2024 Predictions for Medical Device & Life Sciences Product, Systems, and Software Development
As the medical device & life sciences industry transitions into 2024, we aim to gain a deeper insight into the factors driving transformation in the development of products, systems, and software and explore how teams within this sector are adapting to meet the challenges posed by these evolving complexities.
In part four of this six-part series, we asked the following industry experts to weigh in on the medical device & life sciences product, systems, and software trends they are anticipating in the coming year:
- Shawnnah Monterrey, MBA – CEO, BeanStock Ventures
- Vincent Balgos – Director, Solutions and Consulting, Jama Software
- Romer De Los Santos – Senior Solutions Consultant, Jama Software
We like to stay on top of trends in other industries as well. Read our Automotive predictions HERE, Aerospace & Defense HERE, Industrial & Consumer Electronics (ICE) HERE, SoftTech HERE, and Product & Engineering Teams HERE.
2024 Predictions for Medical Device & Life Sciences Development
Design Trends – What are the biggest trends you’re seeing in your industry right now? How will they impact medical device & life sciences development?
Shawnnah Monterrey: We are seeing a significant increase in healthcare innovations, especially with in-vitro diagnostics, and clinical decision support software.
The ability to connect medical devices to share medical device data through emergence, evolution of cloud computing, and the increase in data storage capability has led to the derivation of new clinical insights, in diagnostics, and clinical decision support. Artificial Intelligence (AI) and Machine Learning (ML) are being applied to clinical and patient data in unique and novel ways, such as in-vitro fertilization, cancer treatment recommendations, and the automation of status-quo manual clinical processes.
The increase in research allocated to understanding our DNA, and its relationship on our health, has led to the rapid adoption of DNA-based clinical tools utilizing next-generation sequencing and other DNA detection technologies such as DNA nanotechnology tools, chip-based digital Polymerase Chain Reaction (PCR) detection, Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) diagnostic technology, etc. to aid in the diagnosis and treatment of complex diseases such as cancer, neurodegenerative diseases and dementia and even behavioral, and psychiatric disorders.
Vincent Balgos: As we’re seeing in other industries, a common trend in the medical industry is that organizations are refreshing their internal processes to scale, integrate, and increase efficiency. With extrinsic pressures (market, financial, and regulatory), there is continual effort to optimize organization activities, specifically around product development processes, and leverage previous work as much as possible.
Biggest Challenges – What are some of the biggest challenges you think medical device & life sciences companies will be working to overcome in 2024?
Monterrey: A few of the biggest challenges companies will face in 2024 include but are not limited to:
- Being competitive and innovative in a highly regulated environment
- Understanding regulatory requirements in new or less mature regulated areas
- Obtaining funding to support regulatory and development efforts
Companies who are focused on aligning their product roadmap with a sound regulatory strategy will not only unlock funding but obtain revenue faster, which will allow them to leap ahead of the competition.
Regulations – What changing regulatory guidelines do you anticipate having an impact on companies in 2024?
Monterrey: U.S. Food & Drug Administration (FDA) is not known to be fast, but within recent years, the FDA has released a record number of guidances and have even changed the medical device regulation in a few areas. While the industry is playing catchup on hundreds of new guidances in areas such as:
- Software as a Medical Device (SaMD)
- Clinical Decision Support Software
- Mobile Applications
The FDA is working on furthering the regulation and guidance around many areas including, 510(k) Third Party Review Program, In Vitro Diagnostics (IVDs), AI/ML, and the use of real-world and simulated data in pre-market submissions.
It would be wise for companies to start understanding and applying new draft guidances that are relevant to their products in advance of the final draft. Once a final version is issued it could drastically interrupt your product development and launch plans.
Balgos: There are a few regulations that will start or continue to have an impact on the industry:
- FDA’s Final Guidance on Cybersecurity for Medical Devices – Continuing the focus on Software (SW) in previous years, this new final guidance will require ongoing discussions on the new security requirements (ex: Software Bill of Materials (SBOM)), activities, and expected documentation.
- FDA’s proposed ruling on Laboratory Developed Tests (LDT) – In the latest turn of events in this long running topic, this new proposed rule to transition away from Enforcement Discretionary (ED) to more explicit LDT oversight by FDA will have significant impact to the laboratory industry. Industry feedback has been active and complex, so will be interested to see if there will be a resurgence of the previous VALID Act or will the new proposed ruling stand as is.
- Based on FDA’s proposed 2024 list of prioritized guidances, there will be additional information around AI/ MLin context of lifecycle management, pre-submissions, and change management considerations.
- In the EU, both the Medical Device Regulation (MDR) and In-Vitro Dianostics Regulation (IVDR) will continue to impact companies as they transition to these new rulesets. Even with the time extension on MDR, companies are continuing to struggle in converting their processes to comply with the new regulations as 2024 rolls out.
Romer De Los Santos: The FDA just released the final guidance on cybersecurity in medical devices that includes additional tasks and deliverables that medical device manufacturers must start to implement. Design and development procedures for software that is part of or is a medical device itself will need to be updated with this new guidance in mind. Software Bill of Materials (SOBM), security risk assessments, threat modeling, and consideration of the entire lifecycle for security risks and mitigations are just some of the things that are required in today’s interconnected world.
Tool Innovation – From a medical device & life sciences engineering toolset perspective, what are some of the processes you think forward-thinking firms will be working to leverage or incorporate into their process and why?
Monterrey: Product development costs, regulatory complexity, and time-to-market are all increasingly trending topics in the medical device industry. Companies that are thinking ahead of these trends are focusing on their competitive advantage, which includes their innovation or core Intellectual Property (IP) and leveraging the support of industry experts and built–for–purpose tools.
- Investing in existing regulatory and quality management frameworks, including software, built-in processes, and training
- Hiring regulatory and quality experts who understand the regulatory landscape and have domain expertise related to their products
- Integrating medical/clinical grade or complaint platform software, components, and development tools
De Los Santos: Firms will need to leverage tools like Jama Connect to start to track security risks, SBOM, and the documentation for a multitude of software variants, upgrades, and patches. While the tools enable compliance with regulatory requirements, medical device manufacturers need to create a robust and lightweight design and development process that leverages the capabilities of their tools. For many firms, this means looking at the total development lifecycle holistically instead of tacking on quick fixes to their procedures to meet current regulatory requirements.
What role will cybersecurity play in medical device & life sciences development in the coming year and beyond?
Monterrey: Per the current FDA guidance, obtaining per-market approval/clearance for a medical device with firmware or software, connected, or not connected all require some level of cybersecurity compliance, especially around risk management. This has put an extra strain on medical device manufacturers because the guidance is very technical and rigorous and currently does not provide guidance around the level of application based on the risk of the device. I hope to see a future revision that accommodates lower risk devices, but for now it’s worth investing in cybersecurity experts who can help you certify your device and associated processes.
Balgos: As noted in a recent FDA webinar around cybersecurity, there is continual discussion in how to regulate this topic, and the expected deliverables to the agency. One area is SBOM and how to properly document all the elements of software for a medical device.
De Los Santos: Cybersecurity will play a starring role as manufacturers start to revise their design and development processes to include it.
In your opinion, what are the biggest differences between medical device & life sciences companies that will survive to see 2030, and ones that don’t?
Monterrey: Those who survive to see 2030 will respect the regulatory landscape and put in place proper attention and investment, instead of those trying to delay, resist, or evade the inevitable. Although it might not feel like it, the changes being put in place are to our benefit, with the intent of providing the industry with a clearer pathway for new innovations. It will just take a while for the regulations to harmonize and for the industry to adopt to the new ways of thinking by leveraging data, tools, and expertise to rapidly innovate.
De Los Santos: Companies that are adaptable and innovative with not only their products, but their design and development process will survive to see 2030.
What advice would you give to new companies entering the medical device & life sciences industry?
Monterrey: Build your product for the industry – align your product development efforts with your business model and regulatory strategy and do not try to obtain premarket approval for your device without the support of experts in the industry unless you have done so successfully before.
De Los Santos: Keep it simple.
What topic(s) do you wish companies were paying more attention to?
Monterrey: I wish more companies would focus on defining their regulatory strategy early in the development lifecycle and not wait until they have only six months or less to start thinking about getting their device approved or cleared. Depending on the complexity of your device, regulatory compliance efforts could take 12-36 months, with most of the efforts around verification and validation. Six months prior is often too late and could be detrimental to your business launch plans that do not meet your stakeholder expectations.
De Los Santos: I wish companies would focus on fixing their process problems instead of patching them. A little more front-end work will save future teams lots of time.
What is the biggest mistake you see companies in medical device & life sciences making right now?
Monterrey: Two biggest mistakes I see are:
- Trying to make a medical device not a medical device, even though it is a medical device
- Not narrowing down a product’s intended use for the first launch
Balgos: Cutting corners for short-term gain, but in reality, these cuts will actually cause long-term consequences exponentially. Example: Documentation. Time and time again, our technical customers (and from my own personal experience) are being pressured to get products out the door and do the documentation later. There are several issues with that: 1) technical documentation and files are required for regulatory submissions for market clearance, 2) this generally conflicts with most good Engineering and Quality practices as they will need time for review/approval, and 3) it’s much harder to document something long after it’s happened. These issues culminate in taking much longer to complete the documentation, and thus impacts the long term.
De Los Santos: Companies should not make their procedures more complex than they need to be.
What is the most innovative thing you’ve seen in medical device & life sciences this year that you anticipate other companies following suit in coming years?
Monterrey: The most innovative things I have seen is the creative use of simulated and real-world data to support pre-market approval and the novel application of AI, which uses data from multiple unrelated devices to diagnose, treat, or support various diseases and medical conditions. I am seeing more products provide a technology platform for multiple intended uses. Companies that are successful, understand the long game and focus on the easiest-to-launch intended use first, generate revenue, and then focus on further product applications, including innovations that require a more rigorous regulatory pathway.
What do you think will remain the same in your industry throughout 2024?
Monterrey: I think 2024 will be a very innovative year meaning there are more changes to come, and we will continue to see new and novel clinical innovations continue to disrupt the industry. 2024 is going to be an exciting and unprecedented year!
Do you think there will be any major disruptors in medical device & life sciences in the coming year? How do you think it will impact the industry?
Monterrey: Major disruptors will come from those focusing on diseases and conditions that have previously been ignored or neglected. One area I would like to see advance is the use of software as a therapeutic as opposed to prescription pharmaceuticals, devices, or surgery. Because of limitations in reimbursement and the non-traditional use of software as a therapeutic device, this area has experienced challenges which has delayed its adoption.
Balgos: The emergence of AI/ML has the potential to become an industry disruptor, dependent on its application or intended use. We can see its impact already in non-medical software, so it is only a matter of time before its influence is felt in the medical industry. Hence, there are continual discussions from FDA, industry bodies and experts, in how to regulate, develop and manage AI/ML for medical devices.
What do you predict for regulation in the medical device & life sciences industry in 2024?
Will those trends still be prevalent five years from now? 10 years?
Monterrey: As I stated last year, I still see progress around the harmonization of guidances and standards, which will eventually allow for a more standard way to approach pre-market approval — but I stated previously, this will be messy and complex before it clears itself out. I primarily see the increased use of simulated and real-world data as a new way to validate devices. Animal and in-human use will decrease, and publicly available and validated datasets will become available to quickly assess new medical devices for safety and efficacy.
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