Medical Device Commercialization: 9 Steps from Sketch to Launch

Shrinidh Joshi, medical device consultant on Kolabtree, provides a detailed guide to medical device commercialization in 9 steps from sketch to launch. Read to understand how to convert an idea to a commercially viable product. 

In this article, I would like to talk with you about what a medical device startup or an established company should know when they want to take an idea from the back of a napkin to the commercialization of a product. Technology from an individual idea, invention, research in a university or national lab, hospital, or from an entrepreneur becomes a tangible product when the idea, concept, or technology is translated into something commercially viable.

Being a scientist and medical device consultant, I understand that an idea or a concept to develop a medical device can come from anyone at any time. For example, the first personal glucose monitor was presented in 1956 by Leland Clark [1] and it was later modified and improved in 1981 by Bayer [2]. It is not necessary that only experienced engineers or highly recognized surgeons can bring a novel device to the market, it can come from anyone. For most of the medical device startups which are still new in the field, the biggest challenge is their perception of the medical device industry as a highly regulated domain with multiple roadblocks. This is not true if you work with an expert who can simplify the process. Nevertheless, there is a lot to consider, and this can be an intimidating process, but once you know how to do it right, it is very rewarding and worth pursuing. As per the recently published data, approximately 88% of the corporations that develop medical devices are not able to provide considerable ROI to their investors [3]. So, in the first part of this article, I have shared some important commercialization tips which can help medical device startups or a medical device company of any size.

Medical device conceptualization

Medical device commercialization begins with the conceptualization. The value of the medical device conceptualization is primarily associated with the fact that from concept, you should be taking into consideration the manufacturability of that device.

From day one, you should consider how it’s going to be manufactured? This is important for a couple of perspectives:

1. Economics
   One, economics is many times overlooked during medical device development mainly by small startups or cross-functional organizations that are entering into the medical device domain from different backgrounds such as pharma, biotech, or academia. Medical device companies have to design a product to be economical and fit their defined business model. When a medical device company goes out with a targeted sales price, and that sales price is driven by an equation that considers what their margin needs to be, it drives back to what the cost of goods of the devices [4, 5]. Simply put, as a medical device company you need to understand that from the concept stage and that will allow you to ultimately produce a device that meets the economic requirements.
2. Value proposition
   Second, for a medical device company and medical device to be successful, it needs to deliver a clear value proposition to the various key stakeholders. Beginning with the patient, it’s important to consider whether the problem medical device company is addressing is truly an unmet medical need and whether their technology will profoundly impact patient outcomes or quality of life. If a medical device is intended for the physician’s use (for example a spirometer or a blood-oxygen monitor), it is important to consider whether there is a demand for the product. Sometimes it is crucial to find out whether that demand is sufficiently high to overcome the inertia of practicing medicine traditionally. In recent times when the medical device industry is working diligently to integrate digital health, Artificial Intelligence (AI), Machine Learning (ML), and Big Data to focus critically toward value-based care, real-world data and evidence, a medical device company should be considering the health-economics of a medical device which will draw support from hospital administrators, insurance companies and pharmaceutical/medical device industry.

The other value which can impact medical device commercialization is the fact that while you’re considering how to design it, you should be designing for manufacturability from the concept.

One of the biggest challenges that I’ve seen most of the medical device companies experience is the transfer from either product development, design verification, or validation into manufacturing. Many times, what happens there are delays associated with the transfer to manufacturing because there are issues that don’t allow it to be manufactured, and that could force you to go back through a design iteration. If this happens medical device companies lose some time, and time is a problem because everyone desires to get their products into the market.

9-Step Process for Medical Device Commercialization

Conventionally, commercialization is a nine-step process from sketch to launch. These steps include:

•   Sketch (either from the back of the napkin to more sophisticated device design),
•   Patent analysis,
•   Market relevance,
•   Regulatory compliance,
•   Quality assurance,
•   Implementation,
•   Human factors and usability,
•   Business development and marketing, and
•   Launch.

These steps do not necessarily need to be followed in sequence, sometimes they need to be followed in parallel or in a different order than listed above. As long as, when all of them are considered during the development and commercialization process then they set a trajectory for the success of the medical device. There will always be some challenges and room for improvement, but the steps listed above would help to put a process in place that can allow a medical device company to avoid pitfalls; such as the pitfalls associated with the regulatory challenges, pitfalls associated with the design for manufacturability, pitfalls associated with having a great product but finding out that it can’t be sold because it’s non-economical. They can’t make a margin on it, and therefore, there’s no product. For example, I had worked with a company in the past that had already spent millions of dollars developing a medical device and their device had been through verification, but later, they figured out it was too expensive to produce. Therefore, the company couldn’t make a margin, and now they were in a position of either having to cancel it or look at some other way to produce it. It’s not an unusual challenge but it could have been avoided by proper planning and execution.

1. Planning Phase (Sketch)

A medical device company should spend a good deal of time in the planning phase. However, this phase should not be as long as the development phase. The main goal of the planning phase is to invest time in defining the product requirements. During the planning phase, a medical device firm may want to invest time in developing the product strategy around the regulatory side of the business, and then also, consider costs. By narrowing and creating a real focus on what that product is and the strategy to bring it to market, will allow you to then go into the development phase and have an effective, efficient process because now you know what the endgame is. By devoting your time and resources to the planning phase you’ve tried to address the issues upfront so that you’re not just meandering down a development path. It’s a very focused path with a very focused effort.

During the sketching phase, it is too early to map out the ROI, but it is a good idea to consider the returns at the beginning of the process when you’re taking a medical device from a napkin to the development phase. You need to have a strategy on ROI and a concept of how you’re going to approach this. All the key personnel of the project should meet during the planning phase and do the homework about what their year one projections are, and year two, three, four, and five. Such homework is pivotal so that they can put a strategy together that makes sense and it will also position them to be successful. The worst thing a medical device company (or perhaps any company) can do is launch a product, and everybody loves it, but they can’t get any because it’s back-ordered due to the capacity or some other reason.

2. Patent Analysis

The most important step is to make sure the Intellectual Property (IP) is under your control. IP is the way a medical device company can commercialize their product and make money. When you are introduced to technology or invent a technology on your own, the first thing to do is the IP. Once IP is covered then you look at the marketplace. Even if a medical device company has to go through the design re-iteration phase, I would suggest them to make sure that their IP is under control. If I have to list a few of the issues that medical device innovators could face in the event of an IP dispute, they are legal expenses, public relation issues or relationship building issues, impact on development, production or sales, and last but not least is the management distraction.

To ensure that your new medical device IP is protected from its planning and development stage you should consider filing for both medical device patent and medical product trademark protection. For any medical device, it is advisable doing reverse-engineering and filing for protection for each alternate design or improvement. Medical device companies should establish where the medical product will be manufactured, sold, and distributed. It is recommended that you file for protection in countries where the cost/benefit ratio is balanced. For marker size, a good rule of thumb is to make an assumption that an international market is a similar size to the US market. During your medical device design, you might be dealing with a bunch of freelancers and contract subject matter experts (SMEs) rather than employing them full time, in this case having non-disclosure agreements (NDA) from all investment partners, developers, manufacturers, freelancers, contractors, and distributors, as well as any other individuals who will have access to proprietary information. Nowadays you can also consider having IP insurance for balancing the cost versus the protection you’ll receive by having such insurance.

3. Market Relevance

Market research is very important when you are considering medical device commercialization. As a medical device startup, you need to make sure there is a market for your product. It is strongly recommended to perform your due diligence on any potential competitors to measure your product against their already marketed products. During the market research phase, there are some key questions that you should be asking yourselves:

•       Is my medical device going to be relevant in the market?
•       Will my device fill an unmet need?
•       Is it going to change how the delivery of medicine is being done?
•       Who would buy my product and where in the world could I sell it?
•       Is it going to improve how things are going to be done? 
•       Is it going to improve the quality of life?
•       What other products serve a similar function to the product I am planning to launch?
•       What are the competitive products, technologies, and/or services currently available?
•       How is my product going to be superior to my competitors?

As a medical device company, you have to prove to yourselves that the questions listed above are properly happening and addressed during the initial brainstorming session or at least discussed during kickoffs. If this is not happening, you are not going forward. As per my recommendations, you should take some time to write down a description of your product (in a broader way than the planning phase) and then make a list of answers to the above questions. This list does not need to be exhaustive or set in stone, however, having such a list will help as a good resource to determine the market demand for your medical device. I will go one step beyond and say this list will help you to remind your purpose as an entrepreneur in case you are the founder of a medical device startup and you really want to take it far. Unfortunately, I have seen a lot of amazing products and solutions that can help mankind but no one can afford to pay for such solutions, or it costs hundreds of millions to get to the maker and people are only going to pay few bucks for that product. A financial viability model is done during the market relevance phase which is different than a budget or a pro forma balance sheet. This is something that is done to evaluate the efficacy relative to what the market will bear and determine if a medical device firm can build something for a reasonable price. This is key-different countries and regions will pay different prices for the same device. For example, one of my clients had done cultural research to ball-park the price for their device by keeping the major factor in my mind that their device may be biased in a certain culture than others. This kind of exercise helped them to dictate how much capital they can raise. Such factors are difficult to gauge if you are unaware of the international marketplace.

In nutshell, to bring a medical device to market, it must have a competitive edge over other products aimed for the same purpose, and you will need to outline and plan to highlight the differentiating edge at the earliest stage.

4. Regulatory Compliance

Regulatory compliance or regulatory strategy is one of the most challenging aspects of launching a medical device. It is advisable to find a regulatory champion earlier in the development to successfully navigate regulatory waters. As a medical device company, you should also do some research on the potential regulatory pathways for your device when you are preparing a pitch deck or drafting a business plan.

I have been always asked when is the right time to nail down a specific, detailed regulatory plan? I would say as early as you can because that will help you solve other pieces of the puzzle quickly. It is very important to remember that every medical device is different, and they have their own regulatory strategy.

There is no prescribed regulatory pathway but the best strategies for regulatory compliance have proactive planning with clear documentation and rationale for every step taken towards device development. Every major market has a specific regulatory framework. As a medical device company, you don’t need to waste time in understanding the granular difference across regulatory requirements but sticking with a proper business plan will provide you a good return on investment. It is also important to use one market as a steppingstone to enter another regulatory market. For a medical device, it is important to understand, define, and document the intended use which can help you to establish the scope of the device and will be useful when you are defining user needs, design inputs, and other design and development activities. Intended use is also important to support regulatory product classification, which ultimately dictates the pathways for the marker clearance from regulatory agencies.

Take the example of the FDA, having a regulatory champion or an attorney is very valuable for regulatory compliance. Regulatory experts with prior FDA experience under their belt can help to shorten the timeline to educate the FDA on your project needs.  Every minute spent on educating or meeting compliance with the FDA is time away from the market.  Regulatory attorneys can help to expedite this process. Finding the right regulatory attorneys that interface with the FDA on an ongoing basis is important. Having a relationship with the FDA is incredibly important. For any medical device company seeking FDA approval, it is important to utilize an option to meet regulators early on. Apply for pre-submission meetings with the FDA. Such meetings are very valuable. Pres-submission meetings should be part of your process and it is very important to do your homework properly and understand their viewpoint rather than entering into an argument with regulators.

It sometimes seems that having a regulatory attorney or spending too much on regulatory expertise is cost-prohibitive for a startup but what you don’t want to do is have to be faced with a design redo or an iteration. There are enough of such challenges as you move through the development process. To get to the end and then find out that you haven’t met the regulatory compliance then you have to start over or do it all over again. That could be very expensive, and you are delaying your entry into the market.

Once you get through the hurdles of the regulatory pathway, you have to get into the quality assurance for the market adoption.

5. Quality Assurance

As a medical device company, you have to have a quality system in place. A Quality Management System (QMS) is imperative for a successful launch of your product. You have to work under a QMS when bringing a product to the market, it saves time, money, and other valuable resources. Most importantly, For the US market, the FDA expects an applicant to follow the regulations outlined in the 21 CFR part 820, whereas outside the US, ISO 13485 guidelines need to be followed. There is a huge overlap between these two guidelines and most of the time being compliant with one set you up for the compliance with other without having to do redundant testing. The beauty of QMS is, there is no one size fits all kind concept for QMS, and you have the autonomy to create one that works for your company and its needs. Some CDMO’s and medical device companies are doing a phenomenal job by creating a culture of quality and doing the right things the first time which can help them to improve efficiency and as a byproduct, they can deliver safe and quality compliant medical device all the time. There are some essential components of quality assurance (QMS) that must be implemented from the beginning which include document control and record management, design controls, risk management, and supplier management. In the engineering and implementation phase, remaining components of quality such as CAPA, complaint resolution, deviation requests, and investigation, etc. will be addressed.

6. Implementation

When you are at the implementation stage, you have already gone through the prototype stage. During prototyping your device, you should have already faced common problems and have troubleshooting strategies to improve certain features of your medical device. Now it’s time to scale up your 3D printed device to an actual molded device.  Once you’re satisfied with the basic design it may be time to get into partnership with a contract manufacturer to build a more robust prototype. This working prototype should be used for basic feasibility studies. The purpose of feasibility studies is to determine whether you should move forward with pursuing a full-blown project and take it into the engineering phase or reconsider the prototypes. I have been through this stage often and one of my advice for the startups is to secure funding upfront for the feasibility testing. Sometimes when startups are boot-strapping for the beta testing they try to go with only one prototype rather than having a proper design of experiments (DoE) kind approach and have at least 2-3 different prototypes to test (if possible). This approach can save time because engineering and implementation are incredibly hard. Additionally, if you have tested your final prototype in the feasibility studies then you can leverage those results for regulatory submission. In case a medical device company wants to leverage results from feasibility studies then they need to make sure all the studies are done under design controls. The implementation phase requires proper project management and detailed attention to device design together with a lot of creativity. The reason to have creativity in this phase is that you may need to have someone who can think outside of the box and help you solve the problems. Going through this phase requires a lot of effort and believe me you need to have the right people besides you when you are in the implementation phase. I could not emphasize more on the creative teamwork within the engineering team to resolve the issues.

Human factors and usability are covered in detail in article 1 of this series [6]. It is important to remember that if your medical device is coming in contact with a patient or someone needs to operate your medical device, then the FDA has implemented a new standard that they monitor very closely. Human Factors use case scenarios must be documented and should be demonstrated within your device including for the Software as a medical device.

The Business Development and Marketing aspects of medical device commercialization together with the launch is covered in detail here. 

Need help with medical device commercialization? Consult Kolabtree experts for help. View a list of freelance medical device experts here.

Read also: How much does it cost to hire a medical device consultant? 

REFERENCES:

• 1)     Heineman, W.R.; Jensen, W.B. (2006). “Leland C. Clark Jr. (1918–2005)”. Biosensors and Bioelectronics. 21 (8): 1403–1404. doi:10.1016/j.bios.2005.12.005
• 2)     Clarke, S.F.; Foster, J.R. (2012). “A history of blood glucose meters and their role in self-monitoring of diabetes mellitus’. British Journal of Biomedical Science. 69 (2).
• 3)     NVCA research resources. Patient Capital, National Venture Capital Research Resources. Available online at https://nvca.org/redearch/research-resources/
• 4)     https://www.mpo-mag.com/issues/2018-09-07/view_columns/the-impact-of-changing-healthcare-economics-on-device-design/
• 5)     https://www.kolabtree.com/blog/medical-device-development-and-design-a-definitive-guide/

All articles in this series:
Medical Device Development and Design: A Definitive Guide
Medical Device Development: 3 Tips for Success
Medical Device Design: The Essential, Step-by-Step Guide
Medical Device Commercialization: 9 Steps from Sketch to Launch
How to Overcome Medical Device Commercialization Challenges
Medical Device Launch: Key Steps to Bring Your Product to Market
Medical Device Post-Market Surveillance: A Comprehensive Guide