Why a Product-centric Approach to Quality Matters

Full transcript below:

Inga Hansen

Hello everyone and welcome. My name is Inga Hanson, I’m the Managing Editor of MedTech Intelligence and I will be your host for today’s webinar, Why a Product-centric Approach to Quality Matters.

We’d like to thank Arena, a PTC Business, for sponsoring today’s webinar so we can bring it to you at no cost. We’ve a couple housekeeping items before we begin. You are listening in using GoTo’s web-based broadcast system.

This uses your computer speaker system by default, and there is no call-in number. If you’re having problems with the audio, please increase your computer’s volume or you can log out and log back in.

If you continue to have audio issues, please contact Veronica Allen via the chat box on the right-hand side of your screen to let her know that you’re having sound issues. Today’s event will consist of a 45-minute panel discussion followed by a live Q&A.

If you have questions, you can submit them into the question box in the control panel on the right-hand side of your screen and we will answer those at the end of the presentation. If there are any questions we’re not able to get to due to time, we will follow up with you and get you an answer.

Now I would like to introduce our speakers. First off is Catie Jelinski. She is the Life Sciences Marketing Senior Manager at Arena, a PTC Business.

Catie has over 25 years of experience in quality and document control at various global medical device companies. She’s been involved in configuration management and PLM for more than 10 years as a business owner and administrator.

Corrective and preventative action cap is her favorite element of the QMS system. Our second panelist is Michael Keer. He is the Founder and CEO of Product Realization Group.

Michael has over 30 years of experience bringing medical devices, clean technology, consumer electronics, and industrial products to market. As the founder of the Product Realization Group, Michael helps guide the world’s most innovative companies to accelerate delivery of their products from concept to full market scale.

Mike shares his expertise through mentoring and lectures at universities as well as industry events. Our final panelist is Angenette Nordqvist. She is the Director of Quality Assurance at SomaLogic.

Angenette has more than 24 years of experience in quality assurance, quality control, Lean Six Sigma, and supply chain. She spent most of those years in the healthcare industry and recently spent time in the automotive industry.

Angenette was a captain in the U.S. Army Reserves and served as a lieutenant and learned as a lieutenant the power of well-defined processes, roles, and responsibilities. She earned a Master’s in Business Administration from the Leeds School of Business at the University of Colorado Boulder, and is certified by the American Society of Quality as Manager of Quality and Organizational Excellence, and also is a certified medical device auditor.

She is a certified Master Black Belt from General Electric. Angenette is currently the Quality Director at SomaLogic, an organization that empowers transformative research in healthcare with the power of proteomics.

Thank you all for being here with us.

Catie Jelinski

Thank you, Inga, and welcome everyone. I think we’re just going to jump right in. So, as we all know, internal teams and their supply chains are more dispersed than ever.

And coordinating the efforts of multiple teams, which they are often spread across the globe, can be a daunting task. Add to that, today’s environment to more remote workers, supply chain disruptions, changing regulations, and rising customer demands.

It’s critical for companies to evaluate their systems and processes to ensure collaboration across teams and supply chain partners. Michael and Angenette, you both have in-depth experience bringing products to market and know what is needed to ensure successful and efficient product development processes despite some of these obstacles.

I’m excited to kick off this discussion so you can share your knowledge with our audience. So, the first question I want to ask is, what is the biggest challenge you face bringing medical device products to market?

Michael, let’s start with you.

Michael Keer

Thank you, Catie. Great lead-in. I’m going to bring up a few different areas. I’ll start with resources. Resources have been a challenge for a while and I think COVID just made getting good resources, qualified resources, even more challenging.

And I don’t see that really easing or going away anytime soon there. With economy going down a bit, there might be easier to get some resources, but I think when you’re talking about expert resources for medical device companies, that’s going to continue to be a challenge.

So that’d be one area. The other I would talk about is component shortages. This has been an off-and-on challenge in medical device, and I think COVID, again, has made it substantially worse the last few years.

I recently talked with one medical device company that I’ve been working with, supposed to start shipping February of this year, will not actually be able to start shipping until November of this year because of component shortages.

So, especially when you’re talking about earlier stage medical device companies, these component shortages can really have a huge impact on the success of the business. And then the final thing I’ll talk about is remote management of global supply chains.

This would include effective management and communication of product data. So, this continues to be a challenge. And since COVID, I would say getting in and out of countries like China is an ever-increasing issue that I don’t see going away anytime soon with the current policies that they have.

And in addition, there continues to be challenges with ocean. How do you ship material, get it across, and then once you’re in the U.S., getting parts actually transported from the ports into the factory.

So those are some of the major issues and I’d love to pass that on to Angenette and get her thoughts. Yeah.

Angenette Nordqvist

Yeah, sure. Great points. So, I reflect on the fact that organizations that aren’t prepared, that don’t have a resilient supply chain, they are in trouble right now and they need to get some business continuity in place.

And what that often means is finding a second source, finding other options, another alternative. This is where good specifications, good records, good documentations, manufacturable designs, all are needed and come into place.

I worked in organizations where there has been a supply chain hiccup and immediate transfer to another supplier is needed.

But the reliance on that supplier’s documentation has been too great. The house was not in order. And so it becomes a very expensive endeavor.

And so, as you were talking about, when these supply chains are impacted, effort needs to then immediately go into dusting off the device master record, the design specifications, the explanation of what the output needs to be, what needs to be manufactured.

And from a risk perspective. And you gave that example, Michael, of a medical device company unable to deliver because of a component shortage.

You can follow that risk to patients perhaps waiting for an appointment for that medical procedure or scan and are delayed because that equipment or spare part or whatever it is, isn’t available due to these supply chain challenges.

Or maybe they’re waiting for a therapy, which at the end of the day will possibly affect their health outcomes.

It’s called a delay-of-care risk. It takes time. And so, it’s better to manage and prepare for and build a resilient supply chain as part of the design procedure and something that should be built into design and development practices, I think from the beginning.

Yeah, I guess those are my reflections.

Catie Jelinski

Well, and I think it’s fair to say that even with all the great planning, companies may have to stop and go back to the beginning because of the supply chain issues. And if they have the planning using the right tools, it makes it so much faster and efficient, and simplification and going back to basics goes a long way.

I think that we need to keep that in mind. That being said, with all of the challenges you’ve just mentioned, how can medical devices and other product companies deal with today’s environment and ensure they’re delivering high-quality and compliant products to market on time?

Michael, do you want to go first again?

Michael Keer

Sure, Catie. Yeah, thanks for that. Yeah, so I would recommend in order to overcome the current challenges and some of these I would concern to be also just good practices, whether it’s medical device or non-medical device for companies developing hardware products.

But the first advice I would give is understand and incorporate a modular design approach for the hardware aspects of your product. So, there’s generally hardware, software.

Software is a lot easier to change than hardware, so I always recommend companies to understand what are the core building blocks of the hardware pieces of the product.

Design those well, make sure parts are available and then you can more easily scale and have less risk of part shortages as you go down the road. So, the idea of concept of modular design approach.

The other would be understand and pick the right development model. There’s a lot of different development models out there. There’s design and build in-house, there’s called original design and manufacturer where you contract somebody else to design and build.

There’s joint development in manufacturing where there’s some combination of both. So, I’m not going to say one is better than the other. I would say depending on your product, depending on your particular situation, understanding the model that’s best for your business, understanding the model that is best for your product, I believe is critical for a successful scaling of the business.

I’d say that that would be another recommendation. The other would be understanding resource. So, you’ve got manufacturing resources, development resources, and then I would call it leveraging outside expertise.

So, it could be regulatory, it could be reliability, it could be design. So, depending on what your core business is, you should be hiring and staffing to manage the core business of your business as opposed to hiring everybody under the sun to do everything.

So, there are very good experts that can do a lot of things. A lot of startup companies that I’ve seen don’t necessarily need full-time resources to do things. So, the idea is if you can leverage an expert outside resource that you don’t need full time, absolutely recommend do it.

If you have something that is critical to your core business, absolutely hire that and make sure that you’re building a strong internal team. And then the other would be check component availability.

We talked about it earlier, I don’t see component shortages, especially medical device, going away anytime soon. So, the more you can incorporate good design practices, understanding parts availability, avoiding single sole-source components as you design, getting manufacturers’ input when you’re in the design process, will make it a lot easier and de-risk, say, the scalability of the product.

And then the final tip I would say is right-size your manufacturing partner. I’ve seen a lot of large companies try and shoehorn into small manufacturers with little effect. Small manufacturers generally get overwhelmed.

I’ve also seen small companies that get excited about working with a JBO or a Foxconn or one of the big tier one companies and they end up being a blip on the back and they never get service and they really aren’t effective.

So again, I’m not going to say there’s one size fits all, but it’s understanding what is the right fit for your business and making sure your business is properly aligned with the manufacturer that you’re selecting.

And with that, I’ll turn it over to Angenette.

Angenette Nordqvist

Yeah, and to just build on that a little bit more, finding those key suppliers, those key partners, and even for smaller companies, some contract manufacturers, it is a way to sort of split up the risk a little bit and to build some supply chain resilience.

These partners that are identified should be a part of the development process where possible to get that input on manufacturing capability and design for manufacturing ability.

But I go back, Catie, to your first question. A responsible medical device manufacturer must build a system that can respond to these supply chain challenges that are inevitable, be it global unrest or natural disaster.

And there’s been a case study done and a real-world example, the earthquake and tsunami in Japan in 2011. It brought serious risk from many perspectives, but for this discussion it had an effect on a critical supply chain within the biopharmaceutical industry.

GE Healthcare has published and has been studied for its response. They were impacted by one of their sole source suppliers for a critical raw material for their widely used chromatography media called Sephacryl.

And the immediate business impact was availability of that raw material into their manufacturing. And this product, this Sephacryl, is a part of, I mean many, many, many very commonly used biopharmaceuticals therapies.

So, we’re talking global impact potentially to patient health. Despite this being sole sourced, they needed to identify a biologically equivalent raw material and they needed to do it quickly.

And of course it can’t happen quickly. And so GE Healthcare, they were very responsible. They did well. Their immediate supply chain needs were met.

They managed their distribution very effectively while they were bringing their supplier back up and requalifying that supplier after the natural urgent issue with the tsunami and that earthquake.

And so, no customer ended up being hindered from their own production. However, it is a lesson to be learned. It is important to take a risk-based approach when you look at your whole supply chain.

And if you don’t have the luxury, Sephacryl I know was designed some 50 years ago, so perhaps these topics weren’t as well formed 50 years ago.

But if you can bring in these concepts as part of design, then that’s what should be done. And boy, it’s powerful if you can identify those critical components or materials early in the design process and identify multiple sources that then get qualified through the manufacturing and through to the customer and the end customer that they qualify multiple suppliers that you’ve used in your supply chain in their final product as well.

We talk about global unrest and the response may be multiple. We might need to find multiple sources for these high-risk components.

Great to have great design activities and collaboration with strong partners and bringing them in early. Very difficult to succeed without strong systems.

That’s where the tools come in. Having a strong eQMS and product lifecycle management system that can easily connect to some enterprise resource planning, boy that’s nice.

And boy, it enables a more comprehensive view and controls in the systems. The systems can’t stand alone. Obviously the content has to be there, but we can have some great content that’s difficult to access and difficult to connect within and make it the very challenging task that we have at hand, make it even harder.

So great partners, contract manufacturers, suppliers, and then getting those right tools in place I think are important.

Catie Jelinski

I can’t even imagine trying to do some of this stuff from a paper-based system, especially when you have a team in Malaysia and a team in Mexico and a team in the United States.

If you’re not connected with the right tools, you’re not going to be able to respond quickly. And the right tools and programs also help for managing the entire product lifecycle across all the departments, design, quality, supply chain, and manufacturing.

And I believe that this approach to managing quality is necessary for today’s medical device companies. It is a necessity. Angenette, how can you help explain how a product-centric approach to quality is different and why it matters so much?

Angenette Nordqvist

Yeah, so I mean for me you have to have a solid QMS, and today’s ISO standards more and more they’re asking for that process focus, that risk- based approach.

It’s a must for medical device companies. The ISO standards now show this plan, do, check, act, continuous improvement. They even have … ISO 9001 has SIPOC as a model for defining a process, which I really dug.

So they got to kudos from me on that addition. And so, building a good quality management system with total quality management, building that continuous improvement cycle into processes, I think is key.

That framework. And then making sure that the new product introduction, design controls processes, transfer into manufacturing goods process and production controls, management of nonconformances and being able to connect those nonconformances, collect them and connect them to a CAPA or to a material BOM that then would translate to a SCAR, a supplier corrective action.

Being able to connect all those dots and having the structure in the QMS there I think is key. The product quality approach to me is also important and is a requirement in order to enable a product-centric approach.

And this means that you have that clear walk from the design essentials, what’s critical to the performance, the functionality, and the safety in device world, what’s critical to that design.

And translating that to design requirements, design outputs to critical quality attributes that need to be measured at incoming inspection, to understanding what in the manufacturing process can impact these critical quality attributes and getting controls around them.

So having that framework in place, I think with that product quality view is very important. And with both of those pieces we get to that product-centric approach.

And what this means is that we can do the walk on a product, on a finished part number, product number, and check that quality back.

Customers are wanting more and more to see their product and their product walk and take that lot number or take that serial number and work with their suppliers to show evidence that this was manufactured, going back from the finished product that they received through distribution.

But then backwards, through the final inspection, the manufacturing, the controls in manufacturing, the material BOM, the performance, the NCRs, the improvements that were made, and changes in a controlled manner to those particular components in the bill of materials, back to the supplier controls and supplier selection as well.

And certainly device manufacturers that are submitting product to the FDA should be expected to be able to demonstrate that walk, that they can show those design essentials that we talked about with a product quality sort of focus, but in that specific part number or equipment number or whatever you product number to show that traceability and then objective evidence that those critical quality attributes have been effectively controlled.

And again, hard to do if you don’t have a good system in place to help you, but it is a must. I would say in automotive, certainly medical device, a product-centric approach is required today.

Catie Jelinski

Right, and I think having access to those records is really important, so I couldn’t agree with you more. Any organization wanting to play in any of these fields, you have to respect the requirements and build the system and the structure and the products to enable those controls for safe and effective medical devices.

And we have to talk about patient safety, right? Compliance is necessary, but patient safety must be the goal. Everyone checks off that box, that compliance mark, but really, patient safety must be our goal, at least I think so.

And taking a proactive quality approach, which is product-centric to me, I think is very imperative.

So with that in mind, do you have any tips for improving supply chain collaboration and compliance throughout the new product development process, especially in an FDA-regulated environment?

Angenette, we’ll start with you.

Angenette Nordqvist

Yeah, so I think it’s important again to identify, to build a strong supplier base and identify those strong partners, that if you’re using a contract manufacturer, strong partners are enablers to having a successful and consistent manufacturing of safe and effective devices.

And that relationship should last a while and that confidence and trust should build so that when your supplier is making a change, they’re notifying you in time, they’re taking the proper steps and you have that sort of accountability and that open and transparent dialogue.

And then it’s important that manufacturers, again, if you’re the final finished device manufacturer, you’re contributing a component or a material, that the records are in place, that the design history file is there.

The design essentials have been identified in the design history file, and these have been translated into component critical to quality or critical quality attributes that are monitored and measured so that we hit those key functional specifications and functions, I guess is another way to say it.

So that we hit that through the design and we can show that path of control from the design into our partners, our supplier base back into our manufacturing, and then into those final records.

And again, product lifecycle management comes into play. Those tools we want to hear from the field, when we hear from the field, we must act on what we learn and we must do those controlled changes at the component level, qualify them up through the subsystem, through the system level, and then also obviously work with suppliers as they are impacted and contributing.

And so, gosh, I guess some closing thoughts for me. I mean we want the world, don’t we? And in fact, in the device environment, we require extreme control.

It is a must. We need a good system, good records, we need strong partners, tight connections throughout the product lifecycle, through the documents, through continuous improvement, objective evidence everywhere.

Easy, right? Michael, what do you think?

Michael Keer

That was a lot of great information, Angenette, so thank you for that. I’m going to broaden it out a little bit. So great, I would say core data management, product centric, how do you deal with that?

Over the last 30 years in Product Realization Group, I’ve developed what I call the eight best practices of product realization. I’m going to kind of walk through at a very high level each one of these.

Can go into a lot more detail, but at a high level I would say if you follow these practices, it can go a long way to improving your overall product development processes and reduce the risk of commercializing products.

So, the first would be around the team. So, create a strong new product introduction team, understand and create clear requirements. This would be things like marketing requirements, product requirements, design requirements, as well as a detailed schedule that is realistic.

I’ve worked with many, many companies that think a schedule is half what it really is or think it’s going to cost half what it really is. So really getting into the weeds of what does it take to develop a product and then having that detailed with the right set of team, getting the right inputs early can make a huge difference in terms of the success of a project.

The other would be, as I talked about earlier, there’s the model. Are you going to design and build in-house? Are you going to find an ODM, a contract manufacturer JDM? So, understanding strategically what is the right model, selecting the right model before you really go into a full scale development in manufacturing, again, it’s critical.

I’ve seen companies start one way and then go the other and that can … again, it’s about delay, that can delay the schedule by several months. So companies that understand and have the right models, I would say can accelerate and get products to market faster.

The other would be the concept of agile hardware development. So historically when I started in the hardware space, it was very waterfall, companies doing one thing, then another.

And I’m not saying that you can do agile hardware the same you can for software, you’re not going to do two-week sprints and you’re not going to be throwing out changes every day.

But the idea of cycles of innovation, I’ve seen hardware companies use that actually very effectively. And then driving to what I call minimum viable products.

So, as you go through these cycles of innovation, you’re constraining your design space, you’re understanding better functionality and then leading to an MVP.

Again, companies that try and over-engineer put too much into a product I’ve seen have a lot of challenges. So, what is the minimum required functionality and then how do you drive to that functionality, leveraging this agile hardware methodology?

So that would be the next. And then risk, there’s a whole bunch of risk out there. I’ve seen most of it, whether it be regulatory, market, supply chain, you name it.

I would say it’s a lot of technology-driven companies, whether it be medical device or not, often focus on what I call technology risk. Does the product work, does it not work? Does it meet the features?

And that is very important. But the biggest risk I’ve seen companies fail is market. Whether that product works or not, if there’s no demand or if you can’t sell a product at a profit, it doesn’t matter how well the technology works.

So, it’s not going to sell itself even though a lot of technologists think it will. And then regulatory, I’ve seen a lot of companies … think companies like Theranos who kind of poo-pooed the FDA and where’d that get them, right?

Again, none of these to me are rocket science, but understanding what they are mitigating early is really quite important. Yeah. And then understanding design for excellence, design for manufacturing, design for tests.

So, all these things would happen in what I would call the engineering verification part of the development process. And a lot of companies that rush products to market and they really don’t do a full comprehensive review of the product often run into trouble.

Maybe they have parts that you can’t buy or the product is failing in the field or it’s not meeting all the requirements because they really haven’t done an effective job of design for excellence. So before really, really ramping into scale, you should be validating the cost, you should be validating the design, you should be making sure that the MVP is working the way that it should be before you start really scaling into volume.

And then next one I’ll go over very quickly because Angenette I think covered it very well, which is a regulatory, understand regulations. I would add beyond FDA, there is also a lot of other regulatory bodies that need to be addressed.

UL, FCC, if it’s defense, you’ve got defense requirements. These days, environmental, RoHS. So, there’s a whole bunch of requirements.

Again, the companies that I’ve seen most successfully develop products are the ones that understand and have a clear plan for how they’re going to meet the requirements. One company a few years back that tried to skirt around FCC requirements ended up failing three times and burned about nine months of a development schedule just because they were trying to shoehorn their way in around the regulations.

So regulatory bodies don’t have a sense of humor, you got to do it right when you’re designing these things. And the other, I’ll talk about just a broadening the idea of PLM, eQMS.

I would also add there are other systems, there’s development tools, there’s customer relationship management tools, there’s ERP systems and companies that I’ve seen be most successful understand how all these systems play together.

They put a master record in one and then they deploy it into the other systems. Companies that I’ve seen less effective tend to have what I call silos of data where they have data in engineering and then they have data in the PLM and then they have data in manufacturing.

Over time this  data tends to be out of sync and then you get errors and then you get problems with actually scaling the business. So, understanding what are all the systems that you need and then how does that data integrate among systems early on I think can go a long way for, again, de-risking how you scale the business and the product.

And then the final, we talked a lot about supply chain, so it’s really kind of reinforcing what we’ve already said. If you are going to use remote manufacturing or not remote, make sure that you have clear understanding of what the need is and then you have clear resources that are there to support.

So, if it’s a U.S. factory, make sure you can get on site and see what’s going on and manage what’s going on. I always say managing a CM is a marriage.

I mean, it’s not a throw it over the wall kind of thing and assume that everything’s going to be fixed by the manufacturer. I spent eight years in manufacturing, and the companies that I work with that we had the best relationships were not the ones necessarily that had the biggest budgets, weren’t the ones that had the highest volume, they were the ones that paid the most attention and really understood what they needed and they invested the time and energy to build a good relationship.

So, especially with supply chain problems, I think spending and investing time in the relationship, building personal relationship. If you want to be top in the queue, make sure you have a good relationship with the parts supplier or the manufacturer.

So, I’ll end it with that. There’s a lot there. I do have these eight best practices available, either email, websites, so if anybody is interested, happy to share that.

With that I’ll turn it back to Catie.

Catie Jelinski

What I think is really interesting is what you just mentioned about the vendors, and you need to have a partnership and it’s not just with the vendors, but it’s also with your teams.

So having that cross-functional team in place, but actually collaborating with them, people don’t do that well, but the ones that do it well are the successful ones.

And mitigating the risk ahead of time, thinking about it, you have to do that because of the supply chain issues. They’re not going to go away.

And records, if it’s not documented, it didn’t happen. But if you can’t find those records, it still didn’t happen. So having a validated eQMS system that’s integrated with all the other systems, that’s where you’re going to find the success.

And so, thank you guys very much for the discussion today. I think this was fun. I wish this could actually last a little bit longer, but we are at the end of the discussion and so we’re going to open the floor for questions.

So, to those of you on the line, we’re going to encourage you to stay for this dialogue and if you have questions, please, Inga will tell you how to do that.

Inga Hansen

Yes, we do have some questions coming in and you can type your questions into the box; it’s the question box on the right-hand side of your screen, so please feel free to enter those.

And I want to start actually with Michael, this is on the tail end of the best practices. There was a question of were those in order of priority or are there areas that companies need to focus their energy first?

Michael Keer

Oh, that’s a great question. Yeah, no, I structured those. I would say relative to the product development flow, so starting with creating requirements, ending with manufacturing.

So they’re all important. I would say I’ve seen companies fail in any one of those categories, but just the logical flow of how a product gets developed. I start at the beginning, create requirements, create a team, and then ending with managing the supply chain.

Inga Hansen

And follow-up question, in terms of that product introduction team, who should be involved from the outset?

Michael Keer

Yeah, that’s a great question too. So again, the most successful companies I’ve seen have the key elements around the product as part of that NPI team.

That’s generally going to involve engineering, quality, marketing, field service, manufacturing, I think maybe others, but at a high level those are, I would say, some of the key elements.

So, the idea is that you want to have a broad enough team, any area that could impact you, let’s say regulatory or supply chain, you have those inputs early, you can mitigate the risks on those areas early and you’re not essentially design centric and then throwing things over the wall and then seeing what problems come out.

Angenette Nordqvist

And I would just add to that the design and development plan, the planning phase of design is where all of those roles are outlined, Michael, that you mentioned, and what their role is in the project so that everything is clear from the start, what the scope is, the marketing plan, the regulatory plan, the supply chain manufacturing plan, all at the onset.

Good planning is I think important there too.

Michael Keer

Yeah, no, I’ll just give a simple example that I actually experienced with a medical device company that had a anti-gravity treadmill, very, very cool product and they didn’t involve field service when they were designing the product.

So, the width of the product was about half an inch wider than the door that was needed to get it into the customer. So once it was designed …

Angenette Nordqvist


Michael Keer

An inch isn’t very much, but they could have easily … if they had had that field service impact to say, “Hey, we need to fit it through a doorway,” they could have done it, but they didn’t have the right team.

Because they didn’t have the right team forever, now they have to disassemble, reassemble, knock walls out, et cetera. Quite a challenge. So these things really do make a difference, yeah.

Catie Jelinski

And I was going to say, you need to have requirements that are clear, concise, and validated and approved and documented. Because if they would’ve had that requirement about the doorframe, they wouldn’t have had that issue.

So, it’s a big deal.

Inga Hansen

And we had a question asking if you could comment further on implementing the supplier into the development and design process.

Angenette Nordqvist

Sure. So it’s a matter of trust and building confidence, certainly legal and putting the right contracts in place, that really helps.

But we want to hear from the suppliers on what they recommend, much like a field service engineer, but what do they recommend to design the product in a way that it is manufacturable, that the supplier can actually produce the parts that the specs, the tolerances aren’t competing with each other, but they may come with recommendations, too, from a cost perspective that maybe material X that might be a little bit more cost efficient, actually meets the specifications and needs because they come with their core competencies and expertise.

So, I think how do you involve them at design planning stage as part of that supply chain strategy and manufacturing planning activity and then begin inviting them in as the design inputs have been sort of generated, now we need to do that development work and make them a part of it, a part of the team.

Michael Keer

Yeah, I would just add that I see it a little bit as a two-layered process where early on you may not have enough information to even engage a contract manufacturer. So the importance of a qualified team and a team that has enough knowledge and expertise to really understand what is going to be needed.

And then once you get to that engineering verification, DFM, DFX, that to me is really where you engage the supply chain. You’ve got enough product design done where you can start now sending out specifications, requirements to your manufacturing partners, and then involving them to make sure that let’s say the initial scoping that’s been done by the internal team is validated, if there’s any other additional inputs, those get incorporated before the design is finalized.

Inga Hansen

And this is a little bit in a similar vein of when you are investigating contract manufacturers, are there any sort of questions or strategies to make sure you’re finding someone that’s going to be a good fit for that long-term partnership?

Michael Keer

Yeah, absolutely. So, I’ve got about a 15-question matrix and that’s going to be anything from what is their technical expertise to what is their cost to what is their delivery, what is their quality, et cetera.

So all these things are important, but I think they’re going to, again, vary in importance depending on the company and depending on the priorities of the company. How complex is the product? If it’s, let’s say a very simple recording device and your value’s in the software, you might just go with an ODM model and easy.

Or if you have a very complicated product and your level of technical support you’re going to need from your product manufacturer’s going to be quite a bit higher. It’s understanding what are the elements and then what are the weightings of those elements as you go into the selection process.

And again, my recommendation would be at least kind of minimum two, generally three, maybe even four when you’re going through this process. And then there’s a lot more than just technical capabilities.

There’s management fit, how does your culture work with their culture? Are they able to scale with your business? Those kind of things. But high level, understand what your selection criteria is, don’t just go with one, go with more than one.

And then I think based on that process, and it can take a while, maybe three to four months to make a good selection, but based on doing your homework and doing a good job, you can select a good vendor. Yeah.

Inga Hansen

Okay. And there’s a question, can you speak to agile hardware development and when to start design controls?

Michael Keer

Yeah, I’m not probably as versed as Angenette in design control, so I may turn that one over to you. But in terms start at the beginning, the idea… and it’s a little bit of a concept, it’s the idea of going through cycles of innovation versus a waterfall.

So the first cycle would be concept, feasibility, going through that loop, testing, verifying, and then once you go through that prototyping, and then once you go through that pre-production and then on into production.

So that’s again the concept of agile hardware. And then in terms of the other question, Angenette, you probably.

Angenette Nordqvist

Yeah, I mean, so design controls, we need to have the concept in place and have some feasibility studies having been performed. And then once the holders of the budget say we are a go, design controls begin.

And that begins with the design planning that we talked about. Once we have the design outputs, once the trace matrix, which another concept, won’t go into too much detail, but once that trace matrix has been reviewed and approved, we’re in a design freeze.

At that point, change control comes into play. But yeah, that I would say after feasibility studies and that business case, marketing has done a great job with their business case, the project committee or the approval committee, whoever has the purse strings, once they give the go, then design controls is on.

Inga Hansen

And you guys spoke quite a bit about the need for resilient supply chain redundancy. I had a question. How do you maintain relationships when you are building in redundancy to have potentially multiple suppliers?

Angenette Nordqvist

I would say our suppliers should also have redundancies and they should respect the fact that we are building a very secure and competent supply chain because that will build some more security that we have a solid business plan and operation and that will continue to provide them business in the future.

So I would be concerned about a supplier that would be sensitive to being a single source. Michael, what do you say?

Michael Keer

Yeah, no, 100%. Yeah, I mean the other concept I would say is I think there’s two types of parts that I’ve seen in my experience. One is standard off the shelf.

Standard parts, easy to buy, you get duplicate. The more of those you can design in, the better. Problem is, many companies have specific technology and they have to go with sole source or single source.

Earlier in my career I worked with a very specialty laser company doing optical telecom and they had one laser that one manufacturer bought and that was it. I mean, if they wanted that technology to work, they had to use that vendor.

So on the standard off-the-shelf parts, I would say look for parts easily cross referenceable, easily available, easy to buy, not too difficult. The other element would be how do you mitigate risk?

When you have a part that is difficult to buy, sole source, single source, how do you understand and manage the risk around that? There’s a lot of different strategies. One is good vendor relations, we talked about that before.

The other is risk buys and I’ve done that before as well, where you take some amount of money to de-risk and you say, “Hey, I’m going to commit X amount of money to buy X number of parts,” and have what’s called buffer stock in order to mitigate that risk.

It costs money, but it’s a way to relieve some of the risk. So, like that company I talked about earlier that had a nine-month delay, well if they had pre-purchased some of those parts and had them in inventory, they would’ve been able to ship in February.

So, you’re always going to have risk. It’s how you manage the risk, I think, is how companies succeed or fail.

Inga Hansen

We have time for one more question, and this one had to do with supplier documentation. How do you reduce your reliance on the supplier documentation?

You had mentioned that being a concern.

Angenette Nordqvist

Yeah, what I’ve seen, and especially with smaller organizations, they look for those great partners and then they build confidence in, while we’re buying their development, it’s our design.

They are performing the development, they are doing the design controls. And I would say bring them in-house, because at the end of the day, this is your IP.

I mean, it’s your content. That record that they’ve developed, you have paid for. And it could be as easy as just doing a regular transfer and then working with them on their change control to make sure that they’re updating their records.

But then again, bringing it in-house. So have, physically having it in your eQMS, in your design history file, I think is key. And then again, holding them accountable to that change control.

Inga Hansen

Great. And we actually have one last question that came in. So we will hop on that. And the question is, what criteria should we consider for outsourcing the design?

Angenette Nordqvist

I think Michael said it earlier. If it’s a critical sort of item, it’s your core competency. Right, Michael, you hold it.

I’ll let you, yeah, take it on.

Michael Keer

Yeah. But yeah, no, just following, I mean it’s really about what is critical to your business and then how do you right-size or how do you define the model that’s going to best support the product?

It’s really a product centric. Again, we’re talking about product centric. So for example, if you have a very simple product, easy to manufacture, scalable, the core competency of your business may be around software, IOT, collecting software data.

I’ve seen a lot of that. Then do you really even need to design that product? Could you just buy off-the-shelf kind of data collection package? And that’s where your ODM model will come into play.

If you’re talking about, let’s say intuitive surgical where you’ve got a very complex robotic system, you’re likely going to outsource subassemblies to manufacturers because strategically that makes sense.

Maybe printed circuit boards and other things. But I believe intuitive and other very complicated parts, they actually do final assembly in-house because they need to. It’s too complicated and too risky to trust to outside partners.

So, there’s a very big range and it’s really up to what is the business strategy, what is the product strategy, and then how do you leverage elements of supply chain that are going to best support where you want to go as a business?

Inga Hansen

Great. Well, Catie, Michael and Angenette, thank you so much for being here with us today and for the wonderful discussion.

Catie Jelinski , Angenette Nordqvist

Thank you. Thank you for having us.

Michael Keer

Thank you.

Inga Hansen

And thank you all for attending and we do want to remind you to visit MedTechIntelligence.com to look at some of our upcoming webinars and events, and hope y’all have a wonderful rest of your day.

Catie Jelinski

Thanks so much. Bye.

Michael Keer


Angenette Nordqvist

Thanks, bye-bye.