There is a fine balance in medical research commercialization that the industry generally tries to strike, primarily between research/regulatory integrity and timely innovation. The speed of innovative therapeutic, pharmaceutical, and diagnostics production during the COVID-19 pandemic [1] showed that when directed, the pipeline can be focused, swift, and unhesitating [2] (albeit doubtful due to a lack of traditional clinical trial data [3]).
For researchers and medtech innovators, this journey can be thrilling, exhausting—or both. As a former researcher, I often see colleagues yearn for their research to make a translational impact but be put off by how difficult it can be to turn a publication into a product, policy, or program. While we don't tackle policy or programs at Megrez, we do work on products encompassing medical devices and interfaces, and so would like to take the time to briefly delve into the overarching pipeline for medical research product commercialization.
A note on hardware vs. software development
Software development and deployment often cost less, take less time, and generally undergo fewer regulatory and standard processes compared to hardware devices [4]; this is common in almost any industry, not just medical devices. As such, there is a tendency for many institutions to favor the development of software interfaces, such as artificial intelligence and its uses in medicine, as opposed to the development of potentially equally lifesaving medical hardware [5].
This is neither good nor bad. Digitally-based innovations can potentially save more lives per dollar [6] compared to hardware developments, but at the same time, we have de-emphasized the need for lifesaving devices, hardware, and infrastructure. This poses long-term concerns, including thelack of student interest in hardware-related engineering such as electronics engineering, mechanical engineering, and biomedical engineering compared to software-related degrees [7].
We find that most of our work combines both hardware and software development. Biomedical engineers often require software interfaces; likewise, digital researchers and modellers often require methods of gathering data through new sensors.
What does it mean to productize or commercialize medical research?
We clarify here that we start at the point where your research has borne fruit and results—that is, it is no longer a theory on paper, but a verifiable concept or prototype that has been tested and that has produced the desired result. Your research should be completed or projected to be completed satisfactorily before embarking on commercialization.
Productization: to build a product from your research
- Research work differs significantly from what is seen in the operating room, the pharmacy shelves, and the pediatric clinics.
- Productization is theprocess of elevating, complementing, and packaging your research so that it becomes usable by its target audience (clinicians, patients, etc.) [8].
- This can involve additional design and engineering, packaging, branding, marketing, and medical device or medical interface regulations.
Commercialization: to earn money from your research
- Commerce is the activity of buying and selling, especially on a large scale [9].
- Productized research can be commercialized but does not have to be.
- This often involves business development and strategy, multinational regulations and commercial standards, as well as sales and distribution pathways.
What's the difference? You can absolutely productize your research without commercializing it. Many researchers obtain grants to develop their products and subsequently distribute them without any intention of profiting from them—for instance, if it is targeted for use by low-income audiences.
The intention of commercializing, on the other hand, is to ensure that your product is profitable. Lifesaving, sure, but also profitable for all stakeholders involved. This is the path often preferred and taken by many medical research innovators.
Before you start commercialization or productization, you should have at leastone proven concept or prototype (a PoC) [10].
The process of medical research commercialization
We start here with a PoC–a concept or prototype that has shown that it does what you wanted it to do.
Step 0: Validation
The crucial question researchers need to ask themselves here is as follows:
- What is your purpose in productizing or commercializing your research?
Researchers ought to be honest about both personal and professional objectives here, even if it is just with themselves. Getting more funding, gaining recognition and awards, and earning additional financial stability outside of research are all legitimate considerations that come with research work. These are important aspects to keep in mind on top of the core goals of saving lives or alleviating clinical work. Once thought through, delve deeper into supporting questions:
Ascertain the feasibility and potential of your idea in its specific context.
- Does it work for your target audience and users and benefit them? Have you gotten tangible proof that your PoC works in the context that you would like it to? If commercializing, would they be willing to pay for your product?
- What existing infrastructure is there to support your product?
- What other competitors are there on the market against your product?
Furthermore, you will need to consider where you are aiming to take the product.
If you are planning on commercializing it, what is your exit strategy for the product? Would you sell the rights to the product? Take a percentage profit of sales? Build a business around the product and then build more products under the new brand?
What is the extent of possible commercialization? What is the relevant industry outlook?
Step 1: Fill in prototyping holes
Perhaps you're a bioengineer who needs a database and an app to pair with your sensors, or maybe you're an AI engineer who needs a very specific and nonexistent sensor to capture data in a very specific, sensitive way. Perhaps you need industrial design for a casing, or additional electronics for your product on top of its basic functions.
Ideally, you would be able to do this with a single party, but if you have constraints, you may want to do it across multiple vendors.
Step 2: Pilot testing and data collection with the intended audience
These are not quite clinical trials. Consider it a soft, informal precursor.
Work with collaborators to soft-test the MVP and collect some initial data without the rigor of official clinical trials. You will use this opportunity to gather initial data to support further development and commercialization of your project under your grant. This should provide you with crucial data and feedback on your project.
Step 2.5: Decide if you want to move forward with the project
Some projects look good prima facie but perform poorly during soft tests or otherwise. They might be disruptive in clinical settings [11], or unusable due to hardware interference [12] and limitations. Alternatively, there might be limited interest from users on a larger scale or the deployment of the product may impede existing processes too much. There may be difficulty in the deployment logistics of an item [13]—war, for instance, may very easily put an end to efforts to distribute lifesaving medical care in certain countries. The projected costs of development [14] may also outweigh the benefits and earnings of its sales and usage (although there is always a debate regarding the price of life).
Think about the commercialization journey seriously and ask yourself a few questions:
- Is it imperative to undergo this journey?
- What are the benefits of commercializing your research? How many lives will it save, or how many clinicians will it help? Will it help reduce operational burdens? Will it reduce mortality rates during certain procedures?
- Which external parties will benefit if you undertake this effort?
- Will it be personally beneficial to you to undertake this effort?
Some projects are truly thankless, and the benefit is in their deployment. You will not be able to earn money from this project due to its nature–the distribution of cheap diagnostics as an aid to developing countries. The reward is in the idea that you are saving lives. It doesn't mean they shouldn't be translated; just that they just be commercialized because you cannot earn money from them. You develop these products solely for the sake of saving lives or helping people, with no intention of profit.
Some projects are very commercially viable. These projects have clear use cases and markets, as well as people who are able and willing to pay for the product. These projects will need to focus not just on the development of the product, but also on the business strategy of the product, including sales and distribution, strategy and marketing, and how to adjust as we go. The consideration of profit will be higher in these projects, and researchers will be able to gain some financial return from the project in various ways.
Step 3: Package your product
If you have decided to move forward with your project, it's important to provide it with its own identity so that ideas and plans can coalesce appropriately around it. This is a huge turning point for your product because you are consciously and purposefully dedicating yourself to it after MVP tests and evaluations of whether it would be useful and worthy of your time.
Product identity
Don't spend too long on this: things will evolve and change. Just go with one thing first-give your project a name. That step makes it real to you, the researcher, and your willingness to undertake this journey. Depending on where you are in the productization/commercialization journey on the business end, spend a small amount of time (half a day, at maximum) coming up with a fun name, logo, and product tagline.
Next steps
Develop a quick one-page plan regarding what you will need to do next. Do it on paper if you need to—there is no need to use any fancy software.
Step 4: Prepare for formalization
You'll spend some time dredging through your development history for documents, paperwork, source code, and logs that you'll need to comply with clinical trials, standards, regulations, and certifications.
First, decide which countries you'll be distributing in. The standards, certifications, and regulations for medical devices or medical consumer products differ from country to country [15]—and not just for medical-related standards either. This includes things like more obscure certifications such as electrostatic certifications, if necessary.
Next, dig up all the relevant documentation. Ideally, everything would have been kept most robustly, but unless you specialize in commercialization, it would be uncommon to have all your documentation formatted in such a comprehensive or compiled manner. Get everything together and organize it.
Step 5: Work on the business end of things
For non-commercial productization:
- Source for additional funding and grants for the remainder of the project, if need be.
- Develop plans for distribution to the target audience.
For commercialization projects:
- Appoint a product owner or manager if you are not planning on being one yourself. Decide if you want to own the product or eventually sell it to someone else to distribute.
- Define and affirm your market, sales and distribution strategy, and partnerships
- Formalize and confirm your branding and marketing efforts
Most researchers are not business owners but find that they need business development advice sparingly until this stage. We recommend that you find a business-minded partner as early as possible to consider your product's strategy. It can heavily influence the design and engineering of the product, and having someone familiar with these aspects means that you are free to focus on the technical development and productization of your research.
Step 6: Initiate formalization processes
A brief, non-exhaustive list of potential certifications, standards, and regulations to consider:
Products
- General medical device classifications and regulations
- Specialized medical device standards, if needed
- Electronic or electrical regulations and standards
- Country-specific regulations
- etc.
Businesses
- ISO certifications
You should also be logging work needed for clinical trials and initiating proposals and paperwork if you have not (ideally, this would be going on in parallel with product development).
Lastly, you should also be thinking about the paperwork needed to address intellectual property protections, either via your research institution or through an external party. This typically takes the form of a patent application if viable.
Step 7: Redesign for manufacture (hardware only)
Search for and assess various manufacturers for their suitability in manufacturing your product.Contract or OEM manufacturers [16] are oftentimes able to handleturnkey projects [17], although you should source specifically for medical device manufacturers [18] rather than general manufacturers. Products that go on to sell very well may eventually consider building their own factories and assembly lines, but this is not what we want to do at this moment.
Redesign your products for manufacturing methods, some of which come with specialized requirements and considerations. You'll need to work with your specific manufacturer and their team of designers/engineers on this. You'll also be making any necessary final decisions on color, material, and finishing (commonly known as CMF). Make sure to consider ease of assembly (e.g., combining two parts into one) and maintenance (e.g., easy to take part for cleaning).
Step 8: Look for customers (or distribution partners)
If commercializing, it's important to get confirmations of interest, soft orders, or even pre-orders of the item if possible. If productizing without commercializing, you will need to speak to potential distribution partners to ensure that your product can reach the audience it needs.
Step 9: Scale production
With medical devices, this looks like full-scale manufacturing for a few hundred or even a thousand pieces. While we try to encourage low-volume manufacturing to start to be cautious, keep in mind that some processes have universal setup costs that are the same whether you are ordering 1, 10, or 10,000 pieces. Proceed with larger orders depending on market demand.
With software, it becomes essential to develop robust architecture to support the use of your interface by thousands or even hundreds of thousands of users. Ensure that data is protected and that security is robust; further ensure that supporting third-party applications, servers, and database applications are all supported well. If you are using proprietary technology belonging to others, ensure that proper permissions are obtained, or look for substitutes.
Step 10: Sales and distribution
The process doesn't stop with a one-time production and sale. If the device or interface works well, you may want to place more orders depending on the presence of demand. Continue gathering data and feedback on the device and execute updates and changes to your product or interface as needed. Be aware that new changes or updates will often mean—for medical devices, medical software, and medtech in general—a redo of the entire set of standards and regulations for the sake of robustness inpatient and clinical protections.
Therein ends our rough overview of the productization pipeline.
Fallacies of innovation
Innovative does not equate to lifesaving: this is more apparent in medicine than anywhere else, and the tendency for bureaucrats and grant managers to prioritize the acquisition of intellectual property, patents, and trademarks over non-innovative but essential projects is common. In the business of saving lives, it will become important for every participant, whether engineer, manager, or researcher, to consider where their priorities lie.
Final notes
While the cost, timeline, and specifications vary from project to project, most commercialization efforts go through the same process or cycle in one form or another. Repeat each phase as necessary; it gets more expensive to make changes and adjustments the further you go down the pipeline. Similarly, it becomes important to have someone on the team who has sufficient distance, vision, and perspective to begin considering end-stage pipeline concerns at the start of the journey.
We summarize the steps loosely as follows, and note that not every project follows the same pathway:
- Fill in prototyping holes
- Pilot testing and data collection with the intended audience
- Decide if you want to move forward with the project
- Package your product
- Prepare for formalization
- Work on the business end of things
- Initiate formalization processes
- Redesign for manufacture (hardware only)
- Look for customers (or distribution partners)
- Scale production
- Sales and distribution
References
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