plans and financial projections.

Working on translational projects, especially in areas such as med-tech, often requires collaborations with technical consultants, CDMOs (Contract Development and Manufacturing Organizations), and other external experts. It is highly unlikely that a single academic laboratory has the wide range of expertise needed to develop a product fit for use in patients. Managing projects that intertwine both external and university laboratories can be challenging. Academia is not used to running at pace when it comes to research and development projects. If shared equipment breaks, it can take weeks to organize repairs. Academia’s bureaucracies are also not used to functioning at industry speeds. When projects receive translational grants, it can take many months to get the paperwork in place for all the relevant internal and external partners. These delays can severely impact momentum and motivation, especially when these projects are often steered by PhD students or postdoctoral researchers on fixed-term contracts. There are financial implications of such delays as well. On a translational project, it will often be the case that a patent application has been filed, and hence, the patent clock is ticking. Administrative delays in such situations represent potentially large lost revenues in the future, assuming the project succeeds with its commercialization objectives. It is vital that universities, which often have senior positions such as Deputy or Pro Vice Chancellors for Innovation, address these systemic problems and ensure that processes are in place to facilitate the rapid delivery of contracts and other associated paperwork for multi-partner collaborations, if they truly wish to reap the benefits of translational ventures and support their academics on their translational journeys. Time-to-market and first-mover advantage are core considerations in industry; academics and their university ecosystems venturing into this space therefore need to prioritize these as well.

• Academic institutions, such as universities and associated hospital trusts, should analyze their grant data for previous years and publish statistics about the time taken from a grant’s decision letter to grant activation (and ideally also analyze the time taken for signing subcontractor agreements). This will help identify the scale of the delays and may help identify bottlenecks in the process.

• External funders and universities/hospital trusts should agree on standards regarding the time between receiving a grant’s (positive) decision letter and the start of the grant. This should not exceed 3 months at most, with the intention being to activate grants and sign contracts (including with all external partners/consultants) within 4–6 weeks of a decision letter.

• Universities/hospital trusts should consider assigning individual grant coordinators from within their research/finance offices to every successful grant, who are accountable for setting up the relevant contracts in a timely manner. If feasible, it may help to establish a system of incentives (linked, for instance, to progression in salary scales and promotions) for such administrators that reward rapid turnaround on grant initiation if certain metrics are achieved.

• For shared equipment within academia, especially equipment being used for translational projects, departments should budget to ensure appropriate levels of service contracts to facilitate rapid maintenance when needed. This could be supported via the overheads on translational grants, for instance.

• External funders should consider streamlining processes on translational grants to speed up the application process. For major grants with multi-stage application processes, initial screening should ideally be completed within a month, and the whole process should ideally not exceed 4 months, from initial application to decision letter. This may require reviewers to be remunerated to incentivize and enforce faster review turnaround times; some funders do indeed pay reviewers for their time, so a precedent exists.

• Universities/hospital trusts should ensure that there is adequate legal support available for contract reviews to avoid delays with paperwork involving funders or external contractors/collaborators.

There are, unsurprisingly, major differences in culture between academia and industry. Academia prioritizes the open sharing of data and ideas. Students and researchers are encouraged to engage with a wide audience about their research, present at conferences, and publish as soon as possible; indeed, success in the academic system depends on this dissemination of one’s research. However commendable this may be from a knowledge exchange perspective, the reality is that for developing a commercial product, in our current ecosystem, one cannot disclose an innovation until the intellectual property is protected. In some cases, such as in drug development, it further makes sense to keep chemical structures confidential as trade secrets and delay patent filings, to ensure that patents are filed on the most relevant “lead” compounds after various medicinal chemistry stages of lead optimization. This also ensures that the patents are active for as long as possible once the drug eventually hits the market and that the enormous costs of drug development can be recouped. However, within academia, this flies in the face of the existing incentive system, and early-career researchers, in particular, are under constant pressure to publish. We need a system of incentives within academia that recognizes the value of industry-facing research and supports people in such situations; otherwise, we risk losing out on valuable opportunities, with potential solutions to real problems languishing unused in a publication with no hope of commercialization. Politicians and the wider public also need to realize that developing a product based on an academic innovation involves much more work and funding than publishing an initial paper on the technology. To paraphrase the old adage on inspiration/perspiration, the initial idea is really just 1% of the journey, the main challenges come thereafter. Ideas are cheap; implementation and execution are where the greatest hurdles lie.

Another area in which academia and industry differ widely is in their research and development processes. In industry, one encounters what is called the verification and validation (or V) model of product development (Fig. 1). This involves starting from a problem or commercial case, documenting user needs explicitly, and using the user requirements to define product requirements (ideally in a version controlled document management system); only once product (technical) requirements are specified does one actually begin to develop the sub-system specifications (such as detailed designs of the electronics). These then need to be tested rigorously, recorded, and used to verify that each sub-system specification tested meets its requirements, subsequently the product design requirements are met, the user requirements are satisfied, and hence, the product is validated. Only then does one proceed with marketing and commercialization. Verification and validation procedures are an integral part of developing a medical device and typically need to be documented in a manner that has traceability and document version control—these will be needed when future auditors question various development choices and also help the continuity of a project, especially when the project extends over many years, with different people working on it through this period. This method of working is, however, quite alien to academia, and convincing researchers in academic settings to adopt such processes can be a challenge. In academia, despite years of training, one usually does not encounter such systems—we are often doing translational research without having some of the basic tools required for the job. This is an aspect that universities can improve, especially with industry-focused PhD programs (such as the Doctoral Training Centres and iCASE studentships in the UK). Building a product development mindset may help improve the rigor of basic academic research as well and also better prepare students for the world outside academia, where the majority will inevitably end up.

• University technology transfer offices (TTOs) should provide regular training and consultations to PhD students and postdoctoral researchers, highlighting the importance of not disclosing confidential IP at conferences. They should also engage frequently with supervisors and senior academics to reinforce the importance of IP protection, particularly in relation to academic meetings/conferences.

• PhD programs in relevant fields should facilitate knowledge exchange with industry mentors and provide training on industry norms of product development and documentation.

• Universities should consider instituting enterprise related career pathways, such as enterprise and/or industry fellowships, to support academics interested in translating their research. Importantly, contracts should be drafted such that these pathways are compatible with external schemes, such as the Royal Society’s Industry Fellowships or the Royal Academy of Engineering’s Enterprise Fellowships, as well as ensuring eligibility to apply for major translational grants from external funders. Furthermore, such schemes need to be flexible—if the academic establishes a spin-out and raises investment, it should be straightforward to change the contract to a part-time position with the university, enabling more time to be devoted exclusively to the spin-out, while retaining the security of an academic contract if so desired.

• Career progression in such industry/enterprise fellowships within academia should be based on innovation/entrepreneurship related metrics, rather than publications—it is often necessary to withhold publication for many years to properly secure IP. Metrics could include funding raised (either translational grants and/or investment), IP filings, user validation reports, regulatory/market research, and industry traction.

• Universities should recognize the time devoted to entrepreneurship activities in their work metrics for academics, equivalent to teaching or research commitments.

Maybe the greatest challenge for translational ventures is, unsurprisingly, raising the funding to bring their research out of the laboratory and into the real world. The funding landscape also influences the decision on when to formally spin out the intellectual property from the university into a commercial entity. The UK ecosystem has a range of translational funding opportunities, with impact accelerator or confidence-in-concept type awards usually administered internally within universities to support very early-stage work; later, the major translational schemes from government funders, such as UKRI (UK Research and Innovation) or NIHR (National Institute for Health and Care Research), can provide significant support, akin to a seed-stage investment round. The UK’s impact accelerator type awards are a very useful source of flexible financing to test out ideas, commission regulatory/market research, and kick-start translational projects. Given that they are internally administered within universities, they also have relatively fast application turnaround times. However, as mentioned above, the larger external grants can take a lot of time to both prepare and administer and are highly competitive. Eventually, especially in the biomedical space, the funds that will be required to successfully develop a product will require private risk capital.⁷ 

To raise private risk capital, academics need to first eschew any uncomfortableness around the idea of wealth creation—investors will invest their funds only if they see potential for a viable return on investment. There is sometimes an attitude within academia that money and wealth are “impure” and that one does not want to be seen to care about such matters. However, this attitude misses the point that without the potential for commercial success, especially in the very expensive world of biomedical translation, these projects will rarely (if ever) see the light of day, and societal benefits will not be seen. Even as a society, we desperately need innovation led wealth creation that not only benefits end users or systems but also, as a corollary, raises tax revenues to pay for public services. Governments should also note that taxation and regulation must be innovator-friendly—short-sighted policies that do not appreciate the significant personal risks taken by early-stage founders will backfire, and if pushed too far, entrepreneurs will look for jurisdictions with more founder-friendly policies in which to establish their ventures.

In the UK, Innovate UK grants provide vital support to early-stage businesses. However, for a business whose first funding is via an Innovate UK grant, there may be a cash-flow problem since these grants are normally paid in arrears and one needs money in the company bank account before one can even use such a grant. The European Innovation Council grants often do pay some costs up front, and changing the Innovate UK policy to match this would be extremely helpful for the UK’s early-stage businesses. Similarly, the UK’s SEIS/EIS (Seed/Enterprise Investment Scheme) schemes have been vital to support the early stages of investment into high-risk innovation driven companies, but it is a common complaint that the UK ecosystem does not adequately support the later stage scale-up growth capital required for these businesses, which leads to the country missing out on the largest gains. Supporting value creation and enhancing risk appetite will be vital in the coming years if the UK is to capitalize on its success in starting innovation-led businesses.

University TTOs also need to be pragmatic when it comes to spin-out terms. There is currently a wide disparity among different universities in the UK when it comes to licensing IP into a spin-out company, and these negotiations can take many months to finalize. Universities that take too much equity in the company strongly deter private investors. In this regard, Imperial College London in 2023 published details about their “Founders Choice^TM” program,⁸ which may be a useful starting point for other universities to consider. For device based spin-out companies, they propose that the university take either a 10% dilutable equity stake or a 5% equity stake that is non-dilutive until the first £5 million (cumulative) investment is raised. TTOs should also consult a broad group of early-stage investors to determine what the investor community views as a viable and fair university stake in an early stage company (note that this also varies based on the type of technology being commercialized, so it will not be appropriate to produce a one-size-fits-all term sheet for all spin-outs). It is also important for the academics involved in the project to carefully consider their own contributions to the future of the spin-out and ensure that the founders taking the most risk (for example, going full-time into the company) are adequately incentivized. Investors care more about what happens post their investment and wish to see teams incentivized for future work, rather than work that has happened up to the point of the investment.

• Innovate UK should pay grant costs (at least partly) up front rather than in arrears.

• It may be beneficial to enhance the scope of the impact accelerator awards and increase the maximum funding available through those grants—without compromising on flexibility and speed, which are the major positives of the schemes.

• TTOs should start negotiations on equity in spin-out companies from a more pragmatic position—certainly, universities who ask for more than 15%–20% equity at the start are doing their founders a disservice. TTOs should also canvass opinions from the investor community in drawing up their guidelines.

• Academic founders based in the UK can look up the details of shareholdings of companies spun out of their universities on Companies House and thus gauge the level of equity typically taken by the university, in advance of starting negotiations. It would be worth comparing those terms with spin-outs from other universities as well.

• Governments should incentivize the deployment of growth/scale capital in local companies, to enable the country that fostered the initial work to reap the long-term benefits. This is undoubtedly a complicated area, but potential levers include tax incentives, simplification of the regulatory/compliance landscape, and a balanced approach to employment rights.

Translating university research into real-world commercial applications, of course, involves many other considerations beyond those discussed in this brief Perspective, and given the challenges described, it may seem a daunting path to traverse. However, if successful, the benefits can be very rewarding for founders, their universities, and wider society. There are relevant examples of success stories in the medical device space that can serve as benchmarks for future developers. In the UK, Endomag (Endomagnetics Ltd.) was spun out of research at University College London and the University of Houston, pioneering a magnetic sensing technology to help clinicians more precisely mark and remove breast cancer tissue. The company website reveals that their “Magseed^®” technology has been used in over 325 000 patients (as of March 2025). Endomag successfully navigated the route through from idea to spin-out to revenue generation and finally an exit last year, being acquired by Hologic, a women’s health focused health and med-tech company.⁹ In 2021, a Cambridge based startup, CMR Surgical, closed a $600 million Series D investment round that valued the company at $3 billion, to further expand commercialization of its next-generation surgical robotics system Versius^®.¹⁰ 

Given the potential for such success, it behooves us within the translational academic community to foster current and future academic entrepreneurs delivering life-changing innovations for the benefit of society. This will involve addressing the challenges discussed above and also educating and mentoring academic founders as they navigate their path through the system. A number of practical recommendations have been proposed here, but this is just one perspective—we require far more interactions between academia, industry, regulators, health systems, and policy makers to develop and implement systemic changes to incentivize not only early innovation but also scale-up and commercial value creation. I strongly believe that we should be facilitating the translation of university research more efficiently than is being done at present and that maybe a readjustment of academia’s risk tolerance is needed to truly unleash the potential of the work taking place. We must protect the university’s role in the generation of knowledge, but also facilitate its exploitation and translation into real-world benefits wherever possible. When working in such fields, just writing papers simply isn't enough.

J.C. acknowledges support from the National Institute for Health and Care Research (NIHR) under its Invention for Innovation (i4i) program (Grant Award ID: NIHR206478). The views expressed are those of the author and not necessarily those of the NIHR or the Department of Health and Social Care. J.C. would also like to express thanks to the numerous colleagues and mentors within translational academia, technical/regulatory consultancies, and the startup/spin-out community with whom he has had useful discussions, which have contributed to a number of points in this article.

J.C. declares that he is a co-founder and Director of ArtioSense Limited and a co-founder of BioTryp Therapeutics Limited. Furthermore, he is a member of the Industrial Advisory Board of APL Electronic Devices. The views expressed are personal and not representative of any other organization.

Jehangir Cama: Conceptualization (lead); Writing – original draft (lead); Writing – review & editing (lead).

Data sharing is not applicable to this article as no new data were created or analyzed in this study.