When you are looking to bring external regulatory or quality resources into your business, there is so much to consider. Will you feel more confident working with established consultancies, or are you looking to work with independent contractors?
It is a challenge finding the right consultants who not only have the required expertise but also fit in with your company culture. The benefit of bringing in the right skillset can be the difference between getting your product to market in a timely and efficient manner and ensuring you are compliant or ‘missing the boat’ completely. As a medical device consultancy company ourselves, we appreciate bringing in the right resource is vital to support your business. We are regularly asked by our customers what the differences are between consultant and consultancy for which we give our honest opinion.
We look at the potential positives and negatives of using different-sized businesses and identify some of the top small to medium-sized medical device consulting firms in the industry today.
Independent Consultant
There are so many great independent contractors in the market that have a wealth of expertise, from Regulatory Affairs to Quality Assurance, as well as Medical Writing. It is about making sure you find the right person with the correct expertise for your project.
Independent contractors will have a limited company, but they will also be a one-person business that may have several projects at any one time.
If you choose to work with independent contractors, it is important to make sure you carry out due diligence by interviewing them, obtaining work references and ensuring they have the correct liability insurance in place.
Consultancy Companies
Just like with contractors, there are many great consultancy companies out there to choose from. They tend to have several members of staff, all with varying areas of expertise they can offer. This will allow the team to leverage their expertise and provide an overall work package to suit your specific needs.
Just as with independent contractors, it is important that you carry out your due diligence by requesting their skillset, e.g. IVD, SaMD, etc., client testimonials/case studies and their liability insurance.
Calling Out the Positives and Negatives
So, what are the actual positives and/or negatives of working with an independent contractor vs. a consultancy company?
Below, we have documented what we believe to be the positives and negatives of working with a consultancy vs. an independent contractor;
| Independent Contractor | Consultancy | |
| Cost | The hourly rate of a contractor will most likely be lower than that of a consultancy (which may not always be the case). Lower costs can be due to less overheads e.g. professional and employee costs, office space, marketing costs etc., meaning they can offer a more competitive price. | The hourly rate quoted may be higher (this may not always be the case), with deliverables being presented in a timelier manner saving on initial outlay. |
| Speed | Quicker turnaround times on your request due to the number of clients they have on their books; potentially less “red tape” and paperwork. | Slower turnaround times for your project due to a higher number of clients meaning a delayed start date. It should be noted that this is not always the case and will be dependent on the size of the consultancy. |
| On-time deliverables | Individual contractors need to take well-earned holidays. They could also have unexpected absences, which impact timeline deliverables and business continuity of your company. | A team of people who can step in for planned holidays or unexpected absences resulting in the required results being delivered on time. |
| Skillset | Individuals can have high areas of expertise from their time in the field but there can also be individuals who have a niche skill set.There may be limits on their knowledge resulting in a delay in project. That being said, it shouldn’t be discounted, as contractors often have built up a network of similar-minded experts who can help with their queries. | Consultancies have a team who have a wealth of experience in different areas of the Medtech sector; this allows them to offer an overall package of work, meaning you don’t have to look elsewhere. |
| Resource | Contractors could work on several projects with limited resource in place. | Allocated resource is customarily assigned to your project. |
With the above information in mind, it is always worth speaking with and getting a few quotes from different companies to understand the market costs and whether they are right for you.
So, who are some of the well-known and top UK consultancies today?
We have documented several companies below, but these are not limited as there is a continued growing number of consultancies entering the field today.
Meddev Solutions – A Trinzo Company
Meddev Solutions is based in Northern Ireland and is part of the Trinzo Company. They offer consultancy services for medical devices as well as pharmaceuticals, as well as have a wide range of training available from SaMD to Risk Management and EU MDR/IVDR courses.
They can provide support activities such as:
- Remediating audit findings
- Device development and CE marking
- QMS requirements
- Technical documentation
- Risk management
- Clinical requirements
- Standards compliance
- Verification and validation
- Supplier management
- Product registration
- Recalls and adverse event management
- Product design
Apotech Consulting
Apotech Consulting is based in London and Paris; they work in the fields of Pharmaceutical, Biotech and Medtech, concentrating on Quality Assurance, including audits, regulatory affairs and validation activities. They specialise in the UK, EU and US markets; some of their specialism in the medical device/IVD industry are as follows;
- UKCA & CE Marking
- EU MDR & IVDR transition
- UK Responsible Person (UKRP)
- FDA Regulatory submissions; 510(k), De Novo, PMA
- Clinical Evaluation and Performance Evaluation report authoring
- USA & EU Regulatory Strategy
Imed Consultancy
Imed Consultancy was established in 2012 and currently has 13 team members ranging in different areas of expertise. They specialise in Regulatory Affairs and Quality Assurance in medical devices, including Class III, active & implantables, Software as a Medical Device (SaMD) and IVDs from the UK to the EU and the USA, but also further afield.
They also offer additional services such as UK Responsible Person (UKRP), Person Responsible for Regulatory Compliance (PRRC), Global Registrations and numerous training courses that can be customised.
Advena
Advena has been established for over 25 years; not only do they offer support with medical devices, including IVDs, but they also support the cosmetic market access from a regulatory and quality perspective.
They offer a fully equipped electronic QMS system to clients to organise, control and help implement all the necessary areas of their QMS.
Some of the other services they offer include;
- Medical Device & UK Responsible Person services
- PRRC services
- QMS review and implementation, including ISO 13485 and MDSAP
- Auditing services
Psephos Biomedica
Psephos Biomedica is a medical device regulatory, clinical, and quality consultancy that was founded in 2001. They specialise in working with all different classes of devices from class I through to class III and cover areas such as Digital Health and AI, Cardiovascular, Neurovascular, Surgical and IVDs.
They also assist with clinical services for UK clinical submissions, which include:
- Integrated clinical and regulatory approach from first-in-human / early-stage feasibility studies through to pivotal trials.
- Clinical trial strategy, design and management (ISO 14155 / MDR / FDA)
- Competent authority, ethics committee, and related clinical study approvals
- Clinical evaluation plans and reports
- Post Market Clinical Follow-Up (PMCF), including registries
Do you need help to understand the ever-changing regulatory landscape and the requirements, or who to work with? Get in touch with us today for a no-obligation chat to see if we are the right fit for you, at tel: +441484662575 or via info@lfhregulatory.co.uk. Alternatively, you can also simply click on the ‘Contact Us’ button below to see how we can help.
