You ask, how to overcome medical device commercialization challenges?
Author Shrinidh Joshi, medical device consultant at Kolabtree provides expert tips. Read on.
Before a medical device is ready to enter the market, it is put through rigorous testing to verify that it is safe, functional, and reliable. For a medical device firm, it might seem a daunting task to conduct all the testings required by a regulatory agency, however, some of the main tests your device has to go through from a business development and marketing point of view are listed below:
- Testing for stability of product: Your medical device is exposed to different temperatures, light, drop, pH, agitation, gravity, and levels of humidity. In some cases when your medical device contains a drug product you may have to follow ICH guidelines to simulate accelerated and/or real-time aging and check the impact of all these tests on the strength, quality, and maybe purity of medical device.
- Verification and validation of medical device design: The medical device is checked to verify it is meeting requirements consistently. Design feedback can be drawn out of these testings.
- Testing for process validation: Here the testing protocol is designed to validate the manufacturing process. This protocol should challenge the process equipment and overall manufacturing processes to ensure their ruggedness to produce the product dependably.
- Reviews for regulatory and safety of the medical device: This is the most important phase and it can determine the speed of commercialization for your medical device. In most cases the regulatory expert will suggest that you ensure all documentation is in place. However, this is easier said than done. You need to make sure a separate and complete set of documentations are maintained for each country wherever you are planning to sell your device.
Medical device commercialization: Best practices
Regulatory requirements
The best practice to speed up the medical device commercialization is to focus on “Regulatory Early”. Include compliance thinking sooner in the device development process. Having a regulatory acumen early on, and making investments by including risk management and design controls in your process, can save time and efforts down-the-road. There are cases when it is too expensive to fail and cost-prohibitive to remediate and resubmit.
Business plan
It’s also important to have a strong business development and marketing team, who can create a strong go-to-market strategy with a clear understanding of the clinical need. Working with a freelance medical device specialist can help you make sure that your intended use, indication for use and preliminary function of your device is clearly defined. Poorly defining these three things is an expensive mistake that can be prevented early on. A freelance life science content writer can help you create effective marketing communication material, especially white papers and press releases that can be sent to all stakeholders.
IP & Funding
Make sure that you secure IP rights to safeguard your innovation. This is not just for your own safety but it is also assuring for potential investors. Getting funding is a major hurdle faced by medical device startups. Investors focus in a big way on your IP portfolio, and they are unlikely to invest in innovations that may compete with yours. It is essential to perform due diligence and create a strong pitch, highlighting the USP of your product (may be safer or more cost-effective) to convince potential investors.
Key points in medical device commercialization
Some of the key points to be considered for the commercialization of a medical device are:
- Focus: If your medical device company starts with the sole focus on the technology rather than solving a problem or focusing on the patient-centered approach, it is very likely that it might make investors, accelerators or incubators, and other stakeholders nervous.
- Minimum Viable Product (MVP): Whenever a scientist comes up with an innovative medical device idea it is common to continue development until s(he) can make a perfect design. However, this habit could be damaging for commercialization. It is important to remember what your medical device is targeting and when is the right time to stop development and stress test your product. Learning to break the habit of perpetually perfecting your design is detrimental for market adoption. However, as a medical device developer, your mission is to obtain feedback from the end-user and be receptive to it. Taking opinions from contract manufacturers or regulators, and different opinions, along with expertise and knowledge, could actually help you to make a sound judgment.
- Clarity on design controls: Mapping your design controls and having a clear design on what exactly needs to be done is very important. In cases when you have to make changes then having proper justification of each change made is also required.
- Regulatory approval: The mantra to clear the regulatory approval stage is to determine all the major as well as minor milestones that are required to be achieved before you can reach the finish line of approval. I have seen cases when a mapping of minor and major regulatory milestones early from the investment stage had helped clients to secure 2x funding from the investors and had actually propelled their development faster. Clear regulatory plan can increase your company’s and product’s value.
- Rule of thumb: For every issue, you might be faced during medical device commercialization, you have to remember a rule of thumb or 1/10/100 rule. This rule basically focuses on how much any potential issue might cost, if that issue would have been identified early on? What will be the cost of that issue, in case if the issue is caught in the later stages of the development such as validation and verification process of designing your device? This 1/10/100 rule is applicable to all areas and you should design an in-house FMEA document based on this rule which can remind you to act proactively on issue identification and resolution.
- Prevent risks early: What are the different ways you can employ to minimize, prevent, and identify any unexpected issues, twists, challenges, and turns, sooner in the development than later. For example Minimum viable product (MVP), prototypes or iteration, user and stakeholder feedback, and performance tests including beta-testing.
- Medical device platform technology and pipeline of tests: Commercialization, market adoption, and marketability should justify your selection of a classification of a medical device, selection of an appropriate regulatory pathway, and finally selection of a suitable reimbursement strategy.
Outsourcing some of these tasks to specialists can help you reduce time to market while streamlining costs and accelerating growth. Kolabtree’s global pool of medtech consultants can help you overcome challenges related to regulatory compliance, marketing and product development.
References:
1) https://www.statnews.com/2020/02/10/10-reasons-why-health-care-startups-fail/
2) Scanlon and Lieberman; Commercializing medical technology; Cytotechnology; 2007;
About the Author: Shrinidh Joshi is a medical device consultant on Kolabtree. He has over 10+ years of experience in pharmaceutical, clinical, regulatory, and medical writing. He has worked both within and outside academia, for organizations of all sizes. He has written several white papers, research papers, and a book chapter.
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