For startups developing the MedTech solutions that are shaping the future of healthcare the journey is long and fraught with challenges in all areas, including: product development, clinical validation, regulatory approval and clearance, and market readiness, to name a few. Even the most experienced teams will have difficulty acquiring the expertise necessary to successfully navigate this journey on their own.
Because of this complexity and the fast changing MedTech landscape it is almost a necessity for MedTech firms to engage expert consultants with specialized knowledge in key areas. Specifically in the area of Regulatory Affairs and regulatory strategy, working with the right advisor can help firms avoid costly missteps, delays and even failure, and ensures a more strategic, efficient and streamlined path to market.
But how can MedTech and Digital Health companies select the right Regulatory Affairs consulting partner for their particular needs?
Below are seven key factors MedTech companies should consider when selecting a Regulatory Affairs consulting partner. These criteria will help ensure firms choose a provider with the knowledge, experience, and strategic alignment required to successfully navigate the regulatory complexities necessary to get digital health solutions to market and gain adoption.
1. Knowledge and Expertise
A competent regulatory affairs provider must have deep expertise in medical device regulations, quality systems, and clinical evidence requirements. Look for a team with experienced regulatory professionals who understand the intricacies of Health Canada, FDA, EU MDR/IVDR, and any other relevant global framework for your needs.
Their ability to understand and interpret complex and evolving regulatory guidelines, and provide strategic guidance ensures your MedTech startup builds a solid foundation for market approval and long-term compliance. It is also important for a Regulatory Affairs consultant to be connected to other experts in the MedTech ecosystem that can be consulted or brought onboard when necessary to advance a project.
This happens often in a field where a single new MedTech innovation could encompass multiple types of hardware components, software (On the Cloud) and AI/ML to diagnose, monitor and treat a condition through the delivery of a drug. The complexities of each MedTech innovation are unique and the solutions must be tailored to your specific challenges. Is your Regulatory strategy expert up to the task?
2. Experience and Track Record
Not all regulatory consultants have the same level of experience across different device types, risk classes, clinical applications and healthcare topics. And going through the process on many occasions on a variety of client engagements encompassing a wide array of clinical applications is the best way to obtain that experience.
Assess their track record of securing regulatory approvals from Health Canada and the FDA, such as 510(k) clearances to De Novo and PMA approvals, as well as CE marking if your plans include the EU. A provider with a history of success in your specific device category and regulatory agency can help navigate challenges efficiently, avoiding delays and costly rework.
Does your Regulatory Affairs advisor have experience with medical devices integrating emerging technology in healthcare such as AI/ML algorithms, which are now present in most medical devices and for which the regulation is quickly evolving. Have they worked with these technologies across various clinical applications such as Monitoring, or Diagnostics, or Precision Medicine? Have they worked on client projects across a wide range of healthcare topics?
BML Health helps MedTech startups and growing companies manage the complex stakeholder interactions necessary to get digital health solutions to market and gain adoption. With a core competence in Regulatory Strategy, BML Health will help your firm successfully navigate today’s complex and evolving regulatory landscape. Is your firm facing challenges with regulatory strategy?
Or simply want to make sure you get it right from the start?
Get in touch and let’s discuss it.
3. Strategic and Cultural Fit
Underestimated in importance because it is not an easily quantifiable technical or scientific factor in a field that is highly technical and scientific, in our experience the misalignment of strategic and cultural fit between MedTech company and regulatory affairs consultant is one of the top reasons for project failure in medical device regulatory certification mandates.
Regulatory affairs is not just about compliance it’s about aligning with your startup’s vision, risk tolerance, resources, capabilities and commercialization strategy. Your provider should understand your business goals, working seamlessly with your team to integrate regulatory strategy across the medical device development process.
Find an RA advisor that truly understands your needs and considers your project an important undertaking, that commits experienced team members and resources, and has a partnership mentality. Do they understand and want to work with startups? Do they understand and take your resource constraints – financial, timelines, people – into consideration? Is the success of your venture important to them?
Is your regulatory strategy being tailored to your specific challenges and designed for incremental progress and intermediate milestones to mitigate risk and keep costs manageable. Or are you receiving a standardized cookie cutter solution optimized for a different era of medical device regulatory requirements.
A good business and cultural fit ensures smoother collaboration and a regulatory roadmap that supports your overall business trajectory. A bad fit can lead to project failure and in cases where the project cannot be ‘rescued’, the end of the company itself.
4. Range of Services
Your Regulatory Affairs consulting advisor should offer more than just submission preparation or a narrow Regulatory Affairs offering. A services offering encompassing areas adjacent to Regulatory requirements ensures that your provider can see the big picture and how your firm fits in it.
Look for providers that support regulatory strategy development, but also understand and can help with quality management systems (ISO 13485, FDA QSR), clinical validation, clinical integration, market readiness, post-market surveillance, and regulatory change management.
A broader service offering means the advisor has greater competencies and a better understanding of the complex stakeholder interactions necessary to get digital health solutions to market and gain adoption. A Regulatory Affairs consulting partner that understands Clinical Validation and Clinical Workflow Integration can provide invaluable support in guiding your device through its full lifecycle, from development to commercialization and beyond.
A Regulatory Affairs advisor who also understands your business and commercialization strategy, and how it is impacted by regulatory requirements, can be a tremendous asset. Beyond securing regulatory approvals, they help align regulatory strategy with market entry, reimbursement, and investor expectations, ensuring compliance helps drive business success. As opposed to the more typical scenario where regulatory challenges can hinder the business and its prospects.
5. Innovation and Adaptability
The relentless pace of scientific and technological innovation in MedTech is creating significant challenges for MedTech companies in product development, clinical validation, regulatory clearance, market readiness, and more. It is creating similar challenges for regulators and the regulatory experts that help companies navigate this complex environment. Is your regulatory affairs expert keeping up with the rapid pace of change?
In particular the explosion of emerging technologies in healthcare, including Software as Medical Device (SaMD), Artificial Intelligence and Machine Learning (AI/ML), Virtual Reality and Augmented Reality (VR/AR), Connected devices and Cloud platforms, are impacting every facet of medical device development and pushing regulatory boundaries. Legacy regulatory advisors are also having a hard time understanding their impact and advising their clients on how to address them.
In addition to deep knowledge of the existing regulatory landscape your Regulatory Affairs provider should be forward-thinking and understand how your unique MedTech innovation is affected by these factors, staying on top of regulatory trends and adapting strategies to align with emerging regulation.
Their ability to innovate within regulatory frameworks can help you leverage new regulatory pathways to accelerate approvals. Your provider should be able to apply a nuanced approach that is targeted at your pain points and designed for incremental progress and intermediate milestones to mitigate risk.
Regulatory obligations don’t end with market approval. Choose a provider that offers ongoing support for post-market surveillance, reporting, and compliance with evolving regulations. If your device requires modifications, software updates, or new clinical claims, a knowledgeable consultant will help manage regulatory change submissions efficiently, keeping your device in market with minimal disruption.
Applying legacy regulatory framework consulting models in today’s fast evolving MedTech environment is a recipe for project, and potentially company failure. Work with an RA advisor that understands the changes taking place in MedTech and is evolving with the times.
6. Reputation and Testimonials
A Regulatory Affairs services provider’s reputation in the MedTech industry speaks volumes about their reliability and effectiveness. There is no better source of information on what it’s like to work with a provider than previous clients. Seek references and testimonials from past clients, speak to them if possible and see what they have to say? Are they willing to say it in public and captured on video? What was it like to work with the provider? Would they do so again or recommend them to others with similar challenges?
Are the Regulatory Affairs provider and key team members known for their expertise and competence? Do their projects ever need to be ‘rescued’? More importantly, if so who is doing the rescuing. Are they responsive and available? Resourceful and innovative? Energetic and entrepreneurial? Are they resilient?
In the long and challenging medical device development journey MedTech startups will need to be all of those things, and so will their Regulatory Affairs advisors. As described in point 5, much of what is happening in the MedTech industry today is being done for the first time, and Regulatory Affairs advisors need to be every bit as tenacious and dedicated to their mission as the companies they are advising.
Strong relationships with regulatory bodies and complementary ecosystem members such as universities, incubators, accelerators and investors are also positive indicators to take into account. The bottom line is reputation is external, ask around, mostly prior clients if possible and you’ll get the information you need.
7. Overall Cost and ROI
Regulatory consulting is an investment that can make or break your MedTech startup, and the lowest priced option is not necessarily the best. Evaluate the provider’s pricing structure relative to how it measures up on the other six factors.
A higher price for a service offering of greater value – superior knowledge, experience, cultural fit, adaptability, network, track record – is a better investment and will yield greater ROI than a lower price for a standardized package offering from an inadequate, for whatever reason, advisor.
A strong regulatory partner will help you avoid costly missteps, accelerate time to market, and ensure compliance efficiency, ultimately driving business success. A weak or ineffective provider can do tremendous damage to a startup with limited resources, a short runway and high cash burn. If the RA provider gets it wrong the firm may not have the resources required to survive to correct the errors and try again.
Therefore cost is just one factor to consider when selecting a regulatory strategy partner, and not the most important. Focus on the other six factors to identify the best fit for your company and then consider price. In the end if the regulatory advisor doesn’t help your firm achieve its necessary milestones a short term monetary savings is meaningless.
Conclusion
Selecting the right Regulatory Affairs consulting partner is one of the most important early decisions MedTech startups have to make. By considering key factors such as expertise, experience, strategic fit, adaptability, network and reputation, companies can improve the likelihood that they will engage a partner that helps them achieve their strategic business objectives.
In an industry where regulatory missteps can be costly and even company ending the right regulatory strategy consultant can be a strategic asset, helping to accelerate time to market, mitigating risks, and driving long-term success.
If you are experiencing challenges with your Medical Device Regulatory Strategy, or in any facet of your medical device development journey get in touch and let’s talk.
About BML Health
We support innovative Medtech companies that are shaping the future of healthcare. BML Health understands the impact of emerging technology in MedTech and Digital Health. Get in touch with us to learn how our iterative, lean and efficient approach to product development, clinical validation and regulatory affairs can help your organization get its MedTech solutions to market and gain adoption.
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