This is Spilling the Tea, a video series where we interview diagnostics industry leaders to get their perspective on “what’s now and what’s next” in the industry.

In this episode, Invetech’s Stephen Hess is joined by Joen Johansen, President of MDC Associates, to discuss:

  • What will be some of the permanent shifts in diagnostic product development as we move beyond the pandemic? [2:17]
  • Are we shifting towards government and private partnerships more permanently? [4:23]
  • When is the FDA approval backlog of non-COVID related products likely to start clearing? [6:18]
  • Are we seeing an inflection point of acceptance for complex POC instruments in the marketplace? [7:21]

Watch the 12-minute video to hear about these and other trends in the diagnostic industry.

Video transcription

Stephen Hess: Hi, I’m Stephen Hess, VP of Business Development with Invetech, and this is Spilling the Tea, a video series where we interview diagnostic industry leaders to get their perspective on what’s now and what’s next in the industry. Today, I’m fortunate to speak with Joen Johansen, President of MDC Associates. Joen, thanks so much for joining me today. Can you please start off with a quick introduction?

Joen Johansen: Thank you very much for allowing me to come on. My name Joen Johansen, I’m President of MDC Associates. We are a regulatory affairs, quality systems and CRO service provider for the IVD industry. We have been in business for more than 30 years, and I’ve been with the company for more than two years now.

Lessons learned from 2020

Stephen: So Joen, we’ve been so impacted by the pandemic in 2020. What are some of your biggest “aha moments” or lessons learned from last year?

Joen: Certainly, a number of aha moments and learnings from last year. Related to IVD and our business, we realized how archaic the testing capacity and the services that are provided around that was. It took a lot to ramp up testing. And we’ve been struggling now to get the testing to the level that it needs to be.

So one is, of course, with the testing capacity, where it’s performed, but also the infrastructure to help develop new diagnostics really wasn’t there. So that really had to be built within a very short period of time, and that’s what we’ve seen, which I think actually portends quite well for the IVD industry overall.

What are some of the more permanent shifts in diagnostic product development?

Stephen: So, going forward, some of these changes are under the Emergency Use Authorization, but which of these do you think are going to be sticking going forward as a permanent change in 2021 and beyond?

Joen: There are a number of changes I think that are going to stick. There’s going to be a continued emphasis on the importance of diagnostics, certainly to address a pandemic like this, but also in other areas where people are starting to realize the value of having access to fast and accurate diagnostics.

We’ve certainly seen some things at the FDA and other agencies that are approving diagnostics or authorizing diagnostics. And our hope is that the takeaway from this is some new ways to be able to assess diagnostics or evaluate diagnostics, so that they can be authorized much faster than in the past. And maybe there’s some new ways to review these once they’re submitted for authorization.

Stephen: How do you see shifts in product development then going forward? So, the authorization will be faster, but do you see shifts in how products are being developed?

Joen: Yes, absolutely, we’re starting to see a shift. Traditionally with diagnostics, it can be a pretty long process to go through. And very often, it’s one process after the other – very sequential. More people are realizing that things have to be done and run in parallel. More can be developed and assessed in parallel to make the whole process move faster. And that means we should be able to get diagnostics to market faster. And also I think because of the shorter timeframe, you might generate more interest from folks outside of the diagnostic community, who can now see that there’s a way to get diagnostics onto the market sooner, maybe at a lower investment cost than what they had originally thought it would be. I think that is something that is going to stick with us for some time to come.

Are we shifting towards government and private partnerships more permanently?

Stephen: One of the things on the validation side that we’ve seen the government step up on is providing samples and test sites through the CDC. Do you see that happening going forward in key strategic areas, or do you think this is just a one-off due to COVID?

Joen: We’ve seen some partnerships between the government, NIH, CDC, and the like, and also government labs and private labs. I think there are going to be labs that are going to be set up to help validate new tasks. And then depending on the type, maybe some that are more important for national emergencies are going to stick within government labs, but then the private labs are going to have the capacity and the know-how to help validate tests that might not fall under an Emergency Use Authorization. As long as there are new diagnostics coming through, there will be enough studies and opportunities for those laboratories to help validate new tests.

Joen: Once we have the chance to reflect on the pandemic, people will say, okay, what is the long-term strategy around diagnostics? How do we ensure that we keep supporting development of diagnostics? What needs to be invested in, in terms of the government, such as providing laboratory services versus how do we encourage private laboratories or hospital-based laboratories to help the diagnostic industry? So we’ll see what comes out of that in the next year, or the next couple of years.

When is the FDA approval backlog of non-COVID related products likely to start clearing?

Stephen: It’s interesting that how much of government has played a role this year in the COVID pandemic. And some of the non-strategic assays that have been developed are waiting for approval from the FDA. Do you have a sense for when that log jam may break loose?

Joen: I don’t have a good sense for that. We’re seeing some of that with our clients – non-COVID related products that are stuck. And I think there are different parts of the laboratory, and different types of tests that might have an easier time getting through once the FDA has more capacity to review. Our hope is that by the middle of this year, we should start to see that clearing. I think it’s really dependent upon the pandemic, the new administration, and the direction that we see them going.

Are we seeing an inflection point of acceptance for complex POC in the marketplace?

Stephen: You mentioned that there may be a shift in the development of assays and collaborations. How do you see the financial piece of the market changing, especially around Point of Care (POC) instruments? In the past, POC has had a lot of promise, but hasn’t seen a lot of traction. Now with COVID, there’s a lot more POC instruments that have been developed with the POC assay on it and they are now out there in the market. Is this the inflection point of acceptance of complex POC out in the marketplace?

Joen: There’s a recognition – not just within but also outside of the IVD industry – of the value of access to diagnostics in locations that are not traditional locations for testing such as going to the physician’s office and sending it off to a central lab or going to the hospital and it’s run there. But rather other facilities, pharmacies and other types of facilities where testing can be done quickly.

People are really seeing the value and the convenience of that. So I think the demand is going to be there. A key aspect is going to be reimbursement, and can those tests be reimbursed at a high enough rate. That’s the thing that’s going to drive implementation.

I think people are starting to realize the importance of bringing diagnostics and those results much closer to individuals and patients. So I think that’s going to naturally drive more platforms coming out. And then I think the evidence of a buildup, that shows the value of doing that. Then those are going to start to achieve a greater reimbursement. Insurance companies are going to start recognizing the value of that and it’s just going to self-perpetuate that that is going to happen.

I mean, the other thing we’ve seen that’s been very helpful for the diagnostic industry, and specifically for POC, is that there has been a lot of investment from government, private industry as well, in new platforms that are coming out.

And if we sort of look back to an earlier time where there was a moment like this, a national emergency that led to development of a diagnostic, we can sort of look back to the GeneXpert from Cepheid that was developed when there was a scare around anthrax. The government supported investment to get a very easy to use and essentially, a POC platform, developed. And then from there, the company was just able to develop new assays, not necessarily related to a national emergency, but actually it was demonstrated to be very valuable in terms of patient management.

And so now we’ve amplified that in this pandemic. A lot of companies that are still struggling, might not actually get a product to market, but certainly there are a lot more platforms that are coming. So the options are going to be much greater. And I think that people are going to sort of will their way to get these platforms into clinical settings where they’ll actually have a meaningful benefit for patient care.

Stephen: Democratizing diagnostics. Right?

Joen: Very much so. Yes.

Stephen: Well, thank you, Joen. If people want to get in touch with you or learn more about MDC, where can they find you?

Joen: You can visit us at our website:

Stephen: Great. And then finally, for 2021, what one word or phrase would you use to describe your outlook?

Joen: Optimistic, for sure.

Stephen: Excellent. Well, that is the Tea. Joen, thanks so much for joining us today. And it’s been a pleasure speaking with you, and it’s great hearing MDC’s views on this new world.

For more information about MDC Associates, visit or follow MDC Associates on LinkedIn.

Guide: Best Practices for Point of Care Product Development

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