Interview Transcript: Jan Moe, Vice President of Sales, Amicas Inc., Oct 22, 1998.

J: okay I got involved with Amicas and, actually was auto site group, about six months ago in actually was about year ago... Okay Levy try again.

C: you can make it all up, but the story at least has to be straight. [Laughter]

J: know it was interesting I've been in medical sales and marketing for [cough] 20 years and have always worked for fairly small companies, 20 million or under and for the last ten years, until year ago when I started with Amicas, I was working for nuclear medicine company and the on the... why am I nervous? I was working for nuclear medicine company as director of marketing and sales, and so I covered all the United States in marketing and sales and I had people that reported to me as marketing, sales, technical service.

C: what was the name of the company?

J: the company was CIS U.S. and they were located in Bedford MA, and it was a subsidiary of a French company, and the French company was quite large. And it was interesting that was a small company here in the U.S. with 55 employees, but in France there were thousands of employees...

C: and was all nuclear medicine there is well?

J: mostly nuclear medicine, but the interesting thing was in the small company with 55 employees, you could make fairly quick decisions, we didn't have to go through a big corporate structure until and in we wanted to acquire another company, or wanted to do something where we wanted to get the mother company involved, at that point everything slowdown to a halt. And of course they wanted to do it one way, but we knew our own market better than they did and so I been working with them for about ten years and um, exactly ten years, and I was ready for change, because they were rather risk averse. When I started with the company in we were doing about a million dollars and sales, and last year we did 17 million, so we were growing the company by acquisition and by the sales of existing products. But I could see that the next two or three years there was nothing on the horizon, so I decided I was looking for something new and exciting to do, and my husband has been involved with medical sales and management for quite a while and Adrian had actually approached him and asked him if he knew anybody in marketing and sales that might be willing to come with a start-up company, might actually be willing to not be paid once awhile or, at all. And someone who knew something about the hospital settings selling into hospitals FDA requirements I So requirements, so my husband gladly volunteered my name. The first in introduction I had to Amicas was I went into see Adrian a few times had mass general an I took the infamous two or that he gives and didn't understand anything that he told me but shook my head a lot and smiled. Then I went to the big convention in November, which was the RSNA, an I found out a lot more about the product real fast and I knew it was something that was exciting and it was a concept that the market wasn't quite ready for, and we were, well Amicas was...

C: you can just say "Sean" whenever you mean Amicas... [laughter]

J: was developing this, and it's an obvious product for the future. So even though people would come up to the booths then you tell them what the product was, they would look at you with that blank stare, their eyes would roll up into their head, you just knew that the concept was right, or I knew the concept was right. And so about three months after that, I quit my job and I decided to go with Amicas full-time, because what I had been trying to do was to do a full-time job in the day, and and at night to Amicas, but that's impossible because people work during the day, they don't work at midnight when you're, trying to call people waited night in, they don't like it when you get them out of bed to talk about Amicas. So I quit my job.

C: this was its CS U.S.? Where they doing stuff with MGH there?

J: at CIS U.S.? Yes a little bit, we sold mostly radiopharmaceutical products, and many of them we were the only one sold in United States, so if they wanted it they had to come to us. It sounds great, it sounds like, "oh you had a captive market," but it wasn't all that great because they were old products and the reason we were the only ones is because no one else wanted them. There's only so much iodine 131 you can sell in the United States, sulfur call I products, and we worked at mass general on that. We also sold a big blood there radiator which had Cs 137 in it, this weighed five thousand pounds, and we actually but one in MGH, so at that point I knew a little bit about the mass general's radiation safety people and their rules and regulations about radioactive send radiology but that was my only real contact.

C: so this was a real switch them?

J: oh definitely I've always been in medical devices and all of a sudden I've switched over to software and I am not technical and software at all I'll admit this right up front, it's taken me a really long time to understand what this product is all about, an I feel I'm about 50 percent there. Because every time I listen to Sean are Adrian give a presentation and there is a technical question asked, I cringe because I have no idea what the answer is, but I learned something new every time, it's great.

C: well it sounds like a difficult challenge, because if you know the FDA rules for devices, this is something that seems to not fit into that...

J: well actually it does everything you do with marketing and sales of a device in the medical world is very similar to what you would do with software. With the FDA they're very interested in validation, whether it's validating putting two pieces of plastic together, and what kind of glue you're using to do that, or if you're validating the process of the software, their interested in the quality of the product and is it can harm the patient, or be good for the patient. And you still have to have a 510k, so you're in different classifications but you're really addressing very similar markets so it's not that different, the difference comes in with a device you can hold it, and you can say see this is how you work it, with software... with a device you can also say pick up a manual and say "here's the manual", with software your working with people that like to do everything on the computer you say "oh you wanna see the manual, the me go on to the home page" but basically FDA is looking for quality in the medical world and ISO is very similar. And

C: now oh other a lot of things that in terms of the FDA are sort of grandfathered in? So that for instance, the use of medical images doesn't have to be validated because they're validated in DICOM, or the devices that produce them?

J: I'm not expert in FDA but basically the FDA once to validate the fact that if you say that the image quality is going to be X that when it comes across every time its X. And that you validate this may be wants every week, every month whenever you tell them into the do for validation you have to follow through with it. But is far as grandfathering, I'm not sure there's a lot grandfathered in software because my grandfather wouldn't know what software was [laughter].

C: one more joke like that...

J: oh I'm not supposed to joke? Its true really the software is the new development and even the equipment that had computer programs on them 10 years ago that's new software. There's nothing... the FDA started the five 10k program in 1976 I believe, so there wasn't anything before 1976 that was using digitized images. You were using the film and that was what you thought you were going to use for the rest of your life. With the ISO that's completely new to everyone in the medical world and is no such thing as grandfathering ISO into place.

C: ISO 9000 or ISO everything?

J: ISO 9000 medical world and ISO of course is a European standard vs. FDA which is American standard. Okay, is it over?

C: well actually like to hear more about this because that something that I'm trying to piece together the political issues around something like this. Lemme give you the example that always comes up what I tell people about telemedicine which is this question of if you have in a string of doctors, one in Turkey and, for instance, one in Brigham and Women's Hospital, who are all operating were using subset of images along the lines, then the question of liability becomes important. In United States, you just sue everyone, but when its international, you have a different issue there, because well I suppose you can take things to international law, but... so I guess the concern people have is who are the people that are responsible for that, is it just ISO and FDA?

J: actually neither FDA nor ISO care what goes on. FDA has always been worried about the manufacture of the product and the quality that goes into the products of, if you using a specific glue or a specific plastic you have to let the FDA I know exactly what that is, if you make it change in the product to have to submit a yearly report, what the know exactly what that is. So its always been very easy in the medical market with the FDA because the only thing the commercial people really had to do with FDA was if you had a customer complaint because the FDA once to know, if there are complaints, great having a lot of similar complaints from other customers what you doing about them are you going back and looking at your revs or your lot numbers, the FDA once to know is this a trend is it something that the hospitals doing wrong, maybe they should going talk with a hospital and see if maybe they're not qualified people at the hospital, so quality control and quality assurance has always been the people they're responsible for FDA, and everybody else's said oh that's quality assurance quality control we don't get too involved with that. And quality assurance would go through manufacturing and they would go through the standard operating procedures for, that you have told the FDA that you're going to follow, and your not following them and they would internally make changes. Then I So came along. The European said we wanna system that is not just manufacturing, we wanna whole quality system. So before you can sell a product into any of the European communities, what we want is the commercial people to tell us, when you quote a product are you putting the same thing you quoted everybody else, are you quoted the right product is at the right rev, are you quoting and then they want something else and you're not writing that down, if the order comes in to customer service are you paying attention to what they are saying or you just sending out anything, and so they want you to be very interested in the quality and taking care of the customer, whereas in the U.S. the FDA doesn't really care, as long as it's not a product complaint they don't care if you have no customer service, they of course one your salespeople to represent the product properly, and they're interested in your ads any literature, but day-to-day operations they're not interested in what in, 12 they don't concern themselves with governing that. But I So they govern everything, everything that you do, and the difference is when you set up and FDA system, you have a regulatory affairs person and that person you know they write all the rakes and everything in you really don't want them in your office visits a little too scary to get into the scanner detail, so its like their responsibility you always put them over in a corner anyways good morning and have lunch with them but that's it. In sales and marketing unless this a product complaint, it has nothing to do with regulatory. I So, on the other hand they come in and I So wants everybody in the company to know what is I So the quality system are you doing what you're ISO procedures tell you your supposed to do, and I So they always tell you win you first get started, we don't care if your making the best product, we just wanna know that whatever your doing your actually doing, which seems a little bit odd but hopefully you doing both. But they're validation procedures are much stricter.

C: so how do they enforce this kind of thing?

J: FDA just knocks on your door they come in and say "you're going to be audited today" and everyone charges into their offices and hopes it they're not invited to the meeting. And the idea is that you have rules where the FDA signs in you take them to the conference room you only give them what they ask because you do want them involved with everything in the company and it's usually a very formal procedure. Also you don't pay the FDA people to come in they just volunteer it. With a pharmaceutical company, they are required becoming more often than device company. As a matter of fact in a device company they don't have to come in at all, unless there some reason why they need to come in. I So on the other hand, it involves the entire company and it has to start with the chairman of the board in the President and CEO, and I So wants everyone to be involved, its like one big I So party, and the difference is you pay the I So auditors to come in, and he auditors first come in before you get your before you get your I So certification, you have pre-auditors come in. You pay a lot of money for these pre-auditors and there's only 10 companies in United States that have these auditors, and you pay these people to come in and see if you're following I So procedures, and whether or not your following your own procedures according to I So standards, then they'll give you report and they're very friendly they'll say this is okay an amount was to give you advice but if you do it this way you have a better time with your auditor, so they're very friendly, this is not a relationship or your hiding in your office you wanna talk with these people. Then about two months later after you've cleaned up all the things that you had done wrong on the initial audit that's unofficial, you invite the real auditors to come in, then you pay them to come in, and your paying them to come from Europe, and they come to your company, and stay anywhere from one day to a week...

C: like in-laws...

J: [laughter] actually it's better, you could send the back to the hotel, they don't complain about your cooking. And they come in and they do a full audit all the different areas. Where the FDA comes in they might only be interested in one area, I So will go through all 21 areas of the guidelines. Then you get your certification, and then one see year after that you have to pay for these auditors to come back in...

C: once a year!

J: once a year.

C: now is there some other mandate about having an ISO 9000 certification, other than having then so you can deal with other companies? What's the real goal of having the I So 9000 certification?

J: the reason you wanna have I So 9000 certification, well for So of course you wanna have the best quality system, at Amicas we already have the best quality product [laughter]. After June 1998, European companies and hospitals are not allowed to buy from companies that are not I So 9000 unless they can justify into the European Community. So in fact, any device or pharmaceutical companies that were not I So 9000 certified by last June, cannot deal of the European Community. And Europe is a big market for most U.S. companies So everyone has jumped on the bandwagon. But I So is not uneasy thing to get your certification and it takes a year to go through your company, even if you're using outside consultants to get the I So 9000.

C: it sounds to me like, when Adrian first mentioned to me, it sounds like the specificity of it is actually had to capture, for someone like Sean and Jack, the design procedures that they have to go through or the openness of the system the sense that for a given customer you might have to customize in a different way, is it really actually hard to do that were doesn't fit into their guidelines.

J: well as long as they, the give you very broad guidelines, then you set up your own guidelines your own rules and regulations, so you have to write your own guidelines to what you know you can fit into.

C: yes but presumably you can't say, everything is subject to revision...

J: you can but you won't get your certification. In a system where your trying to customize things, it's very hard for I So to get their hands around that, so what they want is a wanna flowchart where this is what normally happens, but this is the way we customize things you go to block 3 in you put a narrow down then you continue to go around. But the FDA is the same way they don't want you to customize, they want you to sell the product you say you're going to sell. I don't think I So knows how to deal with software, medical devices are easy, pharmaceuticals is the pH right, but when it comes to software I'm not sure they really have a good grasp.

C: especially something like this which is reorganizing healthcare...

J: that's right not only that but it's a new concept. {Interruption}

Interview clip with Jan Moe: ISO

Interview clip with Jan Moe: ISO and FDA

Last Modified 11-Sep-99 9:34 PM ckelty@mit.edu

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