August, 2023 | QAdvis AB

The above is a quote from Peter Drucker (1909 – 2005) the founding father of modern management studies. And nothing could be more true, especially if you decide to start a business in the medical device consulting industry.

That is exactly what Robert Ginsberg and Nils-Åke Lindberg did in 2013 when they founded QAdvis AB.

It is said that the first year of a dog’s life is roughly fifteen human years. The second year is nine years and each additional year four or five years. In a way the same can be said for companies. The first years are dog years for all companies, but in the medical device sector the dog life never stops, the fast development of technology accompanied by updated regulations makes you feel like each year is at least five years all the time. You can never relax thinking “I got this” since the only constant is change. The ground you are standing on is always moving and your knowledge and methods must evolve and follow. This is the environment in which the seed of QAdvis was planted and has grown ever since.

Since 2013 the world has seen tremendous change, in Sweden alone the population has increased with nearly a million people and the petrol prices has increased by 45%. In the medical device field, the changes have been even bigger. ISO 13485:2003 was replaced by the 2016 edition, and the Medical Device Regulation and the In Vitro Diagnostic Regulation replaced the MDD and the IVDD respectively, which was the single biggest change for medical devices and invitro diagnostics in 20 years. The fast development of software also initiated the IMDRF to release the first guidance for Software as a Medical Device (SaMD) in 2013, and the development of software and especially AI has since then exploded. In addition, we’ve seen Canada discontinue the CMDCAS and adopt MDSAP, we’ve seen Brexit as well as the breakdown of the MRA between EU and Switzerland leading to the introduction of UKRP and CH-REP.

And all these changes were made to the living and breathing medical device industry. Like doing knee-surgery during a marathon, or like that episode “Wrong Trousers” in the British stop-motion animated comedy “Wallace & Gromit” where the anthropomorphic beagle Gromit is sitting on a full speed toy train and building the tracks in front of him as he goes, simultaneously navigating through treacherous surroundings.

In such a changing world, the need for knowledge of what to do and how to do it, was and is insatiable. Knowledge, although necessary, is however not enough. Even very knowledgeable people will fail if they fail to understand the needs of the customer. With that in mind, QAdvis decided to employ seasoned “humble experts” with a deep understanding of customer needs building the foundation for our “solution-oriented knowledge” approach. This has turned out to be a winning concept. Since 2013 the revenue has increased by 200% and the number of employees is continuously growing and today, we have offices in two countries and customers in many more.

This is an exceptional growth and QAdvis was therefore awarded Gasell Company of the year 2021 by Dagens Industri, the biggest daily business paper in the Nordic countries. To quote the founders’ words at the time “We have no ambition to be the biggest, but we for sure want to be the best.”

Now that we celebrate our 10^th anniversary, or 59^th anniversary in dog years, we look back on 10 years of success for us and our customers, and we are looking forward with anticipation to the next 10 years and the future.

Having dual sourcing of important components causes additional work, takes more time and negotiation price could be less successful with half the volumes.

If you add this to the fact that you also double your suppliers with additional supplier control, validations and possible Notified Body involvement, the natural question would be: Why on earth would I do this?

The simple answer to this question is risk management.

With the situation in the world right now, procuring components, especially electronic components could be difficult. And as a medical device manufacturer you cannot change components at a whim.

Change control and verifications demand time as well as resources. Also, the fact that everything is “just in time” these days means that if your single supplier runs into problems, delays can quickly become severe problems. Another scenario would be that the supplier ceases operations entirely for some reason. What do you do then? How much of the components do you have in stock before you run out? This is especially a problem if you outsource parts of the manufacturing itself or buy finished parts to be included in your device.

A real-life scenario was when a critical supplier who manufactured complicated parts to the legal manufacturer suffered a major natural disaster causing the entire production to be halted for more than a year. That caused a huge setback when all shipment of devices was halted once the stock ran out.

So, for components or details that cannot be easily replaced, a second supplier can be a good idea. Also, for price negotiations it can be a good thing to be able to match the prices between two suppliers. If delays or if serious problems occur at one manufacturer, this could be more efficiently handled if you already have a replacement.

The most difficult part is probably to sell in the idea to the management team since it will add costs. Especially if you haven’t had any problems so far. But even though you never had a fire at home, you still continue to pay your home insurance.

So, plan ahead and make your disaster management process include the risk of catastrophic events not only on your site, but also at critical suppliers.

What will you do? What level of safety do you need? It all depends on the criticality of the components you require, and the risks associated with it.

If you would like to know more or if you need guidance, contact us at info@qadvis.com or annelie.hagstrom@qadvis.com

Whenever you see a successful business, someone once made a courageous decision.

The above is a quote from Peter Drucker (1909 – 2005) the founding father of modern management studies. And nothing could be more true, especially if you decide to start a business in the medical device consulting industry.

Why having a second supplier could make sense even if it costs more.

Having dual sourcing of important components causes additional work, takes more time and negotiation price could be less successful with half the volumes.