The UK issued its HTRIP report about the Challenges and Opportunities for the UK HealthTech Industry early in 2023. One of the topics it identified was that in vitro diagnostic companies were struggling to find appropriate consultants. This then begs the question: What should you look for in regulatory consulting and how to find your IVD consultant?
This blog will focus on some key points to ask yourself when you are seeking a regulatory affairs consultant. Choosing a consultant is a very personal choice. We considered the criteria to consider when selecting a consultant, what is your primary need, for example, knowledge or human resources; is this a one-off need, or do you want to establish an arrangement with a go-to partner who can support your changing needs? Here are some things to consider and recommendations.
Knowledge
- Is the consultant truly an expert in your field? Many people think that the IVD and medical device requirements are the same. Structurally, the regulations may look similar; however, if you need support for analytical and clinical performance, you really need expert knowledge for these specific scientific studies. If you are updating your complaint-handling system, transferable skills between medical devices and IVDs may be appropriate.
- Consultants should always share CVs. Look at the CV and also look at LinkedIn. If they claim they are an IVD ‘expert', have they ever worked for an IVD company? How long did they work for them, and in what capacity?
- Be aware that serial contractors who have never worked in the industry may have a limited overall understanding of full regulatory obligations. Contractors are great if you need manpower and have the knowledge and time to guide the contractor; this can be cost-effective. If you need manpower rather than knowledge, this may be a cost-effective option, but it may not provide the desired result. It is, therefore, essential to determine whether you need knowledge or manpower when contacting a consultant so you can evaluate the costs versus experience.
- Do they publish posts that will indicate how current their knowledge is and how relevant it is to your needs? Is the communication clear, practical, and in a style that helps you understand the topic?
- Ask colleagues for recommendations or look at LinkedIn. Are they connected to anyone you may know who can provide a recommendation?
- Consultants cannot usually share their client lists; however, they can tell you about the type of products they have worked with, the services they provide, and whether the files they have worked on have received appropriate clearances or approvals.
- Do they participate in organizations such as trade associations/ RAPS? This may be a good source for recommendations. It would be best to ask how they keep up to date with best practices.
Service offering
- Many IVD companies are changing their go-to-market strategy from the EU first and then the US to the US as the first market entry point. If you have not determined which market you will address first, ensure you work with a regulatory affairs consultant with a good grounding in both regions. Regulatory requirements for target entry should be built into design control, now we have passed the date of application no new devices are legacy.
- Talk to your prospective consultant to see whether they have experience writing documentation to support your needs. If it is the first time for them to write the particular document you need, it will likely take longer and hence cost more as they create fresh content.
- If considering EU and US market entry, do they have experience with both EU Notified Bodies and FDA; for example, do they have experience in writing both 510k/PMA and EU technical files, and can they discuss the challenges this can entail? Have they participated in pre-submission meetings with FDA? What interactions have they had with notified bodies, and which notified bodies have they interacted with?
- You need to identify an organization that can address your needs now and in the future. Some companies will use different regulatory affairs consultants for different countries. Unfortunately, the regulations in the US and EU are configured differently. Data can be repurposed, but you want to avoid one consultant undoing the work of the other. Both consultants may be correct from their perspectives. If you are creating files for multiple countries, you will want someone who can create documentation that satisfies all regulators effectively and efficiently and has experience doing this.
- For successful market access, you may require in-country representation. Is it advantageous to work with an organization that can offer all these services for all the countries on your business plan?
- If possible, find an organization with a broad service offering. Regulatory consulting can often be like medicine; you go to the consultant with a symptom, but you need to identify and then fix the root cause as well as the symptom to employ the most efficient and cost-effective solutions. It, therefore, helps to work with a regulatory consultancy with a broad spectrum of knowledgeable experts so that they can not only address the symptom but help identify and address the root cause. For example, a manufacturer may look for a consultant because they have received a number of notified body technical file questions and ask for medical writing support for the Analytical Performance Report; however, the real problem may not be the quality of the medical writing but that the data itself does not meet the intended purpose or support the state of the art in the EU. This is why industry design and development combined with regulatory knowledge is ideal.
Culture
- Make sure you talk with the consultant you will be working with. Can you work with this person? It's a bit like choosing a personal trainer; they will need to motivate you but sometimes help you to be realistic about your expectations.
- Consider whether language or time zone is important to your relationship.
- Does their communication style help you understand the topic? Communication is a very personal thing, and you are selecting a key partner to work with, so you must be on the same wavelength.
Are you thinking about using an external regulatory affairs consultant?
Get familiar with Qserve IVD consultancy or contact us for a first introduction.
Coming up in the next blog:
When should IVD companies engage with a regulatory affairs consultant?
Part 2 | 'Good Help is Hard to Find' – engaging with a consultant at the right time could save you time therefore money.