How to choose a Medical Device consultant (by a medical device consultant)
The nature of medical device or combination product development is that many projects, at one point or another, are likely to engage external support - in the form of medical device consulting. This is true from the largest pharma to the smallest startup, and is due to the high complexity, large breadth, and many niche topics that have to come together to make a medical device successful. From specific knowledge on biology, chemistry, or engineering through quality and regulatory, to market access and reimbursement, the world of medical device development is too large for most companies to keep all needed skills available at all times.
In short: It's rare that a single organisation has, internally, the complete breadth of skills needed to bring a product successfully to market.
Given that interaction with a type of medical device consultant is likely, there is little guidance available on what to consider when finding the consultant that's right for you, your project, and your organisation.
So, as working medical device consultants, we thought it would be helpful to pull together our view on what does and doesn't work when finding the right support for your project. These thoughts are based on direct experience of successful, and not so successful projects, large and small, and working with everyone from 1-person startups to 100,000 employee multinationals.
1. Skills-Need matching
Perhaps the most obvious requirement, but not all medical device consultants are equal at all tasks. There are as many types of medical device consultant as there are skill niches within Medical Device and Combination Product development. Some examples of the focus areas of other medical device consultants we know include:
Regulatory submissions (US, EU, or global)
Technical development and prototyping skills for medical devices
Usability, user needs, and human factors engineering
Clinical evidence planning and reporting
Quality Management System buildouts
Pricing and reimbursement
Clinical trial planning and execution
Overall product strategy
Project management and realisation
etc.
The first task in finding the right medical device consultant is to ask yourselves what skills are needed for your medical device to succeed. This then allows you to find a consultant with the right skills and experience what match your need - by talking to them, reviewing their website, or talking to other organisations that have used them before to understand the areas they are strong in.
This is an important first step to get right - we've seem many project struggle and fail due to a mismatch between the skills of the consultant and the needs of the project
2. Breadth and depth of experience
As a follow-on from point one, it's also key to understand the breadth and depth of experience of the key consultants you will be working with - not all consultants are created equal. Note here the point around consultants rather than consultancy. You may be talking in the sales process with a senior manager of 20+ years experience, but particularly in larger consultancies they are unlikely to be the person working on your project, which is often given to a more junior member of staff.
Smaller consultancies often mean that the person you initially talk to is the person working on your project, but it's also key to explore how the depth and breadth of their experience overlaps with your need. They may have decades in a large pharma, but how long have they been consulting? They may be a long time in consulting, but have they demonstrably developed deep knowledge of the medical device space? Your regulatory consultant may be a deep expert on 510(k)s, but does that experience translate to the PMA you need for your Class III implantable?
With any consultant it's worth digging deeper into the depth and breadth of their experience and how well it meets the needs of your project
3. Right strategic level
Often not considered but hugely important is choosing a medical device consultant who will work at the right strategic level for your project. We have seen many projects flounder because an organisation engaged a consultancy who did a superb job of the wrong things. Projects that needed expert review and guidance of the project positioning and strategy ending up with a very highly engineered prototype of a device that no health system would adopt. Equally challenging are situations where, for example, a startup needs hands on help on a regulatory submission, but can only get from their medical device regulatory consultants general comments, feedback, and opinion - rather than the time spent writing a submission that gets a device through approval.
In these situations the consultants engaged had the breadth and depth of experience needed to truly help the client organisations get to where they needed to be, but working at the wrong strategic level meant that their skills were not able to be used to meet the needs of the project.
A related key question is: do you need guidance, or do you need hands on help? Or both? Matching the type of consulting received to the type of consulting needed will go a long way to success in a medical device consulting relationship. In response to this we have developed at FSI a five level model in terms of strategic support levels
Contractor - the provision of on-site practical skills under your direct guidance
Consultant - the provision of skills that are specialist and self-directed that integrate with your team as a trusted partner
Coach - the provision of skills that teach you how to address your challenges rather than address them on your behalf
Advocate - broad and personal 1:1 support to help you across a wide range of areas to achieve your goals. A mix of doing, teaching, and advising
4. Cost
Cost is always a sensitive topic in the world of consulting and rightly so. No side of the consulting relationship want to lose out, either by over paying for the value of work received, or undercharging for the impact one has on a project.
The cost question is often also compounded as many organisations see consultants as fully interchangeable, and so the consultant that comes in with the lowest price wins.
Of course we all need to be cost conscious, but it's important to be mindful that the right consultant is not often the cheapest. Particularly as support gets more strategic or specialist, then the average hourly or project rate rises. As the three points we've already discussed lay out, not all medical device consultants are equally able to help your solve your challenge, and so while cost should be a factor, it is a mistake to make it the only factor when choosing a consultant to work with.
Key questions to ask yourself when considering and comparing the cost of consultants include:
What is the value to the organisation of the proposed work to my organisation? And does the cost match that value? Big mismatches should be a warning flag. Good consultants know the value of the work they deliver, and will aim to charge that. Poor consultants often under charge and under deliver.
What is the cost of getting this decision wrong? And how much am I willing to pay to avoid these costs? In most cases getting a cheap mismatched consultant is more costly than getting a well matched expensive one. The challenge is these costs occur downstream - in missed deadlines, technology failures, mispositioned clinical evidence, or regulatory approval delays or rejections
Do I know what other consultants are charging for similar work? Benchmarking across several potential consultants can be a good way of verifying you're paying the right prices for the right work
Overall it's important to be cost-mindful - taking into account a wide range of factors to make sure you pay the right price for the right work
5. Integrated partner vs. Siloed supplier
A common story we hear when talking to our clients about previous consulting experiences they've had is the following:
They find a consultant with the right experience, for the right cost, at the right strategic level. They get the contract organised and begin work. Then communication drops off. The consultant turns up to weekly check in calls, but the details of the work they are doing remain a mystery. They deliver on time and on budget, but the work is misaligned against the needs of the project, particularly if those needs have evolved - meaning extra time, cost, and effort to put right. Or in the worst case endangering the success of the project overall.
These clients have unfortunately experienced a medical device consultant with a siloed supplier mindset. These consultants often require the full details of what they should deliver defined ahead of time in an RFP with every i dotted and every t crossed. They then take the work and beaver away internally to deliver to their interpretation of the needs of the RFP without coming up to check or alignment, optimisations or project evolution.
The ideal consulting partner is exactly that - a partner - proactively in communication around the project and seeking to integrate as deeply as possible into the project, the team, and your way of working. This way of working shows a dedication to delivering the right thing for a project, not simply what was initially asked for.
Finding a medical device consultant able to work as an integrated partner, rather than a siloed supplier is essential in getting what you need for your medical device or combination product project to succeed.
6. Retained value
On optimal medical device consultant is not one that keep your reliant on them and so returns again and again, but one that provides retained value to your organisation - helping you to develop the skills and experience for you to take on more of the same work were it to become a need again in the future.
Often this retained value comes from getting the points above right - connecting with an experienced consultant with the right skills for your project, who is deeply embedded as a core part of your team. It also relies on the mindset of the consultant themselves, and the extent to which they are willing to be open, explanatory and supportive to your organisation achieving the right thing, over what is of most benefit to the consultant themselves.
Finding a consultant that can build retained value in your organisation gives you the best long term value, even once the consultant themselves have completed the immediate task
Summary
Finding the right medical device or combination product consultant to support your development journey is not a straightforward task. It requires careful understanding of the precise needs of your project against the capabilities and experience of the consultant, as well as their ability to work closely and deeply with you to get the right result, rather than the easy result.
For this reason, costs need to be considered mindfully - the lowest bid is rarely the best, and often results to greater cost over the long term. It's important to assess the bid put in by a consultant against the value of the work to you as an organisation, and selecting for long term value.
This also takes a little bravery on the part of clients. Above all consulting is a deeply personal relationship. Much depends on whether the person in front of you is someone you feel you can trust with substantial parts of the future of your business. Often the best relationship is the one which will drive the greatest value to you.
Are you trying to find a consultant to help with your medical device or combination product development journey? Feel free to message me here or on Linkedin for a 1:1 no-obligation chat to see how we can help you