Lasinpuhaltamo Hakola thought it could navigate the MDR regulatory jungle without assistance, but delving into the regulations felt overwhelmingly challenging. In addition to MDR, organizations conducting public procurement have imposed new requirements on companies, particularly regarding social responsibility, for example. In terms of regulations, the requirements are generally the same for small sole proprietors as they are for international health technology giants. Clinipower developed a small business ISO 13485 quality management system and a sustainability plan for Lasinpuhaltamo Hakola.
Text and image: Minna Torppa
The regulation applies to both small and large companies, even small ones can succeed if they want to
The manufacturing of medical devices and their components is a highly competitive industry, but the Oulu based Lasinpuhaltamo Hakola demonstrates that even a small company can succeed. Key factors include finding niche specialized products and utilizing expert assistance to navigate the regulatory jungle.
Glassblower Ilpo Keskitalo blows firmly into a heated glass rod and spreads his hands like a conductor. The glass stretches into a slender thread and bends with small wrist movements. Only a faint clink is heard as Keskitalo places the bent blank on the table. Then, with bare fingers, he grabs a new rod and brings it into the flame of the 1040-degree blowtorch.
A hundred meters from the glass workshop on Kiviniemi’s coastal road, a snowy sea glimmers in the sunlight, and beyond the door opens the garden of an idyllic wooden house, but all this remains hidden behind covered windows and doors, as focus is now the priority! Glassblowing is always precise work, and the manufacturing of regulated products demands even greater accuracy.
“We have registered hospital products that are classified as medical devices. They are distributed to various wellbeing regions across Finland, to companies in the chemical industry, and to the University of Oulu. Quality must be maintained at a high level. If there is even the slightest suspicion of a defect in a product, its place is in the trash,” Ilpo Keskitalo emphasizes.
Skater bends glass
With his loose beanie and tattooed arms, the laid-back and cheerful sole entrepreneur seems to have glided from a skateboard ramp or snowboard to the blowtorch. Those are indeed the places where he spends his free time, but at Hakola, the products are crafted with professionalism. The foundation for Keskitalo’s work is provided by the glassblower artisan training he received at the Ikaalinen Handicraft and Industrial Art Institute.
“I was interested in blowing specialty glass from the very beginning, but since it cannot be studied in Finland, I decided to complete a basic vocational qualification in Ikaalinen. Through glassblower Olli Pohjolainen, I got a connection to Finnish SpecialGlass Oy and, through its CEO Tuomo Latopelto, to Seppo,” Ilpo nods toward Seppo Karjalainen, who is diligently working at another blowtorch.
The man, with the build of a tenacious marathon runner, is one of the few hospital and laboratory glassblowers in Finland. Getting to be his apprentice was a stroke of luck for Ilpo, as Seppo Karjalainen is perhaps the most experienced among hospital and laboratory glassblowers. He began glassblowing at the age of 15 and has continued it for 54 years.
In 1990, Seppo, who bought the glassblowing workshop from his employer, worked for a long time with his cousin and later alone. At times, entrepreneurship was brutally demanding. Seppo recounts an order for 30,000 suction tips, which he manufactured without any assistance. Additionally, he describes months of 12-hour workdays with no days off. “The nights became so short that once I fell asleep at the blowtorch. I badly burned my hand. That put an end to my overtime.”
Suction tips remain the flagship product of Lasinpuhaltamo Hakola. Ilpo starts his workday at eight in the morning with office tasks and aims to extinguish the blowtorch flame by four in the afternoon. However, fulfilling orders sometimes requires extra effort. If he comes to the workshop on weekends, he often blows art glass. Nowadays, Seppo only visits the workplace a few days a month.
Clinipower helped in the regulatory jungle
Clinipower’s message to small entrepreneurs like Ilpo is that even a small, dedicated company can develop its operations to meet updated requirements.
Ilpo Keskitalo began as an apprentice under Seppo Karjalainen in 2021. In November of last year, he became the owner of the glassblowing workshop. He recounts that the first steps as a new entrepreneur were not entirely easy:
“Just when I had bought the company, I learned that the requirements for the medical device system were becoming stricter and that the changes brought by the Medical Device Regulation (MDR) would also affect the glassblowing workshop. That came as a surprise to Seppo too. When I called an official to inquire about the regulations, the clerk encouraged me to consider shutting down such a small business, noting that many had ceased operations even in Central Europe. That wasn’t very encouraging. Even earlier, the teacher-apprentice relationship between Seppo and me had been considered financially risky at Finnvera, the agency granting business financing. Their decision-making process took far too long from my perspective. So, I ended up buying the company from Seppo.”
Seppo explains that initially, he and Ilpo thought they could navigate the MDR regulatory jungle on their own. Seppo’s daughter has a commercial education, and his spouse is a doctor, but even for them, delving into the regulations felt overwhelmingly difficult. Consequently, Ilpo sought help elsewhere. He says that the very first contact with Clinipower and the conversation with Maija Laukkanen brought a sense of security. “It felt like that woman knows what she’s talking about.”
Maija Laukkanen’s message to small entrepreneurs like Ilpo is that even a small company dedicated to its business can develop its operations to meet the updated requirements. In addition to MDR, organizations conducting public procurements have imposed new requirements on companies regarding, for example, social responsibility. Regarding regulations, the requirements are generally the same for small sole proprietors as for international health technology giants. Lasinpuhaltamo Hakola is Clinipower’s smallest customer. Clinipower developed for Lasinpuhaltamo Hakola a small business ISO 13485 quality management system and a sustainability plan.
