Unique Challenges for Medical Device Manufacturing

The medical device manufacturing industry, one of the most crucial and life-saving industries in the world will evolve a great deal in the coming years considering increasing health concerns and a rising population. Medical device manufacturers are seeking new technological solutions to take on these new challenges.

Regulatory compliance

One of the most pervasive challenges in medical device manufacturing is navigating the industry’s regulatory environment. Manufacturers often face uneven regulations with inconsistent language and standards. It may not always be clear whether something must meet a given set of standards or not.

The best way to approach this variable is to create consistency internally. Manufacturers are embracing high-quality standards for all devices, regardless of their legal requirements. Industry-recognized standards like ISO 13495, which outlines quality management systems for medical devices, provide a reliable starting point.

When regulatory discrepancies arise, the most successful companies aim for the most stringent so they meet as many standards as possible. Often manufacturers set up a regulatory compliance committee composed of experts who are deeply familiar with relevant regulations. Any decisions pass through them before going into practice.

Product quality

To minimize product recalls and customer dissatisfaction, product quality is paramount. The FDA-regulated medical device manufacturing industry compiles every piece of information to meet the growing government requirements. Using best-in-class software, businesses can track devices by their batch number, lot number, or serial number to systematize every process and minimize product recalls.

High Healthcare Costs

High costs are another one of the most substantial challenges in the healthcare industry. Roughly 46 million U.S. adults can’t afford quality care. While medical devices aren’t the only contributing factor, high device costs exacerbate this issue.

Medical device manufacturers face increasing pressure to lower product costs, but that can be a challenge with high production expenses. One solution is to opt for disposable products over more expensive, longer-lasting ones. While this may seem counterintuitive from a consumer standpoint, sterilization can cost as much as $10 per instrument, so reusable products don’t always save money long-term.

3D printing can also reduce production healthcare expenses. Since this process adds material instead of cutting it away, it reduces waste and saves energy costs. Total production costs decrease as a result.

Slow, Expensive R&D

Medical device manufacturing relies on thorough research and development, even more so than other sectors. Running the necessary clinical trials is often a slow and expensive process, delaying time to market and hindering profitability. One promising solution to this issue is embracing technology like robotic process automation (RPA) and the cloud.

Cloud-based collaboration tools can connect disparate clinical systems, consolidating data from multiple sources to provide more comprehensive results. Some of these systems connect more than 20,000 hospitals, helping manufacturers test products across considerable sample sizes. Using the cloud also allows data from all these sources update in real-time, speeding the R&D process.

RPA can combine with these cloud solutions to further accelerate R&D. RPA automates routine tasks like data entry and organization, providing faster results and letting workers focus on value-adding tasks. Clinical trials will be shorter and more accurate with these technologies, reducing costs and leading to faster ROIs.

Cybersecurity

Cybersecurity is a growing concern in the industry on two fronts. As more manufacturers implement smart factory technologies, they unintentionally provide more access points for hackers, raising the risk of a cyberattack. Medical devices must also feature better cybersecurity features as hacks on healthcare institutions become more common.

Hosting devices on networks that are separate from other data and machinery mitigates their risk. This separation will ensure one breached device won’t grant hackers access to the entire facility. Data encryption, frequent software updates, and basic cybersecurity training for all employees will also help.

As for connected medical devices, manufacturers must ensure they have reliable built-in security features. Encryption and a way to authenticate over-the-air updates are two of the most crucial considerations. Devices should also require passwords by default and require manual input to connect to other systems.

Supply Chain Disruptions

The COVID-19 pandemic uncovered another challenge in medical device manufacturing: fragile supply chains. As different countries enacted varying lockdown restrictions, disruptions rippled throughout supply chains. This resulted in delayed deliveries and rising material prices, creating financial issues and production bottlenecks.

Counterfeits

As medical devices become more in-demand, counterfeits will flood the market to take advantage of the trend. These fake products can divert revenue from legitimate device manufacturers and endanger the patients who use them.

Medical device manufacturers can fight counterfeits by implementing a system to verify their products’ authenticity. Blockchain technology may be the ideal platform. Blockchains provide a transparent, immutable list of records, making it easy to prove a product’s validity.

Manufacturers can assign each product a unique identifier on a blockchain. Shipping partners and recipients can then use it to verify the items when they receive them. If the shipment doesn’t have a blockchain record or doesn’t match what it should, all parties will know it’s a fake.

Business Process Improvement

Managing every product, operation, and resource of a business is difficult. A medical device manufacturing business needs to facilitate cross-functional automation, seamless data sharing, and mobile access to files and documents. Software that breaks down silos and supports operations such as warehouse management, production, procurement, quality control, shipping, and other basic functions will promote better decision-making and time management.

Recruiting, Hiring, and Retention Challenges

At first glance it seems like medical devices, technology hardware, construction equipment, etc. are all under the engineering umbrella and for the most part we make a broad assumption that engineers are interchangeable – if you can be a good high-tech executive, you can be a good pharma executive, for example. According to Jax Willey, Practice Leader – Medical Devices & Medical Device Manufacturers at BrainWorks, that is not true. The medical device manufacturing industry requires a different mindset and a different set of skills.

A great many medical device manufacturers are contract manufacturers. That is, a medical technology or OEM company such as Stryker may design a product and then bid it out, and a contract manufacturer will do the actual build and assembly.

A contract manufacturer may specialize in a number of types of manufacturing. They may use injection molding to make  disposable catheters for medical devices on the one hand, or  manufacture an implant that’s going to stay inside the body (Class III), or an orthopedic tool to assist surgery. They also may do electromechanical assembly, e.g., for a portable device to allow a patient to do dialysis at home.

There are original designers that design and prototype medical devices as well. This comprises mostly manufacturing, but it could also include medical devices in the pharmaceutical or bio pharma area or biotherapeutics. The field of medical devices covers manufacturing, but it’s manufacturing that impacts people’s lives directly, for example in the case of a joint replacement, being on a ventilator, or using a prosthetic limb.

As noted above, the products of medical manufacturing are highly regulated, so people have to be familiar with the FDA and the ISO certifications.

Being so highly regulated, if there is a position open for an operations director in a medical device company, the company is likely to want somebody who’s come from a medical device company than other industries.

For these reasons, medical device manufacturers will look for people from their own industry, who have the medical device and the regulatory licensing experience, who know how to function in that environment. Experience in, say, manufacturing doesn’t necessarily transfer into the medical device industry. Aerospace experience sometimes will, because it will include experience with FAA government regulation, but more because they’re very similar as far as adherence to making sure that in the end  the  safety factor is paramount.

It’s also about quality, because when you’re working in medical devices, those quality managers, quality engineers, technicians, have to perform at a very high standard, because if they miss something, however minor it may seem, if it’s something that’s going to malfunction when someone’s in the middle of a procedure, it could be irreparably damaging or fatal.

Thus, recruiting and hiring in the medical devices industry is notably different from other technical or engineering fields in that it carries a much greater concern for “soft” skills. This is because teams in this field require a higher degree of collaboration and engagement, so hiring managers and companies have less tolerance for people with a “go it alone” mentality. What is being sought is more of a servant leadership model, which is to serve the shop floor. Even when  hiring a general manager, the priority is to be out on the shop floor and to support all of the people there. Equal with this is compassion for the end user of the product they are manufacturing – recognition of the very personal nature of their work, even though they will never meet or know the user.

All of this flies in the face of societal stereotypes of engineers and manufacturers as being concerned only with “hard” issues – data, mechanics, etc. In every phase of the medical device manufacturing process – Research and Development, Quality Assurance, and Manufacturing, what is required here is the human connection and building a strong, creative team where everyone’s contribution is sought, valued, and listened to rather than a conflict of egos over who has the best idea or technical skill. What is needed in medical device manufacturing is engineers who are experts not only with the products but also have the human factor that will bring enormous value over time to a company.

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