Consultants Hiring Problems and Solutions: we will try to address here the main issues companies may encounter during and after the hiring process of a quality and regulatory affairs consultant.
Lack of experience with the device classification
You wouldn’t be fit to prepare some elaborate meal if all you had done so far were pasta. That would be quite a stretch and there could some “surprises” for the guests.
The same goes for the consultants. They might be experts quality system, design control, validation, risk management etc… but what if they have only applied it to low class of risks devices (ultrasound for instance) and your product is a drug eluting stent ? It’s a completely different field and for instance, some risks may be overlooked. In the other direction, someone mostly familiar with high risk devices, might develop disproportionate solutions and documentation for your low risk device. So it is very important to make sure that the consultant is familiar with the device class you are producing. That way, he or she will be more familiar with the guidance documents and applicable standards specific to your devices.
Consultants Hiring Problems and Solutions: Lack of experience with the regulatory pathway
Before you start to discuss your pathways to get your device to market with the consultants you should review their experience with the various pathways and supporting submissions. This is especially true when you anticipate further support. So you should inquire about the following :
Has the consultant prepared CE marking submission with the technical file preparation and the quality management system compliance ? Have they prepared 510(k) submissions? Have they prepared IDE submissions and handled clinical study documentation? Have they prepared PMA documentation and supplements? You don’t want to get a regulatory strategy document from one consultant, only to have to find a new partner to support your submission, if at all possible.
Consultants Hiring Problems and Solutions: Lack of experience with your business size
A consultant may have a only experience working for larger medical device companies and then struggle when working with startups. The mature systems in place in larger device companies is often not directly applicable to a startup. Startups must be lean and agile, and often have to take greater risk, given their minimal funding.
A common mistake is to start to build a full quality management system (QMS) before the company has any devices in commercial distribution. The QMS should be built at the same rate as the product is moving through the different processes and toward distribution. Things like post-market, production, testing would not be needed in the beginning. The right consultant for a startup will understand the need to build a progressive QMS and help limit the expenses.
Conversely, a consultant having experience exclusively with startup medical device companies often will struggle to help a larger client. They can be easily frustrated by the scale of the QMS and struggle for the patience to operate within the system. However, this type of mismatch can be beneficial for a larger company if they are looking to simplify their QMS as part of a lean initiative.
Lack of qualification
You should require whenever possible relevant evidence of qualification from the consultants. It may be training certificate, certification, records of experience, recommendation letters etc… In some cases there are specific requirement that apply to a certain activity such as clinical evaluation in Europe. If you look at the European Medical Device Regulation 2017/745 you will see that there are specific qualification requirements to perform clinical evaluation.
Consultants Hiring Problems and Solutions: Fees inconsistent With Your Need
Getting support from highly-skilled expert for a short duration will likely be expensive; perhaps $200 to $300 per hour, or more. Depending on the size of the consulting firm it could more or less expensive. The trade-of is that small consulting firms are more flexible to take on projects but they may be less adaptable if changes happen during the project. It would be difficult to change or add more resource to the project.
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