Medical Devices - The Natural Path for AlfaNordic

AlfaNordic has traditionally been a competence house focusing on counseling within GMP. GMP is still the core area, but now the course is getting bigger with a new large area, with advice in medical devices. Henrik Linnemann is the current leader of the area, but the plan is for him to be just a kickstarter. Here Henrik introduces the area, but what is the idea of the whole thing in the future?

What does AlfaNordic’s medical devices department look like?

The department consists of 6-7 people – some more hardcore than others – so it is already an out-and-out department staffed with consultants and it has to grow further because it does not yet match the market. Our people are good and they are able to advise our customers as to what important areas to focus on. Most of them are capable of training people both internally and externally. We conduct a lot of internal training ourselves in order to become even better at handling this area. We always have our antennas out and we are working on employing even more people.

It was actually network sales that started it all. We acquired our first assignments via our network and some of our people were able to advise the customers within the medical devices area. And after that, we started to hire more people with these competencies.

Why does AlfaNordic now want to offer medical devices consulting services?

Medical devices constitute a big industry in this country, it is extensively regulated and it overlaps the GMP area which is our core competency. This constitutes a cross field so it is quite natural for us to move in that direction. If we don’t, we theoretically renounce a part of the GMP industry at the same time.

A lot of our people are competent in either area, they have experience from both the medical device and the pharma areas. Changes to the regulations for the device area are ongoing and this means that parts of the area is regulatorily moving towards the regulations that we know from pharma. When new changes are implemented and become effective, many companies will be facing the challenge of interpreting what is required, what is adequate et cetera. It is then our mission to step in and help with the competencies we have at our disposal.

The Medical devices directive is at the present time being updated. It has not yet been approved, but we are talking about for example a QP (Qualified Person) –- that is, a person who approves releases of products. This is something that we recognise from the medicinal product industry. This may become one of the new requirements. There are lots of requirements for the competencies of such a technical person, and this in turn generates a lot of questions: How do we implement all this? Are we now faced with coming up with something new? This is when we can step in and facilitate processes and help our customers because we now have an area at our disposal – a group of people who are well versed in this area and who stay updated. It is not that a market revolution has taken place, but as a company, we have moved along by acquiring a number of broad competencies. So it makes a lot of sense that we now also offer consultancy services within the area of medical devices.

Why are you the one heading the medical services area?

I was an advocate of pushing it, and besides, I am an old validation wizard myself, says Henrik with a twinkle in his eye. And I have previously worked with medical devices. That said, my focus is normally different and we intend to have someone come in and take over my position.

What is going to happen this year to AlfaNordic’s device area?

We need to heighten the general awareness of the fact that we offer consultancy services within medical devices. We have launched a great number of new initiatives. For example, we are establishing contact with a lot of new companies who have not earlier been working with pharma and biotech and therefore do not know us. At the same time, the group must get bigger and better. We aim at finding the right person to manage the area. If such a person is out there and is thinking: “Why, that’s me exactly” I would very much like to hear from him or her.

And who is this right person?

Someone who understands the role of a consultant vs. the role of a person being permanently employed. There are some differences in work routines and some differences in personality. The right person must also have an understanding of the business side of things. When you are heading an area, you have a budget and you have a responsibility for making things happen, and for succeeding. You are responsible for insourcing – that is, for hiring the right persons, and you have to know what types of people are needed. How is the market compared to the people who will be working in it? This area may become big for us so the person must have the ambitions and the initiative required.

It doesn’t actually have to be a person who is a super specialist within medical devices. The person should be more of a leader and sales-oriented person than a specialist. The right person must of course be able to discuss the relevant subjects, but he/she does not need to be at the same detailed level as the super specialists. It is more important that you can sell the services to the customers and nurture the people you hire.

We know that AlfaNordic’s tag line is “Excellence in GMP”. Is this going to be a problem now?

No, I think it is an asset for us that we are profiled on GMP. As we discussed, the two areas are in many ways closely connected. It is just an indication of good synergy – and if the area grows big enough, medical devices may get its own tag line, Henrik concludes with a smile.


AlfaNordic leverer ekspertviden og rådgivning af høj kvalitet gennem alle faser af medicinaludstyrets livscyklus.


Medical Device in AlfaNordic

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